Patients with a prior history of squamous cell or basal carcinoma of the skin or in situ cervical cancer must have been curatively treatedXx_NEWLINE_xXPrior malignancy within 2 years before enrollment other than curatively treated cutaneous basal cell or squamous cell carcinoma, carcinoma in situ of the cervix, anal intraepithelial neoplasia, or cutaneous Kaposi’s sarcoma (KS); participants with prior malignancies must have completed all therapy at least 2 years before enrollment with no evidence of disease since therapy completionXx_NEWLINE_xXParticipants with any concomitant or prior invasive malignancies are ineligible with the following exceptions:\r\n* Treated limited-stage basal cell or squamous cell carcinoma of the skin\r\n* Carcinoma in situ of the breast or cervix\r\n* Prior cancer treated with curative intent with no evidence of recurrent disease 3 years following diagnosis and judged by the investigator to be at low risk of recurrenceXx_NEWLINE_xXHistory of other malignancy, unless the patient has been disease free for at least 5 years. Adequately treated basal cell carcinoma or squamous cell skin cancer is acceptable regardless of time, as well as localized prostate carcinoma or cervical carcinoma in situ after curative treatmentXx_NEWLINE_xXHistologically documented urothelial carcinoma (squamous differentiation or mixed cell types allowed).Xx_NEWLINE_xXNo prior malignancy of any type (including ductal breast carcinoma in situ [DCIS]) within the past 5 years except for current diagnosis of breast cancer, and any prior diagnosis of basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix; patients with a prior history of breast cancer greater than 5 years from study screening may participate in this studyXx_NEWLINE_xXHistory of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior to randomizationXx_NEWLINE_xXNo other malignancy within 5 years of registration with the exception of basal cell or squamous cell carcinoma of the skin treated with local resection only or carcinoma in situ of the cervixXx_NEWLINE_xXSTEP I: Patients with a history of prior malignancy are eligible provided they were treated with curative intent and do not require active therapy (currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma “in situ” of the cervix or breast are not excluded)Xx_NEWLINE_xXHistologically confirmed muscle-invasive urothelial carcinoma of the bladder or upper tract; variant histology allowed as long as urothelial carcinoma is predominant (> 50%); pure small-cell carcinoma is excludedXx_NEWLINE_xXPatients must be disease-free of prior invasive malignancies for > 5 years with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix\r\n* NOTE: If there is a history of prior malignancy, patients must not be receiving other specific treatment for that cancerXx_NEWLINE_xXPatients must not have other current malignancies, other than basal cell skin cancer, squamous cell skin cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast; patients with other malignancies are eligible if they have been continuously disease-free for > 3 years prior to the time of registration; patients with history of RAS mutation-positive tumors are not eligible regardless of interval from the current study; Note: prospective RAS testing is not required; however, if the results of previous RAS testing are known, they must be used in assessing eligibilityXx_NEWLINE_xXPatients must not have other current malignancies, other than basal cell skin cancer, squamous cell skin cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breastXx_NEWLINE_xXHistory of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior to randomizationXx_NEWLINE_xXPathologically confirmed non-squamous non-small cell lung carcinoma (NSCLC)Xx_NEWLINE_xXPathologically proven diagnosis of squamous cell carcinoma (including variants such as verrucous carcinoma, spindle cell carcinoma, carcinoma not otherwise specified [NOS]) of the head/neck (oral cavity, oropharynx, hypopharynx or larynx); pathologic stage III or IVA (American Joint Committee on Cancer [AJCC] 8): T3-T4a, N0-3, M0 or T1-T2, N1-3, M0Xx_NEWLINE_xXPatients must not have poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, goblet cell carcinoid and small cell carcinomaXx_NEWLINE_xXPathologically proven primary cervical cancer I-IIA with squamous cell carcinoma, adenosquamous carcinoma or adenocarcinoma initially treated with a standard radical hysterectomy with pelvic lymphadenectomyXx_NEWLINE_xXIf history of prior malignancy, subject should be in complete remission for >= 5 years at the time of registration (with the exception of basal cell or squamous cell carcinoma of the skin treated with local resection)Xx_NEWLINE_xXOther malignancies are excluded unless the patient has completed therapy for the malignancy >= 12 months prior to randomization and is considered disease-free; patients with the following cancers are eligible if diagnosed and treated within the past 12 months: in situ carcinomas or basal cell and squamous cell carcinoma of the skinXx_NEWLINE_xXPathologically proven diagnosis of a malignant major salivary gland tumor or malignant minor salivary gland tumor of the head and neck of the following histologic subtypes: \r\n* Intermediate-grade adenocarcinoma or intermediate-grade mucoepidermoid carcinoma\r\n* High-grade adenocarcinoma or high-grade mucoepidermoid carcinoma or salivary duct carcinoma\r\n* High-grade acinic cell carcinoma or high-grade (> 30% solid component) adenoid cystic carcinoma\r\n* Patients with diagnoses such as \undifferentiated or poorly differentiated carcinoma\, \carcinoma-ex pleomorphic adenoma\, \carcinoma not otherwise specified (NOS)\ and others should be considered for this trialXx_NEWLINE_xXPatients with mixed urothelial carcinoma and a glandular and/or squamous component will be eligible for the trial, but the presence of other histologic variants, pure adenocarcinoma, or pure squamous cell carcinoma, will make a patient ineligibleXx_NEWLINE_xXPatients must have histologically proven Ta, carcinoma in situ (CIS) or T1 stage urothelial cell carcinoma of the bladder within 90 days prior to registrationXx_NEWLINE_xXPatients must not have pure squamous cell carcinoma or adenocarcinomaXx_NEWLINE_xXUpper age limit of =< 18 years of age for medullary thyroid carcinoma (MTC), renal cell carcinoma (RCC) and hepatocellular carcinoma (HCC)Xx_NEWLINE_xXDiagnosis or treatment for a non-breast malignancy within 5 years of study registration, with the following exceptions: complete resection of basal cell carcinoma or squamous cell carcinoma of the skin and any in situ malignancy after curative therapyXx_NEWLINE_xXExcluding the primary tumor leading to enrollment in this study, any other active malignancy (except for definitively treated melanoma in-situ, basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the bladder or cervix) within the past 24 monthsXx_NEWLINE_xXPatients with two or more active malignancies (synchronous multiple cancers, or metachronous multiple cancers with a disease-free period of ? 5 years, with the exception of carcinoma in situ, mucosal carcinoma, or other carcinomas that have been curatively treated with local therapy)Xx_NEWLINE_xXEndometrial carcinoma.Xx_NEWLINE_xXHistory of other malignancy within 5 years with the exception of prior SCCHN, adequately treated basal cell or squamous cell skin cancer, or carcinoma of the cervixXx_NEWLINE_xXPatients with any other diagnosis except for adenocarcinoma (squamous cell carcinoma, small cell carcinoma, mixed adenosquamous, lymphoma, sarcoma, etc.) will be ineligibleXx_NEWLINE_xXPatients with another active malignancy will not be eligible except for:\r\n* Resected basal cell carcinoma and squamous cell carcinoma of the skin, cervical or prostatic intraepithelial neoplasia, and ductal or lobular carcinoma in situ of the breast\r\n* Patients with localized prostate cancer who have received curative intent therapy are also eligible provided:\r\n** Surgically treated patients have an undetectable prostate specific antigen (PSA)\r\n** Patients treated with brachytherapy have a PSA within the institutional normal range\r\n** Patients who have received pelvic external beam radiotherapy are not eligibleXx_NEWLINE_xXHistologically proven diagnosis of squamous cell carcinoma of the head and neck, including variants such as spindle cell carcinoma, verrucous carcinoma, carcinoma not otherwise specified (NOS), etc.Xx_NEWLINE_xXIndividuals with the following non-invasive cancers are eligible: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skinXx_NEWLINE_xXHistologically confirmed diagnosis of a locally advanced (not amenable to curative therapy such as surgical resection) metastatic cancer of the following histologies: melanoma (MEL), Merkel cell carcinoma (MCC), triple-negative breast cancer (TNBC), ovarian carcinoma, renal cell carcinoma (RCC), colorectal cancer, urothelial carcinoma, or sarcoma.Xx_NEWLINE_xXOther malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skinXx_NEWLINE_xXHas any other histologic type of skin cancer other than invasive squamous cell carcinoma as the primary disease under study, eg, basal cell carcinoma that has not been definitively treated with surgery or radiation, Bowen's disease, Merkel cell carcinoma (MCC), melanoma.Xx_NEWLINE_xXHistopathologically confirmed diagnosis of one the following cancer types:\r\n* Squamous cell carcinoma\r\n* Esthesioneuroblastoma\r\n* Adenoid cystic carcinoma\r\n* AdenocarcinomaXx_NEWLINE_xXPrevious malignant disease (other than Merkel cell carcinoma) diagnosed within 3 years from day 1 of study treatment that could interfere with study endpoints or put patient safety at risk\r\n* (NOTE: Exception will be made for adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ [skin, bladder, cervical, colorectal, breast] or low grade prostatic intraepithelial neoplasia or grade 1 prostate cancer; any other neoplasm, which is adjudged by the treating investigator to have a low risk of recurrence during the study, could be enrolled only after written approval from the medical monitor)Xx_NEWLINE_xXPatients must have no concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix, breast, or bladder; patients with prior malignancies must be disease-free for >= five yearsXx_NEWLINE_xXOther malignancy diagnosed or requiring treatment within the past 3 years with the exception of adequately treated basal cell carcinoma, squamous cell skin cancer, carcinoma in-situ of the cervix or breast or very low and low risk prostate cancer in active surveillance.Xx_NEWLINE_xXHave a histologically proven locally advanced or metastatic high grade neuroendocrine carcinoma (NEC)\r\n* Includes small cell and large cell neuroendocrine carcinoma of unknown primary or any extrapulmonary site\r\n* Includes neuroendocrine prostate cancer (de novo or treatment-emergent) of prostate if small cell or large cell histology\r\n* Mixed tumors, e.g. mixed adenoneuroendocrine carcinoma (MANEC) or mixed squamous or acinar cell NEC are allowed if the high grade (small or large cell) NEC component comprises > 50% of the original sample or subsequent biopsyXx_NEWLINE_xXSubjects with a history of a second primary malignancy; exceptions include: subjects with a history of malignancies that were treated curatively and have not recurred within 3 years prior to study entry; resected basal and squamous cell carcinomas of the skin, and completely resected carcinoma in situ of any typeXx_NEWLINE_xXT0-3, N0 to N2c, M0 squamous cell carcinoma of the oropharynxXx_NEWLINE_xXBiopsy proven squamous cell carcinoma that is HPV and/or p16 positiveXx_NEWLINE_xXUrothelial carcinomaXx_NEWLINE_xXSquamous Cell Carcinoma of the Head and neck (SCCHN)Xx_NEWLINE_xXEndometrial carcinomaXx_NEWLINE_xXPatients with a history of curatively treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix are generally eligible. Patients with a malignancy that has been treated, but not with curative intent, will also be excluded, unless the malignancy has been in remission without treatment for at least 2 years prior to enrollment.Xx_NEWLINE_xXOther malignancies unless the patient is considered to be disease-free and has completed therapy for the malignancy greater than or equal to 12 months prior to study entry. Patients with the following cancers are eligible if diagnosed and treated within the past 12 months: carcinoma in situ of the cervix, and basal cell and squamous cell carcinoma of the skin.Xx_NEWLINE_xXActive malignancy (except for HCC or definitively treated melanoma in-situ, basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix) within the past 36 monthsXx_NEWLINE_xXHistory of other prior malignancy, except squamous cell carcinoma of the cervix or anus, superficial basal cell or squamous cell skin cancer, or other malignancy curatively treated more than 5 years ago before enrollmentXx_NEWLINE_xXPatients must have no concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix and breast, adequately treatment stage I or II cancer from which the patient is in complete remission; patients with other malignancies must also be disease free for at least three yearsXx_NEWLINE_xXPatient has a history of new diagnosis or treatment of cancer other than malignant glioma within five years prior to start of the study, except for basal cell carcinoma or squamous cell carcinoma.Xx_NEWLINE_xXMerkel Cell Carcinoma (MCC)Xx_NEWLINE_xXParticipant has a history of malignancy other than the disease under study within 3 years before Screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with or minimal risk of recurrence within a year from screening)Xx_NEWLINE_xXActive secondary malignancy unless the malignancy is not expected to interfere with the evaluation of safety and is approved by the sponsor; examples of the latter include basal or squamous cell carcinoma of the skin, in-situ carcinoma of the cervix, and isolated elevation of prostate-specific antigen; subjects with a completely treated prior malignancy and no evidence of disease for >= 2 years are eligibleXx_NEWLINE_xXHas a known additional malignancy that has progressed or required active treatment within the last 5 years with the exception of curatively treated basal cell and squamous cell carcinoma of the skin and/or curatively resected in-situ cervical and/or breast cancers, and in-situ or intra-mucosal pharyngeal cancerXx_NEWLINE_xXA history of other malignancy ? 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervixXx_NEWLINE_xXOther malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skinXx_NEWLINE_xXSubjects with the following solid tumors are eligible for screening: Non-small cell lung cancer (NSCLC), Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC), melanoma, bladder, Triple-negative breast cancer (TNBC), and Colorectal carcinoma displaying microsatellite instability (MSI CRC).Xx_NEWLINE_xXDiagnosis of any other malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix.Xx_NEWLINE_xXDiagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, low-risk prostate cancer after curative therapy or complete resection of other advanced malignancy with the expectation that the patient has received curative therapyXx_NEWLINE_xXA history of other malignancy =< 2 years previous; exceptions are malignancies with a negligible risk of metastasis or death (e.g., expected 5-year overall survival [OS] > 90%) that were treated with an expected curative outcome, such as squamous cell carcinoma of the skin, in-situ carcinoma of the cervix uteri, non-melanomatous skin cancer, carcinoma in situ of the breast, incidental histological finding of prostate cancer (tumor, node, metastasis [TNM] stage of T1a or T1b) or synchronous head and neck (H&N) primariesXx_NEWLINE_xXPrevious malignancy, except for non-squamous-cell carcinoma of skin or carcinoma in-situ of the uterine cervix, unless the tumor was treated with curative intent more than 2 years prior to study entry.Xx_NEWLINE_xXPatients must be free of any prior malignancies for >= 1 year\r\n* NOTE: the exception to this would be currently treated squamous cell and basal cell carcinoma of the skin, carcinoma in situ of the cervix, breast, or bladder, or surgically removed melanoma in situ of the skin (stage 0) with histologically confirmed free margins of excisionXx_NEWLINE_xXActive malignant disease relapse or other active malignancy with the exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma “in situ” of the cervix or breastXx_NEWLINE_xXPatients must be free of any prior malignancies for >= 1 year; NOTE: the exception to this would be currently treated squamous cell and basal cell carcinoma of the skin, carcinoma in situ of the cervix, breast, or bladder, or surgically removed melanoma in situ of the skin (stage 0) with histologically confirmed free margins of excision; in addition, it is well-recognized that patients at highest risk for EBV-related lymphoma (ie, those with chronic immunosuppression) are also at high risk for various malignancies, both invasive and non-invasive; therefore, exceptions may also be granted on a case-by-case basis, at the discretion of the PI with approval from the Data Monitoring Committee, for those patients with good clinical control of active malignancy, if the EBV-related lymphoma is considered to be a more immediate threat to the subject’s health and/or lifeXx_NEWLINE_xXOther malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skinXx_NEWLINE_xXActive malignancy (excluding localized squamous cell or basal cell carcinoma of the skin)Xx_NEWLINE_xXPatients with recurrent squamous cell carcinoma or a second primary arising in a previously irradiated fieldXx_NEWLINE_xXHepatocellular carcinoma;Xx_NEWLINE_xXUrothelial carcinoma;Xx_NEWLINE_xXSquamous cell carcinoma of the head and neck;Xx_NEWLINE_xXRenal cell carcinoma (clear cell predominant type);Xx_NEWLINE_xXNon-small cell lung carcinoma;Xx_NEWLINE_xXParticipants with a history of a second primary malignancy. Exceptions include: patients with a history of malignancies that were treated curatively and have not recurred within 3 years prior to study entry; resected basal and squamous cell carcinomas of the skin, and completely resected carcinoma in situ of any typeXx_NEWLINE_xXHistory of malignancy (other than MM) unless all treatment of that malignancy was completed at least 2 years before consent and the participant has no evidence of disease further exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or breast, or other non-invasive lesion, that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 yearsXx_NEWLINE_xXDisease-free of active second/secondary or prior malignancies for ?2 years with the exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix or breast.Xx_NEWLINE_xXSubjects diagnosed with another malignancy within 3 years prior to study start with the exception of adequately treated basal cell carcinoma, squamous cell carcinoma, non-melanomatous skin cancer or carcinoma in situ of the uterine cervix.Xx_NEWLINE_xXFor papillary renal cell carcinoma patients, the following are required:Xx_NEWLINE_xXHas a known additional malignancy that is progressing or has required active treatment within the past 3 years with the exception of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or curatively resected in situ cancersXx_NEWLINE_xXParticipants who had curatively treated invasive malignancies for which all treatments ended within 1 year prior to the study (with the exception of basal cell or squamous cell carcinoma of the skin)Xx_NEWLINE_xXA diagnosis of another active malignancy with the following exceptions: basal or squamous cell carcinoma of the skin, in-situ carcinoma of the cervix, isolated elevation of prostate-specific antigen, indolent secondary malignancies not requiring active therapy, or with the approval of the principal investigator; subjects with a completely treated prior malignancy and no evidence of disease for >= 2 years are eligibleXx_NEWLINE_xXHistory of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior to study entry.Xx_NEWLINE_xXPathologically confirmed head and neck squamous cell carcinoma (HNSCC)Xx_NEWLINE_xXBiopsy-proven squamous cell carcinoma of the oral cavity or oropharynx without distant organ metastasesXx_NEWLINE_xXDiagnosed or treated for another malignancy within 2 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapyXx_NEWLINE_xXNot on any active therapy for other malignancies with the exception of topical therapies for basal cell or squamous cell cancers of the skinXx_NEWLINE_xXNot on any active therapy for other malignancies with the exception of topical therapies for basal cell or squamous cell cancers of the skinXx_NEWLINE_xXActive malignancy (except for RCC or definitively treated basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix or bladder) within the past 24 monthsXx_NEWLINE_xXHistory of prior cancer within < 2 years, except for basal cell or squamous cell carcinoma of the skin, cervical cancer in situ or other in situ carcinomas.Xx_NEWLINE_xXMust have histologically confirmed squamous cell carcinoma or adenosquamous cell carcinoma of esophagusXx_NEWLINE_xXA history of other malignancy =< 3 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervix or other solid tumors treated curatively and without evidence of recurrenceXx_NEWLINE_xXParticipants with a history of a second primary malignancy; exceptions include: patients with a history of malignancies that were treated curatively and have not recurred within 3 years prior to study entry; resected basal and squamous cell carcinomas of the skin, and completely resected carcinoma in situ of any typeXx_NEWLINE_xXHistory of prior malignancy that will interfere with the response evaluation (exceptions include in-situ carcinoma of the cervix treated by cone-biopsy/resection, non-metastatic basal and/or squamous cell carcinomas of the skin, any early stage (stage I) malignancy adequately resected for cure greater than 5 years previously).Xx_NEWLINE_xXParticipants with a history of a second primary malignancy; exceptions include: patients with a history of malignancies that were treated curatively and have not recurred within 5 years prior to study entry; resected basal and squamous cell carcinomas of the skin, and completely resected carcinoma in situ of any typeXx_NEWLINE_xXConcurrent other malignancy, unless the patient has been disease-free for at least five years following curative intent therapy, with the following exceptions: (1) adequately treated in-situ carcinoma of cervix; (2) localized basal cell or squamous cell carcinoma of skin; (3) previous malignancy confined and treated locally (surgery or other modality) with curative intent.Xx_NEWLINE_xXAny active malignancy within the past year, except basal cell or squamous cell skin cancer or carcinoma in situ that is unlikely to progress in two yearsXx_NEWLINE_xXBasal cell carcinoma of the skin, medulloblastoma, small-cell lung cancer, or hematologic malignanciesXx_NEWLINE_xXPrior malignancies within the past 3 years (with allowance for adequately treated in situ carcinoma of the cervix uteri, and basal cell or localized squamous cell carcinoma of the skin treated with curative intent)Xx_NEWLINE_xXPatients with mucinous carcinoma, low grade endometrioid carcinoma, low grade serous carcinoma or carcinosarcomaXx_NEWLINE_xXAnal Squamous Cell CarcinomaXx_NEWLINE_xXCervical Squamous Cell CarcinomaXx_NEWLINE_xXVulvar Squamous Cell CarcinomaXx_NEWLINE_xXSmall Cell Lung CarcinomaXx_NEWLINE_xXThyroid CarcinomaXx_NEWLINE_xXKnown additional malignancy within 2 years prior to enrollment with the exception of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or curatively resected in situ cancersXx_NEWLINE_xXPathologic findings consistent with small-cell or neuroendocrine carcinoma of the prostateXx_NEWLINE_xXParticipant has prior malignancies, except lobular breast carcinoma in situ, fully resected basal cell or squamous cell carcinoma of skin or treated cervical carcinoma in situ. Cancer treated with curative intent ? 5 years previously will be allowed. Cancer treated with curative intent < 5 years previously will not be allowed. Randomization Exclusion CriteriaXx_NEWLINE_xXSubjects with known active central nervous system metastasis, glioma and nervous system malignancies including carcinomatous meningitis or other invasive malignancy within 5 years except for noninvasive malignancies such as cervical carcinoma in situ, non-melanomatous carcinoma of the skin or ductal carcinoma in situ of the breast that has/have been surgically cured.Xx_NEWLINE_xXPrevious malignant disease other than the target malignancy to be investigated in this trial within the last 3 years, with the exception of basal or squamous cell carcinoma of the skin or cervical carcinoma in situ. Any prior cancer must not be getting active treatment and must be in continuous complete remission for at least 3 years.Xx_NEWLINE_xXPrior cancer diagnosis except the following:\r\n* Squamous cell cancer of the skin without known metastasis\r\n* Basal cell cancer of the skin without known metastasis\r\n* Carcinoma in situ of the breast (ductal carcinoma in situ [DCIS] or lobular carcinoma in situ [LCIS])\r\n* Carcinoma in situ of the cervixXx_NEWLINE_xXParticipants with a history of a second primary malignancy; exceptions include: patients with a history of malignancies that were treated curatively and have not recurred within 3 years prior to study entry; resected basal and squamous cell carcinomas of the skin, and completely resected carcinoma in situ of any typeXx_NEWLINE_xXParticipant has a newly diagnosed, histologically confirmed, stage I-IV squamous cell carcinoma or squamous cell carcinoma in situ of the oral cavity or oropharynx and will be undergoing definitive surgical, radiotherapy, or chemoradiation treatment; patients who are NOT candidates for localized treatment (surgery, radiation or chemoradiation) with curative intent (i.e.patients with distant metastasis or contra-indication to localized treatment) are not eligible ORXx_NEWLINE_xXDiagnosed or treated for another malignancy within 2 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapyXx_NEWLINE_xXAdequately treated urothelial papillary non-invasive carcinoma or carcinoma in situXx_NEWLINE_xXActive malignancy (other than BRAFv600 mutation-positive melanoma) or malignancy within 3 years prior to screening are excluded, with the exception of resected melanoma, resected basal cell carcinoma (BCC), resected cutaneous squamous cell carcinoma (SCC), resected carcinoma in situ of the cervix, resected carcinoma in situ of the breast, in situ prostate cancer, limited-stage bladder cancer, or any other curatively treated malignancies from which the participant has been disease-free for at least 3 years Ocular Exclusion Criteria:Xx_NEWLINE_xXPatients must have histologically proven urothelial carcinoma of the bladder; those with mixed histology, including a component of urothelial carcinoma, are eligible; pure small cell carcinoma, pure adenocarcinoma, and pure squamous cell carcinoma are excludedXx_NEWLINE_xXParticipant with a history of a second cancer diagnosis or reoccurrence < 5 years from study entry with the exception of a history of squamous or basal cell carcinoma of the skin < 5 years from study entry will not be excluded from this studyXx_NEWLINE_xXHave a concurrent malignancy or have had another malignancy within 1 year prior to initiation of screening (with the exception of adequately treated basal or squamous cell carcinoma, melanoma in situ, early-stage prostate cancer (T1a-cN0M0), ductal carcinoma in situ of the breast or cervical carcinoma in situ)Xx_NEWLINE_xXDiagnosed with another malignancy (other than malignancy for which transplant was performed) within 3 years of enrollment, with the exception of completely resected basal cell or squamous cell carcinoma of the skin, resected in situ cervical malignancy, resected breast ductal carcinoma in situ, or low-risk prostate cancer after curative resection.Xx_NEWLINE_xXBaseline skin exam is required for all patients; Note: cutaneous squamous cell carcinoma (SCC) lesions identified at baseline must be excisedXx_NEWLINE_xXHistory of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior study entryXx_NEWLINE_xXPrior history of malignancy other than HCC, dermatologic basal cell or squamous cell carcinomaXx_NEWLINE_xXPresence or history of a malignant disease other than disease to be treated in current protocol that has been diagnosed and/or required therapy within the past 3 years; exceptions to this exclusion include the following: completely resected basal cell and squamous cell skin cancers, indolent malignancies that currently do not require treatment, and completely resected carcinoma in situ of any typeXx_NEWLINE_xXNo known diagnosis of invasive squamous cell carcinoma within the previous 2 yearsXx_NEWLINE_xXEndometrial carcinoma.Xx_NEWLINE_xXGastric carcinoma.Xx_NEWLINE_xXDiagnosis of unknown primary squamous cell carcinoma of the head and neckXx_NEWLINE_xXHistory of prior invasive malignancy diagnosed within 3 years prior to study enrollment; exceptions are malignancies with a negligible risk of metastasis or death (e.g., expected 5-year OS > 90%) that were treated with an expected curative outcome, such as squamous cell carcinoma of the skin, in-situ carcinoma of the cervix uteri, non-melanomatous skin cancer, carcinoma in situ of the breast, or incidental histological finding of prostate cancer (TNM stage of T1a or T1b)Xx_NEWLINE_xXPrior cancer diagnosis, unless the patient has been disease free for >= 3 years, with the following exceptions:\r\n* Squamous cell cancer of the skin without known metastasis\r\n* Basal cell cancer of the skin without known metastasis\r\n* Carcinoma in situ of the breast (ductal carcinoma in situ [DCIS] or lobular carcinoma in situ [LCIS])\r\n* Carcinoma in situ of the cervixXx_NEWLINE_xXA history of other malignancy =< 2 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervixXx_NEWLINE_xXMalignancy not in remission or w/in last 3 yrs (exceptions: basal or skin squamous cell carcinoma or in situ cervix cancer)Xx_NEWLINE_xXHistologically document transitional cell carcinoma with the presence of any of the following stages: carcinoma in situ (CIS), high­grade Ta, any grade T1, or any grade cT2­T4, considered appropriate for radical cystectomy; subjects with mixed histology are required to have a dominant transitional cell carcinoma (TCC) patternXx_NEWLINE_xXPatients with an active second malignancy other than adequately treated squamous or basal cell carcinoma of the skinXx_NEWLINE_xXPatient with a concurrent malignancy or history of a malignant disease other than NSCLC that has been diagnosed and/or required therapy within the past 3 years. Exceptions to this exclusion include the following: completely resected basal cell and squamous cell skin cancers, and completely resected carcinoma in situ of any type.Xx_NEWLINE_xXSecond malignancy other than in situ carcinoma of the cervix, unless the tumor was treated with curative intent at least two years previously and subject is in remissionXx_NEWLINE_xXDiagnosed or treated for a non-hematologic malignancy within 2 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapyXx_NEWLINE_xXPatients with secondary malignancy that requires active systemic therapy that will interfere with interpretation of efficacy or toxicity of selinexor; (Note: patients with basal or squamous skin carcinoma, cervical carcinoma in situ, localized breast cancer requiring hormonal therapy or localized prostate cancer [Gleason score < 5 are allowed])Xx_NEWLINE_xXA history of other malignancy =< 3 years previous with the exception of previous head and neck cancer treated only by surgery, basal cell or squamous cell carcinoma of the skin which were treated with local resection only, or carcinoma in situ of the cervix\r\n* Note: patients with synchronous head and neck cancer primaries are an exception to this criterion and may qualify for the studyXx_NEWLINE_xXMeasurable metastatic (stage IV) or unresectable non-small cell lung cancer (including but not limited to squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinomas) with at least one lesion that is resectable for TIL generation; (Note: neuroendocrine tumors are not eligible)Xx_NEWLINE_xXOther malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skinXx_NEWLINE_xXPathologically confirmed squamous cell carcinoma, undifferentiated carcinoma, or poorly differentiated carcinoma of the oropharynx, larynx, or hypopharynx with no evidence of distant metastasis; biopsy sampling of primary tumor with pathology report documenting diagnostic tissue type is requiredXx_NEWLINE_xXOther malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin, or low-risk prostate cancer after curative therapyXx_NEWLINE_xXAny other malignancy diagnosed within 1 year of study entry (except basal or squamous cell skin cancers or noninvasive cancer of the cervix) is excludedXx_NEWLINE_xXDiagnosis or treatment for another malignancy within 2 years of enrollment, with the exception of adequately treated in-situ carcinoma of the cervix, uteri, basal or squamous cell carcinoma or non-melanomatous skin cancerXx_NEWLINE_xXDisease free of prior malignancies for >= 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix or breast; patients with early stage of prostate cancer under clinical surveillance without therapy are eligibleXx_NEWLINE_xXFree of prior malignancies for >= 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix or breastXx_NEWLINE_xXHistory of other active malignancies other than multiple myeloma within the past 3 years prior to study entry, with the following exceptions: adequately treated in situ carcinoma of the cervix uteri, basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin, localized prostate cancer Gleason grade 6 or lower AND with stable prostate specific antigen (PSA) levels off treatment, previous malignancy confined and surgically resected (or treated with other modalities) with curative intent.Xx_NEWLINE_xXPrior history of non-breast malignancies unless they have been disease free for 5 or more years and are deemed by their physician to be at low risk for recurrence. Further, patients who have the following cancers treated within the prior 5 years are permitted: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, basal cell or squamous cell carcinoma of the skin.Xx_NEWLINE_xXPatients with another primary malignancy within 3 years prior to starting study drug, with the exception of adequately treated in-situ carcinoma of the uterine cervix, clinically localized prostate cancer, biochemically relapsed non-metastatic prostate cancer (i.e. prostate specific antigen [PSA] only disease), or skin cancer (such as basal cell carcinoma, squamous cell carcinoma, or non-melanomatous skin cancer)Xx_NEWLINE_xXPatients must be disease-free of prior invasive malignancies for >= 2 years with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix (for phase II only); patients with the following prior or concurrent diagnoses are eligible: lobular carcinoma in situ, contralateral ductal carcinoma in situ, or contralateral invasive ductal and/or lobular cancer (and no prior adjuvant chemotherapy for previous breast malignancy)Xx_NEWLINE_xXBiopsy/pathology-proven clear cell renal cell carcinoma (CCRCC) with metastasesXx_NEWLINE_xXSubjects diagnosed with another cancer in the past 3 years; excluding basal cell carcinoma or squamous cell carcinoma, of skin which were completely cured by resectionXx_NEWLINE_xXHistory of other malignancy (apart from basal cell carcinoma of the skin, or in situ cervix carcinoma) except if the patient has been free of symptoms and without active therapy during at least 2 yearsXx_NEWLINE_xXConcurrent malignancy other than Kaposi sarcoma, resectable squamous cell or basal cell skin cancer, or T1 anal cancer amenable to surgical resectionXx_NEWLINE_xXPrevious malignant disease other than breast cancer within the last 5 years, with the exception of basal or squamous cell carcinoma of the skin, cervical carcinoma in situ, or low-risk cancers considered curatively treated (i.e. complete remission achieved at least 2 years prior to first dose of study drugs and additional therapy not required while receiving study treatment).Xx_NEWLINE_xXDisease free of prior malignancies for >= 3 years with exception of currently treated basal cell or squamous cell carcinoma of the skin, or carcinoma “in situ” of the cervix or breast.Xx_NEWLINE_xXActive secondary malignancy other than skin cancer (e.g., basal cell carcinoma or squamous cell carcinoma) that in the investigator’s opinion will shorten survival to less than 1 yearXx_NEWLINE_xXPatients with a concurrent or prior malignancy are ineligible unless they are patients with curatively treated carcinoma-in-situ or basal cell carcinoma of the skin. Patients who have been free of disease (any prior malignancy) for at least 3 years are eligible for this studyXx_NEWLINE_xXBiopsy-proven non-hematopoietic malignancy, except for germ cell cancer. Small cell lung carcinoma is eligible for this study.Xx_NEWLINE_xXPatients with histologically confirmed, potentially curable squamous-cell carcinoma, adenocarcinoma, or large-cell undifferentiated carcinoma of the esophagusXx_NEWLINE_xXPrevious or concomitant cancers within the past 3 years other than curatively treated carcinoma in situ of the cervix, basal cell carcinoma of the skin, curative treatment for transitional cell carcinoma of the bladder, and low risk prostate cancer; except for prostate cancer (which can be observed if low risk), other cancers listed must have been treated in the past 3 years without evidence of recurrence at the time of registrationXx_NEWLINE_xXOther malignancy diagnosed or requiring treatment within the past 3 years with the exception of adequately treated basal cell carcinoma, squamous cell skin cancer, carcinoma in-situ of the cervix or breast or very low and low risk prostate cancer in active surveillanceXx_NEWLINE_xXPatients with a history of another primary malignancy within 2 years other than curatively treated carcinoma in situ (CIS) of the cervix, or basal or squamous cell carcinoma of the skinXx_NEWLINE_xXHistory of other malignancy that could affect compliance with the protocol or interpretation of results\r\n* Patients with a history of curatively treated basal or squamous cell carcinoma or stage 1 melanoma of the skin or in situ carcinoma of the cervix are eligible\r\n* Patients with a malignancy that has been treated with surgery alone with curative intent will be included. Individuals in documented remission without treatment for >= 2 years prior to enrollment may be included at the discretion of the investigatorXx_NEWLINE_xXSubject has a history of other malignancies prior to study entry, with the exception of:\r\n* Adequately treated in situ carcinoma of the breast or cervix uteri\r\n* Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin\r\n* Prostate cancer with no plans for therapy of any kind\r\n* Previous malignancy confined and surgically resected (or treated with other modalities) with curative intentXx_NEWLINE_xXPreviously diagnosed malignancy excluding basal or squamous cell carcinoma of the skin (unless disease-free for 5 years or more)Xx_NEWLINE_xXDisease free of prior malignancies for > 2 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma “in situ” of the cervix or breastXx_NEWLINE_xXA history of other high grade malignancy =< 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervix, or other tumors discussed with the study principal investigator (PI)Xx_NEWLINE_xXSecond malignancy other than in situ carcinoma of the cervix, unless the tumor was treated with curative intent at least two years previously and subject is in remissionXx_NEWLINE_xXHistory of other active malignancies other than CLL within the past 3 years prior to study entry, with the exception of adequately treated in situ carcinoma or the cervix uteri or breast, basal cell or localized squamous cell carcinoma of the skin, previous malignancy confirmed and surgically resected (or treated with other modalities) with curative intent or without relapse for >= 2 yearsXx_NEWLINE_xXDiagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapyXx_NEWLINE_xXLocalized clear cell renal carcinoma without evidence of distant metastasesXx_NEWLINE_xXConcurrent malignancy or history of a previous malignancy within 1 year prior to first dose of the current study, unless curatively resected basal, squamous cell carcinoma of the skin, breast ductal/lobular carcinoma in situ or cervical carcinoma in situXx_NEWLINE_xXHistory of another malignancy within 5-years of date of except history of (h/o) basal cell or squamous cell carcinoma of skin or polycythemia vera or essential thrombocythemiaXx_NEWLINE_xXActive secondary malignancy, unless the malignancy is not expected to interfere with the evaluation of safety and is approved by the Medical Monitor; examples include basal or squamous cell carcinoma of the skin, in-situ carcinoma of the cervix, and isolated elevation of prostate-specific antigen; patients with a completely treated prior malignancy with no evidence of disease for >= 2 years are eligibleXx_NEWLINE_xXA history of other malignancy =< 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection onlyXx_NEWLINE_xXPreviously treated in situ carcinoma (i.e., noninvasive)Xx_NEWLINE_xXNoninvasive basal cell and squamous cell skin carcinomaXx_NEWLINE_xXSubjects with poorly differentiated or small cell carcinoma histologyXx_NEWLINE_xXPatients with a prior malignancy within the last 5 years (except for skin basal or squamous cell carcinoma, or in situ cancer of the cervix)Xx_NEWLINE_xXDisease free of prior malignancies for >= 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix or breast; patients with early stage of prostate cancer under clinical surveillance without therapy are eligible; patients with B-cell lymphomas treated with curative intent, and in remission for at least 2 years, may be in included (after discussion with principal investigator [PI])Xx_NEWLINE_xXHistory of other malignancy that could affect compliance with the protocol or interpretation of results; patients with a history of curatively treated basal or squamous cell carcinoma or stage 1 melanoma of the skin or in situ carcinoma of the cervix are eligible; patients with early stage of prostate cancer under clinical surveillance without therapy are eligibleXx_NEWLINE_xXSubject has a previous (within 5 years) or current malignancy other than the target cancer with the exception of curatively treated local tumors such as carcinoma in situ of the breast or cervix, basal or squamous cell carcinoma of the skin, or prostate cancer with Gleason Grade < 6 and prostate-specific antigen within normal range.Xx_NEWLINE_xXA history of other malignancy =< 2 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or low risk/curatively treated prostate, thyroid, and cervical cancersXx_NEWLINE_xXPatients with concomitant or prior invasive malignancies within the past 5 years; subjects with limited stage basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the breast, or non-muscle invasive bladder cancer, are eligible as long as they received curative intent therapyXx_NEWLINE_xXDose Escalation, Renal insufficiency and CPI-Treated Expansion cohorts: Histologically confirmed Transitional Cell Carcinoma of the Urothelium (TCCU) (i.e., cancer of the bladder, renal pelvis, ureter, or urethra). Subjects with Urothelial Carcinoma with squamous differentiation or mixed cell types are eligible.Xx_NEWLINE_xXPatients with a previous history of non-breast malignancy are eligible only if they meet the following criteria for a cancer survivor: (1), and (2)\r\n* Has undergone potentially curative therapy for all prior malignancies\r\n* Has been considered disease-free for at least 1 year (with the exception of basal cell or squamous cell carcinoma of the skin or carcinoma-in-situ of the cervix)Xx_NEWLINE_xXMetastatic or recurrent carcinoma of the nasopharynx, squamous cell carcinoma of unknown primary, squamous cell carcinoma originating from skin and salivary glands or non squamous histologies (eg. mucosal melanoma).Xx_NEWLINE_xXPrior history of malignancy, other than MDS or AML, unless the subject has been free of the disease for ?1 year prior to the start of study treatment However, subjects with the following history/concurrent conditions are allowed: basal or squamous cell carcinoma of the skin; carcinoma in situ of the cervix; carcinoma in situ of the breast; incidental histologic finding of prostate cancerXx_NEWLINE_xXAdvanced Renal Cell CarcinomaXx_NEWLINE_xXAdequately treated in situ carcinoma of the cervix uteri or carcinoma in situ of breast;Xx_NEWLINE_xXBasal cell carcinoma of the skin or localized squamous cell carcinoma of the skin;Xx_NEWLINE_xXHas histologies other than squamous cell, adenocarcinoma, or adenosquamous carcinoma of the cervix.Xx_NEWLINE_xXPatients must have no concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix, breast, or bladder; patients with prior malignancies must be disease-free for >= five yearsXx_NEWLINE_xXPatients with active malignancies other than NSCLC or prior curatively treated malignancy at high risk of relapse during the study period with the exception of localized squamous or basal cell skin cancersXx_NEWLINE_xXp16-positive squamous cell carcinoma of the pharynx, larynx or oral cavityXx_NEWLINE_xXPrevious or concurrent malignancy with exception of adequately treated basal cell or squamous cell carcinoma, in-situ carcinoma of the cervix or breast, treated curatively and without evidence of recurrence for at least 3 years prior to study drug infusion, or prostate cancer that was treated with prostatectomy or radiotherapy over 2 years before day 1 of protocol therapy and patients whose prostate-specific antigen (PSA) is undetectable at study entryXx_NEWLINE_xXPatients must have histologically or cytologically confirmed squamous cell carcinoma of oral cavity, oropharynx, paranasal sinuses, hypopharynx, or larynx; squamous cell carcinoma of unknown primary in cervical lymph node can be included only if p16 status is positiveXx_NEWLINE_xXPatients with another active cancer (excluding basal cell carcinoma, cervical carcinoma in situ or melanoma in situ); prior history of other cancer is allowed, as long as there was no active disease within the prior 2 yearsXx_NEWLINE_xXOther malignancy within 5 years of registration with the exception of basal cell or squamous cell carcinoma of the skin treated with local resection only or carcinoma in situ of the cervixXx_NEWLINE_xXNo active second malignancy with the exception of basal or squamous cell carcinoma of the skinXx_NEWLINE_xXPathological diagnosis of squamous cell carcinoma of the lungXx_NEWLINE_xXNo other active malignancies within the past 36 months (with the exception of nonmelanoma skin cancers or carcinoma in situ of the bladder) or life-threatening illnessesXx_NEWLINE_xXOther malignancy within the past 2 years, except for the following if treated and not active: basal cell or nonmetastatic squamous cell carcinoma of the skin, cervical carcinoma in situ or International Federation of Gynecology and Obstetrics (FIGO) stage 1 carcinoma of the cervixXx_NEWLINE_xXHistologically proven advanced or metastatic non-small cell lung cancer or squamous cell carcinoma head and neck with tumor at least 1 cm in sizeXx_NEWLINE_xXDisease-free of prior malignancies for >= 2 years with the exception of basal or squamous cell skin carcinoma, carcinoma “in situ” of the breast or cervix, or localized prostate cancer (treated definitively with hormone therapy, radiotherapy, or surgery)Xx_NEWLINE_xXHistory (within 2 years prior to first study drug administration) of another malignancy unless the malignancy was treated with curative intent and likelihood of relapse is small. Subjects with a history of squamous or basal cell carcinoma of the skin or carcinoma in situ of the cervix may be enrolled.Xx_NEWLINE_xXcuratively treated cervical carcinoma in situXx_NEWLINE_xXPrior, unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skinXx_NEWLINE_xXSkin cancer other than actinic keratosis, basal cell carcinoma, and squamous cell carcinoma in situ in the field of RTXx_NEWLINE_xXHistory of malignancy (other than multiple myeloma) if all treatment of that malignancy was completed at least 2 years before consent and the patient has no evidence of disease (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or breast, or other non-invasive lesion, that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years)Xx_NEWLINE_xXPatients must not have any other malignancies within the past 2 years except for in situ carcinoma of any site, or adequately treated (without recurrence post-resection or post-radiotherapy) carcinoma of the cervix or basal or squamous cell carcinomas of the skin.Xx_NEWLINE_xXHas a diagnosed additional malignancy within 2 years prior to first dose of trial treatment with the exception of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin or curatively resected in situ breast cancers; subjects with another malignancy diagnosed > 2 years prior to the first dose of trial medication who were treated with curative intent and are not undergoing active therapy will be eligibleXx_NEWLINE_xXActive secondary malignancy other than skin cancer (e.g., basal cell carcinoma or squamous cell carcinoma) that in the investigator’s opinion will shorten survival to less than 1 year.Xx_NEWLINE_xXEvidence of non-bladder urothelial (transitional cell) carcinoma by biopsy, cytology, or radiological imaging within the past 2 years of treatment (e.g. upper tract transitional cell carcinoma, urethral urothelial carcinoma)Xx_NEWLINE_xXOther malignancy diagnosed or requiring treatment within the past 3 years with the exception of adequately treated basal cell carcinoma, squamous cell skin cancer, carcinoma in-situ of the cervix or breast, or low-risk Gleason grade =< 6 localized prostate cancer not requiring therapyXx_NEWLINE_xXColorectal cancer/carcinoma (CRC), glioblastoma (GBM), squamous cell carcinoma of the head and neck (HNSCC), or squamous non-small cell lung cancer (sqNSCLC)Xx_NEWLINE_xXHistory of other active malignancy that could affect compliance with the protocol or interpretation of results\r\n* Patients with a history of curatively treated basal or squamous cell carcinoma or stage 1 melanoma of the skin as well as any in situ carcinoma are eligible\r\n* Patients with a malignancy that has been treated with curative intent will also be eligible; individuals in documented remission without treatment for >= 2 years prior to enrollment may be included at the discretion of the investigatorXx_NEWLINE_xXPatients with other prior malignancies must have had a >= 2-year disease-free interval, except for: in situ carcinoma of the cervix, in situ ductal carcinoma of the breast, in situ prostate cancer, in situ bladder cancer; these must have been deemed stable and not expected to relapse; in addition, early stage skin cancers, including basal, squamous cell cutaneous carcinoma, and melanoma, are permitted if previously treated with curative intent and not expected to relapseXx_NEWLINE_xXPathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma of the oropharynx, which include the sites tonsil, base of tongue, soft palate, or posterior oropharyngeal wall; histologic variants will be included (papillary squamous cell carcinoma and basaloid squamous cell carcinoma); cytologic diagnosis from a cervical lymph node is sufficient in the presence of clinical evidence of a primary tumor in the oropharynxXx_NEWLINE_xXPatients with another active cancer (excluding basal cell carcinoma or cervical intraepithelial neoplasia [CIN/cervical carcinoma in situ] or melanoma in situ); prior history of other cancer is allowed, as long as there is no active disease within the prior 5 yearsXx_NEWLINE_xXThe subject must not have had diagnosis, detection, or treatment of another type of cancer =< 2 years prior to randomization (except basal or squamous cell carcinoma of the skin that has been definitively treated); questions regarding the inclusion of individual subjects should be directed to the principal investigators, Dr. Isaacs and Dr. PishvaianXx_NEWLINE_xXHistory of other malignancy =< 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervixXx_NEWLINE_xXFree of prior malignancies for 3 years with exception of patients diagnosed with basal cell or non-metastatic squamous cell carcinoma of the skin, or carcinoma in situ of the cervix or breast, who are eligible even if they are currently treated or were treated and/or diagnosed in the past 3 years prior to study enrollment.Xx_NEWLINE_xXActive malignancy requiring systemic therapy, other than CLL, with the exception of: adequately treated in situ carcinoma of the cervix uteri; adequately treated basal cell carcinoma or localized squamous cell carcinoma of the skin; previous malignancy confined and surgically resected (or treated with other modalities) with curative intent.Xx_NEWLINE_xXRenal cell carcinoma without any clear (conventional) cell componentXx_NEWLINE_xXPrior history of malignancies unless the patient has been disease free for >= 5 years; exceptions include basal cell carcinoma or squamous cell carcinoma of the skin; carcinoma in situ of cervix; carcinoma in situ of breast, localized prostate cancer, or superficial bladder cancer that has undergone curative therapyXx_NEWLINE_xXPatients with any other concomitant or prior invasive malignancies are ineligible; however, patients with prior cancer treated with a curative intent with no evidence of recurrent disease 5 years following diagnosis and judged by the investigator to be at low risk of recurrence are eligible; patients with treated limited stage basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the breast or cervix are eligibleXx_NEWLINE_xXPatients diagnosed with additional malignancy within 3 years before the first OBP-301 administration with the exception of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or curatively resected in situ cervical and/or breast cancers.Xx_NEWLINE_xXPRE-CHEMORADIATION SAMPLE COLLECTION: Patients must have histologically proven primary carcinoma of the bladder or urethra or lower ureter (adenocarcinoma or transitional or squamous-cell carcinoma)Xx_NEWLINE_xXSTUDY TREATMENT: Patients must have histologically proven primary carcinoma of the bladder or urethra or lower ureter (adenocarcinoma or transitional or squamous-cell carcinoma)Xx_NEWLINE_xXHistologically proven squamous cell carcinoma, adenocarcinoma or undifferentiated carcinoma of the esophagus or gastroesophageal (GE) junctionXx_NEWLINE_xXActive secondary malignancy other than skin cancer (e.g., basal cell carcinoma or squamous cell carcinoma) that in the investigator’s opinion will shorten survival to less than 1 year.Xx_NEWLINE_xXHistology other than squamous cell carcinomaXx_NEWLINE_xXActive malignancy requiring systemic therapy, other than CLL, with the exception of: adequately treated in situ carcinoma of the cervix uteri; adequately treated basal cell carcinoma or localized squamous cell carcinoma of the skin; previous malignancy confined and surgically resected (or treated with other modalities) with curative intentXx_NEWLINE_xXHistological confirmation of renal cell carcinoma (RCC) (any histology)Xx_NEWLINE_xXHistory of other malignancy =< 3 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervixXx_NEWLINE_xXHistologically proven squamous cell carcinoma of the larynx.Xx_NEWLINE_xXHistory of other malignancy that could affect compliance with the protocol or interpretation of results\r\n* Patients with a history of curatively treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix are generally eligible; patients with a malignancy that has been treated, but not with curative intent, will also be excluded, unless the malignancy has been in remission without treatment for >= 2 years prior to enrollmentXx_NEWLINE_xXAny previous history of another malignancy (other than cured basal cell or squamous cell carcinoma of the skin or cured in-situ carcinoma) within 5 years of study entry;Xx_NEWLINE_xXMalignant disease, other than that being treated in this study. Exceptions to this exclusion include the following: malignancies that were treated curatively and have not recurred within 2 years prior to study treatment; completely resected basal cell and squamous cell skin cancers, and completely resected carcinoma in situ of any type.Xx_NEWLINE_xXHistological confirmation of non-small cell lung cancer (NSCLC) by either biopsy or cytology will be is required for the primary diagnosis and is recommended for recurrent disease. The following primary cancer types are eligible: squamous cell carcinoma, adenocarcinoma (with or without bronchioloalveolar carcinoma features), large cell carcinoma (with or without neuroendocrine features), neuroendocrine carcinoma (either NSCLC with neuroendocrine features or atypical carcinoids, but not small cell lung carcinoma), bronchioloalveolar cell carcinoma, or non-small cell carcinoma not otherwise specifiedXx_NEWLINE_xXAny other previous malignancies (except for cervical in situ cancers treated only by local excision, and basal and squamous cell carcinomas of the skin) within 5 yearsXx_NEWLINE_xXHistological confirmation of renal cell carcinoma (RCC) with a predominantly (> 50%) clear cell componentXx_NEWLINE_xXNo history of malignancy within 2 years of enrollment except for basal cell carcinoma of the skin, squamous cell skin cancer or carcinoma in situ of the cervixXx_NEWLINE_xXDiagnosed or treated for another malignancy within 2 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy or subjects with indolent second malignanciesXx_NEWLINE_xXPatients with any concurrent active malignancies as defined by malignancies requiring any therapy other than expectant observation or hormonal therapy, with the exception of squamous and basal cell carcinoma of skinXx_NEWLINE_xXHistory of prior malignancy that has not been in remission for >5 years, with the exception of basal cell or squamous cell carcinoma.Xx_NEWLINE_xXHistory of previous malignant disease within the last 2 years with the following exceptions: basal or squamous cell carcinoma of the skin, cervical carcinoma in situ, ductal carcinoma in situ of the breast, papillary or follicular thyroid carcinoma, and non-muscle invasive bladder cancerXx_NEWLINE_xXReceived prior cancer therapy for the head and neck squamous cell carcinoma (HNSCC) that is being resectedXx_NEWLINE_xXHistory of malignancy, treated or untreated, within the past five years whether or not there is evidence of local recurrence or metastases, with the exception of basal cell carcinoma of the skin and cervical carcinoma in situXx_NEWLINE_xXEvidence of metastatic disease or other malignancy (except squamous or basal cell skin cancers)Xx_NEWLINE_xXPatients with any concurrent active malignancies as defined by malignancies requiring any therapy other than expectant observation or hormonal therapy, with the exception of squamous and basal cell carcinoma of skinXx_NEWLINE_xXAdequately treated in situ carcinoma of the cervix uteri or carcinoma in situ of breast;Xx_NEWLINE_xXBasal cell carcinoma of the skin or localized squamous cell carcinoma of the skin;Xx_NEWLINE_xXPathologically-proven diagnosis of squamous cell carcinoma of the oropharynx or larynx; squamous cell carcinoma of unknown primary is not allowedXx_NEWLINE_xXSubject has a history of another malignancy within 5 years before cycle 1, day 1 (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator, with concurrence with the IND office and supporter's medical monitor, is considered cured with minimal risk of recurrence)Xx_NEWLINE_xXHistological confirmation of renal cell carcinoma (RCC) with a clear-cell componentXx_NEWLINE_xXMalignancies requiring active therapy, with the exception of basal cell or squamous cell carcinoma of the skin which can be treated with local resection only or carcinoma in situ of the cervixXx_NEWLINE_xXPatients with second malignancies in addition to their lymphoma are not eligible if the second malignancy has required treatment (including maintenance therapy) within the past 4 years or is not in complete remission; there are two exceptions to this criterion: successfully treated non-metastatic basal cell or squamous cell skin carcinomaXx_NEWLINE_xXPatients must not have had another primary malignancy within 2 years prior to starting study treatment with the exception of adequately treated basal cell carcinoma, squamous cell carcinoma or other non-melanomatous skin cancer, or in-situ carcinoma of the uterine cervix, or any local cancers that are deemed to be cured from investigator’s point of viewXx_NEWLINE_xXPrior history of malignancy in the past 3 years with the exception of basal cell and squamous cell carcinoma of the skin; other malignancies that are considered to have a low potential to progress may be enrolled at discretion of principal investigator (PI)Xx_NEWLINE_xXPatients with prior, unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skinXx_NEWLINE_xXSubjects with a history of or a current malignancy except for treated basal or squamous carcinomas of the skin completely resectedXx_NEWLINE_xXConcomitant malignancies except cutaneous squamous cell carcinoma or basal cell carcinomaXx_NEWLINE_xXMalignancy within the 2 years prior to entry in study, excluding adequately treated squamous cell skin cancer, basal cell carcinoma, and carcinoma in situ; treatment must have been completed (with the exception of hormonal therapy for breast cancer) with cure/remission status verified for at least 2 years prior to entry in this studyXx_NEWLINE_xXMalignancies other than RCC within 5 years of first study treatment with the exception of those with negligible risk of metastases or death and/or treated with expected curative outcome (carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer, ductal carcinoma in situ of the breast, non-muscle invasive urothelial carcinoma)Xx_NEWLINE_xXHistologic or cytologic diagnosis of endometrial carcinoma (including endometrioid, serous, mixed adenocarcinoma, clear-cell carcinoma, or carcinosarcoma).Xx_NEWLINE_xXPatients with concomitant or prior invasive malignancies within the past 3 years; subjects with treated limited stage basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the breast or cervix are eligibleXx_NEWLINE_xXDiagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapyXx_NEWLINE_xXPatients must not have any other malignancies within the past 2 years except for in situ carcinoma of any site, or adequately treated (without recurrence post-resection or post-radiotherapy) carcinoma of the cervix or basal or squamous cell carcinomas of the skin or active non-threatening second malignancy that would not, in the investigator's opinion, potentially interfere with the patient's ability to participate and/or complete this trial; examples include but not limited to: urothelial cancer grade Ta or T1, adenocarcinoma of the prostate treated by active surveillanceXx_NEWLINE_xXDiagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapyXx_NEWLINE_xXDisease free of prior malignancies for >= 5 years with the exception of:\r\n* Currently treated squamous cell and basal cell carcinoma of the skin, or\r\n* Carcinoma in situ of the cervix, or\r\n* Surgically removed melanoma in situ of the skin (stage 0) with histological confirmed free margins of excision, or\r\n* Prostate cancer (T1a or T1b using the TNM [tumor, nodes, metastasis] clinical staging system) that has/have been surgically cured, or\r\n* Any other malignancy that has/have been curatively treated with surgery and/or localized radiationXx_NEWLINE_xXPatients with additional (other than AML) active malignancies, other than curatively treated carcinoma in situ (CIS) of the cervix, or basal or squamous cell carcinoma of the skin; patients are not considered to have a \currently active\ malignancy if they have completed therapy for a prior malignancy and disease free from prior malignancies for > 2 yearsXx_NEWLINE_xXPatients with other active malignancies are ineligible for this study, other than superficial localized skin cancer (basal or squamous cell carcinoma)Xx_NEWLINE_xXPrevious malignant disease other than adenocarcinoma of the small intestine within the last 5 years, with the exception of basal or squamous cell carcinoma of the skin or cervical carcinoma in situ considered curatively treated (i.e. complete remission achieved at least 2 years prior to first dose of avelumab AND additional therapy not required while receiving study treatment)Xx_NEWLINE_xXHistory of other malignancies, except for malignancy surgically resected (or treated with other modalities) with curative intent, adequately treated in situ carcinoma of the breast or cervix uteri, basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin; malignancy treated with curative intent with no known active disease present for >= 3 yearsXx_NEWLINE_xXHistory of other malignancy that could affect compliance with the protocol or interpretation of results; patients with a history of curatively treated basal or squamous cell carcinoma or stage 1 melanoma of the skin or in situ carcinoma of the cervix are eligible; patients with a malignancy that has been treated with surgery alone with curative intent will also be excluded; individuals in documented remission without treatment for >= 2 years prior to enrollment may be included at the discretion of the investigatorXx_NEWLINE_xXPatients with prior, unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skinXx_NEWLINE_xXPresently has a second malignancy other than squamous cell carcinoma of the head and neck (SCCHN), or history of treatment for invasive cancer other than SCCHN in the past 3 years. Exceptions are:\r\n* Previously treated in-situ carcinoma (ie, noninvasive)\r\n* Cervical carcinoma stage 1B or less\r\n* Noninvasive basal cell and squamous cell skin carcinoma\r\n* Radically treated prostate cancer (prostatectomy or radiotherapy) with normal prostate-specific antigen, and not requiring ongoing antiandrogen hormonal therapyXx_NEWLINE_xXAll subjects must have cutaneous squamous cell carcinoma that is not curable by surgery or radiation; both locally advanced and metastatic squamous cell carcinoma will be includedXx_NEWLINE_xXAdequately treated urothelial papillary noninvasive carcinoma or carcinoma in situ.Xx_NEWLINE_xXDiagnosis or treatment for another malignancy within 5 years prior to study registration, with the following exceptions: complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, any in situ malignancy, and low-risk prostate cancer after curative therapyXx_NEWLINE_xXSubject has a history of other malignancies prior to study entry, with the exception of: adequately treated in situ carcinoma of the cervix uteri or carcinoma in situ of breast; basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin; previous malignancy confirmed and surgically resected (or treated with other modalities) with curative intent or completed definitive therapy (chemotherapy, radiation, others) for the malignancy at least 1 year prior to the date of screeningXx_NEWLINE_xXPresence of other active invasive cancers other than the one treated in this trial within 5 years prior to screening, with the exception of appropriately treated basal-cell carcinoma of the skin, in situ carcinoma of the uterine cervix, or other local tumours considered cured by local treatment.Xx_NEWLINE_xXPrior malignancy (including invasive or ductal in-situ breast cancer) within 5 years prior to randomization, except curatively treated basal cell carcinoma of the skin and carcinoma in situ of the cervixXx_NEWLINE_xXBeing actively treated for a concurrent malignancy with the exception of basal cell carcinoma or carcinoma in situ of the cervixXx_NEWLINE_xXHas a diagnosed additional malignancy within 5 years prior to first dose of study treatment with the exception of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or curatively resected in situ cervical and/or breast cancersXx_NEWLINE_xXPatients must not have a different active malignancy, except for skin basal cell carcinoma, skin squamous cell carcinoma and cervical intraepithelial neoplasiaXx_NEWLINE_xXHistory of malignant tumors other than Kaposi sarcoma (KS) or KSHV-associated multicentric Castleman disease (MCD), unless:\r\n* In complete remission for >= 1 year from the time response was first documented or\r\n* Completely resected basal cell carcinoma or\r\n* In situ squamous cell carcinoma of the cervix or anusXx_NEWLINE_xXA history of other malignancy =< 5 years from diagnosis of indexed breast cancer (BC) with the exception of basal cell or squamous cell carcinoma of the skin treated with local resection only or carcinoma in situ of the cervixXx_NEWLINE_xXHas pancreatic tumor other than adenocarcinoma, including: acinar cell carcinoma, pancreaticoblastoma, malignant cystic neoplasms, endocrine neoplasms, squamous cell carcinoma; vater and periampullary duodenal or common bile duct malignanciesXx_NEWLINE_xXHas a diagnosed additional malignancy within 1 year prior to first dose of study treatment with the exception of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or curatively resected in situ cervical and/or breast cancersXx_NEWLINE_xXSubject has a concurrent active malignancy under treatment, with the exception of:\r\n* Adequately treated carcinoma in situ of the breast or cervix uteri\r\n* Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin\r\n* Low-grade, early-stage prostate cancer with no requirement for therapy\r\n* Previous malignancy confinedXx_NEWLINE_xXHistory of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within the last 3 years.Xx_NEWLINE_xXHistory of other malignancy within the previous 3 years, except basal cell or squamous cell carcinoma, or non-muscle invasive bladder cancer.Xx_NEWLINE_xXPatients must be disease-free of prior invasive malignancies for >= 2 years with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix; patient with the following prior concurrent diagnoses are eligible: lobular carcinoma in situ, contralateral ductal carcinoma in situ, or contralateral invasive ductal and/or lobular carcinomaXx_NEWLINE_xXPrior malignancy or myelodysplastic syndrome (active within 3 years of screening) except completely excised non-invasive basal cell or squamous cell carcinoma of the skin, and in situ squamous cell carcinoma of the cervixXx_NEWLINE_xXOther invasive malignancy within 2 years except for noninvasive malignancies such as cervical carcinoma in situ, non-melanomatous carcinoma of the skin or ductal carcinoma in situ of the breast that has/have been surgically curedXx_NEWLINE_xXOther invasive malignancies within 2 years except for noninvasive malignancies such as cervical carcinoma in situ, non-melanomatous carcinoma of the skin, or ductal carcinoma in situ of the breast, etc. that has/have been surgically curedXx_NEWLINE_xXPatients who have a history of another malignancy within the previous 12 months; \r\n* NOTE: Exclusions include:\r\n** Patients with a disease-free interval of > 12 months and/or have not received systemic therapy for > 12 months for another malignancy are eligible\r\n** Basal cell carcinoma of the skin, squamous cell carcinoma of the skin or in situ cervical cancer that has undergone potentially curative therapy are eligible\r\n** If another malignancy is incidentally found during study eligibility work up and does not require treatment the patient will be eligible; this should be clearly documented in the medical record at the time of study registrationXx_NEWLINE_xXPatients must have pathologically-confirmed, previously untreated, p16-positive oropharyngeal squamous cell carcinomaXx_NEWLINE_xXPatients with imaging findings consistent with renal cell carcinomaXx_NEWLINE_xXPathologic subtypes other than pure adenocarcinoma; acinar cell carcinoma, squamous cell carcinoma, spindle cell carcinoma, neuroendocrine cancer, and mixed types are not eligibleXx_NEWLINE_xXPatients with prior malignancies within the last 5 years except resected basal cell carcinoma or treated cervical carcinoma in situXx_NEWLINE_xXPatients must have histologically-confirmed head and neck squamous cell carcinoma with no evidence of distant metastasis; the primary site may be the oral cavity, oropharynx, larynx, or hypopharynx; patients with squamous cell carcinoma of unknown primary, metastatic to cervical lymph nodes, are permitted to enrollXx_NEWLINE_xXDiagnosis or treatment for any malignancy other than non-Hodgkin lymphoma (NHL) within the 3 years preceding day 1 of the protocol therapy; exceptions are:\r\n* Basal or squamous cell carcinoma of the skin\r\n* In situ malignancy that has been completely resected\r\n* Prostate cancer that was treated with prostatectomy or radiotherapy over 2 years before day 1 of protocol therapy as long as the prostate specific antigen (PSA) is undetectableXx_NEWLINE_xXFree of prior malignancies for 2 years with exception of patients diagnosed with basal cell or squamous cell carcinoma of the skin, or carcinoma \in situ\ of the cervix or breast, who are eligible even if they are currently treated or have been treated and/or diagnosed in the past 2 years prior to study enrolment; if patients have another malignancy that was treated within the last 2 years, such patients may be enrolled if the likelihood of requiring systemic therapy for this other malignancy within 2 years is less than 10%, as determined by an expert in that particular malignancy at MD Anderson Cancer Center, and after consultation with the principal investigatorXx_NEWLINE_xXA history of other malignancy =< 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervixXx_NEWLINE_xXDiagnosis of germ cell tumor, small cell carcinoma or hematologic malignancyXx_NEWLINE_xXDiagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapyXx_NEWLINE_xXAny other malignancy within 3 years prior to registration, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervixXx_NEWLINE_xXAny active malignancy within the past year, except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or breast; patients with history of prior malignancies should be free of disease for at least 3 years to be eligible for this studyXx_NEWLINE_xXConcurrent malignancies except basal or squamous cell carcinoma of the skin, or cervical carcinoma in situ treated with curative intent; any cancer from which the patient has been disease free for at least 2 years is permissibleXx_NEWLINE_xXPatients with a prior malignancy with in the last 5 years (except for basal or squamous cell carcinoma, or in situ cancer of the cervix)Xx_NEWLINE_xXHave one of the following advanced (unresectable and/or metastatic) solid tumor indications that has progressed following standard therapies, where standard therapies are available:\r\n* Squamous cell carcinoma of the skin \r\n* Small cell malignancies of non-pulmonary origin\r\n* Adrenocortical carcinoma\r\n* Medullary renal cell carcinoma \r\n* Carcinoma of unknown primary\r\n* Penile carcinoma\r\n* Vascular sarcoma\r\n* Germ cell tumor\r\n* Paraganglioma-pheochromocytoma \r\n* Other rare tumors (except those tumor types listed in exclusion)Xx_NEWLINE_xXIs participating in cohort 10 and has melanoma; non-small cell lung cancer; hepatocellular carcinoma; Merkel cell carcinoma; colon or rectal adenocarcinoma; anal canal squamous cell carcinoma; pancreas adenocarcinoma; esophageal squamous cell carcinoma or adenocarcinoma (including gastroesophageal [GE] junction); biliary tract adenocarcinoma (gallbladder and biliary tree but excluding ampulla of vater cancers); carcinoid tumors; neuroendocrine carcinomas (well or moderately differentiated pancreatic neuroendocrine tumor); estrogen receptor (ER)-positive human epidermal growth factor receptor 2 (HER2)-negative breast cancer; triple negative breast cancer; ovarian epithelial, fallopian tube or primary peritoneal carcinoma; endometrial carcinoma; cervical squamous cell cancer; vulvar squamous cell carcinoma; small cell lung cancer; mesothelioma (malignant pleural mesothelioma); thyroid cancer (papillary or follicular subtype); salivary gland carcinoma; nasopharyngeal carcinoma; glioblastoma multiforme; leiomyosarcoma; prostate adenocarcinoma; gastric adenocarcinoma; or small bowel malignancyXx_NEWLINE_xXThe subject must have a histologically or cytological-proven diagnosis of one of the following malignancies:\r\n* Oral, oropharyngeal, hypopharyngeal or laryngeal squamous cell carcinoma\r\n* Non-small cell carcinoma of the bronchus and/or lung\r\n* Ductal or lobular carcinoma of the breast\r\n* Serous carcinoma of the ovary, fallopian tube, or other uterine adnexa\r\n* Urothelial cell carcinoma of renal pelvis, ureter, or bladder\r\n* Cutaneous squamous cell carcinomaXx_NEWLINE_xXThe subject has a history of unrelated neoplastic disease, which has been deemed active within thirty-six (36) months of the screening evaluation, with the exception of the following:\r\n* Non-invasive non-melanoma skin cancer such as superficial basal cell carcinoma or squamous cell carcinoma\r\n* In female subjects: high-grade or low-grade squamous intraepithelial lesions or equivalent cervical lesions\r\n* In male subjects: tumors of the prostate with a combined Gleason score =< 7Xx_NEWLINE_xXPrior history of malignancy in the past 3 years with the exception of basal cell and squamous cell carcinoma of the skin; other malignancies that are considered to have a low potential to progress may be enrolled at discretion of principal investigator (PI)Xx_NEWLINE_xXHas a known additional malignancy that has had progression or has required active treatments in the last three years; exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer; a history of prostate cancer that was treated with surgery is acceptable, provided that the following criteria are met: stage T2N0M0 or lower; prostate specific antigen (PSA) undetectable for 1 year while off androgen deprivation therapy; patients on active surveillance for low grade prostate cancer are allowed to participateXx_NEWLINE_xXPatients with an active second invasive malignancy, other than basal cell carcinoma of the skin.Xx_NEWLINE_xXOther malignancies within the past 2 years (not including basal cell carcinoma of the skin, prostate cancer or in situ cervix carcinoma).Xx_NEWLINE_xXHas histologically confirmed urothelial carcinoma of the bladder; those with mixed histology, including a component of urothelial carcinoma, are eligible; pure small cell carcinoma, pure adenocarcinoma, and pure squamous cell carcinoma are excludedXx_NEWLINE_xXA history of other malignancy =< 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervixXx_NEWLINE_xXPrior history of malignancies, other than MDS or AML, unless the subject has been free of the disease for >= 1 year; however, subjects with the following history/concurrent conditions are allowed: basal or squamous cell carcinoma of the skin; carcinoma in situ of the cervix; carcinoma in situ of the breast; incidental histologic finding of prostate cancer (T1a or T1b using the tumor, node, metastasis [TNM] clinical staging system)Xx_NEWLINE_xXA history of other malignancy =< 3 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervixXx_NEWLINE_xXConcurrent, active malignancies in addition to those being studied (other than cutaneous squamous cell carcinoma or basal cell carcinoma)Xx_NEWLINE_xXPatient has a history of another malignancy within 2 years prior to starting study treatment, except for cured basal cell carcinoma of the skin or excised carcinoma in situ of the cervixXx_NEWLINE_xXAny other malignancies within the past 2 years other than basal cell skin cancer or carcinoma in situ of the cervixXx_NEWLINE_xXPatients with second malignancies in addition to their B-cell malignancy are not eligible if the second malignancy has required treatment (including maintenance therapy) within the past 4 years or is not in complete remission; there are two exceptions to this criterion: successfully treated non-metastatic basal cell or squamous cell skin carcinomaXx_NEWLINE_xXPatients with primary effusion lymphoma or other concurrent malignancy, except for basal cell carcinoma or squamous carcinoma of the skin or in situ cervical or anal dysplasiaXx_NEWLINE_xXHistory of malignant tumors other than KS or KSHV-MCD, unless:\r\n* In complete remission for >= 1 year for the time complete remission was first documented\r\n* Resected basal cell or squamous cell carcinoma of the skin\r\n* In situ cervical or anal dysplasiaXx_NEWLINE_xXadequately treated local basal cell or squamous cell carcinoma of the skin;Xx_NEWLINE_xXcervical carcinoma in situ;Xx_NEWLINE_xXPrior, unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skinXx_NEWLINE_xXSmall-cell lung cancer/mixed NSCLC with small cell component or other neuroendocrine lung cancers (typical and atypical carcinoids, large-cell neuroendocrine carcinomas). Large-cell carcinoma.Xx_NEWLINE_xXAny evidence of disease from another malignancy or history of other malignancy =< 3 years previous (with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervix); patients with history of prostate cancer treated without radiotherapy and no evidence of disease are eligibleXx_NEWLINE_xXDONOR: Any malignancies in the 2 years prior to baseline, excluding: basal cell carcinoma, in situ malignancy, low-risk prostate cancer, cervix cancer after curative therapyXx_NEWLINE_xXDiagnosis of prior malignancy within the past 2 years with the exception of successfully treated basal cell carcinoma, squamous cell carcinoma of the skin, carcinoma \in situ\ of the cervix or breast; history of other malignancies are allowed if in remission (including prostate cancer patients in remission from radiation therapy, surgery or brachytherapy), not actively being treated, with a life expectancy > 3 yearsXx_NEWLINE_xXA history of other malignancy =< 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection onlyXx_NEWLINE_xXFree of prior malignancies for 3 years with exception of patients diagnosed with basal cell or squamous cell carcinoma of the skin, or carcinoma \in situ\ of the cervix or breast, who are eligible even if they are currently treated or have been treated and/or diagnosed in the past 2 years prior to study enrolment; if patients have another malignancy that was treated within the last 2 years, such patients can be enrolled, after consultation with the principal investigator, if the likelihood of requiring systemic therapy for this other malignancy within 2 years is less than 10%, as determined by an expert in that particular malignancy at MD Anderson Cancer CenterXx_NEWLINE_xXNo evidence (within 5 years) of prior malignancies (except successfully treated basal cell or squamous cell carcinoma of the skin)Xx_NEWLINE_xXHistologic evidence of neuroendocrine or small cell carcinoma of the prostateXx_NEWLINE_xXPrior systemic therapy for renal cell carcinomaXx_NEWLINE_xXPrior or second primary malignancies within the last two years (except carcinoma in situ of the cervix, non-metastatic prostate cancer, or basal cell or squamous cell carcinoma of the skin which were treated with local resection only; prior adjuvant androgen deprivation therapy in the case of prostate cancer is permitted, but current adjuvant androgen deprivation therapy is not)Xx_NEWLINE_xXPatient has a history of other malignancy, unless the patient has been disease free for at least 5 years. Adequately treated basal cell carcinoma or squamous cell skin cancer is acceptable regardless of time, as well as localized prostate carcinoma or cervical carcinoma in situ, after curative treatment.Xx_NEWLINE_xXActive malignancy within the last 3 years, except for adequately treated basal cell carcinoma, squamous cell skin cancer, low-risk prostate cancer (i.e. prostate-specific antigen [PSA] =< 10, Gleason sum =< 6), or carcinoma in situ of the cervix or breastXx_NEWLINE_xXPatients with histologic evidence of small cell carcinoma of the prostate will not be eligibleXx_NEWLINE_xXPrior, unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skinXx_NEWLINE_xXPatients may have had a prior diagnosis of cancer if it has been > 3 years since their last treatment (with the exception of squamous cell carcinoma or basal cell carcinoma of the skin or cervical intraepithelial neoplasia)Xx_NEWLINE_xXPatients with a history of any active malignancy requiring on-going treatment, except basal cell carcinoma or squamous cell carcinoma of the skinXx_NEWLINE_xXDisease free of prior malignancy for < 5 years with the exception of curatively treated basal cell carcinoma of the skin, carcinoma in situ of the cervix, or transitional cell carcinomaXx_NEWLINE_xXSquamous cell histology or mixed, predominantly squamous adenosquamous carcinomaXx_NEWLINE_xXPresence or history of a malignant disease other than lung adenocarcinoma that has been diagnosed and/or required therapy within the past year and is undergoing active anticancer treatment; exceptions to this exclusion include the following: completely resected basal cell and squamous cell skin cancers, and completely resected carcinoma in situ of any typeXx_NEWLINE_xXAny other malignancy within 3 years prior to randomization, except for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or localized papillary carcinoma of the thyroidXx_NEWLINE_xXMalignancies other than RCC within 5 years of first study treatment with the exception of those with negligible risk of metastases or death (carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer, ductal carcinoma in situ of the breast, non-muscle invasive urothelial carcinoma)Xx_NEWLINE_xXKnown additional malignancy that is progressing or requires active treatment excepting basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer. A history of prostate cancer that was treated with definitive intent (surgically or through radiation therapy) is acceptable provided that the following criteria are met: Stage T2N0M0 or lower; Gleason score ?7 and prostatic-specific antigen (PSA) undetectable for at least 1 year while off androgen deprivation therapy that was either treated with definitive intent or untreated in active surveillance that has been stable for the past year prior to study allocationXx_NEWLINE_xXHistologic epithelial cell types include serous, endometrioid, clear cell, or undifferentiated carcinomas, transitional cell carcinoma, mixed epithelial carcinoma, malignant Brenner's tumor, or adenocarcinoma not otherwise specified (NOS)Xx_NEWLINE_xXKnown additional malignancies within the past 3 years (excluding basal of squamous cell skin cancers, carcinoma in situ (CIS) or localized prostate cancer that has been treated or is being observed)Xx_NEWLINE_xXNon-hematologic malignancy within the past 3 years aside from the following exceptions: \r\n* Adequately treated basal cell or squamous cell skin cancer \r\n* Carcinoma in situ of the cervix \r\n* Prostate cancer < Gleason grade 6 with a stable prostate specific antigen (PSA) \r\n* Successfully treated in situ carcinoma of the breastXx_NEWLINE_xXPrior malignancy with in the last 5 years (except for basal or squamous cell carcinoma, or in situ cancer of the cervix)Xx_NEWLINE_xXPHASE II: Previous or current invasive malignancies of other histologies requiring treatment within the last 2 years, with the exception of adequately treated basal cell or squamous cell carcinoma of the skinXx_NEWLINE_xXActive malignancy requiring treatment other than ALL within two years prior to start of treatment, with the exception of basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, localized prostate cancer, or ductal breast carcinoma in situ (DCIS) or lobular breast carcinoma in situ (LCIS) of the breastXx_NEWLINE_xXPatients with any component of small cell lung carcinomaXx_NEWLINE_xXPHASE I STUDY ELIGIBILITY CRITERIA:\r\nPatients with any other concomitant or prior invasive malignancies are ineligible; however, patients with prior cancer treated with a curative intent with no evidence of recurrent disease 5 years following diagnosis and judged by the investigator to be at low risk of recurrence are eligible; patients with treated limited stage basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the breast or cervix are eligibleXx_NEWLINE_xXPHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C):\r\nPatients with any other concomitant or prior invasive malignancies are ineligible; however, patients with prior cancer treated with a curative intent with no evidence of recurrent disease 5 years following diagnosis and judged by the investigator to be at low risk of recurrence are eligible; patients with treated limited stage basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the breast or cervix are eligibleXx_NEWLINE_xXPHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nPatients with any other concomitant or prior invasive malignancies are ineligible; however, patients with prior cancer treated with a curative intent with no evidence of recurrent disease 5 years following diagnosis and judged by the investigator to be at low risk of recurrence are eligible; patients with treated limited stage basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the breast or cervix are eligibleXx_NEWLINE_xXPHASE II STUDY METASTATIC CASTRATE-RESISTANT PROSTATE CANCER COHORT 4 ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nPatients with any other concomitant or prior invasive malignancies are ineligible, however, patients with prior cancer treated with a curative intent with no evidence of recurrent disease 2 years following diagnosis and judged by the investigator to be at low risk of recurrence are eligible; patients with treated limited stage basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the breast are eligibleXx_NEWLINE_xXPHASE II COLORECTAL CANCER COHORT 6 (MEDI+C ONLY):\r\nPatients with any other concomitant or prior invasive malignancies are ineligible; however, patients with prior cancer treated with a curative intent with no evidence of recurrent disease 5 years following diagnosis and judged by the investigator to be at low risk of recurrence are eligible; patients with treated limited stage basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the breast or cervix are eligibleXx_NEWLINE_xXPatients with another primary malignancy within 3 years prior to starting study treatment with the exception of adequately treated basal cell carcinoma, squamous cell carcinoma or other non-melanomatous skin cancer, or in-situ carcinoma of the uterine cervixXx_NEWLINE_xXHistological/cytological diagnosis of non-small cell lung cancer (NSCLC). Squamous cell (epidermoid), adenocarcinoma, bronchoalveolar carcinoma and large cell anaplastic lung carcinoma histologies are eligible. Mixed histologies of NSCLC (i.e., adenosquamous) are eligible. Mixed NSCLC/small cell lung carcinoma (SCLC), and variant large and small cell lung cancer are NOT eligible for this study.Xx_NEWLINE_xXOther malignancy within three years, unless the probability of recurrence of the prior malignancy is <5%. Patient's curatively treated for squamous cell carcinoma and basal cell carcinoma of the skin and carcinoma in situ of the uterine cervix (CIN) or patients with a history of malignant tumor in the past that have been disease free for at least five years are also eligible for this study.Xx_NEWLINE_xXAny concomitant or prior invasive malignancies with the following curatively treated exceptions:\r\n* Treated limited stage basal cell or squamous cell carcinoma of the skin\r\n* Carcinoma in situ of the breast or cervix\r\n* Primary endometrial cancer meeting the following conditions: stage not greater than IA, grade 1 or 2, no more than superficial myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated subtypes, including papillary serous/serous, clear cell, or other International Federation of Gynecology and Obstetrics (FIGO) grade 3 lesions\r\n* Prior cancer treated with a curative intent with no evidence of recurrent disease 3 years following diagnosis and judged by the investigator to be at low risk of recurrenceXx_NEWLINE_xXActive second malignancy within 2 years prior to enrollment ([in addition to the primary tumor types specified by cohort in Inclusion Criterion Number 1], but not including definitively treated superficial melanoma, in-situ, basal or squamous cell carcinoma of the skin).Xx_NEWLINE_xXDisease free of prior malignancies with exception of currently treated basal cell, squamous cell carcinoma of the skin, carcinoma \in situ\ of the cervix or breast, or other malignancies in remission (including prostate cancer patients in remission from radiation therapy, surgery or brachytherapy), not actively being treatedXx_NEWLINE_xXThe patient with a previous history of non-breast malignancy is eligible for this study only if the patient meets the following criteria for a cancer survivor; a cancer survivor is eligible provided the following criteria are met: (1) patient has undergone potentially curative therapy for all prior malignancies, (2) patients have been considered disease free for at least 1 year (with the exception of basal cell or squamous cell carcinoma of the skin or carcinoma-in-situ of the cervix)Xx_NEWLINE_xXHistory of other active malignancies < 3 years prior to screening except basal cell carcinoma, low grade Gleason score ? 6 prostate cancer that has been removed with undetectable prostate-specific antigen (PSA), and in situ cervical carcinoma.Xx_NEWLINE_xXSecond malignancy other than basal cell or squamous cell carcinoma of the skin or in situ carcinoma of the cervix or the breast, unless they are successfully treated with curative intent for more than 2 years before entering the studyXx_NEWLINE_xXConcurrent active or measurable malignancies, except basal cell carcinoma or squamous cell carcinoma of the skinXx_NEWLINE_xXHistory of any treatment for cancer within the past two years other than basal cell or squamous cell carcinoma of the skin that has been treated with curative intentXx_NEWLINE_xXPrior history of cancer within the last three years except for basal cell carcinoma of the skin or carcinoma in situ of the cervix; patients with previous malignancies but without evidence of disease for 3 years will be allowed to enter the trialXx_NEWLINE_xXOther active malignancy with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only, carcinoma in situ of the cervix, or synchronous head and neck (H&N) primariesXx_NEWLINE_xXInvasive malignancy other than ameloblastoma within 3 years, excluding curatively treated basal cell carcinoma, and other highly curable cancers such as early stage cutaneous squamous cell carcinoma (T1 NO) cervical carcinoma in situ (CIS), early stage prostate cancer, thyroid cancer, breast cancer, or history of malignancy with confirmed activating RAS mutation at any timeXx_NEWLINE_xXHistory of other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or basal cell, or squamous cell carcinoma of the skinXx_NEWLINE_xXPatients with active concurrent malignancy, other than superficial, non-invasive squamous cell carcinoma of the skin or uterine cervix, within the past three yearsXx_NEWLINE_xXDiagnosis or treatment for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, any in situ malignancy, or low-risk prostate cancer after curative therapyXx_NEWLINE_xXThe patient with a previous history of non-breast malignancy is eligible for this study only if the patient meets the following criteria for a cancer survivor; a cancer survivor is eligible provided the following criteria are met: \r\n* Patient has undergone potentially curative therapy for all prior malignancies\r\n* Patients have been considered disease free for at least 1 year (with the exception of basal cell or squamous cell carcinoma of the skin or carcinoma-in-situ of the cervix)Xx_NEWLINE_xXMalignancy other than lymphoma, unless (1) in complete remission and more than 5 years from last treatment, or (2) cervical/anal squamous cell carcinoma in situ or (3) superficial basal cell and squamous cell cancers of the skinXx_NEWLINE_xXHistory of other active malignancies within 2 years of study entry, with exception of (1) adequately treated in-situ carcinoma of cervix; (2) localized basal cell or squamous cell carcinoma of skin; (3) previous malignancy confined and treated locally (surgery or other modality) with curative intent.Xx_NEWLINE_xXDisease free of prior malignancies for > 2 years with exception of currently treated basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma “in situ” of the cervix or breastXx_NEWLINE_xXSecond primary malignancy except most situ carcinoma (e.g. in situ carcinoma of the cervix, adequately treated non-melanomatous carcinoma of the skin) or other malignancy treated at least 5 years previously with no evidence of recurrenceXx_NEWLINE_xXPrior, unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skinXx_NEWLINE_xXA history of other malignancy =< 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervixXx_NEWLINE_xXPresence or history of a malignant disease other than thyroid cancer that has been diagnosed and/or required therapy within the past year and is undergoing active anticancer treatment; exceptions to this exclusion include the following: completely resected basal cell and squamous cell skin cancers, and completely resected carcinoma in situ of any typeXx_NEWLINE_xXA combination of small cell and non-small cell lung cancer, pulmonary carcinoid tumour or large-cell neuroendocrine carcinoma (LCNEC).Xx_NEWLINE_xXOther malignancy within 3 years, except for noninvasive malignancies such as cervical carcinoma in situ (CIS), non-melanomatous carcinoma of the skin or ductal carcinoma in situ (DCIS) of the breast that has/have been surgically cured, or prior malignancy considered by the investigator to be of low likelihood for recurrenceXx_NEWLINE_xXDisease free of prior malignancies for 3 years with exception of currently treated basal cell squamous cell carcinoma of the skin, or carcinoma “in situ” of the cervix or breast; patients with malignancies with indolent behavior such as prostate cancer treated with radiation or surgery can be enrolled in the study as long as they have a reasonable expectation to have been cured with the treatment modality receivedXx_NEWLINE_xXPrior or simultaneous malignancies within the past two years (other than cutaneous squamous or basal cell carcinoma, melanoma in situ or thyroid carcinoma)Xx_NEWLINE_xXPrior or simultaneous malignancy within the past 2 years (other than cutaneous squamous or basal cell carcinoma, melanoma in situ, thyroid carcinoma, or low-risk prostate cancer); in-situ carcinoma is allowedXx_NEWLINE_xXPrevious or concurrent malignancies at other sites within the last 5 years, with the exception of in situ carcinoma of the cervix and adequately treated basal cell carcinoma or squamous cell carcinoma of the skin; in addition, patients with prior or concomitant, based on hysterectomy, stage IA endometrial adenocarcinoma with less than 3 mm depth on invasion, absence of lymphovascular space invasion and absence of grade 3, papillary serous or clear cell histology are allowedXx_NEWLINE_xXA history of other malignancy =< 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervixXx_NEWLINE_xXCOHORT II: Patients with a history of non-breast malignancies are eligible if they have been disease free for 5 or more years prior to enrollment and are deemed by their physicians to be at low risk for recurrence; patients with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skinXx_NEWLINE_xXHistory of other malignancies within 5 years prior to day 1 except for tumors that in the opinion of the investigators have a negligible risk for metastasis or death, such as (but not exclusively) adequately controlled basal cell carcinoma, squamous-cell carcinoma of the skin, or early-stage bladder cancerXx_NEWLINE_xXA history of other malignancy =< 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervixXx_NEWLINE_xXHistory of another malignancy within 3 years, except cured basal cell carcinoma of the skin or excised carcinoma in situ of the cervixXx_NEWLINE_xXHave other concurrent malignancy (subjects with treated squamous cell carcinoma of the skin or basal cell carcinoma of the skin may be included), evidence of extrahepatic cancer from their primary malignancy, or ongoing, medically significant active infection.Xx_NEWLINE_xXSubjects with active other tumors, except early stage squamous cell carcinoma of the skin, basal cell carcinoma of the skin, or cervical intraepithelial neoplasia (CIN)Xx_NEWLINE_xXConcurrent, active malignancies in addition to those being studied (other than cutaneous squamous cell carcinoma or basal cell carcinoma)Xx_NEWLINE_xXPatients with histologic evidence of small cell carcinoma of the prostate will not be eligibleXx_NEWLINE_xXpatients curatively treated for localized squamous or basal cell carcinoma of the skin or for carcinoma in situ of the uterine cervix (CIN) or breast,Xx_NEWLINE_xXNo other malignancy within past five years except basal cell carcinoma of the skin, cervical carcinoma in situ, or non-metastatic prostate cancerXx_NEWLINE_xXThe patient has had prior head and neck squamous cell carcinoma (HNSCC), with the exception of superficial cutaneous basal cell or squamous cell carcinomasXx_NEWLINE_xXHistory of prior malignancy within the last 5 years, with the exception of curatively treated basal or squamous cell carcinoma of the skin and low-grade in situ carcinoma of the cervixXx_NEWLINE_xXDuctal carcinoma in-situ with microinvasions (T1mic)Xx_NEWLINE_xXNo active second malignancy except for basal cell carcinoma of the skinXx_NEWLINE_xXPrior malignancy (active within 5 years of screening) except basal cell or completely excised non-invasive squamous cell carcinoma of the skin, or in situ squamous cell carcinoma of the cervixXx_NEWLINE_xXPathologic diagnosis of urothelial or squamous cell carcinoma of the bladderXx_NEWLINE_xXNewly diagnosed MCL: Disease free of prior malignancies of equal to or greater than 6 months with exception of currently treated basal cell, squamous cell carcinoma of the skin, carcinoma \in situ\ of the cervix or breast, or other malignancies in remission (including prostate cancer patients in remission from radiation therapy, surgery or brachytherapy), not actively being treated, with a life expectancy > 3 yearsXx_NEWLINE_xXPatients with a history of another primary malignancy within 5 years other than curatively treated carcinoma in situ (CIS) of the cervix, or basal or squamous cell carcinoma of the skinXx_NEWLINE_xXPatients with a history of carcinoma in remission, on no therapy or on hormonal therapy for the adjuvant treatment of breast carcinoma or prostate carcinoma are included in the studyXx_NEWLINE_xXHistory of another malignancy within 2 years, except cured basal cell carcinoma of the skin or excised carcinoma in situ of the cervixXx_NEWLINE_xXPrior or simultaneous malignancies within the past two years (other than carcinoma in situ of the cervix, carcinoma in situ [CIS] of the colon, melanoma in situ, thyroid cancer, and basal cell or squamous cell carcinoma of the skin)Xx_NEWLINE_xXHistory of current diagnosis of other cancer except curative cervical cancer in situ, basal or squamous cell carcinoma of the skinXx_NEWLINE_xXPatients with active or untreated malignancy-- with the exception of cutaneous basal or squamous cell carcinomas, or in situ cervical carcinoma-- are ineligible; the risk of recurrent malignancy secondary to this drug is unknownXx_NEWLINE_xXPatients with active malignancy of other type than required for this study, are not eligible with the exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma “in situ” of the cervix or breast; patients with malignancies with indolent behavior such as prostate cancer treated with radiation or surgery can be enrolled in the study as long as they have a reasonable expectation to have been cured with the treatment modality receivedXx_NEWLINE_xXActive skin lesion consistent with squamous cell carcinoma at the time of randomization, or a current or prior history of malignant melanoma within 5 years of study entry.Xx_NEWLINE_xXDisease-free of prior malignancies for >= 2 years with the exception of basal or squamous cell skin carcinoma, carcinoma “in situ” of the breast or cervix, or localized prostate cancer (treated definitively with hormone therapy, radiotherapy, or surgery)Xx_NEWLINE_xXPatients with a history of prior secondary malignancy that requires active systemic therapy that will interfere with interpretation of efficacy or toxicity of IMMU-114, or limit survival to 2 years. These patients should be discussed with the sponsor prior to enrollment. Patients with basal or squamous skin carcinoma, cervical carcinoma in situ on biopsy, localized breast cancer requiring hormonal therapy or localized prostate cancer (Gleason score < 5) do not require discussion.Xx_NEWLINE_xXPatients with other malignancies diagnosed within 2 years prior to study registration; skin squamous or basal cell carcinoma are exceptionsXx_NEWLINE_xXPatients must have pathologically confirmed, previously untreated, resectable, squamous cell carcinoma of the larynx or hypopharynxXx_NEWLINE_xXCervical cancer participants will be American Joint Cancer Commission (AJCC) stages pT1 ,2, N1, M0 with squamous carcinoma, adenocarcinoma, adenosquamous carcinoma, or glassy cell carcinoma histologyXx_NEWLINE_xXHistory of malignancy other than squamous cell carcinoma, basal cell carcinoma of the skin or carcinoma in situ of the cervix within the last 5 years.Xx_NEWLINE_xXBiopsy proven, within 16 weeks prior to study entry, sinonasal adenoid cystic carcinoma, adenocarcinoma, mucoepidermoid carcinoma, squamous cell carcinoma, including sinonasal carcinoma, sinonasal undifferentiated carcinoma, Schneiderian carcinoma, myoepithelial carcinoma, undifferentiated carcinoma, esthesioneuroblastoma, or melanoma American Joint Committee on Cancer (AJCC) 7th edition stage III - IVA/B tumors, or with skull base or intracranial extension; pathology must be confirmed by review at the treating institutionXx_NEWLINE_xXPatients with adenoid cystic carcinoma, adenocarcinoma, mucoepidermoid carcinoma, myoepithelial carcinoma who have undergone gross total resection who refuse chemotherapy may receive radiation aloneXx_NEWLINE_xXEligible patients will have pathologically proven primary locally advanced cervical cancer with squamous cell carcinoma, adenosquamous carcinoma or adenocarcinoma histology suitable for primary treatment with chemoradiation with curative intentXx_NEWLINE_xXHistory of malignant tumors other than KS, unless:\r\n* In complete remission for >= 1 year from the time response was first documented or\r\n* Completely resected basal cell carcinoma or\r\n* In situ squamous cell carcinoma of the cervix or anusXx_NEWLINE_xXMyelodysplasia or any active malignancy other than HL, or < 5 years remission from any other prior malignancy, except adequately treated basal cell or squamous cell carcinomaXx_NEWLINE_xXPrior or simultaneous malignancies within the past two years (other than cutaneous squamous or basal cell carcinoma, melanoma in situ or thyroid carcinoma)Xx_NEWLINE_xXPast or present history of malignant tumors other than Kaposi sarcoma unless one of the following:\r\n* Complete remission for >= 1 year from completion of therapy\r\n* Completely resected basal cell carcinoma\r\n* In situ squamous cell carcinoma of the cervix or anusXx_NEWLINE_xXOther malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skinXx_NEWLINE_xXDisease free of other malignancies beside the AML or myelodysplastic syndrome (MDS) for >= 2 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma \in situ\ of the cervix or breastXx_NEWLINE_xXActive secondary malignancy other than skin cancer (e.g., basal cell carcinoma or squamous cell carcinoma) that in the investigator's opinion will shorten survival to less than 1 yearXx_NEWLINE_xXPathological finding consistent with small cell carcinoma of the prostateXx_NEWLINE_xXConcurrent, active malignancies in addition to that being studied (other than cutaneous squamous cell carcinoma or basal cell carcinoma)Xx_NEWLINE_xXNo concurrent active malignancies are allowed on study for >= 2 years prior to treatment start with the exception of currently treated basal cell or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix or breastXx_NEWLINE_xXMalignant disease, other than that being treated in this study. Exceptions to this exclusion include the following: malignancies that were treated curatively and have not recurred within 2 years after completion of treatment; completely resected basal cell and squamous cell skin cancers; any malignancy considered to be indolent and that has never required therapy; and completely resected carcinoma in situ of any typeXx_NEWLINE_xXPreviously treated in-situ carcinoma (ie, noninvasive)Xx_NEWLINE_xXNoninvasive basal cell and squamous cell skin carcinoma Radically treated prostate cancer (prostatectomy or radiotherapy) with normal prostate-specific antigen, and not requiring ongoing antiandrogen hormonal therapyXx_NEWLINE_xXPatients with a concurrent active malignancy (except squamous or basal cell carcinoma of the skin)Xx_NEWLINE_xXPrevious or current malignancies of other histologies within the last 5 years, with the exception of cervical carcinoma in situ, adequately treated basal cell or squamous cell carcinoma of the skin, and treated low-risk prostate cancerXx_NEWLINE_xXHistologically confirmed primary non-metastatic NSCLC; eligible histological subtypes include: squamous cell carcinoma, adenocarcinoma, squamous-adeno carcinoma, large-cell carcinoma, and non-small cell carcinoma not otherwise specifiedXx_NEWLINE_xXOther malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skinXx_NEWLINE_xXOther malignancies =< 3 years prior to registration except for adequately treated carcinoma of the cervix or basal or squamous carcinomas of the skinXx_NEWLINE_xXPatients with a history of non-breast malignancies are eligible if they have been disease-free for 5 or more years prior to enrollment and are deemed by their physician to be at low risk for recurrence; patients with the following cancers are eligible if diagnosed and treated within the past 5 years; carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skinXx_NEWLINE_xXInclusion Criteria:\n\n        Target Population\n\n          1. Only node-negative patients are eligible: Histological confirmed endometrial carcinoma\n             with no macroscopic remaining tumour after primary surgery and lymph-node negative\n             disease, with one of the following postoperative FIGO 2009 stage and grade:\n\n               1. Stage I grade 3 endometrioid adenocarcinoma\n\n               2. Stage II endometrioid adenocarcinoma\n\n               3. Stage I and II type 2 histology (clear cell, serous, squamous cell carcinoma, or\n                  undifferentiated carcinoma) Prior therapy\n\n          2. Patients have undergone hysterectomy (total abdominal hysterectomy, radical\n             hysterectomy, laparoscopic or robotic hysterectomy) and bilateral\n             salpingo-oophorectomy (BSO) and pelvic lymphadenectomy (LNE).\n\n          3. LNE: minimum 12 pelvic nodes (6 from each side) should be removed. Para-aortic LNE is\n             optional\n\n          4. Omentectomy strongly recommended in clear cell, serous or undifferentiated carcinoma.\n\n          5. Surgery performed within 10 weeks of randomization. If the dates for hysterectomy and\n             lymph node dissection are different, 10 weeks are counted from the last surgery, and\n             in that case the gap between two surgeries should not exceed 8 weeks.\n\n             Other inclusion criteria\n\n          6. Patients must give informed consent according to the rules and regulations of the\n             individual participating centres\n\n          7. Patients have not received any other anticancer therapy other than surgery.\n\n          8. Adjuvant vaginal brachytherapy is permitted in both arms. In chemotherapy arm, timing\n             of VBT should not cause delay in chemotherapy delivery.\n\n          9. Patients must have a WHO performance status of 0-2\n\n         10. Patients must have an adequate bone-marrow, renal and hepatic function (WBC\n             ?3.0x109/L, neutrophils ?1.5x109/L, platelets ?100x109/L, total S-bilirubin <2 x upper\n             normal value, ALAT <2.5 x upper normal value, estimated GFR >50 ml/min (measured or\n             calculated according to Cockroft-Gault or Jeliffe). Up to 5% deviation for\n             hematological values and 10% deviation for s-bilirubin and ALAT are tolerated.\n\n         11. Life expectancy of at least 12 weeks\n\n         12. Patients must be fit to receive combination chemotherapy\n\n         13. Patient's age >18 years\n\n        Exclusion criteria:\n\n        Target Disease Exceptions\n\n          1. Carcinosarcoma, Sarcomas or small cell carcinoma with neuroendocrine differentiation.\n\n             Prohibited Treatments and/or Therapies\n\n          2. External Beam Radiotherapy\n\n          3. Concurrent cancer therapy\n\n          4. Concurrent treatment with an anticancer investigational agent or participation in\n             another anticancer clinical trial Other exclusion criteria\n\n          5. Previous or concurrent malignant disease except for curatively treated carcinoma in\n             situ of the cervix or basal cell carcinoma of the skin\n\n          6. Active infection or other serious underlying medical condition, which might prevent\n             the patient from receiving treatment or to be followed\n\n          7. Whatever reasons which interferes with an adequate follow-upXx_NEWLINE_xXPrior or simultaneous malignancies within the past two years (other than cutaneous squamous or basal cell carcinoma, melanoma in situ or thyroid carcinoma)Xx_NEWLINE_xXPatients must have a confirmed (by a MDACC pathologist) cytologic or histological diagnosis of locally advanced squamous cell carcinoma, poorly differentiated carcinoma, or sinonasal undifferentiated carcinoma of the nasal cavity and/or paranasal sinuses.Xx_NEWLINE_xXMalignant solid tumor (e.g. squamous cell carcinoma of the head/neck/cervix) within 2 years if HCTXx_NEWLINE_xXDisease free of prior malignancies for ? 2 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma \insitu\ of the cervix or breastXx_NEWLINE_xXConcurrent malignancy (excluding basal and squamous cell skin cancers).Xx_NEWLINE_xXHistory of squamous cell carcinoma of the head/neck/cervix within 2 years of HSCTXx_NEWLINE_xXDocumented urothelial carcinoma (transitional cell carcinoma) including urinary bladder, renal pelvis, ureters, urethra meeting all of the following criteriaXx_NEWLINE_xXcervical carcinoma in situXx_NEWLINE_xXtreated basal-cell or squamous cell skin carcinomaXx_NEWLINE_xXThere is reasonable expectation of response to pembrolizumab or nivolumab, and one of the drugs is available from the commercial supply; this includes (but is not limited to) the following tumor types: melanoma, non-small cell lung cancer, renal cell carcinoma, squamous cell carcinoma of the head and neck, bladder cancer, and classic Hodgkin lymphomaXx_NEWLINE_xXHistologically confirmed stage IV NSCLC (adenocarcinoma, squamous cell carcinoma, large cell carcinoma, or not otherwise specified) or recurrent NSCLC not amenable to curative therapyXx_NEWLINE_xXPathologically confirmed diagnosis of squamous cell carcinoma of the mouth, oropharynx, hypopharynx or nasopharynxXx_NEWLINE_xXOther malignancies unless the patient is considered to be disease-free and has completed therapy for the malignancy greater than or equal to 12 months prior to study entry. Patients with the following cancers are eligible if diagnosed and treated within the past 12 months: carcinoma in situ of the cervix, colorectal carcinoma in situ, melanoma in situ, and basal cell and squamous cell carcinoma of the skin.Xx_NEWLINE_xXAny type of cancer (other than basal-cell or squamous-cell carcinoma of the skin, primary brain tumor or intracerebral metastasis and acute leukemia);Xx_NEWLINE_xXMalignancy within last 5 years, except for basal or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix that has been successfully treated.Xx_NEWLINE_xXPrior malignancy (other than basal cell carcinoma and cervical in situ carcinoma) unless treated with a curative intend and without evidence of malignant disease for 1 year before screening. Patients with prior hematologic malignancies that have progressed to AML (such as Myelodysplastic syndrome, myeloproliferative neoplasms, bi-phenotypic leukemias, AcuteLymphocyticLeukemia) or AML that has relapsed are eligible;Xx_NEWLINE_xXHistory of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within the last 3 years.Xx_NEWLINE_xXMalignancy other than the disease under study within 2 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence)Xx_NEWLINE_xXSubject has a prior history of other malignancies unless disease free for ? 5 years, except for basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, or localized prostate cancer with Gleason score < 7 with stable prostate specific antigen (PSA) levels.Xx_NEWLINE_xXOther current malignancy (except squamous or basal cell skin cancers)Xx_NEWLINE_xXActive second invasive malignancy, other than basal cell carcinoma of the skin.Xx_NEWLINE_xXA concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix, breast, or bladder; subjects with prior malignancies must be disease-free for >= five yearsXx_NEWLINE_xXHistological confirmation of non-clear cell renal cancer (including chromophilic [papillary], chromophobic, oncocytic, sarcomatoid, collecting duct [Bellini's duct]), translocation-type carcinoma or medullary renal cell carcinomaXx_NEWLINE_xXPatients must be disease free of any prior malignancies for >= 3 years\r\n* The exception to this would be currently treated squamous cell and basal cell carcinoma of the skin, carcinoma in situ of the cervix, breast, or bladder, or surgically removed melanoma in situ of the skin (stage 0) with histologically confirmed free margins of excisionXx_NEWLINE_xXPatients must be disease-free of prior invasive malignancies for >2 years with the exception of basal cell or squamous cell carcinoma of the skin.Xx_NEWLINE_xXPatients are excluded if they have a history of metastatic cancer in addition to melanoma or a history of uncontrolled non-metastatic cancer. Patients with localized squamous cell carcinoma and/or basal cell carcinoma are not excluded.Xx_NEWLINE_xXHistory of another malignancy within 3 years, except cured basal cell carcinoma of the skin or excised carcinoma in situ of the cervixXx_NEWLINE_xXPatients with a past or current second malignancy are NOT eligible aside from the following exceptions:\r\n* Patients who have been free of malignancy for at least 5 years\r\n* Patients who have a history of completely resected basal or squamous cell skin cancer, successfully treated in situ carcinoma of the breast or cervix, or pre-cancerous lesions of the colonXx_NEWLINE_xXPatient with other malignancies from which the patient has been continuously disease-free for < 3 years, with the exception of melanoma, cervical carcinoma in situ, basal cell or squamous cell skin cancer, ductal or lobular carcinoma in situ of the breastXx_NEWLINE_xXHistory of other malignancy within the last 5 years other than curatively treated basal and squamous cell carcinoma of the skin or carcinoma of the cervix in situXx_NEWLINE_xXHistory of recent cancers (except for colorectal cancers, non-melanoma skin cancers, basal cell carcinomas, squamous cell carcinomas) in the past 5 yearsXx_NEWLINE_xXPrevious history of cancer, other than adequately treated basal cell or Stage 1 squamous cell carcinoma of the skin;Xx_NEWLINE_xXHistory of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior to randomizationXx_NEWLINE_xXORAL CAVITY SQUAMOUS CELL CARCINOMA COHORT: Pathologically confirmed (histology or cytology) stage III or IVA squamous cell cancer of the oral cavity (excluding lip)Xx_NEWLINE_xXORAL CAVITY SQUAMOUS CELL CARCINOMA COHORT: Disease is surgically resectable with curative intentXx_NEWLINE_xXORAL CAVITY SQUAMOUS CELL CARCINOMA COHORT: Hemoglobin > 9 g/dLXx_NEWLINE_xXORAL CAVITY SQUAMOUS CELL CARCINOMA COHORT: Lymphocyte count > 500 x 10^9/mLXx_NEWLINE_xXORAL CAVITY SQUAMOUS CELL CARCINOMA COHORT: Neutrophil count > 1500 × 10^9/mLXx_NEWLINE_xXORAL CAVITY SQUAMOUS CELL CARCINOMA COHORT: Primary tumor of the oropharynxXx_NEWLINE_xXORAL CAVITY SQUAMOUS CELL CARCINOMA COHORT: Any investigational agent within the previous 30 daysXx_NEWLINE_xXORAL CAVITY SQUAMOUS CELL CARCINOMA COHORT: Evidence of distant metastases (M1 disease) or other concurrent primary malignancyXx_NEWLINE_xXORAL CAVITY SQUAMOUS CELL CARCINOMA COHORT: Stroke or other symptoms of cerebral vascular insufficiency within the last 3 monthsXx_NEWLINE_xXORAL CAVITY SQUAMOUS CELL CARCINOMA COHORT: Prior axillary dissectionXx_NEWLINE_xXHPV-ASSOCIATED OROPHARYNX SQUAMOUS CELL CARCINOMA: No prior radiation above the claviclesXx_NEWLINE_xXHPV-ASSOCIATED OROPHARYNX SQUAMOUS CELL CARCINOMA: Hemoglobin > 9 g/dLXx_NEWLINE_xXHPV-ASSOCIATED OROPHARYNX SQUAMOUS CELL CARCINOMA: Lymphocyte count > 500 x 10^9/mLXx_NEWLINE_xXHPV-ASSOCIATED OROPHARYNX SQUAMOUS CELL CARCINOMA: Neutrophil count > 1500 x 10^9/mLXx_NEWLINE_xXHPV-ASSOCIATED OROPHARYNX SQUAMOUS CELL CARCINOMA: ECOG performance status < 2Xx_NEWLINE_xXHPV-ASSOCIATED OROPHARYNX SQUAMOUS CELL CARCINOMA: Tumor of the oral cavityXx_NEWLINE_xXHPV-ASSOCIATED OROPHARYNX SQUAMOUS CELL CARCINOMA: Any investigational agent within the previous 30 daysXx_NEWLINE_xXHPV-ASSOCIATED OROPHARYNX SQUAMOUS CELL CARCINOMA: Evidence of distant metastases (M1 disease) or other concurrent primary malignancyXx_NEWLINE_xXHPV-ASSOCIATED OROPHARYNX SQUAMOUS CELL CARCINOMA: Stroke or other symptoms of cerebral vascular insufficiency within the last 3 monthsXx_NEWLINE_xXHPV-ASSOCIATED OROPHARYNX SQUAMOUS CELL CARCINOMA: Prior axillary dissectionXx_NEWLINE_xXHistory of active malignancies other than chronic lymphocytic leukemia (CLL) within the past 3 years prior to study entry, with the exception of:\r\n* Adequately treated in situ carcinoma or the cervix or breast\r\n* Basal cell or localized squamous cell carcinoma of the skin\r\n* Previous malignancy treated with curative therapy and not expected to relapseXx_NEWLINE_xXSerious autoimmune disease HLA SCREENING: • History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within the last 3 years MAIN SCREENING:Xx_NEWLINE_xXSubject has prior history of malignancies, other than MM, unless the subject has been free of the disease for >= 5 years with the exception of the following malignancies:\r\n* Basal cell carcinoma of the skin\r\n* Squamous cell carcinoma of the skin\r\n* Carcinoma in situ of the cervix\r\n* Carcinoma in situ of the breast\r\n* Incidental histologic finding of prostate cancer (T1a or T1b using the tumor, node, metastasis [TNM] clinical staging system) or prostate cancer that is curativeXx_NEWLINE_xXPrevious malignancy with life expectancy less than 6 months or requiring systemic treatment (except colorectal cancer, history of basal cell carcinoma of skin or pre-invasive carcinoma of the cervix with adequate treatment)Xx_NEWLINE_xXPatients with neuroendocrine or small cell carcinoma of the prostateXx_NEWLINE_xXDiagnosis of another malignancy within 3 years, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix.Xx_NEWLINE_xXRENAL COHORT: Histological documentation of renal cell carcinoma with a clear cell component in the metastatic renal cell carcinoma cohortXx_NEWLINE_xXThe subject has a histologic or cytologic diagnosis of squamous cell carcinoma of the oral cavity, oropharynx, paranasal sinuses, hypopharynx, or larynx; squamous cell carcinoma of unknown primary in cervical lymph node can be included only if human papillomavirus (HPV) status is positiveXx_NEWLINE_xXPrior treatment with cabozantinib or pembrolizumab; or any prior immunotherapy for treating squamous cell carcinoma of the head and neckXx_NEWLINE_xXDisease free of prior malignancies for >= 5 years with the exception of:\r\n* Currently treated squamous cell and basal cell carcinoma of the skin, or\r\n* Carcinoma in situ of the cervix, or\r\n* Surgically removed melanoma in situ of the skin (stage 0) with histological confirmed free margins of excision , or\r\n* Prostate cancer (T1a or T1b using the TNM [tumor, nodes, metastasis] clinical staging system) that has/have been surgically cured, or \r\n* Any other malignancy that has/have been curatively treated with surgery and/or localized radiationXx_NEWLINE_xXHistory of other malignancies, except for malignancy surgically resected (or treated with other modalities) with curative intent, adequately treated in situ carcinoma of the breast or cervix uteri, basal cell carcinoma of the skin or localized squamous cell carcinoma of the skinXx_NEWLINE_xXConcurrent active malignancy, with the exception of early stage basal cell or squamous cell skin cancerXx_NEWLINE_xXA history of other malignancy =< 3 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervixXx_NEWLINE_xXDisease free of prior malignancies of equal to or greater than 6 months with exception of currently treated basal cell, squamous cell carcinoma of the skin, carcinoma \in situ\ of the cervix or breast, or other malignancies in remission (including prostate cancer patients in remission from radiation therapy, surgery or brachytherapy), not actively being treated, with a life expectancy > 3 years.Xx_NEWLINE_xXFOR TISSUE COLLECTION TO ESTABLISH PDX (PART 1): Disease free of other prior malignancies of >= 3 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, carcinoma \in situ\ of the cervix or breast, or other malignancies in remission (including prostate cancer patients in remission from radiation therapy, surgery or brachytherapy) or not actively being treated, with a life expectancy > 2 years.Xx_NEWLINE_xXPatient has a history of another malignancy within 2 years prior to starting study treatment, except for cured basal cell carcinoma of the skin or excised carcinoma in situ of the cervix.Xx_NEWLINE_xXPatients must be disease-free of prior invasive malignancies for > 5 years prior to registration with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervixXx_NEWLINE_xXBasal cell carcinoma (BCC)Xx_NEWLINE_xXHave histological diagnosis of squamous cell cancer of the head & neck with confirmation of HPV positivity or squamous, non-squamous, adenosquamous, carcinoma or adenocarcinoma of the cervix which HPV positivity is not requiredXx_NEWLINE_xXPrevious or concurrent malignancy with the following exceptions:\r\n* Adequately treated basal cell or squamous cell carcinoma of skin with adequate wound healing prior to study entry\r\n* In situ carcinoma of the cervix treated curatively and without evidence of recurrence\r\n* Primary malignancy completely resected and in complete remission >= 1 yearXx_NEWLINE_xXThe patient has an active second malignancy other than curatively resected basal cell or squamous cell carcinoma of the skin, in situ carcinoma of the bladder, or other cancers for which they are treated with curative intent with no active disease in the 3 years prior to enrollment.Xx_NEWLINE_xXPatients must have no concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix, breast, or bladder; patients with prior malignancies must be disease-free for >= five yearsXx_NEWLINE_xXParticipant is < 2 years free of another primary malignancy; exceptions include basal cell skin cancer, stage 0-I squamous cell cancer of the skin, cervical carcinoma in situ, anal carcinoma in situXx_NEWLINE_xXNon-invasive basal cell or squamous cell skin carcinoma.Xx_NEWLINE_xXIncluded tumor types\t\r\n* T cell and NK cell lymphomas, including, but not limited to: cutaneous T-cell lymphomas (CTCL), mycosis fungoides (MF), Sezary syndrome (SS), peripheral T-cell lymphoma (PTCL), ALK-positive and ALK-negative anaplastic large cell lymphoma (ALCL), and NK-cell lymphomas\r\n* Merkel cell carcinoma\r\n* Squamous cell carcinoma of the skin, including keratoacanthomas, vulvar squamous carcinoma, and mixed histology tumors, such as basosquamous carcinoma, and squamous cell carcinoma of unknown primary consistent with skin origin\r\n* Other non-melanoma skin cancers\r\n** Basal cell carcinoma\r\n** Malignant sweat gland tumors, including porocarcinoma, hidradenocarcinoma, spiradenocarcinoma, cylindrocarcinoma, microcystic adnexal carcinoma and related entities, squamoid eccrine ductal carcinoma, cutaneous adenoid cystic carcinoma, digital papillary adenocarcinoma, primary cutaneous mucinous carcinoma, endocrine mucin-producing sweat gland carcinoma, primary cutaneous signet ring cell carcinoma, cutaneous apocrine gland carcinoma, and extraocular sebaceous carcinoma\r\n** Adnexal carcinoma\r\n** Trichilemmal carcinoma\r\n** Extramammary Paget’s disease\r\n** Any other rare tumor of the skin with approval of principle investigator (PI)Xx_NEWLINE_xXPreviously diagnosed malignancy excluding basal or squamous cell carcinoma of the skin (unless disease-free for 5 years or more)Xx_NEWLINE_xXPrior history of malignancies, other than multiple myeloma (MM), unless the patient has completed definitive treatment and has been free of the disease for >= 3 years; patients who are free of disease < 3 years may enroll after discussion with the principal investigator; exceptions include the following (i.e. the following are eligible to participate):\r\n* Basal or squamous cell carcinoma of the skin\r\n* Carcinoma in situ of the cervix\r\n* Ductal carcinoma in situ of the breast\r\n* Incidental histologic finding of prostate cancer (T1a or T1b) managed with surveillanceXx_NEWLINE_xXRectal cancer histology other than adenocarcinoma (i.e., sarcoma, lymphoma, squamous cell carcinoma, mucosal melanoma, etc.)Xx_NEWLINE_xXPatients with the following histologies are not eligible for either study cohort:\r\n* Non-small cell lung cancer, squamous cell carcinoma of head and neck, melanoma, renal cell carcinoma, bladder cancer, Hodgkin’s lymphoma, Merkel cell carcinoma, and MSI-H colorectal cancerXx_NEWLINE_xXPatients must have no concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix, breast, or bladder; patients with prior malignancies must be disease-free for >= 5 yearsXx_NEWLINE_xXHistory of other malignancy (apart from basal cell carcinoma of the skin, or in situ cervix carcinoma) except if the patient has been free of symptoms and without active therapy for at least 2 years.Xx_NEWLINE_xXPatients with active malignancies other than SCLC or patients with prior curatively treated malignancy at high risk of relapse during the study period with the exception of localized squamous or basal cell skin cancersXx_NEWLINE_xXPathologically confirmed squamous cell carcinoma of the head and neck (SCCHN), not previously treatedXx_NEWLINE_xXParticipants with a history of other malignancy which could affect compliance with the protocol or interpretation of results; individuals with a history of curatively treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix are allowed; participants with a malignancy that has been treated with curative intent will also be allowed if the malignancy has been in remission without treatment for >= 2 years prior to cycle 1, day 1Xx_NEWLINE_xXPatients with a history of acute myeloid leukemia (AML), or patients with a history of any other primary malignancy within 3 years prior to initiation of treatment on this study; exceptions include: patients with a history of malignancies (other than AML) that were treated curatively and have not recurred within 3 years prior to study entry; resected basal and squamous cell carcinomas of the skin; and completely resected carcinoma in situ of any typeXx_NEWLINE_xXPatients with a prior history of malignancies, other than multiple myeloma, are excluded unless the subject has been free of the disease for >= 5 years with the exception of the following non-invasive malignancies: \r\n* Basal cell carcinoma of the skin \r\n* Squamous cell carcinoma of the skin \r\n* Carcinoma in situ of the cervix \r\n* Carcinoma in situ of the breast \r\n* Incidental histological findings of prostate cancer (T1a or T1b using the TNM [tumor, nodes, metastasis] clinical grading system) or prostate cancer that is curativeXx_NEWLINE_xXAny concomitant or prior invasive malignancies with the following curatively treated exceptions:\r\n* Treated limited stage basal cell or squamous cell carcinoma of the skin\r\n* Carcinoma in situ of the breast or cervix\r\n* Primary endometrial cancer meeting the following conditions: stage not greater than IA, grade 1 or 2, no more than superficial myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated subtypes, including papillary serous/serous, clear cell, or other Federation of Gynecology and Obstetrics (FIGO) grade 3 lesions\r\n* Prior cancer treated with a curative intent with no evidence of recurrent disease 5 years following diagnosis and judged by the investigator to be at low risk of recurrenceXx_NEWLINE_xXActive cancer (either concurrent or within the last 3 years) that requires nonsurgical therapy (e.g. chemotherapy or radiation therapy), with the exception of surgically treated basal or squamous cell carcinoma of the skin, or melanoma in situXx_NEWLINE_xXMalignancy other than lymphoma, unless (1) in complete remission and more than 5 years from last treatment, or (2) cervical/anal squamous cell carcinoma in situ or (3) superficial basal cell and squamous cell cancers of the skinXx_NEWLINE_xXPatients must be disease free of prior invasive malignancies for > 5 years, with the exception of curatively treated basal cell or squamous cell carcinoma of the skin or cancer in-situ of the cervixXx_NEWLINE_xXIndividuals with a history of an invasive malignancy are ineligible except for the following circumstances: a) individuals with a history of invasive malignancy are eligible if they have been disease-free for at least 3 years and are deemed by the investigator to be at low risk for recurrence of that malignancy; b) individuals with the following cancers are eligible if diagnosed and treated - carcinoma in situ of the breast, oral cavity or cervix and basal cell or squamous cell carcinoma of the skinXx_NEWLINE_xXHistologically proven squamous cell carcinoma of the oropharynx, hypopharynx or larynxXx_NEWLINE_xXSecond primary malignancy; exceptions are 1) patient had a second primary malignancy but has been treated and disease free for at least 3 years, 2) in situ carcinoma (e.g. in situ carcinoma of the cervix), 3) non-melanomatous carcinoma of the skinXx_NEWLINE_xXAny active malignancy within the past year, except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or breast.Xx_NEWLINE_xXIndividuals with a history of an invasive malignancy except for the following circumstances: a) individuals with a history of invasive malignancy are eligible if they have been disease-free for at least 3 years and are deemed by the investigator to be at low risk for recurrence of that malignancy; b) individuals with any of the following cancers are eligible if diagnosed and treated: carcinoma in situ of the breast, oral cavity or cervix and basal cell or squamous cell carcinoma of the skinXx_NEWLINE_xXPrevious or current malignancies of other histologies within the last 5 years, with the exception of in situ carcinoma of the cervix, and adequately treated basal cell or squamous cell carcinoma of the skinXx_NEWLINE_xXHistory of a malignancy, excluding adequately treated squamous cell skin cancer, basal cell carcinoma, and carcinoma in situXx_NEWLINE_xXActive second malignancy, aside from basal cell or squamous cell carcinoma of the skin (i.e. malignancy not treated with curative intent or diagnosis within the past 2 years)Xx_NEWLINE_xXConcurrent malignancy requiring therapy (excluding non-invasive carcinoma or\n             carcinoma in situ).Xx_NEWLINE_xXConcurrent malignancy requiring active treatment, except basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situXx_NEWLINE_xXPatient has a history of a prior malignancy within the past 3 years (excluding resected basal cell carcinoma of the skin or in situ cervical cancer)Xx_NEWLINE_xXPatients with treated limited stage basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the breast or cervix are eligible; patients with stage IA endometrial cancer are eligible if the following conditions are met: without vascular or lymphatic invasion AND no serous, clear cell or grade 3 histology; patients with early stage I or II cancers treated with curative intent who have no evidence of recurrent cancer 3 years following diagnosis and judged by the investigator to be at low risk or recurrence are eligibleXx_NEWLINE_xXPatients must have histologically or cytological confirmed malignancy in the following disease groups: melanoma that is metastatic or unresectable, non-small cell lung carcinoma, renal cell carcinoma, sarcoma, colon carcinoma, non-Hodgkin lymphoma, squamous cell head and neck carcinoma, or cutaneous squamous cell carcinoma, for which standard curative or palliative measures do not exist or are no longer effective; the primary site may be cutaneous or unknown, but mucosal and ocular primaries are excluded\r\n* Note: patients with non-small lung cancer must have had prior epidermal growth factor receptor (EGFR) and anaplastic lymphoma receptor tyrosine kinase (ALK) testing; patients with sensitizing mutations in EGFR or ALK rearrangements should have been treated with prior targeted agents and have had progression or discontinued due to toxicity from these agentsXx_NEWLINE_xXNon-hematologic malignancy within the past 3 years aside from the following exceptions:\r\n* Adequately treated basal cell or squamous cell skin cancer\r\n* Carcinoma in situ of the cervix \r\n* Prostate cancer < Gleason grade 6 with a stable prostate-specific antigen test (PSA)\r\n* Successfully treated in situ carcinoma of the breastXx_NEWLINE_xXPatients must have no concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix, breast, or bladder; patients with prior malignancies must be disease-free for >= five yearsXx_NEWLINE_xXPatients in whom histologic diagnosis is not consistent with ductal adenocarcinoma such as adenosquamous, squamous cell, colloid, islet cell, serous or mucinous cystadenoma or cystadenocarcinoma, carcinoid, small or large cell carcinoma, intraductal oncocytic papillary neoplasms (IOPN), osteoclast-like giant cell tumors, acinar cell carcinoma, pancreatoblastoma, solid pseudopapillary tumors, undifferentiated small cell carcinoma and non-epithelial tumors (sarcomas, gastrointestinal [GI] stromal tumor, lymphoma)Xx_NEWLINE_xXPatients with a secondary primary cancer (excluding baso/squamous cell carcinoma of skin) within 1 year will be excludedXx_NEWLINE_xXSince p53 mutations occur in a wide variety of tumor types, this is a mixed histology study for incurable tumors; subjects with the following solid tumors are eligible for screening: non-small cell lung cancer, squamous cell carcinoma of the head and neck, hepatocellular carcinoma, renal cell carcinoma, melanoma, bladder, soft tissue sarcoma, triple-negative breast cancer, and colorectal carcinoma displaying microsatellite instability and pancreatic cancerXx_NEWLINE_xXNo other malignancies in addition to AML that are currently requiring treatment with the exception of basal cell or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix or breastXx_NEWLINE_xXPatients with other active malignancies; however, patients with skin cancers, namely basal cell or squamous cell carcinoma, and malignancies treated with curative intent having no known active disease present for >= 2 years, may be eligibleXx_NEWLINE_xXConcomitant malignancies or previous malignancies within the last 5 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervixXx_NEWLINE_xXPatients must have persistent, recurrent or metastatic squamous cell carcinoma, adenosquamous carcinoma or adenocarcinoma of the cervix with documented disease progression (disease not amendable to curative therapy); NOTE: the following cervical tumors are not eligible: minimal deviation/adenoma malignum, gastric type adenocarcinoma, clear cell carcinoma and mesonephric carcinoma; histologic confirmation of the original primary tumor is required via the pathology reportXx_NEWLINE_xXPathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma (including the histological variants papillary squamous cell carcinoma and basaloid squamous cell carcinoma) of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal walls); cytologic diagnosis from a cervical lymph node is sufficient in the presence of clinical evidence of a primary tumor in the oropharynx; clinical evidence should be documented, may consist of palpation, imaging, or endoscopic evaluation, and should be sufficient to estimate the size of the primary (for T stage)Xx_NEWLINE_xXPatients must have histologically or cytologically confirmed squamous cell carcinoma of the skin; patients who present with “squamous cell carcinoma of unknown primary lesions” at the time of diagnosis will be eligible if patients have a plausible primary skin site removed in the past; similarly, patients with neck, parotid, or facial lymph nodes positive for squamous cell carcinoma with no identifiable mucosal primary would also be eligibleXx_NEWLINE_xXPatients with second malignancies in addition to multiple myeloma are not eligible if the second malignancy has required treatment within the past 3 years or is not in complete remission; there are two exceptions to this criterion: successfully treated non-metastatic basal cell or squamous cell skin carcinomaXx_NEWLINE_xXPathologically (histologically or cytologically) proven diagnosis of stage IIIA or IIIB non-small cell lung cancer within 84 days of registration; eligible histologies include adenocarcinoma, adenosquamous, large cell carcinoma, squamous carcinoma, non-lobar and non-diffuse bronchoalveolar cell carcinoma or non-small cell lung cancer not otherwise specified [NOS])Xx_NEWLINE_xXHistory of another malignancy requiring active treatment within 2 years prior to starting study treatment, except cured basal cell carcinoma of the skin or excised carcinoma in situ of the cervixXx_NEWLINE_xXPatients must have no concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix, breast, or bladder; patients with prior malignancies must be disease-free for >= three years prior to registrationXx_NEWLINE_xXBiopsy proven squamous cell carcinoma of the head and neck (SCCHN)Xx_NEWLINE_xXPatients with prior malignancy are eligible; however, the patient must be in remission from the prior malignancy and have completed all chemotherapy and radiotherapy at least 6 months prior to registration and all treatment-related toxicities must have resolved; patients with basal cell or squamous cell carcinoma of the skin are eligible regardless of disease statusXx_NEWLINE_xXHistory of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior to randomizationXx_NEWLINE_xXPresence of an invasive malignancy other than the study indication under this trial within 3 years of study enrollment except for carcinoma in situ CIS, squamous cell carcinomas of the skin, or basal cell carcinoma of the skin; a diagnosis of an invasive malignancy within 3 years is allowed if both the cure rate is felt to be > 80% and there has been no evidence of disease in the past yearXx_NEWLINE_xXParticipants who have another cancer diagnosis, except that the following diagnoses will be allowed:\r\n* Squamous cell cancer of the skin without known metastasis; note, patients with suspected cutaneous squamous cell carcinomas (cuSCCs) should have them excised prior to study registration\r\n* Basal cell cancer of the skin without known metastasis\r\n* Carcinoma in situ of the breast (ductal carcinoma in situ [DCIS] or lobular carcinoma in situ [LCIS])\r\n* Carcinoma in situ of the cervix\r\n* Any cancer without distant metastasis that has been treated successfully, without evidence of recurrence or metastasis for over 3 yearsXx_NEWLINE_xXOther malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skinXx_NEWLINE_xXPatients with other malignancies within the past 2 years, except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin or surgically treated early stage solid tumors are ineligible to participate in this studyXx_NEWLINE_xXSubjects must be at least 3 years from any prior malignancy and have no evidence of the malignancy at the time of enrollment; subjects with adequately treated squamous cell or basal cell carcinomas of the skin, multiple primary melanomas, or any carcinoma in situ will be allowedXx_NEWLINE_xXSecond malignancy other than in situ carcinoma of the cervix, unless the tumor was treated with curative intent at least two years previously and subject is in remissionXx_NEWLINE_xXHistory of prior malignancy within the past 5 years, except for curatively treated basal cell carcinoma of the skin, cervical intra-epithelial neoplasia, or localized prostate cancer with a current PSA of < 1.0 mg/dL on 2 successive evaluations, at least 3 months apart, with the most recent evaluation no more than 4 weeks prior to entryXx_NEWLINE_xXHistory of prior malignancy within the past 5 years, except for curatively treated basal cell carcinoma of the skin, cervical intra-epithelial neoplasia, or localized prostate cancer with a current prostate-specific antigen (PSA) of < 1.0 mg/dL on 2 successive evaluations, at least 3 months apart, with the most recent evaluation no more than 4 weeks prior to entryXx_NEWLINE_xXPatient must not have a history of other malignancy =< 3 years previous with the exception of previous head and neck cancer treated only by surgery and basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervixXx_NEWLINE_xXPatients with any component of small cell lung carcinoma are excludedXx_NEWLINE_xXHistory of another malignancy within 3 years, except cured basal cell carcinoma of the skin, treated ductal carcinoma in situ (DCIS), cured early stage prostate cancer without detectable prostate-specific antigen (PSA) or excised carcinoma in situ of the cervixXx_NEWLINE_xXNo clinical evidence of other malignancies (except basal cell carcinoma)Xx_NEWLINE_xXPrior malignancy of any type that occurred less than 5 years previously, except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervixXx_NEWLINE_xXOther malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skinXx_NEWLINE_xXPatient with a history of a prior malignancy with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma or an in situ malignancy; adequately treated localized prostate carcinoma with prostate-specific antigen (PSA) < 1.0; or who has undergone potentially curative therapy with no evidence of disease for five years, and/or who is deemed at low risk for recurrence by his/her treating physicianXx_NEWLINE_xXDiagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapyXx_NEWLINE_xXHistologic proof of non-small cell histology (adenocarcinoma, adenosquamous, large cell carcinoma, squamous carcinoma, non-lobar and non-diffuse bronchoalveolar cell carcinoma or non-small cell lung cancer not otherwise specified [NOS]) within 12 weeks of registration; note: mixed small cell and non-small cell histologies are not eligible for this studyXx_NEWLINE_xXPatients must have pathologically-confirmed, previously untreated, clinically accessible (without general anesthesia) locally advanced squamous cell carcinoma of the larynx, hypopharynx, oropharynx, or oral cavity or nonresectable head and neck squamous cell carcinomas of the skinXx_NEWLINE_xXPatients with a history of an invasive malignancy within the last 3 years are not eligible for the protocol; patients who are no evidence of disease (NED) from a prior invasive malignancy for at least 3 years or longer are eligible for the trial; patients with history of benign tumors such as a pituitary macroadenomas, meningiomas, or craniopharyngiomas are eligible as long as the benign tumor is under local control regardless of the time frame; patients with concurrent adequately treated basal cell or squamous cell carcinoma of the skin are also eligible for the protocolXx_NEWLINE_xXParticipants with previous history of another malignant condition are excluded, except for localized cancers that have been adequately treated; this includes completely resected basal cell carcinoma or squamous cell carcinoma of the skin, in situ malignancy (e.g. ductal carcinoma in situ [DCIS] of the breast), good risk prostate cancer after curative therapy and/or considered appropriate for watchful waiting (e.g. Gleason 6 or less, T2 or less and prostate-specific antigen [PSA] < 10) , and stage I cervical cancer; if invasive malignancy was experienced 2 or more years ago and confirmed as cured, these participants may be considered for the study on case by case basis with PI discussion and approvalXx_NEWLINE_xXHistory of (H/o) another malignancy within 5-years of date of HCT except h/o basal cell or squamous cell carcinoma of skin or PV or ETXx_NEWLINE_xXHistory of malignancy of other organ system within past 5 years, except treated basal cell carcinoma or squamous cell carcinoma of the skin and ? pathological tumor-2 (pT2) upper tract urothelial carcinoma at least 24 months after nephroureterectomy. Also patients with genitourinary cancers other than urothelial cancer or prostate cancer that are under active surveillance are excluded (see inclusion criterion 9)Xx_NEWLINE_xXMyoepithelial carcinomaXx_NEWLINE_xXMyoepithelial carcinomaXx_NEWLINE_xXHistory of small-cell or neuroendocrine prostate carcinomaXx_NEWLINE_xXIn situ carcinoma of the cervix or other noninvasive carcinoma or in situ neoplasm.Xx_NEWLINE_xXPatients must have histologically proven urothelial carcinoma of the bladder; those with mixed histology, including a component of urothelial carcinoma, are eligible; small cell carcinoma, pure adenocarcinoma, and pure squamous cell carcinoma are excludedXx_NEWLINE_xXHas a diagnosed additional malignancy within 3 years prior to first dose of study drug with the exception of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or curatively resected in situ cancers.Xx_NEWLINE_xXHistologically-diagnosed advanced (unresectable and/or metastatic) Non-small Cell Lung Cancer (Phase l only), Melanoma (Phase l only), Colorectal, Head and Neck SCC (squamous cell carcinoma), Ovarian Cancer, Glioblastoma or Renal Cell Carcinoma.Xx_NEWLINE_xX1e. Renal Cell Carcinoma Have histologically confirmed diagnosis of predominant clear cell renal cell carcinoma.Xx_NEWLINE_xXSubject has any other malignancy within 5 years prior to randomization. Exceptions include the following: squamous cell carcinoma of the skin, in-situ carcinoma of the cervix, uteri, non-melanomatous skin cancer, carcinoma in situ of the breast, or incidental histological finding of prostate cancer (TNM stage of T1a or T1b) — all treatments that should have been completed 6 months prior to signing ICF.Xx_NEWLINE_xXSubjects with histologically or cytologically NSCLC, melanoma, transitional cell carcinoma of the genitourinary (GU) tract, renal cell cancer, triple negative breast cancer, adenocarcinoma of the endometrium or squamous cell carcinoma of the head and neck (Phase 1).Xx_NEWLINE_xXParticipant diagnosed or treated for another malignancy within 2 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy; patients who have had prior malignancies within the past 2 years but are considered to be “cured” with a low likelihood of recurrence may be eligible at the discretion of the principal investigatorXx_NEWLINE_xXHistological diagnosis of squamous cell carcinoma, adenocarcinoma or adenosquamous cell carcinoma of the cervixXx_NEWLINE_xXPrevious malignant disease (other than gastric cancer) within the last 5 years with the exception of basal or squamous cell carcinoma of the skin or carcinoma in situ (bladder, cervical, colorectal, breast)Xx_NEWLINE_xXParticipant has a history of malignancy (other than multiple myeloma) within 5 years before the date of randomization (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the Investigator, with concurrence with the Sponsor's medical monitor, is considered cured with minimal risk of recurrence within 5 years)Xx_NEWLINE_xXPrior malignancy, except carcinoma in situ of the skin or cervix treated with curative intent and with no evidence of active diseaseXx_NEWLINE_xXAdequately treated in situ carcinoma of the cervix uteri or carcinoma in situ of breast;Xx_NEWLINE_xXBasal cell carcinoma of the skin or localized squamous cell carcinoma of the skin;Xx_NEWLINE_xXMalignancies other than NSCLC within 5 years prior to enrollment, with the exception of those with a negligible risk of metastasis or death (such as adequately treated carcinoma in-situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer, or ductal carcinoma in situ).Xx_NEWLINE_xXPatients must not have any history of other cancer within 3 years from time of randomization with the exception of basal cell skin cancer, squamous cell skin cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast, or resected non-invasive (Ta) urothelial carcinomaXx_NEWLINE_xXHas a prior history of malignancies, other than MM, unless the subject has been free of the disease for ? 5 years (with the exception Basal cell carcinoma of the skin, Squamous cell carcinoma of the skin, Carcinoma in situ of the cervix, Carcinoma in situ of the breast, Incidental histologic finding of prostate cancer [T1a or T1b] or prostate cancer that is curative)Xx_NEWLINE_xXDiagnosis of any other malignancy within 5 years prior to registration, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or of the cervix.Xx_NEWLINE_xXAdequately treated basal cell or squamous cell carcinoma (adequate wound healing is required prior to study entry)Xx_NEWLINE_xXIn situ carcinoma of the cervix or breast, treated curatively and without evidence of recurrence for at least 3 years prior to the studyXx_NEWLINE_xXParticipants with another invasive malignancy in the last 2 years (with the exception of basal cell carcinoma and tumors deemed by the investigator to be of low likelihood for recurrence)Xx_NEWLINE_xXFor urothelial carcinoma:Xx_NEWLINE_xXPatients with nasopharyngeal carcinoma, skin squamous cell carcinoma (SCC), and salivary gland carcinomas are not eligibleXx_NEWLINE_xXPatients with active malignancies other than NSCLC or prior curatively treated malignancy at high risk of relapse during the study period with the exception of localized squamous or basal cell skin cancersXx_NEWLINE_xXHistologically-proven squamous cell carcinoma of the penisXx_NEWLINE_xXSquamous carcinoma of the urethraXx_NEWLINE_xXConcurrent malignancy (other than squamous cell carcinoma [SCC] or basal cell carcinoma of non-penile skin) that has required surgical or non-surgical treatment in the last 3 yearsXx_NEWLINE_xXA history of other malignancy =< 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervixXx_NEWLINE_xXA history of other malignancy =< 1 year previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only, carcinoma in situ of the cervix, or synchronous H&N primariesXx_NEWLINE_xXConcurrent malignancy requiring therapy (excluding non-invasive carcinoma or carcinoma in situ)Xx_NEWLINE_xXPresence or history of carcinoma in situ (CIS)Xx_NEWLINE_xXDocumented histological or cytological diagnosis of renal cell carcinoma with a clear-cell component.Xx_NEWLINE_xXPatients with a previous or current malignancy at other sites should be excluded, with the exception of:\r\n* Curatively treated local tumors such as carcinoma-in-situ of the cervix, basal or squamous cell carcinoma of the skin\r\n* Tumors for which no relapse has been observed within 5 yearsXx_NEWLINE_xXPrior malignancy (including invasive or ductal in-situ breast cancer) within 5 years prior to randomization, except curatively treated basal cell carcinoma of the skin and carcinoma in situ of the cervix.Xx_NEWLINE_xXSubjects with urothelial carcinoma:Xx_NEWLINE_xXHas a second malignancy. Except: malignancies that were treated curatively and have not recurred within 2 years prior to study treatment; completely resected basal cell and squamous cell skin cancers; any malignancy considered to be indolent and that has never required therapy; and completely resected carcinoma in situ of any type.Xx_NEWLINE_xXBasal cell carcinoma of the skinXx_NEWLINE_xXSquamous cell carcinoma of the skinXx_NEWLINE_xXCarcinoma in situ of the cervixXx_NEWLINE_xXCarcinoma in situ of the breastXx_NEWLINE_xXOther active malignancy (except definitively treated melanoma in-situ, basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix or bladder) within past 24 months.Xx_NEWLINE_xXPrior malignancy, except carcinoma in situ of the skin or cervix treated with curative intent and with no evidence of active diseaseXx_NEWLINE_xXHistologically confirmed Transitional Cell Carcinoma of the Urothelium (TCCU) (i.e., cancer of the bladder, renal pelvis, ureter, or urethra). Subjects with Urothelial Carcinoma with squamous differentiation or mixed cell types are eligible.Xx_NEWLINE_xXcervical carcinoma in situ on biopsy or squamous intraepithelial lesion on Pap smear; andXx_NEWLINE_xXHistory of another invasive malignancy (except non-metastatic basal cell carcinoma or squamous cell carcinoma of the skin or cervical carcinoma in situ adequately treated) unless in remission for >=5 years, or a non - invasive malignancy requiring ongoing therapyXx_NEWLINE_xXPrior history of cancer, other than MDS, unless the subject has been free of the disease for ? 3 years. (Basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, and incidental histologic finding of prostate cancer) (T1a or T1b using the tumor, nodes, metastasis [TNM] clinical staging system is allowed)Xx_NEWLINE_xXPathologically (histologically) proven diagnosis of squamous cell carcinoma (including variants such as verrucous carcinoma, spindle cell carcinoma, carcinoma not otherwise specified [NOS], etc.) of the head/neck (oral cavity, oropharynx or larynx); note: hypopharynx primaries are excludedXx_NEWLINE_xXPatients must have no concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix, breast, or bladder. Patients with prior malignancies must be disease-free for five years.Xx_NEWLINE_xXBasal or squamous cell carcinoma of the skinXx_NEWLINE_xXCarcinoma in situ of the cervixXx_NEWLINE_xXCarcinoma in situ of the breastXx_NEWLINE_xXHas a prior history of malignancies, other than MM, unless the subject has been free of the disease for ? 5 years (with the exception Basal cell carcinoma of the skin, Squamous cell carcinoma of the skin, Carcinoma in situ of the cervix, Carcinoma in situ of the breast, Incidental histologic finding of prostate cancer [T1a or T1b] or prostate cancer that is curative)Xx_NEWLINE_xXDiagnosed and/or treated additional malignancy within 5 years of randomization, with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin, and/or curatively-resected in situ cervical and/or breast carcinomaXx_NEWLINE_xXPatients who have been diagnosed or treated for another malignancy within 3 years prior to registration are not eligible aside from these exceptions: completely resected basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy; if a patient had a prior MPN that evolved to a blast phase, but with treatment, reverted to myelofibrosis at the time of screening, these patients (pts) are considered eligible at the discretion of the principal investigator (PI), if not considered suitable for stem cell transplantationXx_NEWLINE_xXPrevious malignant disease (other than MCC) within the last 5 years with the exception of basal or squamous cell carcinoma of the skin and for Part A cervical carcinoma in situ or for Part B carcinoma in situ (skin, bladder, cervical, colorectal, breast or low grade prostatic intraepithelial neoplasia or Grade 1 prostate cancer)Xx_NEWLINE_xXHistory of other malignancy, with the exception of squamous cell carcinoma of the skin, basal cell carcinoma of the skin, cervical intraepithelial neoplasia, or other malignancies that have been in remission for at least 3 yearsXx_NEWLINE_xXPatients must not have prior history of malignancy other than MDS (except basal cell or squamous skin cell carcinoma or carcinoma in situ of the cervix or breast) unless the subject has been confirmed free of disease for >= 3 yearsXx_NEWLINE_xXAdequately treated urothelial papillary non-invasive carcinoma or carcinoma in situXx_NEWLINE_xXHas pancreatic tumor other than adenocarcinoma, including: acinar cell carcinoma, pancreaticoblastoma, malignant cystic neoplasms, endocrine neoplasms, squamous cell carcinoma. Vater and periampullary duodenal or common bile duct malignancies.Xx_NEWLINE_xXPatients with prior malignancies are eligible if they have been disease-free for at least 5 years and are deemed by their physician to be at low risk for recurrence. Patients with squamous or basal cell carcinoma of the skin, melanoma in situ, carcinoma in situ of the cervix, or carcinoma in situ of the colon or rectum that have been effectively treated are eligible, even if these conditions were diagnosed within 5 years of randomization.Xx_NEWLINE_xXPoorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, goblet cell carcinoma, or small cell carcinomaXx_NEWLINE_xXBasal cell carcinoma of the skinXx_NEWLINE_xXSquamous cell carcinoma of the skinXx_NEWLINE_xXCarcinoma in situ of the cervixXx_NEWLINE_xXCarcinoma in situ of the breastXx_NEWLINE_xXKnown previous/current malignancy requiring treatment within ? 3 years except for cervical carcinoma in situ, squamous or basal cell skin carcinoma, and superficial bladder carcinoma.Xx_NEWLINE_xXSubjects with squamous cell carcinoma of the lungXx_NEWLINE_xXOther active, invasive malignancy requiring ongoing therapy or expected to require systemic therapy within two years; localized squamous cell carcinoma of the skin, basal-cell carcinoma of the skin, carcinoma in-situ of the cervix, or other malignancies requiring locally ablative therapy only will not result in exclusionXx_NEWLINE_xXAny active malignancy within the past year, except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or breast.Xx_NEWLINE_xXOther malignancy within the past 3 years with the exception of adequately treated basal cell carcinoma, squamous cell skin cancer, carcinoma in-situ of the cervixXx_NEWLINE_xXHistologically or cytologically documented non-small cell lung cancer (NSCLC), including squamous cell carcinoma, adenocarcinoma (including bronchioloalveolar carcinoma), and large cell anaplastic carcinoma (including giant and clear cell carcinomas) and poorly differentiated (not otherwise specified, NOS) non-small cell lung cancer; totally resected tumors are excluded\r\n* Patients must be M0;\r\n* Patients with T1 or T2 disease with N2 or T3N1-2 disease (stage IIIA) are eligible\r\n* Patients with T4 with any N or any T with N3 disease are eligible (stage IIIB)\r\n* Measurable disease is requiredXx_NEWLINE_xXSquamous cell carcinoma of head and neck sites, including all pharynx, larynx, oral cavity, skin and para-nasal sinus sites; patients with a diagnosis of nasopharyngeal carcinoma, or squamous cell carcinoma (SCC) of unknown primary presenting in the neck clinically compatible with head and neck mucosal primary sites, are eligibleXx_NEWLINE_xXDisease free of prior malignancies for >= 4 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma “in situ” of the cervix or breastXx_NEWLINE_xXDiagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapyXx_NEWLINE_xXMerkel cell carcinoma basket:\r\n* NoneXx_NEWLINE_xXAdvanced Renal Cell CarcinomaXx_NEWLINE_xXFor part 2 patients only: History of other clinically active malignancy within 5 years of enrollment, except for tumors with a negligible risk for metastasis or death, such as adequately controlled basal-cell carcinoma or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix or breast, or early stage endometrial cancer (stage IA/B, grade 1 or 2, endometrioid histology)Xx_NEWLINE_xXParticipant has a history of other active malignancies, including myelodysplastic syndrome (MDS), within the past 3 years prior to study entry, with the following exceptions: Adequately treated in situ carcinoma of the cervix uteri or the breast, basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin, prostate cancer Gleason grade 6 or lower AND with stable Prostate Specific Antigen (PSA) levels off treatment, previous malignancy with no evidence of disease confined and surgically resected (or treated with other modalities) with curative intent and unlikely to impact survival during the duration of the studyXx_NEWLINE_xXHas a diagnosed additional malignancy within 5 years for Cohort 1 and 3 years for Cohort 2 prior to first dose of study treatment with the exception of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or curatively resected in situ cervical and/or breast cancersXx_NEWLINE_xXA history of other malignancy =< 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervixXx_NEWLINE_xXOther malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancerXx_NEWLINE_xXParticipant has a history of malignancy (other than multiple myeloma) within 5 years before Cycle 1 Day 1 (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence)Xx_NEWLINE_xXPatients with any component of small cell carcinoma are not eligible; other variant histologies are permitted provided the predominant (>= 50%) subtype is urothelial carcinomaXx_NEWLINE_xXHave a concurrent active malignancy. Participants with a history of malignancy are eligible provided the participant has been disease-free for ?3 years, with the following exception: Participants with adequately treated basal or squamous cell carcinoma of the skin, preinvasive carcinoma of the cervix, or any cancer that in the judgment of the investigator and Lilly clinical research physician/designee may not affect the interpretation of results (for example, prostate, bladder) are eligible.Xx_NEWLINE_xXHistory of other cancer type, except for cutaneous basal cell or squamous cell carcinoma, or cervical or prostate cancer in situ, within the last 2 years prior to C1D1Xx_NEWLINE_xXHistological confirmation of non-small cell cancer will be required by either biopsy or cytology; the following primary cancer types are eligible: squamous cell carcinoma, adenocarcinoma with or without bronchioloalveolar carcinoma (BAC) features, large cell carcinoma with or without neuroendocrine features, neuroendocrine carcinoma, bronchioloalveolar cell carcinoma, or non-small cell carcinoma not otherwise specifiedXx_NEWLINE_xXPresence or History of another malignancy. Exception: Patients who have been disease-free for 3 years, or patients with a history of adequately treated in-situ carcinoma of the uterine cervix, completely resected basal or squamous cell carcinoma, non-melanomatous cancer of skin, history of stage IA melanoma that has been cured, are eligible.Xx_NEWLINE_xXHistory of malignancy (other than SMM) within 3 years before the date of randomization, except for the following if treated and not active: basal cell or nonmetastatic squamous cell carcinoma of the skin, cervical carcinoma in situ, ductal carcinoma in situ of breast, or International Federation of Gynecology and Obstetrics (FIGO) Stage 1 carcinoma of the cervixXx_NEWLINE_xXDiagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapyXx_NEWLINE_xXDisease free of prior malignancy for < 3 years with the exception of curatively treated basal carcinoma of the skin or carcinoma in situ of the cervixXx_NEWLINE_xXbenign basal cell carcinomaXx_NEWLINE_xXbenign low grade transitional cell carcinoma of the bladderXx_NEWLINE_xXHistory of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.Xx_NEWLINE_xXA prior invasive malignant disease within five years except for skin cancer (squamous cell or basal cell carcinoma)Xx_NEWLINE_xXHistory of other malignancy =< 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervixXx_NEWLINE_xXHistory of prior invasive malignant cancer(s) within the last 5 years except adequately treated or controlled basal cell or squamous cell carcinoma of the skinXx_NEWLINE_xXFree of prior malignancies for 3 years with exception of patients diagnosed with basal cell or squamous cell carcinoma of the skin, or carcinoma “in situ” of the cervix or breast, who are eligible even if they are currently treated or have been treated and/or diagnosed in the past 3 years prior to study enrolment; if patients have another malignancy that was treated within the last 3 years, such patients can be enrolled, after consultation with the principal investigator, if the likelihood of requiring systemic therapy for this other malignancy within 2 years is less than 10%, as determined by an expert in that particular malignancy at MD Anderson Cancer CenterXx_NEWLINE_xXNon-invasive basal cell or squamous cell skin carcinoma.Xx_NEWLINE_xXInvasive cancer other than ovarian cancer within 2 years (except basal or squamous cell carcinoma of the skin that has been definitely treated)Xx_NEWLINE_xXPatients must not have any of the following: acinar cell carcinoma, neuroendocrine carcinoma, cystadenocarcinoma, carcinosarcomaXx_NEWLINE_xXHistory of other malignancy except for adequately treated non-invasive cancers of the skin (basal or squamous cell) or carcinoma in situ of the uterine cervixXx_NEWLINE_xXActive malignancy (except for HCC or definitively treated melanoma in-situ, basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix) within the past 36 monthsXx_NEWLINE_xXDiagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapyXx_NEWLINE_xXSubjects with a history of another primary malignancy =< 3 years ago, with the exception of inactive basal, squamous cell carcinoma of the skin or superficial melanoma only requiring excision, prostate cancer with a prostate specific antigen (PSA) that has not increased for at least 3 months, carcinoma in situ of the cervixXx_NEWLINE_xXHistory of non-breast malignancies within the 5 years prior to study entry, except for carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinomas of the skinXx_NEWLINE_xXTransitional cell, small cell, or squamous cell carcinoma of the prostateXx_NEWLINE_xXHistory of other cancer, excluding squamous cell and basal cell skin cancers =< 2 years prior to registrationXx_NEWLINE_xXPatients with active malignancy of other type than required for this study are not eligible with the exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma \in situ\ of the cervix or breast; patients with malignancies with indolent behavior such as prostate cancer treated with radiation or surgery can be enrolled in the study as long as they have a reasonable expectation to have been cured with the treatment modality receivedXx_NEWLINE_xXHistory of other active malignancies within 2 years of study entry, with exception of (1) adequately treated in-situ carcinoma of cervix; (2) localized basal cell or squamous cell carcinoma of skin; (3) previous malignancy confined and treated locally with curative intentXx_NEWLINE_xXSubject has a previous (within 5 years) or current malignancy other than the target cancer with the exception of curatively treated local tumors such as carcinoma in situ of the breast or cervix, basal or squamous cell carcinoma of the skin, or prostate cancer with Gleason Grade < 6 and prostate-specific antigen within normal range. Modifications to Eligibility Criteria for the following specific tumor types: Phase 2A will be limited to enrolling the following tumor types:Xx_NEWLINE_xXRenal Cell CarcinomaXx_NEWLINE_xXUrothelial CarcinomaXx_NEWLINE_xXThe patient must have a pathologically confirmed diagnosis of clear cell (renal cell) carcinoma, which is currently Stage 4 disease.Xx_NEWLINE_xXHave a history of an invasive metastatic disease, except for the following circumstances: individuals with a history of invasive metastatic disease are eligible if they have been disease-free for at least 2 years and are deemed by the Investigator to be at low risk for recurrence of that metastatic disease; individuals with the following cancers are eligible if diagnosed and treated: carcinoma in situ of the breast, oral cavity or cervix, localized prostate cancer, basal cell or squamous cell carcinoma of the skin.Xx_NEWLINE_xXOther malignancy within the past 3 years with the exception of: a) adequately treated basal cell carcinoma, squamous cell skin cancer, or thyroid cancer; b) cervix or vulva carcinoma in situ; c) cancer considered cured by surgical resection or unlikely to impact survival during the duration of the study, such as localized transitional cell carcinoma of the bladder, or benign tumors of the adrenal or pancreasXx_NEWLINE_xXMalignant disease, other than that being treated in this study. Exceptions to this exclusion include the following: malignancies that were treated curatively and have not recurred within 2 years prior to study treatment; completely resected basal cell and squamous cell skin cancers; any malignancy considered to be indolent and that has never required therapy; and completely resected carcinoma in situ of any typeXx_NEWLINE_xXOther malignancies within the past 3 years except for basal or squamous cell carcinoma of the skinXx_NEWLINE_xXHistologically confirmed non-small cell cancer by biopsy or cytology; squamous cell carcinoma, adenocarcinoma, large cell carcinoma, bronchioalveolar carcinoma, or non-small cell carcinoma (not otherwise specified) are allowedXx_NEWLINE_xXOther coexisting malignancies with the exception of basal cell carcinoma or cervical cancer in situXx_NEWLINE_xXNo previous or current malignancies at other sites within the last 5 years, with exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skinXx_NEWLINE_xXHistory of malignancy (other than multiple myeloma) within 2 years prior to first administration of study drug (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years)Xx_NEWLINE_xXTreatment of other invasive carcinomas within the last five years with greater than 5% risk of recurrence at time of eligibility screening; carcinoma in-situ and basal cell carcinoma/ squamous cell carcinoma of the skin are allowedXx_NEWLINE_xXCarcinoma in situ of the cervixXx_NEWLINE_xXPatient must have recurrent, persistent or metastatic cervical cancer including squamous cell, adenocarcinoma and adenosquamous histologies; mesonephric carcinoma, minimal deviation/adenoma malignum, clear cell carcinoma and gastric type are excludedXx_NEWLINE_xXMalignancies other than the cervical cancer within 5 years prior to cycle 1, day 1, with the exception of those with a negligible risk of metastasis or death, such as adequately controlled basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the breastXx_NEWLINE_xXDiagnosed or treated for another malignancy within 2 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapyXx_NEWLINE_xXPatients with treated limited stage basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the breast or cervix are eligible; patients with stage IA endometrial cancer are eligible if the following conditions are met: without vascular or lymphatic invasion AND no serous, clear cell or grade 3 histology; patients with early stage I or II cancers treated with curative intent who have no evidence of recurrent cancer 3 years following diagnosis and judged by the investigator to be at low risk of recurrence are eligibleXx_NEWLINE_xXHistory of other carcinoma =< 3 years; exception: if risk of recurrence is known to be under 5% at time of randomizationXx_NEWLINE_xXHistologically proven advanced or metastatic solid cancer for which bevacizumab has an indication: renal cell carcinoma, colorectal adenocarcinoma, non-squamous non-small cell lung cancer, platinum-refractory ovarian carcinoma, cervical carcinoma.Xx_NEWLINE_xXOther malignancies within the past 5 years other than basal cell skin cancer or carcinoma in situ of the cervixXx_NEWLINE_xXNot on any active therapy for other malignancies with the exception of topical therapies for basal cell or squamous cell cancers of the skinXx_NEWLINE_xXNon clear cell renal cell carcinoma (RCC)Xx_NEWLINE_xXHigh grade NET or small cell neuroendocrine carcinomaXx_NEWLINE_xXCarcinoma in situ (CIS).Xx_NEWLINE_xXPatients diagnosed with another malignancy - unless following curative intent therapy, the patient has been disease free for at least 2 years and the probability of recurrence of the prior malignancy is < 5%. Patients with curatively treated early-stage squamous cell carcinoma of the skin, basal cell carcinoma of the skin, or cervical intraepithelial neoplasia (CIN) are eligible for this study.Xx_NEWLINE_xXPatients with basal cell carcinoma or squamous cell carcinoma.Xx_NEWLINE_xXPatients with histologically proven squamous cell carcinoma of the larynxXx_NEWLINE_xXPatients with a concurrent or prior malignancy are ineligible unless they are patients with curatively treated carcinoma-in-situ or basal cell carcinoma of the skin; patients who have been free of disease (any prior malignancy) for at least 3 years are eligible for this studyXx_NEWLINE_xXThe participant has a concurrent active malignancy. Previous history of malignancy is permitted, provided that the participant has been free of disease for ?3 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin, preinvasive carcinoma of the cervix, or any cancers that in the judgment of the investigator and sponsor may not affect the interpretation of results (for example, prostate, bladder).Xx_NEWLINE_xXDiagnosed or treated for another malignancy within 2 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapyXx_NEWLINE_xXNot on any active therapy for other malignancies with the exception of topical therapies for basal cell or squamous cell cancers of the skinXx_NEWLINE_xXHistory of other active malignancies other than CLL within the past 3 years prior to study entry, with the exception of:\r\n* Adequately treated in situ carcinoma or the cervix uteri or breast\r\n* Basal cell or localized squamous cell carcinoma of the skin\r\n* Previous malignancy confirmed and surgically resected (or treated with other modalities) with curative intent or without relapse for >= 2 yearsXx_NEWLINE_xXPatients must not have other invasive malignancies within the past 3 years (with the exception of adequately treated basal or squamous cell skin cancers, carcinoma in situ of the cervix and ductal carcinoma in situ [DCIS] of breast)Xx_NEWLINE_xXCarcinoma in situ of the cervixXx_NEWLINE_xXDocumented pathologic diagnosis of renal cell carcinoma (RCC); all subtypes eligible including but not limited to clear cell, papillary, chromophobe, collecting duct carcinoma, medullary carcinoma, and unclassified categories; sarcomatoid and rhabdoid differentiation are allowedXx_NEWLINE_xXPrevious or concomitant malignancy - EXCEPTIONS: patients with curatively treated carcinoma in situ of the cervix, basal cell of the skin, transitional cell carcinoma of the bladder, or early stage cancers at non-overlapping sites with no evidence of disease for >= 3 yearsXx_NEWLINE_xXAny additional solid tumour or hematologic malignancy during the past 5 years except T1 skin lesions of squamous cell carcinoma, basal cell carcinoma, or uterine/cervical cancer.Xx_NEWLINE_xXDisease-free of active second/secondary or prior malignancies for ? 2 years with the exception of currently treated basal cell or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix or breast.Xx_NEWLINE_xXActive cancer (either concurrent or within the last year of starting study treatment) that requires therapy (eg, surgical, chemotherapy, or radiation therapy), with the exception of adequately treated basal or squamous cell carcinoma of the skin, melanoma in-situ, carcinoma in-situ of the cervix or breast, or prostate carcinoma with a prostate-specific antigen value <0.2 ng/mL.Xx_NEWLINE_xXPrior, unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skin; (treatment with tamoxifen or aromatase inhibitors or other hormonal therapy that may be indicated in prevention of prior cancer disease recurrence, are not considered current active treatment)Xx_NEWLINE_xXDiagnosed and/or treated additional malignancy within 5 years prior to randomization with the exception of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or curatively resected in situ cervical and/or breast cancersXx_NEWLINE_xXA history of other malignancy =< 3 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervixXx_NEWLINE_xXA history of other malignancy =< 2 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervixXx_NEWLINE_xXPhase II: has had prior therapy for metastatic renal cell carcinoma.Xx_NEWLINE_xXParticipants with any concomitant or prior invasive malignancies are ineligible with the following exceptions:\r\n* Treated limited-stage basal cell or squamous cell carcinoma of the skin\r\n* Carcinoma in situ of the breast or cervix\r\n* Primary endometrial cancer meeting the following conditions: stage not greater than IA, grade 1 or 2, no more than superficial myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated subtypes, including papillary serous, clear cell, or other International Federation of Gynecology and Obstetrics (FIGO) grade 3 lesions\r\n* Prior cancer treated with curative intent with no evidence of recurrent disease 3 years following diagnosis and judged by the investigator to be at low risk of recurrenceXx_NEWLINE_xXA history of other malignancy =< 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervixXx_NEWLINE_xXAny invasive malignancy within previous 5 years (other than basal cell carcinoma or cervical carcinoma in situ).Xx_NEWLINE_xXParticipant has a history of other malignancies prior to study entry, with the exception of: adequately treated in situ carcinoma of the breast or cervix uteri; basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin; or previous malignancy confined and surgically resected (or treated with other modalities) with curative intent.Xx_NEWLINE_xXPatients with pathologic diagnosis of lung NSCLC or squamous cell carcinomaXx_NEWLINE_xXPatient with history of another malignancy within 2 years prior to starting study treatment, except for cured basal cell carcinoma of the skin or excised carcinoma in situ of the cervixXx_NEWLINE_xXDiagnosed or treated for another malignancy within 2 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapyXx_NEWLINE_xXUncontrolled or significant co-morbid illness including, but not limited to, active or serious infection requiring intravenous antibiotics; symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia; active gastrointestinal bleeding; active liver disease; active malignancy, except for squamous cell carcinoma of the skin, basal cell carcinoma of the skin, carcinoma in situ, stages Ia or Ib invasive squamous cell carcinoma of the cervix treated by surgery and/or radiation therapy, stage Ia grade 1 adenocarcinoma of the endometrium treated with surgery; patients receiving active chemotherapy or radiotherapy; or psychiatric illness/social situations that would limit compliance with study requirementsXx_NEWLINE_xXSafety expansion: patients with one of the following locally advanced unresectable or metastatic pathologically confirmed diagnosis:\r\n* Colorectal carcinoma and appendiceal adenocarcinoma\r\n* Gastro-esophageal carcinoma; Note: esophageal squamous cell carcinoma is exclusionary\r\n* Biliary tract carcinoma; Note: hepatocellular carcinoma is excluded\r\n* Pancreatic carcinomaXx_NEWLINE_xXPatients must have pathologically confirmed HPV-positive squamous cell carcinomaXx_NEWLINE_xXSmall cell or neuroendocrine carcinoma of the prostateXx_NEWLINE_xXDiagnosed and/or treated additional malignancy within 5 years of randomization, with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin, and/or curatively-resected in situ cervical and/or breast cancersXx_NEWLINE_xXDiagnosis of cancer that in not considered cured, except basal cell carcinoma (BCC) of skinXx_NEWLINE_xXHistological confirmation of renal cell carcinoma (RCC) with a clear-cell componentXx_NEWLINE_xXHistory of another malignancy within 3 years, except cured basal cell carcinoma of the skin or excised carcinoma in situ of the cervixXx_NEWLINE_xXCo-existent second malignancy or history of prior solid organ malignancy within previous 5 years (excluding basal or squamous cell carcinoma, in situ carcinoma of the cervix (CIN3), papillary or follicular thyroid cancer or prostate cancer that has been treated curativelyXx_NEWLINE_xXPathology consistent with small cell carcinoma of the prostateXx_NEWLINE_xXParticipant has a history of malignancy (other than multiple myeloma) within 3 years before the date of randomization (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years)Xx_NEWLINE_xXPatients with an active malignancy requiring treatment in the next 12 months (except for basal or squamous cell carcinoma, or in situ cancer of the cervix or breast, and asymptomatic prostate cancer)Xx_NEWLINE_xXPatients with histologically-confirmed, persistent, metastatic or recurrent squamous or non-squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix with documented disease progression (disease not amenable to surgery or standard radiotherapy).Xx_NEWLINE_xXHistory of other malignancy =< 5 years with the exception of basal cell or squamous cell carcinoma of the skin, treated with local resection only, or carcinoma in situ (e.g. of the cervix, breast, prostate, etc.)Xx_NEWLINE_xXPatients with a history of basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix are eligibleXx_NEWLINE_xXPrior breast or non-breast malignancy within 5 years prior to study entry, except for carcinoma in situ and basal cell and squamous cell carcinoma of the skin. Participants with malignancies occurring more than 5 years prior to study entry are permitted if curatively treatedXx_NEWLINE_xXPathological finding consistent with small cell carcinoma of the prostateXx_NEWLINE_xXHistologically confirmed recurrent or metastatic carcinoma of the nasopharynx, squamous cell carcinoma of unknown primary, and salivary gland or non-squamous histologies (eg: mucosal melanoma) are not allowedXx_NEWLINE_xXHistory of malignancy (other than multiple myeloma) within 5 years before the first dose of daratumumab monotherapy (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or breast, or other non-invasive lesion, that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 5 years)Xx_NEWLINE_xXPrevious malignancy less than 3 years ago other than in situ carcinoma of the cervix, basal cell carcinoma or squamous carcinoma of the skin;Xx_NEWLINE_xXPresence of any other active malignancy or prior history of malignancy, except for: basal cell carcinoma of the skin, cervical carcinoma in situ, early stage prostate carcinoma not requiring active treatmentXx_NEWLINE_xXDiagnosed or treated for another malignancy within 3 years of enrollment, with the exception of a) adequately treated basal cell carcinoma, squamous cell skin cancer, or thyroid cancer; b) carcinoma in situ of the breast; c) cancer considered cured by surgical resection or unlikely to impact survival during the duration of the study, such as localized transitional cell carcinoma of the bladder or benign tumors of the adrenal or pancreasXx_NEWLINE_xXPathological finding consistent with small cell carcinoma of the prostateXx_NEWLINE_xXPatients with a history of another malignancy within 2 years prior to registration are not eligible for participation; Note: the exceptions to this include cured basal cell carcinoma of the skin or excised carcinoma in situ of the cervixXx_NEWLINE_xXpatients curatively treated for localized squamous or basal cell carcinoma of the skin or for carcinoma in situ of the uterine cervix (CIN) or breast,Xx_NEWLINE_xXPrevious or current malignancies of other histologies within the last 5 years, with the exception of in situ carcinoma of the cervix and adequately treated basal cell or squamous cell carcinoma of the skinXx_NEWLINE_xXBasal or squamous cell carcinoma of the skinXx_NEWLINE_xXCarcinoma in situ of the cervix or breastXx_NEWLINE_xXBiopsy proven squamous cell carcinoma histology or squamous cell variants (sarcomatoid, verrucous, basaloid, and papillary subtypes) involving the true vocal cordXx_NEWLINE_xXHistory of non-breast malignancies within the 5 years prior to randomization, except for carcinoma in situ (CIS) of the cervix, CIS of the colon, melanoma in situ, and basal cell and squamous cell carcinomas of the skinXx_NEWLINE_xXPathologic finding consistent with small cell carcinoma of the prostateXx_NEWLINE_xXOther malignancies unless the patient is considered to be disease-free and has completed therapy for the malignancy greater than or equal to 12 months prior to study entry. Patients with the following cancers are eligible if diagnosed and treated within the past 12 months: carcinoma in situ of the cervix, colorectal carcinoma in situ, melanoma in situ, and basal cell and squamous cell carcinoma of the skin.Xx_NEWLINE_xXHistopathologic diagnosis of basal or squamous cell carcinomaXx_NEWLINE_xXOther active malignancy except for basal cell or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix or bladderXx_NEWLINE_xXHistory of other malignancy (apart from basal cell carcinoma of the skin, or in situ cervix carcinoma) except if the patient has been free of symptoms and without active therapy during at least 5 years.Xx_NEWLINE_xXParticipant has had another malignancy within the past 5 years with the exception of a) adequately treated basal cell carcinoma, squamous cell skin cancer, or thyroid cancer; b) carcinoma in situ of the breast, cervix or vulva; or c) cancer considered cured by surgical resection or unlikely to impact survival during the duration of the study, such as localized transitional cell carcinoma of the bladder, or benign tumors of the adrenal or pancreasXx_NEWLINE_xXPrior history of malignancy or a concurrent malignancy, with the exception of cutaneous basal cell carcinoma or squamous cell carcinoma, superficial bladder cancer, or in situ carcinoma of the uterine cervix, prostate, or breast, unless a complete remission was achieved at least 3 years prior to study entry and no additional therapy is required or anticipated to be required during the study periodXx_NEWLINE_xXPathological finding consistent with small cell carcinoma of the prostateXx_NEWLINE_xXPatients that have concurrent malignancies (except localized basal cell or squamous cell skin cancers)Xx_NEWLINE_xXHistology other than squamous cell carcinomaXx_NEWLINE_xXPatients with a diagnosis of intrathoracic lung carcinoma of squamous cell histology are not eligible for participationXx_NEWLINE_xXPatients with a concurrent or prior malignancy within the last 2 years, unless they are patients with curatively treated carcinoma-in-situ at any site, or basal cell carcinoma or squamous cell carcinoma of the skin; patients with treated prostate cancer or breast cancer for which no concurrent therapy is indicated are eligible for this study; patients who have been free of disease (any prior malignancy) for >= five years are eligible for this studyXx_NEWLINE_xXActive malignancy (except for adenocarcinoma of the lung or definitively treated melanoma in-situ, basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix) within the past 24months.Xx_NEWLINE_xXConcomitant malignancies or previous malignancies with less than a 5-year disease-free interval at the time of first dose of study treatment; patients with adequately resected basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or ductal carcinoma in situ may be enrolled irrespective of the time of diagnosis.Xx_NEWLINE_xXPatients who are receiving therapy for another active malignancy are NOT eligible for participation\r\n* The exception to this is squamous cell carcinoma or basal cell carcinoma of the skinXx_NEWLINE_xXHistory of other malignancy ? 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervix.Xx_NEWLINE_xXOther malignancy within five years, unless the probability of recurrence of the prior malignancy is <5% as determined by the Principal Investigator based on available information. Patient's curatively treated for squamous and basal cell carcinoma of the skin or patients with a history of malignant tumor in the past that have been disease free for at least five years are also eligible for this study.Xx_NEWLINE_xXHistologically or cytologically confirmed clear cell renal cell carcinoma (ccRCC); pathology report from the original diagnosis of renal cell carcinoma is acceptable; the component of conventional clear cell type > 50% is mandatory only if there is more than one cell type identified in the tumor tissueXx_NEWLINE_xXTreatment for other invasive carcinomas within the last five years who are at greater than 5% risk of recurrence at time of eligibility screening; carcinoma in-situ and basal cell carcinoma/squamous cell carcinoma of the skin are allowedXx_NEWLINE_xXHistory of another malignancy within 3 years, except cured basal cell carcinoma of the skin or excised carcinoma in situ of the cervix, or any tumor that is after clearing with the principal investigator (PI) clearly not considered to have impact on prognosisXx_NEWLINE_xXOther malignancies within the past 3 years except for basal or squamous cell carcinomas of the skinXx_NEWLINE_xXHistory of other active malignancies other than multiple myeloma within the past 3 years prior to study entry, with the following exceptions: adequately treated in situ carcinoma of the cervix uteri, basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin, previous malignancy confined and surgically resected (or treated with other modalities) with curative intent.Xx_NEWLINE_xXActive cancer (either concurrent or within the last 3 years) that requires non-surgical therapy (e.g. chemotherapy or radiation therapy), with the exception of surgically treated basal or squamous cell carcinoma of the skin, melanoma in-situ, or carcinoma in-situ of the cervix.Xx_NEWLINE_xXPoorly differentiated neuroendocrine carcinoma or small cell carcinomaXx_NEWLINE_xXREGISTRATION EXCLUSION CRITERIA: History of other malignancy =< 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervixXx_NEWLINE_xXOther malignancy (in addition to gastric cancer [GC]) within 5 years before enrollment, except for carcinoma in situ of the cervix or squamous or basal cell carcinoma of the skin that has been previously treated with curative intentXx_NEWLINE_xXHistological diagnosis of non-small cell lung cancer (NSCLC). Squamous cell (epidermoid), adenocarcinoma, bronchoalveolar carcinoma, and large cell anaplastic lung carcinoma histologies are eligible as are mixed histologies of NSCLC (i.e., adenosquamous). Mixed NSCLC/small cell lung carcinoma (SCLC), and variant large and small cell lung cancer are not eligible.Xx_NEWLINE_xXOther malignancy within three years, unless the probability of recurrence is <5%. Patients curatively treated for squamous cell carcinoma and basal cell carcinoma of the skin and carcinoma in situ of the uterine cervix (CIN) or patients with a history of malignant tumor in the past that have been disease free for at least five years are also eligible for this study.Xx_NEWLINE_xXSmall cell carcinoma of the prostateXx_NEWLINE_xXNote: patients with early stage squamous cell carcinoma of the skin, basal cell carcinoma of the skin or cervical intraepithelial neoplasia are eligible for enrollmentXx_NEWLINE_xXDisease free of prior malignancies of equal to or greater than 3 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, carcinoma \in situ\ of the cervix or breast, or other malignancies in remission (including prostate cancer patients in remission from radiation therapy, surgery or brachytherapy), not actively being treated, with a life expectancy > 3 yearsXx_NEWLINE_xXDisease free of prior malignancies for >= 2 years with exception of treated basal cell or squamous cell carcinoma of the skin; carcinoma “in situ” of the cervix or breast, or low-risk localized prostate cancer does not outright exclude patients, but such cases need to be discussed with Dr. Zonder prior to enrollmentXx_NEWLINE_xXOther active, invasive malignancy requiring ongoing therapy or expected to require systemic therapy within two years; localized squamous cell carcinoma of the skin, basal-cell carcinoma of the skin, carcinoma in-situ of the cervix, or other malignancies requiring locally ablative therapy only will not result in exclusionXx_NEWLINE_xXPatients with a prior malignancy within the last 5 years (except for basal or squamous cell carcinoma, or in situ cancer of the cervix)Xx_NEWLINE_xXPrior cancer diagnosis except that the following: \r\n* Squamous cell cancer of the skin without known metastasis\r\n* Basal cell cancer of the skin without known metastasis\r\n* Carcinoma in situ of the breast (ductal carcinoma in situ [DCIS] or lobular carcinoma in situ [LCIS])\r\n* Carcinoma in situ of the cervix\r\n* Any cancer without distant metastasis that has been treated successfully, without evidence of recurrence or metastasis for over 5 yearsXx_NEWLINE_xXPatient must not have a history of other malignancy =< 2 years previous with the exception of basal cell or squamous cell carcinoma of the skin which was treated with local resection only, an in situ malignancy, or low-risk prostate cancer after curative therapyXx_NEWLINE_xXHave systemic collagen vascular disorder, systemic autoimmune disease, an organ transplant or diagnosis of cancer within 5 years other than CTCL (not including basal cell carcinoma, non-invasive squamous cell cancer of the skin, malignant melanoma in situ, or cervical carcinoma in situ)Xx_NEWLINE_xXDiagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapyXx_NEWLINE_xXHistologic confirmation of renal cell carcinoma (RCC) with clear-cell componentXx_NEWLINE_xXOther malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skinXx_NEWLINE_xXPathologic subtypes other than pure adenocarcinoma; acinar cell carcinoma, squamous cell carcinoma, spindle cell carcinoma, neuroendocrine cancer, and mixed types are not eligible.Xx_NEWLINE_xXHistory of other clinically active malignancy within 5 years of enrollment, except for tumors with a negligible risk for metastasis or death, such as adequately controlled basal-cell carcinoma or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix or breastXx_NEWLINE_xXNo active malignancy other than NSCLC; patients with a history of basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix, or ductal or lobular carcinoma in situ of the breast within the past 3 years must have been treated with curative intent; patients with a history of prior malignancy are eligible provided they were treated with curative intent and have been free of disease for > 3 yearsXx_NEWLINE_xXTreatment for other invasive carcinomas within the last five years with greater than 5% risk of recurrence at time of eligibility screening; carcinoma in-situ and basal cell carcinoma/squamous cell carcinoma of the skin are allowedXx_NEWLINE_xXPatients without sarcoma, renal cell carcinoma, or melanomaXx_NEWLINE_xXHistory of other malignancies unless a.) the patient has undergone definitive treatment more than 5 years prior and is without evidence of recurrent malignant disease or b.) had basal or squamous cell carcinoma of the skin; superficial carcinoma of the bladder; carcinoma of the prostate with current prostat specific antigen < 0.1 ng/mL; ductal carcinoma in situ; or cervical intraepithelial neoplasia.Xx_NEWLINE_xXOther malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skinXx_NEWLINE_xXDisease free of prior malignancies for >= 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix or breastXx_NEWLINE_xXDiagnosis of any second malignancy within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer, or for in situ carcinoma of the cervix uteri or breastXx_NEWLINE_xXPatients who have been diagnosed with a second cancer (except carcinoma in situ of the cervix and basal cell carcinoma of the skin) which is currently active or has been treated within three years prior to screeningXx_NEWLINE_xXPatients who have a synchronous malignancy or who have been progression-free less than 5 years for a metachronous malignancy (Patients with basal and squamous cell carcinoma of the skin, as well as carcinoma in situ, and intramucosal carcinoma cured by local treatment, are eligible for the study)Xx_NEWLINE_xXDisease free of prior malignancies for >= 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma “in situ” of the cervix or breastXx_NEWLINE_xXDiagnosis of other invasive carcinomas within the last 5 years with greater than 5% risk of recurrence at time of eligibility screening; carcinomas in-situ and basal cell carcinoma/squamous cell carcinoma of the skin are allowedXx_NEWLINE_xXPatients with prior, unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skinXx_NEWLINE_xXOther malignancies within the last 5 years, except for carcinoma in situ of the cervix or basal cell carcinomaXx_NEWLINE_xXPatients with other malignancies diagnosed within 2 years prior to study registration; skin squamous or basal cell carcinoma are exceptionsXx_NEWLINE_xXOther malignancy within the past 3 years, except for the following, if treated and not active: basal cell or nonmetastatic (non-spreading) squamous cell carcinoma of the skin, cervical carcinoma or International Federation of Gynecology and Obstetrics Stage 1 carcinoma of the cervixXx_NEWLINE_xXDisease free of prior malignancies for > = 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, carcinoma \in situ\ of the cervix or breast, or localized prostate cancer.Xx_NEWLINE_xXPrior malignancy within the past 3 years other than complete resection of basal or squamous cell carcinoma of the skin, any in situ malignancy, or low-risk prostate cancer after curative therapyXx_NEWLINE_xXActive second malignancy except localized prostate cancer, basal cell carcinoma of the skin and carcinoma in situ of the skin or cervixXx_NEWLINE_xXPrior or simultaneous malignancies within the past two years (other than cutaneous squamous or basal cell carcinoma, melanoma in situ or thyroid carcinoma)Xx_NEWLINE_xXPatients with another malignancy that was treated within the last three years with the exceptions of localized basal cell carcinoma and cervical carcinomaXx_NEWLINE_xXHistory of prior invasive malignant cancer(s) within the last 5 years except adequately treated or controlled basal cell or squamous cell carcinoma of the skinXx_NEWLINE_xXPatients with any concurrent active malignancies as defined by malignancies requiring any therapy other than expectant observation, with the exception of squamous and basal cell carcinoma of skinXx_NEWLINE_xXOther malignancy (with the exception of cervical carcinoma in situ or basal cell carcinoma of the skin) for which there has been treatment within the last 3 yearsXx_NEWLINE_xXWomen with clinical stage IB2-IVA cervical squamous cell carcinoma, adenosquamous, or adenocarcinomaXx_NEWLINE_xXRadiographic evidence of nonmetastatic renal cell carcinomaXx_NEWLINE_xXHistological verification of clear cell renal cell carcinoma (note: this will be confirmed post informed consent)Xx_NEWLINE_xXHistory of prior other malignancy with the exception of curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix at any time prior to studyXx_NEWLINE_xXHistory of other malignancy < 5 years with the exception of basal cell or squamous cell carcinoma of the skin treated with local resection only, limited stage prostate cancer treated with surgery or radiation therapy with currently undetectable prostate-specific antigen (PSA), or carcinoma in situ of the cervixXx_NEWLINE_xXOther malignancy within last 5 years except for the following: curatively treated basal cell/squamous cell skin cancer, carcinoma in situ of the cervix, superficial transitional cell bladder carcinoma, or in situ ductal carcinoma of the breast after complete resectionXx_NEWLINE_xXOther malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skinXx_NEWLINE_xXPatients must have persistent or recurrent squamous or non-squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix with documented disease progression (disease not amenable to curative therapy); histologic confirmation of the original primary tumor is required via the pathology reportXx_NEWLINE_xXPatients must have histologically-proven (T2, T3, or T4a) urothelial carcinoma of the bladder (UCB) that requires primary radical cystectomy for definitive treatment; patients must not have clinical stage consistent with a low-risk of node metastasis (carcinoma in situ [CIS] only, T1); patients with a T4b (fixed lesion) are not eligible for this study; NOTE: Patients with predominant urothelial carcinoma with elements of adenocarcinoma, squamous cell carcinoma, micropapillary or minor components of other rare phenotypes are eligible; patients with predominantly small cell, squamous cell, or adenocarcinoma histologies are not eligible; patients with other non-urothelial cancers are not eligible (e.g., sarcoma, lymphoepithelial, nested variant); clinical stage is based on all of the following: transurethral resection of bladder tumor(s) (TURBT[s]) that determined the need for cystectomy, bimanual exam and cross sectional imagingXx_NEWLINE_xXDiagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, low-risk prostate cancer, or cancer after curative treatmentXx_NEWLINE_xXPatients with previous history of malignancy within the last 5 years except curatively treated squamous or basal cell carcinoma of the skin or curatively treated carcinoma in-situ of other organsXx_NEWLINE_xXPatient must be disease free of prior malignancies for >= 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma “in situ” of the cervix or breastXx_NEWLINE_xXDisease free of prior malignancies for >= 2 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix or breastXx_NEWLINE_xXConcurrent malignancy (excluding basal and squamous cell skin cancers)Xx_NEWLINE_xXCurrent coexisting malignancy other than basal cell carcinomaXx_NEWLINE_xXPrior history of other malignancies (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless disease free for > = 5 years.Xx_NEWLINE_xXDiagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy.Xx_NEWLINE_xXDisease free of prior malignancies for >= 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma \in situ\ of the cervix or breastXx_NEWLINE_xXPatients must be disease-free of prior invasive malignancies for >= 5 years with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervixXx_NEWLINE_xXPrevious malignant disease (other than target malignancy to be investigated in this trial) within the last 5 years, with the exception of basal or squamous cell carcinoma of the skin.Xx_NEWLINE_xXHistological or cytological confirmation of renal cell carcinoma (RCC) with a clear-cell componentXx_NEWLINE_xXActive malignancy (except for RCC, definitively treated basal or squamous cell carcinoma of the skin, and carcinoma in-situ of the cervix or bladder) within the past 24 months. Subjects with history of localized & low risk prostate cancer are allowed in the study if they were treated with curative intent and there is no prostate specific antigen (PSA) recurrence within the past 5 yearsXx_NEWLINE_xXSubjects with treated limited stage basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the breast or cervix are eligible; subjects with prior cancer treated with a curative intent with no evidence of recurrent disease 5 years following diagnosis and judged by the investigator to be at low risk of recurrence are eligible; subjects with any other concomitant or prior invasive malignancies are ineligibleXx_NEWLINE_xXPrior malignancies at sites other than the head and neck are allowable if there has been greater than or equal to a 3 year disease free interval; basal cell carcinoma of the skin and in-situ cervix dysplasias are allowable within this 3 year interval if completely resectedXx_NEWLINE_xXHistology other than squamous cell carcinomaXx_NEWLINE_xXPatients must have pathological diagnosis of renal cell carcinoma that is metastatic or surgically unresectable; the histology must be clear cell carcinoma or predominant clear cell carcinomaXx_NEWLINE_xXDisease free of prior malignancies for >= 2 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma \in situ\ of the cervix or breast or low risk prostate cancer after curative therapyXx_NEWLINE_xXHistory of another malignancy within the past five years, with the exception of basal skin carcinoma or cervical carcinoma in situ or completely resected colonic polyps carcinoma in situXx_NEWLINE_xXPast or present history of malignant tumors other than KS unless: a) in a complete remission for >= 1 year from the time a response was first documented; b) completely resected basal cell carcinoma; or c) in situ squamous cell carcinoma of the cervix or anusXx_NEWLINE_xXBasal cell carcinoma of the skinXx_NEWLINE_xXSquamous cell carcinoma of the skinXx_NEWLINE_xXCarcinoma in situ of the cervixXx_NEWLINE_xXCarcinoma in situ of the breastXx_NEWLINE_xXDiagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapyXx_NEWLINE_xXBasal cell carcinoma of the skinXx_NEWLINE_xXSquamous cell carcinoma of the skinXx_NEWLINE_xXCarcinoma in situ of the cervixXx_NEWLINE_xXCarcinoma in situ of the breastXx_NEWLINE_xXHistologically confirmed primary adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma of the uterine cervix;Xx_NEWLINE_xXAny histology other than adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma of the uterine cervix;Xx_NEWLINE_xXPatients with a history of another neoplastic disease within the past three years, excluding basal cell carcinoma of the skin, cervical carcinoma in situ, or nonmetastatic prostate cancerXx_NEWLINE_xXActive secondary malignancy other than skin cancer (e.g., basal cell carcinoma or squamous cell carcinoma) that in the investigator's opinion will shorten survival to less than 1 yearXx_NEWLINE_xXDiagnosis of any second malignancy within the last 3 years, except for adequately treated basal cell carcinoma, or squamous cell skin carcinoma or in situ cervical carcinoma.Xx_NEWLINE_xXOther than the primary malignancy, active cancer (either concurrent or within the last 3 years) that requires non-surgical therapy (e.g., chemotherapy or radiation therapy), with the exception of surgically treated basal or squamous cell carcinoma of the skin, melanoma in situ, or carcinoma in-situ of the cervixXx_NEWLINE_xXAdequately treated basal cell carcinoma, squamous cell carcinoma, or in situ cervical cancerXx_NEWLINE_xXHas a solid tumor likely to exhibit elevated levels of EGFR (e.g. head and neck squamous cell carcinoma, non-small cell lung cancer, triple negative breast cancer ,colorectal carcinoma and glioblastoma multiforme).Xx_NEWLINE_xXIslet cell or acinar cell carcinoma or cystadenocarcinomaXx_NEWLINE_xXMalignancy within the 2 years prior to treatment, excluding adequately treated squamous cell skin cancer, basal cell carcinoma, and carcinoma in situ; treatment must have been completed (with the exception of hormonal therapy for breast cancer) with cure/remission status verified for at least 2 years at time of treatmentXx_NEWLINE_xXDiagnosis of small cell carcinoma of the lung, squamous cell carcinoma of the lung or NSCLC NOSXx_NEWLINE_xXConcurrent active malignancy other than adequately treated basal cell or squamous cell carcinoma of the skin or pre-invasive carcinoma of the cervix.Xx_NEWLINE_xXRecent (within 3 years) history of other malignancies, excluding basal cell carcinoma or squamous cell carcinoma of the skinXx_NEWLINE_xXDiagnosed or treated for another malignancy within 2 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapyXx_NEWLINE_xXPatients with a concurrent or prior malignancy are ineligible unless they are patients with curatively treated carcinoma-in-situ or basal cell carcinoma of the skin; patients who have been free of disease (any prior malignancy) for >= five years are eligible for this studyXx_NEWLINE_xXRecurrent or metastatic carcinoma of the nasopharynx, squamous cell carcinoma of unknown primary, squamous cell carcinoma that originated from the skin and salivary gland or paranasal sinus, non-squamous histologies (eg, mucosal melanoma)Xx_NEWLINE_xXDiagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in-situ malignancy, or low-risk prostate cancer after curative therapyXx_NEWLINE_xXActive secondary malignancy unless the malignancy is not expected to interfere with the evaluation of safety and is approved by the Medical Monitor. Examples of the latter include basal or squamous cell carcinoma of the skin, in-situ carcinoma of the cervix, and isolated elevation of prostate-specific antigen. Subjects with a completely treated prior malignancy and no evidence of disease for ? 2 years are eligible.Xx_NEWLINE_xXSquamous cell carcinoma in-situ of a single vocal cord (Tis) is eligibleXx_NEWLINE_xXAdequately treated basal cell carcinoma, squamous cell carcinoma, or in situ cervical cancerXx_NEWLINE_xXDiagnosis of advanced urothelial carcinoma, cervical cancer, cholangiocarcinoma or carcinomas of the biliary tree or squamous cell carcinoma of the head and neck.Xx_NEWLINE_xXNo previous or concurrent malignancy, other than curatively treated in situ squamous cell carcinoma of the cervix or basal cell carcinoma of the skin or non-active breast cancerXx_NEWLINE_xXConfirmed squamous cell carcinoma of the head and neck (oropharynx, oral cavity, hypopharynx, or larynx) or skinXx_NEWLINE_xXPatients must have a diagnosis of a metastatic renal cell carcinoma with a >= 50% clear cell componentXx_NEWLINE_xXConcomitant malignancies or previous non-melanoma malignancies within the last 1 year, with the exception of adequately treated basal or squamous cell carcinoma of the skin, or carcinoma in situ of the cervixXx_NEWLINE_xXOther malignancy within five years, unless the probability of recurrence of the prior malignancy is <5% as determined by the Principal Investigator based on available information. Patient's curatively treated for squamous and basal cell carcinoma of the skin or patients with a history of malignant tumor in the past that have been disease free for at least five years are also eligible for this study.Xx_NEWLINE_xXOther malignancies within the past 5 years other than basal cell skin cancer or carcinoma in situ of the cervixXx_NEWLINE_xXThe patient must have squamous cell carcinoma, adenocarcinoma or malignant salivary gland cancer (e.g. acinic cell, adenoid cystic, mucoepidermoid, salivary duct carcinoma) proven by histologic diagnosis; both mucosal and cutaneous cancers are eligibleXx_NEWLINE_xXPatients with non-squamous cell histologyXx_NEWLINE_xXDiagnosis or treatment for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, any in situ malignancy, or low-risk prostate cancer after curative therapyXx_NEWLINE_xXSecond malignancy other than non-basal cell carcinoma of the skin or in situ carcinoma of the cervix, unless the tumor was treated with curative intent at least two years previously and subject is in remissionXx_NEWLINE_xXPatients must have pathologically-confirmed, resectable, squamous cell carcinoma of the oral cavity, oropharynx, larynx or hypopharynxXx_NEWLINE_xXHistory of another malignancy within 3 years, except cured basal cell carcinoma of the skin or excised carcinoma in situ of the cervixXx_NEWLINE_xXPathologically proven (histologically or cytologically) diagnosis of squamous cell carcinoma (including histological variants like papillary squamous cell carcinoma and basaloid squamous cell carcinoma)Xx_NEWLINE_xXSecond primary malignancy; exceptions are 1) patient had a second primary malignancy but has been treated and disease free for at least 3 years, 2) in situ carcinoma (e.g. in situ carcinoma of the cervix), 3) non-melanomatous carcinoma of the skinXx_NEWLINE_xXPatients with tumors that have a component of small cell carcinomaXx_NEWLINE_xXSubjects with squamous cell carcinomaXx_NEWLINE_xXPrior malignancy (active within 5 years of screening) except basal cell or completely excised non-invasive squamous cell carcinoma of the skin, or in situ squamous cell carcinoma of the cervixXx_NEWLINE_xXPatients with a history of carcinoma in remission (on no therapy or on hormonal therapy for the adjuvant treatment of breast carcinoma or prostate carcinoma) are included in the studyXx_NEWLINE_xXPrevious or concomitant malignancy, except for basal-cell or squamous cell carcinoma of the skin or carcinoma-in-situ of the uterine cervix. Subjects with other malignancies are eligible if they have remained disease free for at least 2 years prior to study entry;Xx_NEWLINE_xXDisease free of prior malignancy for >= 5 years with the exception of curatively treated basal cell carcinoma of the skin or carcinoma in situ of the cervixXx_NEWLINE_xXMetastatic colorectal cancer or head and neck squamous cell carcinomaXx_NEWLINE_xXPast or current malignancy other than SCCHN, except for:\r\n* Cervical carcinoma stage 1B or less\r\n* Non-invasive basal cell and squamous cell skin carcinoma\r\n* Malignant melanoma with a complete response of a duration of > 10 years \r\n* Radically treated prostate cancer (prostatectomy or radiotherapy) with normal prostate specific antigen (PSA), and not requiring ongoing anti-androgen hormonal therapy\r\n* Other cancer diagnosis with a complete response of duration of > 5 yearsXx_NEWLINE_xXPrior malignancy or secondary malignancy within the prior 2 years (except in situ cervical cancer, squamous cell carcinoma or basal cell carcinoma of the skin).Xx_NEWLINE_xXPatients with renal cell carcinoma less than 4 cm in maximum diameter, who are poor surgical candidates are eligible for randomization between SBRT and RFA\r\n* Renal cell carcinoma must be pathologically provenXx_NEWLINE_xXPatients with bilateral renal cell carcinomaXx_NEWLINE_xXPatient is =< 2 years free of another primary malignancy; exceptions include the following:\r\n* Cervical carcinoma in situ\r\n* Anal carcinoma in situXx_NEWLINE_xXPrior malignancy within the past 3 years other than complete resection of basal or squamous cell carcinoma of the skin, any in situ malignancy, or low-risk prostate cancer after curative therapyXx_NEWLINE_xXHistory of other malignancy up to 5 years prior to study entry which could affect compliance with the protocol or interpretation of results. History of curatively treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix, low grade, early stage, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ (DCIS) of the breast treated with lumpectomy alone with curative intent, are generally eligible.Xx_NEWLINE_xXPatients with evidence of other cancer within 5 years, excluding adequately treated basal cell carcinoma or squamous cell carcinoma of the skinXx_NEWLINE_xXHistory of any other malignancy within 5 years (except basal cell carcinoma of the skin or carcinoma in situ of the cervix)Xx_NEWLINE_xXPresence or history of other neoplasms (treated during the last five years prior to study entry) other than carcinoma in situ of the cervix or basal carcinoma of the skinXx_NEWLINE_xXHistory of other malignancy within the last 5 years, except for carcinoma in situ of the cervix or basal cell carcinoma of the skinXx_NEWLINE_xXPrevious or concurrent malignancy with the following exceptions:\r\n* Carcinoma in situ\r\n* Adequately treated skin basal cell or squamous cell carcinoma (adequate wound healing is required prior to study entry)\r\n* In situ carcinoma of the cervix, treated curatively and without evidence of recurrence for at least 3 years prior to the study\r\n* A primary malignancy which has been completely resected and in complete remission for >= 5 yearsXx_NEWLINE_xXcarcinoma in situ of the cervix, orXx_NEWLINE_xXhistory of other invasive malignancy within 3 years except for cervical carcinoma in situ, nonmelanomatous carcinoma of the skin or ductal carcinoma in situ of the breast that has been surgically cured.Xx_NEWLINE_xXHave had at least 2 prior systemic treatments for renal cell carcinoma (RCC)Xx_NEWLINE_xXHistory of other malignancies within 5 years prior to enrollment except for tumors with a negligible risk for metastasis or death, such as adequately controlled basal cell carcinoma, squamous-cell carcinoma of the skin, carcinoma in situ of the cervix, early-stage bladder cancer, or low-grade endometrial cancer\r\n* Malignancies that have undergone a putative surgical cure (i.e., localized prostate cancer post-prostatectomy) within 5 years prior to enrollment may be discussed with the lead primary investigatorXx_NEWLINE_xXSubjects with known history and treatment of malignancy at any site within 2 years of initial prostate cancer diagnosis; with the exception of basal cell carcinoma (BCC)Xx_NEWLINE_xXPatients must have histologically or cytologically confirmed incurable malignancy that is surgically unresectable locally advanced, recurrent, or metastatic (stage IIIB/IV) non-small cell lung cancer (NSCLC); patients with adenocarcinoma, squamous cell carcinoma, large cell carcinoma and sarcomatoid carcinoma will be eligibleXx_NEWLINE_xXHistory of incurable malignancy other than NSCLC within the 5 years prior to start of treatment, with the exceptions of adequately treated intraepithelial carcinoma of the cervix uteri; prostate carcinoma with a prostate-specific antigen value < 0.2 ng/mL; or basal or squamous-cell carcinoma of the skinXx_NEWLINE_xXActive malignancies other than NSCLC within the last 5 years with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skinXx_NEWLINE_xXDiagnosed or treated for another malignancy within 3 years of enrollment, except completely resected basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy.Xx_NEWLINE_xXDiagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapyXx_NEWLINE_xXPrevious malignancy within the past 5 years except for basal or squamous cell carcinoma of the skin, melanoma in-situ, and carcinoma in-situ of the cervixXx_NEWLINE_xXHistory of previous or current malignancy at other sites with the exception of adequately treated carcinoma in-situ of the cervix or basal or squamous cell carcinoma of the skin; patients with a history of other malignancies, who remain disease free for greater than five years are eligibleXx_NEWLINE_xXOther malignancy within the last 5 years, except for carcinoma in situ of the cervix and basal or squamous cell carcinoma of the skinXx_NEWLINE_xXcarcinoma in situ of the cervixXx_NEWLINE_xXHave prior history of other malignancies, excluding basal cell carcinoma or squamous cell carcinoma of the skinXx_NEWLINE_xXHistologically confirmed NSCLC (adenocarcinoma, squamous cell carcinoma, large cell carcinoma, undifferentiated carcinoma or other)Xx_NEWLINE_xXBasal cell carcinoma of the skinXx_NEWLINE_xXDiagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapyXx_NEWLINE_xXParticipant is =< 2 years free of another primary malignancy; exceptions include the following:\r\n* Basal cell skin cancer \r\n* Cervical carcinoma in situ\r\n* Anal carcinoma in situXx_NEWLINE_xXPatients must have no concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix, breast, or bladder; patients with prior malignancies must be disease-free for >= five yearsXx_NEWLINE_xXPrior malignancy, except for adequately treated basal cell or squamous cell carcinoma of the skin, or thyroid cancer; carcinoma in situ of the cervix or breast; prostate cancer of Gleason grade 6 or less with stable prostate-specific antigen (PSA) levels (gonadotropin-releasing hormone [GnRH] analogs or androgen receptor blockers acceptable); or other cancers from which the subject has been disease-free for at least five yearsXx_NEWLINE_xXHistory of other malignancy that could affect compliance with the protocol or interpretation of results\r\n* Patients with a history of curatively treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix are generally eligible; patients with a malignancy that has been treated, but not with curative intent, will also be excluded, unless the malignancy has been in remission without treatment for >= 2 years prior to enrollmentXx_NEWLINE_xXPatients in the expansion portion must have:\r\n* Histologically confirmed diagnosis of metastatic:\r\n** Urothelial carcinoma of the bladder, urethra, ureter, renal pelvis, OR\r\n** Clear cell renal cell carcinoma OR\r\n** Adenocarcinoma of the bladder OR\r\n** Non-resectable squamous cell carcinoma of the penis OR\r\n** Squamous cell carcinoma of the bladder AND\r\n* Patients with urothelial cancer or renal cell carcinoma must have progressive metastatic disease defined as new or progressive lesions on cross-sectional imaging; patients must have at least:\r\n** One measurable site of disease (according to RECIST criteria) or bone disease by NaF PET/CTXx_NEWLINE_xXMerkel Cell CarcinomaXx_NEWLINE_xXSquamous cell carcinoma of the cervix, vagina, or vulvaXx_NEWLINE_xXSquamous cell carcinoma of the Head and NeckXx_NEWLINE_xXSquamous cell carcinoma of the anal canal and penileXx_NEWLINE_xXPathological finding consistent with small cell carcinoma of the prostate.Xx_NEWLINE_xXBasal cell carcinoma of the skin.Xx_NEWLINE_xXSquamous cell carcinoma of the skin.Xx_NEWLINE_xXCarcinoma in situ of the cervix.Xx_NEWLINE_xXCarcinoma in situ of the breast.Xx_NEWLINE_xXOther malignancies unless the patient is considered to be disease-free for 5 or more years prior to randomization and is deemed by the physician to be at low risk for recurrence; patients with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell or squamous cell carcinoma of the skinXx_NEWLINE_xXHistory of second malignancy, other than basal cell carcinoma of the skin or in situ carcinoma of the cervix or the breast, unless the tumor was successfully treated with curative intent at least 2 years before trial entryXx_NEWLINE_xXOther malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin, or low-risk prostate cancer after curative therapyXx_NEWLINE_xXCurrent treatment, or treatment in the previous 24 months, for another non-melanoma malignancy, with the exception of adequately treated basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ of the cervix; patients treated with curative intent for other malignancies within 24 months may be enrolled on a case by case basis after discussion/approval with the study PIXx_NEWLINE_xXPart B3: Renal cell carcinoma (any histology)Xx_NEWLINE_xXCancer, other than basal-cell or squamous-cell carcinoma of the skin;Xx_NEWLINE_xXPart B: Current active malignancies of other types, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin. Prior cancer in remission for 2 years or more would not be excluded.Xx_NEWLINE_xXDisease-free of active second/secondary or prior malignancies for equal to or more than (>=) 1 year with the exception of currently treated basal cell or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix or breastXx_NEWLINE_xXConcomitant malignancies except carcinoma in situ, basal or squamous cell skin carcinoma; low grade prostate cancer treated with prostatectomy more than 10 years ago; early stage melanoma treated with complete surgical excision more than 5 years ago; carcinoma in situ of cervix treated with cone procedure more than 8 years agoXx_NEWLINE_xXAny other current malignancy or previous malignancies within 3 years of enrollment except: curatively treated in situ carcinoma of the cervix uteri; localized basal or squamous cell carcinoma of the skin, curatively treated in situ breast carcinoma, and early stage prostate cancerXx_NEWLINE_xXDiagnosis for other invasive carcinomas (except basal cell carcinoma/squamous cell carcinoma of the skin) within the last five years unless deemed by the investigator to be at low risk for recurrence of that malignancy; carcinoma in-situ is allowedXx_NEWLINE_xXInvasive cancer other than ovarian cancer within 2 years (except basal or squamous cell carcinoma of the skin that has been definitely treated)Xx_NEWLINE_xXHead and neck squamous cell carcinomaXx_NEWLINE_xXDisease free of other malignancies beside the AML for >= 2 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma \in situ\ of the cervix or breastXx_NEWLINE_xXA history of another primary cancer that has been active or treated within the past 3 years prior to start of study treatment, with the exception of adequately treated/resected: basal cell or squamous cell skin carcinoma or actinic keratoses; or carcinoma in situ of the breast or of the cervix; or non-invasive malignant colon polypsXx_NEWLINE_xXPatients with variant histologies (e.g., ductal or small cell carcinoma)Xx_NEWLINE_xXNon-invasive basal cell or squamous cell skin carcinoma.Xx_NEWLINE_xXAn active second primary malignancy with the exception of basal cell or squamous cell skin carcinomaXx_NEWLINE_xXHistory of another malignancy within 5-years of date of HCT except history of basal cell or squamous cell carcinoma of skin or PV or ETXx_NEWLINE_xXConcurrent, clinically significant, active malignancies (excluding basal cell carcinoma or cervical intraepithelial neoplasia [CIN] in situ or melanoma in situ) (Stage II portion only)Xx_NEWLINE_xXSubject has any other malignancy within 5 years prior to signing the ICF. Exceptions include the following: squamous cell carcinoma of the skin, in-situ carcinoma of the cervix, uteri, non-melanomatous skin cancer, carcinoma in situ of the breast, or incidental histological finding of prostate cancer (Tumor, node and metastasis (TNM) stage of T1a or T1b). All treatment should have been completed 6 months prior to signing ICF.Xx_NEWLINE_xXA history of other malignancy =< 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervixXx_NEWLINE_xXOther active, invasive malignancy requiring ongoing therapy or expected to require systemic therapy within two years; localized squamous cell carcinoma of the skin, basal-cell carcinoma of the skin, carcinoma in-situ of the cervix, or other malignancies requiring locally ablative therapy only will not result in exclusionXx_NEWLINE_xXHistory of, or current brain metastasis. Any other malignancy within 5 years prior to randomization with the exception of adequately treated in situ carcinoma of the cervix, uteri, or non-melanomatous skin cancer (all treatment of which should have been completed 6 months prior to enrollment), in situ squamous cell carcinoma of the breast, or incidental prostate cancer.Xx_NEWLINE_xXDiagnosis of urothelial carcinomaXx_NEWLINE_xXHistological diagnosis of squamous cell carcinoma, adenocarcinoma or adenosquamous cell carcinoma of the cervix. Not accepted are small cell, clear cell and other rare variants of the classical adenocarcinoma;Xx_NEWLINE_xXCurrent malignancies at other sites, with the exception of adequately treated basal or squamous cell carcinoma of the skin;Xx_NEWLINE_xXInclusion Criteria:\n\n        Patient has a confirmed diagnosis of a select solid tumor (except with a primary diagnosis\n        of Urothelial cell carcinoma, Cholangiocarcinoma, Endometrial cancer, and Glioblastoma\n        multiforme) or hematologic malignancies and is in need of treatment because of progression\n        or relapse.\n\n        Patient's tumor has been evaluated and pre-identified as having a tumor with a FGFR genetic\n        alteration. The qualifying alteration must be assessed and reported by a CLIA-certified\n        laboratory.\n\n        Patient must have received at least one prior treatment for recurrent, metastatic and /or\n        locally advanced disease and for whom no standard therapy options are anticipated to result\n        in a durable remission.\n\n        Patient must have progressive and measurable disease per RECIST 1.1. or other appropriate\n        hematological response criteria.\n\n        Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ? 1\n\n        Exclusion Criteria:\n\n        Patient has received prior treatment with BGJ398\n\n        Patients with Central Nervous System (CNS) metastasis or leptomeningeal carcinomatosis\n\n        Patient has received chemotherapy or other anticancer therapy ? 4 weeks (6 weeks for\n        nitrosourea, antibodies or mitomycin-C) prior to starting study drug.\n\n        Patients with acute or chronic pancreatitis\n\n        Patients with impaired cardiac function or clinically significant cardiac diseases\n\n        History and/or current evidence of extensive tissue calcification\n\n        Use of medications that increase serum levels of phosphorus and/or calcium\n\n        Current evidence of corneal or retinal disorder/keratopathy\n\n        History and/or current evidence of renal or endocrine alterations of calcium/phosphate\n        homeostasis\n\n        Patients with another primary malignancy within 3 years prior to starting study treatment,\n        with the exception of adequately treated basal cell carcinoma, squamous cell carcinoma or\n        other non-melanomatous skin cancer, or in-situ carcinoma of the uterine cervixXx_NEWLINE_xXPatients must have histologically or cytologically proven primary non-squamous non-small cell lung cancer (adenocarcinoma, large cell carcinoma, adenocarcinoma in situ, mixed histology with < 50% squamous or unspecified); patients with tumors having squamous cell components >= 50% are not eligible; disease must be stage IVXx_NEWLINE_xXPatients diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, or an in situ malignancyXx_NEWLINE_xXConcomitant malignancies or previous malignancies (other than multiple myeloma) with less than a 2-year disease-free interval at the time of first dose of study drug. Patients with adequately resected basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, or Stage 1 prostate cancer are eligible irrespective of the time of diagnosis.Xx_NEWLINE_xXDiagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapyXx_NEWLINE_xXPrevious or concurrent malignancy with the following exceptions: \r\n* Adequately treated skin basal cell or squamous cell carcinoma (adequate wound healing is required prior to study entry)\r\n* In situ carcinoma of the cervix, treated curatively and without evidence of recurrence\r\n* A primary malignancy which has been completely resected and in complete remission for >= 1 yearsXx_NEWLINE_xXCuratively treated cervical carcinoma in situ.Xx_NEWLINE_xXDisease-free period of > 3 years from any other previous malignancies, excluding curatively treated basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix.Xx_NEWLINE_xXOther invasive malignancy within 2 years except for noninvasive malignancies such as cervical carcinoma in situ, non-melanomatous carcinoma of the skin or ductal carcinoma in situ of the breast that has/have been surgically curedXx_NEWLINE_xXSquamous, small cell, carcinoid, adenosquamous, large-cell neuroendocrine, or mixed histology containing small-cell or squamous-cell NSCLCXx_NEWLINE_xXConcomitant malignancies or previous malignancies (other than multiple myeloma) with less than a 2-year disease-free interval at the time of first dose of study treatment. Patients with adequately resected basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, or Stage 1 prostate cancer are eligible irrespective of the time of diagnosis.Xx_NEWLINE_xXHistory of other malignancy =< 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only, carcinoma in situ of the cervix, or localized prostate cancerXx_NEWLINE_xXDoes the patient have a history of prior malignancy, excluding basal or squamous cell carcinoma of the skin, with an expected survival of less than five years?Xx_NEWLINE_xXSubjects with treated limited stage basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the breast or cervix are eligible; subjects with prior cancer treated with a curative intent with no evidence of recurrent disease 5 years following diagnosis and judged by the investigator to be at low risk of recurrence are eligible; subjects with any other concomitant or prior malignancies are ineligibleXx_NEWLINE_xXA history of other malignancy =< 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervixXx_NEWLINE_xXHad a malignancy within 2 years, except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated;Xx_NEWLINE_xXNo non-breast malignancy within the past 5 years other than treated squamous or basal cell carcinoma of the skin or carcinoma in situ (CIS) of the cervixXx_NEWLINE_xXAny other malignancy that required active chemotherapy within the previous 12 months prior to registration and the disease is not currently progressing and/or metastatic; the exception is basal cell or squamous cell carcinoma of the skin, which were treated with local resection only or carcinoma in situ of the cervixXx_NEWLINE_xXPatients with advanced histologically proven squamous cell carcinoma of the lungXx_NEWLINE_xXAny previous malignancy treated with curative intent and the subject has been disease free for less than 5 years prior to randomization, with exception of Carcinoma?in?situ of the cervix, Squamous carcinoma of the skin, Basal cell carcinoma of the skin.Xx_NEWLINE_xXThe patient has an active second malignancy other than curatively resected basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ carcinoma of the cervix, or other cancers for which they are treated with curative intent, and no known active disease in the 3 years prior to enrollment.Xx_NEWLINE_xXCurrent diagnosis of another malignancy within 2 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapyXx_NEWLINE_xXPatients with additional (other than AML) currently active primary malignancy other than curatively treated carcinoma in situ (CIS) of the cervix, or basal or squamous cell carcinoma of the skin; patients are not considered to have a \currently active\ malignancy if they have completed therapy for a prior malignancy and disease free from prior malignancies for > 2 yearsXx_NEWLINE_xXHistopathologic confirmation that at least one of the three target lesions is basal cell carcinomaXx_NEWLINE_xXAny metastatic basal cell carcinomaXx_NEWLINE_xXDiagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapyXx_NEWLINE_xXBasal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix within the past five years treated with curative intent. History of prior malignancy are eligible if disease-free for >3 years.Xx_NEWLINE_xXPatients with histologic evidence of small cell carcinoma of the prostate will not be eligibleXx_NEWLINE_xXDisease free of prior malignancies for >= 3 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma “in situ” of the cervix or breastXx_NEWLINE_xXDiagnosed or treated for another malignancy within 2 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapyXx_NEWLINE_xXPatients must have histological or cytological confirmed malignancy in the following disease groups: melanoma, non-small cell lung carcinoma, renal cell carcinoma or squamous cell head and neck carcinoma, for which no standard effective or curative options are availableXx_NEWLINE_xXPatient must not have a history of other malignancy =< 3 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervixXx_NEWLINE_xXDisease-free of active second/secondary or prior malignancies for equal to or over 5 years with the exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma \in-situ\ of the cervix or breastXx_NEWLINE_xXHistory of another malignancy within 3 years, except cured basal cell carcinoma of the skinXx_NEWLINE_xXPatients with another primary malignancy within 3 years prior to starting study drug, with the exception of adequately treated in-situ carcinoma of the uterine cervix, or skin cancer (such as basal cell carcinoma, squamous cell carcinoma, or non-melanomatous skin cancer)Xx_NEWLINE_xXPatients with a prior malignancy within the last 5 years (except for basal or squamous cell carcinoma, or in situ cancer of the cervix)Xx_NEWLINE_xXConcomitant malignancies or previous malignancies with less than a 5-year disease-free interval at the time of enrollment; patients with adequately resected basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or ductal carcinoma in situ may enroll irrespective of the time of diagnosis.Xx_NEWLINE_xXPatients must have no concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix, breast, or bladder; patients with prior malignancies must be disease-free for >= five yearsXx_NEWLINE_xXThe subject has a pathologic diagnosis of non-small cell lung carcinoma that is metastatic or unresectableXx_NEWLINE_xXDocumented histological or cytological diagnosis of renal cell carcinoma with a clear-cell componentXx_NEWLINE_xXDiagnosis of high-grade (WHO Grade 3) or poorly differentiated NET; high-grade neuroendocrine carcinoma; large cell neuroendocrine carcinoma, small cell carcinoma, or mixed small and large cell carcinoma.Xx_NEWLINE_xXParticipants must have one of the following tumor types: NSCLC, UC, HNSCC, TNBC, RCC, melanoma, cervical cancer, anal cancer, Merkel-cell carcinoma, microsatellite instability (MSI)-High tumors, squamous cell carcinoma of the skin, hepatocellular carcinoma (non-viral), and CRC including microsatellite stable (MSS) and MSI-LowXx_NEWLINE_xXPatients must have histologically or cytologically documented salivary gland cancers; patients that do not have a salivary gland primary must have one of the following histologies - adenoid cystic carcinoma, mucoepidermoid carcinoma, acinic cell carcinomaXx_NEWLINE_xXPatients must have histologically confirmed metastatic or unresectable renal cell carcinoma; predominant clear cell component is required; pure papillary and chromophobe renal cell carcinoma, collecting duct tumors and transitional cell carcinoma are not eligibleXx_NEWLINE_xXOther malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skinXx_NEWLINE_xXTumors with squamous cell histologyXx_NEWLINE_xXMalignancies other than SCCHN within 5 years prior to randomization, with the exception of adequately treated basal or squamous cell skin cancer and carcinoma in situ of the cervixXx_NEWLINE_xXcarcinoma in situ of the cervixXx_NEWLINE_xXOther past or current malignancy (with the exception of basal cell carcinoma of the skin or in situ carcinoma of the cervix or breast) unless the tumour was successfully treated with curative intent at least 2 years prior to trial entry.*Xx_NEWLINE_xXHistological confirmation (by biopsy or cytology) or clinically diagnosed primary NSCLC; the following primary cancer types are eligible: squamous cell carcinoma, adenocarcinoma, large cell carcinoma, bronchioloalveolar cell carcinoma, or non-small cell carcinoma not otherwise specifiedXx_NEWLINE_xXPatients with histologic evidence of small cell carcinoma of the prostate will not be eligibleXx_NEWLINE_xXDiagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy; patients with prior malignancies must be disease free for at least 5 yearsXx_NEWLINE_xXSmall cell carcinoma of the prostateXx_NEWLINE_xXDiagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapyXx_NEWLINE_xXPotential participants who meet any of the following criteria will be excluded from participating in the study: Prior exposure to trabectedin or dacarabazine, less than 3 weeks from last dose of systemic cytotoxic therapy, radiation therapy, or therapy with any investigational agent, other malignancy within past 3 years. Exceptions: basal or nonmetastatic squamous cell carcinoma of the skin, cervical carcinoma in situ, or Federation Internationale de Gynecologie et d'Obstetrique (FIGO) Stage 1 carcinoma of the cervixXx_NEWLINE_xXPotential participants who meet any of the following criteria will be excluded from Participating in the study: Prior exposure to trabectedin, less than 3 weeks from last dose of systemic cytotoxic therapy, radiation therapy, or therapy with any investigational agent, other malignancy within past 3 years. Exceptions: basal or nonmetastatic squamous cell carcinoma of the skin, cervical carcinoma in situ, or Federation Internationale de Gynecologie et d'Obstetrique (FIGO) Stage 1 carcinoma of the cervix does not applyXx_NEWLINE_xXPatient has a history of other malignancies unless has undergone definitive treatment more than 5 yrs prior to study and without evidence of recurrent malignant disease (excluding basal cell carcinoma of the skin; superficial carcinoma of the bladder; carcinoma of the prostate with a current prostate-specific antigen <0.1 ng/mL; or cervical intraepithelial neoplasia).Xx_NEWLINE_xXHistory of previous or current malignancy at other sites with the exception of adequately treated carcinoma in-situ of the cervix or basal or squamous cell carcinoma of the skin; patients with a history of other malignancies, who remain disease free for greater than five years are eligibleXx_NEWLINE_xXAnother primary malignancy (other than squamous cell and basal cell carcinoma of the skin, in situ carcinoma of the cervix, or treated prostate cancer with a stable prostate specific antigen [PSA]) for which the patient has not been disease free for at least 3 yearsXx_NEWLINE_xXConcurrent active malignancy other than adequately treated basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix. A participant with previous history of malignancy other than NSCLC is eligible, provided that he/she has been free of disease for ? 3 yearsXx_NEWLINE_xXhistory of prior malignancy, excluding basal or squamous cell carcinoma of the skin, with an expected survival of less than 5 years.Xx_NEWLINE_xXHistologically confirmed non-small cell lung cancer (NSCLC) or metastasis from another known or unknown primary by biopsy, or recurrent tumors in the setting of prior RFA/microwave or cryotherapy; eligible histological subtypes include: squamous cell carcinoma, adenocarcinoma, large cell neuroendocrine, and non-small cell carcinoma not otherwise specifiedXx_NEWLINE_xXHistological or cytological proof of component (any percent) of clear cell RCC (renal cell carcinoma).Xx_NEWLINE_xXPatients must have a tissue diagnosis of low, intermediate or high grade ductal carcinoma in situ or ductal carcinoma in situ with microinvasion.Xx_NEWLINE_xXHistory of other malignancy unless the malignancy has been in remission without treatment for >/=2 years prior to enrolment, and except for carcinoma in situ of the cervix, basal or squamous cell skin cancer, surgically treated low-grade prostate cancer, or ductal carcinoma in situ (DCIS) of the breast treated with lymphectomy aloneXx_NEWLINE_xXHistory of malignancies other than prostate cancer within the past 5 years, with the exception of treated basal cell/squamous cell carcinoma of the skinXx_NEWLINE_xXConcomitant malignancies or previous malignancies within the last 5 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervixXx_NEWLINE_xXNo patients with history within the last 5 years of previous or current malignancy at other sites with the exception of adequately treated carcinoma in-situ of the cervix or basal or squamous cell carcinoma of the skin; patients with a history of other malignancies who remain disease free for greater than five years are eligibleXx_NEWLINE_xXBasal cell carcinoma of the skinXx_NEWLINE_xXSquamous cell carcinoma of the skinXx_NEWLINE_xXCarcinoma in situ of the cervixXx_NEWLINE_xXCarcinoma in situ of the breastXx_NEWLINE_xXEvidence of metastatic disease or other malignancy (except squamous or basal cell skin cancers).Xx_NEWLINE_xXOther coexisting malignancies or malignancies diagnosed within the last 5 years, with the exception of basal cell carcinoma, squamous cell carcinoma of the skin, or cervical cancer in situ.Xx_NEWLINE_xXDiagnosis of any second malignancy within the last 5 years, except basal cell carcinoma, squamous cell skin cancer, or in situ carcinoma of the cervix uteri that has been adequately treated with no evidence of recurrent disease for 12 monthsXx_NEWLINE_xXPrevious malignancy within 3 years prior to enrollment, except for curatively-treated basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, bladder carcinoma in situ or breast cancer in situXx_NEWLINE_xXHistologically document transitional cell carcinoma with the presence of any of the following stages: carcinoma in situ (CIS), high-grade Ta, or any grade T1, detectable at the time of study accrual; combinations of the aforementioned stages are acceptable; subjects with mixed histology are required to have a dominant transitional cell carcinoma (TCC) patternXx_NEWLINE_xXRecurrent or metastatic carcinoma of the nasopharynx and paranasal sinuses, squamous cell carcinoma that originated from the skin and salivary gland or non-squamous histologies (e.g., mucosal melanoma) and SCCHN of unknown primary origin.Xx_NEWLINE_xXPatients with another active malignancy within the past five years except for carcinoma in situ of cervix or in situ carcinoma of the bladder or non-melanomatous carcinoma of the skinXx_NEWLINE_xXActive secondary malignancy other than skin cancer (e.g., basal cell carcinoma or squamous cell carcinoma) that in the investigator’s opinion will shorten survival to less than 1 yearXx_NEWLINE_xXPatients with another malignancy, unless they have been disease free for 2 years prior to registration, with the exception of\r\n* Basal cell or non-metastatic squamous cell carcinoma of the skin\r\n* Cervical carcinoma in situ or International Federation of Gynecology and Obstetrics (FIGO) stage 1 carcinoma of the cervixXx_NEWLINE_xXA history of other malignancy =< 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervixXx_NEWLINE_xXMalignant disease, other than that being treated in this study\r\n* Exceptions to this exclusion criterion include the following: malignancies that were treated curatively, and have not recurred within 3 years prior to study entry; completely resected basal cell and squamous cell skin cancers; and completely resected carcinoma in situ of any typeXx_NEWLINE_xXPhase II: Diagnosis of any second malignancy within the last 3 years except for adequately treated basal cell carcinoma, or squamous cell skin carcinoma or in-situ cervical carcinomaXx_NEWLINE_xXDiagnosis of prior malignancy within the past 2 years with the exception of successfully treated basal cell carcinoma, squamous cell carcinoma of the skin, carcinoma \in situ\ of the cervix or breast; history of other malignancies are allowed if in remission (including prostate cancer patients in remission from radiation therapy, surgery or brachytherapy), not actively being treated, with a life expectancy > 3 yearsXx_NEWLINE_xXA history of other malignancy =< 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervixXx_NEWLINE_xXPatients with Tl/T2 squamous cell carcinoma of the oral cavity with or without extension to the oropharynxXx_NEWLINE_xXAnother primary malignancy =< 3 years prior to starting study treatment, with the exception of adequately treated basal cell carcinoma, squamous cell carcinoma or other non-melanomatous skin cancer, or in-situ carcinoma of the uterine cervixXx_NEWLINE_xXPatients must be disease-free of other prior invasive malignancies for >= 5 years with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix; prior early stage breast cancers are also allowed as long as prior treatment did not include aromatase inhibitorsXx_NEWLINE_xXNo other malignancy within 5 years of registration with the exception of basal cell or squamous cell carcinoma of the skin treated with local resection only or carcinoma in situ of the cervixXx_NEWLINE_xXPatients with previous or concomitant non-breast invasive malignancy; exceptions are limited exclusively to patients with the following previous malignancies, if adequately treated: basal or squamous cell carcinoma of the skin, in situ non-breast carcinoma, contra- or ipsilateral in situ breast carcinoma, stage Ia carcinoma of the cervixXx_NEWLINE_xXPatients with a histologic diagnosis of squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma of the cervix, stage IA1 (lymph-vascular space invasion [LVSI]+), IA2, and IB1 (tumor size [maximum visible or palpable]) =< 2 cm), any gradeXx_NEWLINE_xXPast history of a cancer diagnosis (excluding basal cell skin carcinoma)Xx_NEWLINE_xXHistory of other clinically active malignancies within 5 years, except for carcinoma in situ of the cervix, basal cell carcinoma, or squamous carcinoma of the skin.Xx_NEWLINE_xXCarcinoma in-situ and tumors determined to be T1-2N0Xx_NEWLINE_xXPrior malignancy (other than basal cell/squamous cell carcinoma of the skin, in-situ cervical carcinoma or superficial transitional cell bladder carcinoma) diagnosed and/or treated within three years of study entryXx_NEWLINE_xXPredominant clear cell renal cell carcinoma (RCC)Xx_NEWLINE_xXOther active malignancy (except definitively treated melanoma in-situ, basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix or bladder) within the past 24 monthsXx_NEWLINE_xXMalignancies other than RCC within 2 years of first study treatment with the exception of those with negligible risk of metastases or death (included but not limited to carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer, ductal carcinoma in situ of the breast, non-muscle invasive urothelial carcinoma, or other malignancy not deemed to impact that patients 5-year life expectancy)Xx_NEWLINE_xXSquamous cell NSCLCXx_NEWLINE_xXBe free of any recurrence of cancer; and have no other cancers within five years of enrollment except for basal cell or squamous cell tumors of the skin that have been surgically excisedXx_NEWLINE_xXPatients must have no concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix, breast, or bladder; patients with prior malignancies must be disease-free for >= five yearsXx_NEWLINE_xXHave a pathologic diagnosis of squamous cell carcinoma of the head and neck regionXx_NEWLINE_xXMultiple cancers except basal cell carcinomaXx_NEWLINE_xXSubjects with an invasive malignancy over the previous 2 years except treated basal or squamous carcinomas of the skin completely resected intraepithelial carcinoma of the cervix and completely resected papillary thyroid and follicular thyroid cancers; other completely resected cancers greater than 2 years may be considered after review by the principal investigator (PI)Xx_NEWLINE_xXOther malignancies within the past three years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skinXx_NEWLINE_xXPatients with squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx will be eligibleXx_NEWLINE_xXHead and neck cancers of non-squamous histology (e.g., adenoid cystic carcinoma, acininc cell carcinoma, adenocarcinoma, sarcoma)Xx_NEWLINE_xXNot on any active therapy for other malignancies with the exception of topical therapies for basal cell or squamous cell cancers of the skinXx_NEWLINE_xXPatients with active malignancies other than NSCLC or prior curatively treated malignancy at high risk of relapse during the study period with the exception of localized squamous or basal cell skin cancersXx_NEWLINE_xXHas a history of other malignancy within the 3 years prior to screening, except adequately treated basal cell or squamous cell carcinoma of the skin, or carcinoma in-situ;Xx_NEWLINE_xXSubjects with concomitant or previous malignancies within the last 5 years are excluded from the study; exceptions include: adequately treated basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, and ductal carcinoma in situ (DCIS)Xx_NEWLINE_xXT0-3, N0 to N2c, M0 squamous cell carcinoma of the oropharynxXx_NEWLINE_xXBiopsy proven squamous cell carcinoma that is HPV and/or p16 positiveXx_NEWLINE_xXDiagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapyXx_NEWLINE_xXPatient must not have a history of other malignancy =< 2 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervixXx_NEWLINE_xXSubjects with a history of prior malignancy other than HL, NHL, or MM that have not been in remission for >5 years, with the exception of basal cell or squamous cell carcinoma, cervical carcinoma in situ on biopsy, or localized prostate cancer (Gleason score <5)Xx_NEWLINE_xXDisease free of prior malignancies for 3 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma \in situ\ of the cervix or breast; patients with malignancies with indolent behavior such as prostate cancer treated with radiation or surgery can be enrolled in the study as long as they have a reasonable expectation to have been cured with the treatment modality receivedXx_NEWLINE_xXHistory of rectal cancer or neoplastic polyp (i.e. intramucosal carcinoma, carcinoma in situ)Xx_NEWLINE_xXHistologically or cytologically documented NSCLC, including squamous cell carcinoma, adenocarcinoma (including bronchoalveolar cell), and large cell anaplastic carcinoma (including giant and clear cell carcinomas) and poorly differentiated non-small cell lung cancer; totally resected tumors are excludedXx_NEWLINE_xXHave not been diagnosed with a prior cancer within the recent 5 years, except basal or squamous cell skin carcinomaXx_NEWLINE_xXPatients must be diagnosed with oropharyngeal squamous cell carcinoma (SCC) that are surgical candidatesXx_NEWLINE_xXHave small cell carcinoma or neuroendocrine component > 50%Xx_NEWLINE_xXMen with a prior diagnosis of cancer < 5 years ago, excluding basal cell carcinoma and/or squamous cell carcinomaXx_NEWLINE_xXSubjects with known esophageal cancer diagnosed by previous endoscopy\r\n* Adenocarcinoma\r\n* Squamous cell carcinomaXx_NEWLINE_xXHistory of invasive malignancy =< 3 years prior to pre-registration; exception: adequately treated carcinoma of the cervix, carcinoma in situ, or basal or squamous cell carcinomas of the skinXx_NEWLINE_xXCarcinoma in situ (CIS) of the cervix or history of cervical cancerXx_NEWLINE_xXHistory of active malignancy, including basal/squamous cell skin cancerXx_NEWLINE_xXOther co-existing invasive malignancies (with the exclusion of basal cell carcinoma or skin squamous cell carcinoma) diagnosed during the last 2 years before randomizationXx_NEWLINE_xXH/L: Without a personal history of melanoma and without a personal history of more than one squamous cell carcinoma (SCC) and/or basal cell carcinoma (BCC).Xx_NEWLINE_xXHistory of other malignancy =< 2 years prior to the registration/randomization evaluation, with the exception of basal cell or squamous cell skin cancerXx_NEWLINE_xXPure small cell carcinoma of the prostateXx_NEWLINE_xXHave history of oral cancer or carcinoma in-situXx_NEWLINE_xXHistory of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior study entryXx_NEWLINE_xXOral carcinoma in situXx_NEWLINE_xXHistory of prior head and neck squamous cell carcinoma (HNSCC) unless curatively treated for >= 1 yearXx_NEWLINE_xXPatients with history of cancer must be in remission, with surgery completed at least 6 months prior to enrollment and chemotherapy completed at least 1 year prior to enrollment (except for basal cell carcinoma of the skin)Xx_NEWLINE_xXParticipants with premalignant lesions (mild dysplasia, moderate dysplasia, severe dysplasia, or carcinoma in situ) of the head and neck, as confirmed by biopsy within the 4 months prior to study entry or a treated primary T1N0 or T2N0 squamous cell carcinoma will be eligibleXx_NEWLINE_xXFor patients with T1N0 or T2N0 treated squamous cell carcinoma they must have been free of disease for a minimum period of 8 weeks, up to a maximum of 3 years following completion of surgery and/or radiotherapyXx_NEWLINE_xXPatients with a treated T1N0 or T2N0 squamous cell carcinoma may have oral premalignant lesions (i.e., hyperplasia, dysplasia, carcinoma in situ) at the time of study entry (provided their stage I or II disease has been definitively treated)Xx_NEWLINE_xXNew diagnosis of carcinomaXx_NEWLINE_xXLung carcinoma:Xx_NEWLINE_xXPancreatic carcinoma:Xx_NEWLINE_xXHead and neck squamous cell carcinoma:Xx_NEWLINE_xXHepatocellular carcinomaXx_NEWLINE_xXHistory of cancer (excluding basal cell carcinoma of the skin) including cervical cancerXx_NEWLINE_xXOther malignancies within 5 years prior to enrollment, with the exception of carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer, or ductal carcinoma in situXx_NEWLINE_xXInvasive malignancy (with the exclusion of basal cell carcinoma or skin squamous cell carcinoma) diagnosed during the last 2 years before randomization; stage I-II invasive malignancies that were diagnosed more than 2 years prior to randomization and have been treated curatively are allowed as long as all treatment is finished at least 18 months prior to randomizationXx_NEWLINE_xXHistory of other malignancy =< 5 years prior to the registration/randomization evaluation, with the exception of basal cell or squamous cell skin cancerXx_NEWLINE_xXCurrently being treated for metastatic transitional cell carcinomaXx_NEWLINE_xXBasal or squamous cell carcinoma of the skinXx_NEWLINE_xXCarcinoma in situ of the cervixXx_NEWLINE_xXCarcinoma in situ of the breastXx_NEWLINE_xXPrior history of invasive cancer within 5 years of study entry or history of metastatic cancer; exceptions include non-metastatic, curatively treated basal and squamous cell carcinoma of the skinXx_NEWLINE_xXPatients must have no concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix, breast, or bladder; patients with prior malignancies must be disease-free for >= five yearsXx_NEWLINE_xXSquamous cell carcinoma of the nasopharynxXx_NEWLINE_xXHistologically or cytologically confirmed small cell carcinoma, squamous cell carcinoma or adenocarcinoma (confirmed at Memorial Sloan Kettering Cancer Center [MSKCC]) of the bladder, ureter, urethra, urachus, or renal pelvis; patients with squamous cell carcinoma and adenocarcinoma are required to have a predominant squamous or adenocarcinoma component as reviewed by the pathologist at MSKCC; however, if any element of small cell or neuroendocrine differentiation is present, the patients will be classified as small cell/neuroendocrineXx_NEWLINE_xXCarcinoma originating in the nasopharynx or paranasal sinus, squamous cell carcinoma that originated from the skin and salivary gland or non-squamous histology (e.g., mucosal melanoma), squamous cell carcinoma of unknown primaryXx_NEWLINE_xXBasal cell carcinoma of the skinXx_NEWLINE_xXSquamous cell carcinoma of the skinXx_NEWLINE_xXCarcinoma in situ of the cervixXx_NEWLINE_xXCarcinoma in situ of the breastXx_NEWLINE_xXReceived treatment for a malignancy (other than SMM) within 3 years before the date of randomization (exceptions are squamous and basal cell carcinomas of the skin, carcinoma in situ of the cervix or breast, or other non-invasive lesion, which is considered cured with minimal risk of recurrence within 3 yearsXx_NEWLINE_xXHistory of malignancy within the last 2 years other than squamous cell carcinoma of the head and neck (SCCHN) and superficial non-melanoma skin cancer; patients with a history of SCCHN must be free of active carcinomaXx_NEWLINE_xXHas active solid tumor malignancies with the exception of localized basal cell or squamous cell skin cancer or the condition under treatment (for example, lymphoma)Xx_NEWLINE_xXAny malignancy within 3 years of baseline; participants with a history of basal cell or squamous cell skin cancer may be enrolled at the discretion of the investigatorXx_NEWLINE_xXIndividuals with a history of cancer diagnosis or reoccurrence < 5 years from study entry may not participate; however, individuals with a history of squamous or basal cell carcinoma of the skin < 5 years from study entry will not be excluded from this studyXx_NEWLINE_xXPatients must have histologically confirmed stage IB2-IVA epithelial carcinoma of the cervix, including squamous cell, adeno-, and undifferentiated carcinoma, and excluding small cell/neuroendocrine carcinoma, who will undergo radiation therapy for cervical cancer with curative intentXx_NEWLINE_xXPatients with small cell/neuroendocrine cervical carcinomaXx_NEWLINE_xXGroup 2 patients:\r\n* Biopsy proven recurrent or metastatic squamous cell carcinoma of the head and neck (HNSCC)\r\n* Patients planning to undergo investigational therapyXx_NEWLINE_xXSubject has prior history of malignancies, other than MM, unless the subject has been free of the disease or >= 5 years with the exception of the following malignancies\r\n* Basal cell carcinoma of the skin\r\n* Squamous cell carcinoma of the skin\r\n* Carcinoma in situ of the cervix\r\n* Carcinoma in situ of the breast\r\n* Incidental histologic finding of prostate cancer (T1a or T1b using the TNM clinical staging system) or prostate cancer that is curativeXx_NEWLINE_xXSubjects with known esophageal cancer (adenocarcinoma or squamous cell carcinoma)Xx_NEWLINE_xXPatients undergoing staging endoscopy for head and neck squamous cell carcinoma (HNSCCa)Xx_NEWLINE_xXPatients with a known prior malignancy who have received systemic chemotherapy within five years, except basal cell carcinoma of the skin, carcinoma in situ of the cervix, prior HCC, and patients with liver mass(es) proven to be metastatic disease are excludedXx_NEWLINE_xXPrior history of any other malignancy within 3 years, other than skin basal cell carcinomaXx_NEWLINE_xXHistory of active co-existing non-prostatic malignancies except basal cell skin cancer or squamous cell skin cancerXx_NEWLINE_xXActive other malignancy (except basal cell or squamous cell skin cancer) within the last 2 yearsXx_NEWLINE_xXBiopsy confirmed diagnosis of squamous cell carcinoma of the head and neckXx_NEWLINE_xXBiopsy proven, squamous cell carcinoma of the head and neckXx_NEWLINE_xXPrior history of carcinomaXx_NEWLINE_xXParticipant with histologic confirmation of newly diagnosed squamous cell carcinoma (SCC) of the head and neckXx_NEWLINE_xXHistory of other malignancy (with the exception of squamous cell or basal cell carcinoma of the skin) diagnosed within the last 3 yearsXx_NEWLINE_xXSystemic treatment for prior cancer within the last 5 years, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skinXx_NEWLINE_xXA history of other malignancy =< 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervixXx_NEWLINE_xXA patient with a history of a previous malignancy is eligible for this study as long as the patient meets the following criteria for a cancer survivor; a cancer survivor is eligible provided that the following criteria are met: \r\n* The patient has undergone potentially curative therapy for all prior malignancies; \r\n* There has been no evidence of any prior malignancies for at least five years with no evidence of recurrence (except for effectively treated basal cell or squamous carcinoma of the skin, carcinoma in-situ of the cervix that has been effectively treated by surgery alone, or lobular carcinoma in-situ of the ipsilateral or contralateral breast treated by surgery alone); and \r\n* The patient is deemed by their treating physician to be at low risk for recurrence from prior malignanciesXx_NEWLINE_xXActive other malignancy (except basal cell or squamous cell skin cancer) within the last 2 yearsXx_NEWLINE_xXBiopsy confirmed diagnosis of squamous cell carcinoma of the head and neckXx_NEWLINE_xXPatients undergoing Mohs surgery for basal cell carcinoma (BCC) or squamous cell carcinoma (SCC)Xx_NEWLINE_xXConcomitant malignancies or previous malignancies with less than a 1-year disease free interval at the time of signing consent; patients with adequately resected basal or squamous cell carcinoma of the skin, or adequately resected carcinoma in situ (e.g. cervix) may enroll irrespective of the time of diagnosisXx_NEWLINE_xXHistory of prior malignancy other than ovarian that has not been in remission for >5 years, with the exception of basal cell or squamous cell carcinoma or cervical carcinoma in situ on biopsyXx_NEWLINE_xXPatients with another active cancer (excluding basal cell carcinoma, cervical carcinoma in situ or melanoma in situ); prior history of other cancer is allowed, as long as there was no active disease within the prior 2 yearsXx_NEWLINE_xXAdvanced paraganglioma, pheochromocytoma, medullary thyroid carcinoma, Merkel cell carcinoma, or high grade extrapulmonary neuroendocrine carcinoma having progressed after 1 or more lines of anticancer chemotherapy (unless no standard treatments available or such treatments are deemed not appropriate)Xx_NEWLINE_xXPatients having a prior malignancy within the past 3 years other than resected of basal or squamous cell carcinoma of the skin, any in situ malignancy, or low-risk prostate cancer after curative therapyXx_NEWLINE_xXPatients must have metastatic renal cell carcinoma (RCC)Xx_NEWLINE_xXSquamous cell, large cell undifferentiated, neuroendocrine or small cell undifferentiated carcinoma of the lungXx_NEWLINE_xXIf a patient is a cancer survivor, the patient must have undergone potentially curative therapy for all prior malignancies, with no evidence of prior malignancy for at least 5 years (except for effectively treated basal cell or squamous cell carcinoma of the skin, or carcinoma-in-situ of the cervix treated by surgery alone)Xx_NEWLINE_xXDuctal carcinoma in situXx_NEWLINE_xXHave a history of carcinoma-in-situ (CIS)Xx_NEWLINE_xXPatients with a diagnosis of small cell carcinoma, adenocarcinoma or squamous cell\n             carcinoma of the bladderXx_NEWLINE_xXCervix carcinoma.Xx_NEWLINE_xXCervical carcinoma in situXx_NEWLINE_xXHistory of another active malignancy within 5 years prior to study entry with the exception of previous or concomitant basal cell skin cancer and previous carcinoma in situ treated curativelyXx_NEWLINE_xXprior malignancy with the exception of basal cell carcinoma or cervical dysplasiaXx_NEWLINE_xXPresence or history of a malignant disease other than an ALK-positive advanced tumor that has been diagnosed and/or required therapy within the past 3 years. Exceptions to this exclusion include the following: completely resected basal cell and squamous cell skin cancers, and completely resected carcinoma in situ of any type.Xx_NEWLINE_xXPatients with concomitant malignancies or previous malignancies within the last 5\n             years, with exception of adequately treated basal or squamous cell carcinoma of the\n             skin or carcinoma in situ of the cervix.Xx_NEWLINE_xXHistologically documented, locally advanced (T4b, any N; or any T, N2-3) or metastatic urothelial carcinoma (mUC) (M1, Stage IV) (also termed transitional cell carcinoma [TCC] or urothelial cell carcinoma [UCC] of the urinary tract; including renal pelvis, ureters, urinary bladder, and urethra)Xx_NEWLINE_xXPatients with a previous malignancy within the past 3 years (other than curatively treated basal cell carcinoma of the skin, in situ carcinoma of the cervix, or any cancer that is considered to be cured and have no impact on PFS and OS for the current NSCLC).Xx_NEWLINE_xXB-cell ALLXx_NEWLINE_xXActive malignancy (except for DTC or definitively treated melanoma in-situ, basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix) within the past 24 months.Xx_NEWLINE_xXOther active invasive malignancy (except for treated basal or squamous cell skin carcinoma, or in situ cervix carcinoma).Xx_NEWLINE_xXPatients diagnosed with another primary malignancy within 3 years prior to study start, with the exception of adequately treated basal cell carcinoma, squamous cell carcinoma, or other non-melanomatous skin cancer, or carcinoma in situ of the uterine cervixXx_NEWLINE_xX