Documented incurable cancer with one of the following histologies: non-small cell lung cancer, malignant melanoma, renal cell cancer, triple negative breast cancer, colorectal cancer with microsatellite instability (MSI), bladder cancer, and metastatic castration resistant prostate cancer. Histologic or cytologic diagnosis of cancer Other active cancer Subjects with peritoneal disease who have failed prior standard chemotherapy and have histologic confirmation of platinum-resistant or refractory epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer, endometrial cancer, cervical cancer, vaginal and vulvar cancer, uterine sarcomas including leiomyosarcoma, carcinosarcoma or high grade endometrial stromal sarcoma, gastroesophageal cancer, pancreatic cancer, cholangiocarcinoma, colorectal cancer, gastrointestinal neuroendocrine tumors, or mesothelioma will be enrolled. Patients with incurable malignancies with >= 50% 2-year cancer-associated mortality (as estimated by two physician and where appropriate according to 2014 NCDB data); diseases include, but are not limited to:\r\n* Ampullary carcinoma\r\n* Appendiceal cancer\r\n* Colorectal cancer (CRC)\r\n* Extrahepatic cholangiocarcinoma (EHCC)\r\n* Esophageal adenocarcinoma\r\n* Gallbladder cancer (GBCA)\r\n* Gastric adenocarcinoma\r\n* Head and neck cancer\r\n* Hepatocellular carcinoma (HCC)\r\n* Intrahepatic cholangiocarcinoma (IHCC)\r\n* Melanoma\r\n* Non-KIT GIST (gastrointestinal stromal tumor)\r\n* Non-small cell lung cancer (NSCLC)\r\n* Ovarian cancer\r\n* Pancreatic ductal adenocarcinoma (PDAC)\r\n* Sarcoma (high-grade)\r\n* Small bowel adenocarcinoma (including duodenal)\r\n* Triple-negative breast cancer (TNBC)\r\n* Urothelial cancer\r\n** Note: we will limit gastrointestinal malignancies to no more than 65% of the case mix Incurable cancer No prior treatment for this diagnosis of cancer Completed cancer treatment with no evidence of active cancer; all post-surgical swelling must be resolved. Patients with a separate non-cutaneous cancer diagnosis for which the patient has not been without evidence of disease for at least 5 years Any other cancer (excluding radically operated localized squamous skin cancer) with clinical activity within the last 2 years Prior cancer diagnosis, except appropriately treated localized epithelial skin cancer or cervical cancer. Any active cancer diagnosis (basal or squamous cell cancers allowed) within the last 5 years for which the patient is receiving active therapy or which is untreated; any cancer diagnosis within the last 5 years that is considered “treated” and/ or on surveillance may be included in the trial Prior history of invasive HPV-related anogenital cancer (cervical, vaginal, vulvar, penile, or anal cancer), or oropharyngeal cancer (base of tongue, tonsil); prior cancer at other sites (including most of oral cavity) or larynx are not exclusions History of any other active cancer diagnosis Patients with uncontrolled diseases other than cancer will be excluded Subjects must be females with a histological diagnosis of ductal carcinoma in situ (DCIS) or invasive breast cancer clinical stage T0-3, N01 and be candidates for primary resection of this cancer; NOTE: subjects with bilateral cancer are eligible\r\n* Primary tumor stage T0-3 at the time of initial diagnosis and ipsilateral nodes must be N0-1 by clinical evaluation; staging is routinely based on the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines and TNM Nomenclature for Breast Cancer from American Joint Committee on Cancer (AJCC) Cancer Staging Manual; all breast cancer patients routinely undergo axillary ultrasound to evaluate nodal involvement Uterine cancer participants will be International Federation of Gynecology and Obstetrics (FIGO) stage IIIC and may have endometrioid cancer, clear cell cancer, uterine papillary serous cancer, carcinosarcoma, or endometrial stromal sarcoma Patients must have adequate transoral exposure of the oral cavity and laryngopharynx for TORS instrumentation; for the non-surgical arm: Patients planned to receive non-surgical treatment (e.g., chemo and/or radiation); the 7 surgical (TORS) arms include: tonsil cancer: T1, tonsil cancer: T2, base of tongue cancer: T1, base of tongue cancer: T2, supraglottic cancer, unknown primary cancer, and other tumors; the 3 non-surgical arms are: tonsil cancer, base of tongue cancer, and supraglottic/hypopharyngeal/other cancers Synchronous cancer. Patient must have diagnosis of lung cancer, breast cancer, colorectal cancer, cholangiocarcinoma, gastric cancer, pancreatic cancer, prostate cancer, uterine cancer, ovarian cancer, esophageal cancer, or head and neck cancer Operable cancer Patients with a cancer diagnosis, receiving chemotherapy, radiation therapy or the combination Synchronous colon cancer Cohort 2 (MTD) only: weight loss of > 5% at any point after a cancer diagnosis or within 3 months prior to this cancer diagnosis; Note: no documentation from the medical record is necessary Patients must not have extrahepatic cancer Gastric Cancer Without a history of a cancer diagnosis Without history of cancer diagnosis using chemotherapy Diagnosis of squamous or undifferentiated gastric cancer SUB-PROTOCOL AIM A: Histological confirmation of renal cell carcinoma, head and neck cancer, endometrial cancer, breast cancer, ovarian cancer, prostate cancer, squamous cell cervical or uterine cancer, or bladder cancer No history of another active cancer Prior surgery for cancer of the anus that removed all macroscopic anal cancer colon cancer Cohort B: Histologically confirmed metastatic solid tumor of epithelial origin, excluding non-small cell lung carcinoma (NSCLC), including but not limited to ovarian cancer, colorectal cancer, pancreatic cancer, gastric cancer, renal cancer, bladder cancer, or breast cancer with radiographic evidence by MRI of at least one measurable brain lesion as defined by RANO criteria that does not require corticosteroids for symptomatic control For the expansion stage, histologically confirmed renal cell cancer (RCC), urothelial bladder cancer (UBC), triple-negative breast cancer (TNBC), non-small cell lung cancer (NSCLC), melanoma, head and neck squamous cell carcinoma (HNSCC), gastric cancer, ovarian cancer, cervical cancer, endometrial cancer, or Merkel cell cancer For Phase 1B: histology specified below i. NSCLC (subjects with documented EGFR mutation or ALK rearrangement should be excluded) ii. ovarian cancer iii. gastric cancer iv. HCC (Barcelona-Clinic Liver Cancer stage C, stage B not amenable to locoregional therapy or refractory to locoregional therapy, and not amenable to a curative treatment approach, and Child-Pugh A) v. HNSCC vi. esophageal carcinoma vii. TNBC viii. cholangiocarcinoma ix. RCC, bladder cancer, melanoma, Merkel-cell carcinoma, sarcoma, GIST, or cuSCC. Or any other solid tumors with known MSI-H or dMMR status, such as CRC or pancreatic cancer Any previous systemic chemotherapy for cancer or radiotherapy for cancer Histopathologically confirmed diagnosis of one of the following cancer types:\r\n* Salivary gland cancer without the presence of extracapsular extension and/or positive surgical margin\r\n* Skin cancer\r\n* Melanoma Prior cancer diagnosis, except appropriately treated localized epithelial skin cancer or cervical cancer Diagnosis of advanced solid tumors limited to: melanoma, kidney cancer, lung cancer, colorectal carcinoma, prostate cancer, and neuroendocrine tumor progressing on standard therapy. Prior oophorectomy for cancer prevention is allowed Patients may have had a prior diagnosis of cancer if it has been > 5 years since their last treatment Patients must have either heregulin-positive cancer, cancer with RAS mutation, IGF-1 positive cancer, or RAS wild type cancer. No other active cancer Survivor of childhood cancer for ?5 years (N = 24) and no history of childhood cancer (N = 24) Patients must have a prior diagnosis of cancer inside the thoracic cavity; both primary thoracic malignancies (such as lung cancer) as well as metastatic lesions (such as metastatic breast cancer or colorectal cancer to the lungs) are allowed; patient must have pathologic confirmation of the recurrent thoracic tumor, or have an enlarging thoracic mass (as seen on two computed tomography [CT] scans at least 6 weeks apart, with either a > 25% or > 5 mm increase in longest dimension) Histologically confirmed diagnosis of locally advanced, recurrent, and/or metastatic triple-negative breast cancer, ovarian cancer, gastric cancer, colorectal cancer, pancreatic cancer, melanoma, or mesothelioma Histologically or cytologically confirmed diagnosis of one of the following solid tumor malignancies for which no standard therapeutic alternatives exist: bladder cancer, breast cancer, castrate-resistant prostate cancer, cervical cancer, colorectal cancer (CRC), gastric cancer, hepatocellular carcinoma (HCC), melanoma, non-small cell lung cancer (NSCLC), ovarian cancer, pancreatic cancer, squamous cancers of the head and neck region (including parotid and nasopharynx). Nasopharyngeal cancer Diagnosis of a chronic pulmonary disorder (a diagnosis of lung cancer is not required as the symptom of dyspnea, not cancer itself, is targeted) CANCER-RELATED CRITERIA Nasopharyngeal cancer Patients must have known HIV infection and histologically confirmed solid malignancy that is metastatic or unresectable and is therefore incurable; although the focus of this trial will be on upper aerodigestive cancers (non-small cell lung cancer, head and neck squamous cell carcinoma, and non-gastroesophageal junction esophageal cancer), patients with other incurable solid tumor with disease potentially sensitive to carboplatin and/or taxanes (including but not limited to salivary gland cancer, gastric cancer, breast cancer, ovarian cancer, or anal cancer, BUT excluding Kaposi sarcoma), will be eligible Women who report that their motivation/desire for sexual intimacy has decreased since her cancer diagnosis Female patients presenting with initial diagnosis of any type of cancer T4 cancer Anyone with a previous cancer diagnosis (excluding skin cancer) Receiving radiation treatment for this cancer at any site within the MDACC Cancer Network (Cancer Network study only) Be a cancer care provider (CCP) working at one of the above cancer centers Have direct contact with cancer patients Primary cancer care at the Massachusetts General Hospital (MGH) Cancer Center or Dana-Farber Cancer Institute (DFCI) Diagnosis of cancer. Secondary cancer diagnosis (prior or current) within the past 5 years Have a diagnosis of cancer or a caregiver to a cancer survivor Previous diagnosis of cancer Individuals with a history of another malignancy are not eligible if the cancer is under active treatment or the cancer can be seen on radiology scans or if they are off cancer treatment but in the opinion of their oncologist have a high risk of relapse within 5 years Other active cancer Adult patients with a cancer diagnosis receiving oral or intravenous (IV) chemotherapy at Dana-Farber on Yawkey 10 History of a cancer diagnosis Diagnosis of cancer or caregiver of someone with cancer Secondary cancer diagnosis within the last 5 years The participant does not have an active cancer diagnosis Diagnosis of cancer with evidence of active disease Diagnosis of cancer Diagnosis of cancer Active cancer History of a cancer diagnosis Poor diagnosis or other cancer Parents will be eligible if they have a diagnosis of incurable cancer of any type Patient must have either a history of cancer or active cancer 10.0 years post first cancer diagnosis No prior type I endometrial cancer diagnosis Prior diagnosis of other cancer Have any other active cancer Diagnosis of cancer Recurrence of cancer or other active cancer Resident of rural and/or Appalachian Kentucky (KY) county at cancer diagnosis Diagnosis of cancer with evidence of active disease Have had a diagnosis of cancer treated with chemotherapy. Cancer patient CAREGIVERS: Has a current cancer diagnosis No evidence of cancer (NED) A current/prior cancer diagnosis Diagnosis of a childhood cancer or similarly treated disease (involving chemotherapy, radiation, or surgery) Participants with a second cancer diagnosis at the time of enrollment will be excluded Diagnosis of cancer within last two years Participants will be patients of Vanderbilt-Ingram Cancer Center (VICC) with a diagnosis of cancer Prior cancer diagnosis Subjective concern about declines in cognitive functioning related to a diagnosis of cancer and/or cancer related treatment At least four weeks after cancer diagnosis Treated for any other cancer Diagnosis of cancer with an active prescription for oral chemotherapy Cancer (solid tumor) diagnosis or mass suspicious of cancer within past six months as per clinical judgment Participants with concurrent active cancer or active cancer within the last 5 years are ineligible unless, at the discretion of the investigator, the patient is deemed to have cancer or cancer treatment that the investigators do not think will interfere with any of the biological measures of the study No active cancer Diagnosis of gynecological cancer of any type or strong suspicion for cancer Diagnosis of cancer with evidence of active disease Diagnosis of cancer Active cancer, defined as a pathologic diagnosis of or treatment for any cancer, other than basal-cell or squamous-cell carcinoma of the skin, within the past six months; or patients with known recurrent or metastatic disease within the past six months; a pathology report issued at the enrolling site confirming the diagnosis of cancer is required for study enrollment Diagnosis of cancer Report sleep problems that began or got worse with the diagnosis of cancer or with chemotherapy; (did your sleep problems begin or get worse with the diagnosis of cancer or with chemotherapy?) Any cancer diagnosis Patients without cancer diagnosis Cancer diagnosis between 6 months and 3 years at the start of the study History of depression before the cancer diagnosis No prior history of cancer; No evidence of cancer (NED) Previous diagnosis of endometrial cancer, successfully treated through surgery No previous diagnosis of endometrial cancer Patients with histologically confirmed diagnosis of cancer; NOTE: patients with active cancer or post treatment are allowed on the study Newly prescribed one of the designated oral cancer medications for treatment of cancer History of diagnosis of cancer Previous diagnosis of stage 4 cancer Patients with known cancer Cancer survivor Prior germ cell cancer Currently being actively treated for cancer other than nonmelanoma skin cancer. History of cancer diagnosis at least one year prior History of skin cancer diagnosis Diagnosis of cancer requiring systemic therapy in the past 5 years Has a current or previous diagnosis of any type of cancer History of invasive cancer diagnosis =< 12 months prior to randomization, excepting nonmelanoma skin cancer; patients with T1a adenocarcinoma of the esophagus arising in the setting of Barrett’s esophagus are eligible for enrollment in the trial Patients with prostate cancer, renal cell cancer, neuroendocrine tumors, lung cancer, colorectal cancers, soft tissue sarcomas, glioma, and thyroid cancer are excluded in the normal and mild cohorts due to a lack of efficacy in these tumor types in phase 2 studies; patients with prostate cancer, renal cell cancer, lung cancer, colorectal cancers, soft tissue sarcomas, glioma and thyroid cancer are allowed to enroll in the moderate and severe cohorts only; patients with neuroendocrine tumors are still excluded from the moderate and severe cohorts Active cancer diagnosis or metastatic disease, except in the case of stage 0 chronic lymphocytic leukemia or nonmelanoma skin cancer >= 2 years since completion of cancer-directed therapy for first cancer Diagnosis of prostate cancer per National Comprehensive Cancer Network (NCCN) guidelines (T1-T4 disease) GYNECOLOGIC CANCER: Women with suspected gynecological cancer Patients with PSMA-positive tumors including prostate cancer, breast cancer, lung cancer, and other tumor types know to express PSMA Known pathological diagnosis of any solid cancer Have been diagnosed with a malignancy/tumor/cancer, including but not limited to: brain tumor, breast cancer, lung cancer, esophageal cancer, lymphoma, or sarcoma Prior histologic diagnosis of cancer or awaiting biopsy or surgery for cancer evaluation of a mass detected on exam or standard imaging; this includes solid tumors as well as hematologic malignancies Inclusion Criteria:\n\n The target population includes adults with small lung nodules that may represent a new\n diagnosis of lung cancer, who typically would be managed by CT surveillance in usual\n clinical practice. Thus, we will enroll all patients:\n\n - aged ?35 years\n\n - at least one nodule measuring ?15 mm in average diameter on chest CT.\n\n Exclusion Criteria:\n\n - Pregnant Women\n\n - Age <35 years\n\n - Known diagnosis of cancer (except non-melanoma skin cancer) within 5 years Patient must have no other active cancer at the time of diagnosis of cervical cancer Cancer survivors with no evidence of disease for at least 6 months as determined by the oncologist and no longer receiving cancer treatment A subset of cancer patients being imaged with PET/CT for diagnosis and/or staging of disease at Case Comprehensive Cancer Center Subjects with a current diagnosis of oral cancer Consented for tissue collection on Mays Cancer Center repository 07-32 (for Mays Cancer Center patients only) Patients must have a current diagnosis of breast cancer, non-small cell lung cancer, or colorectal cancer; the current diagnosis may be an initial diagnosis or recurrence and/or progression of previously diagnosed disease; cancer may be metastatic or non-metastatic PATIENTS: Adult patients (>= 18 years) with a diagnosis of metastatic solid cancer PATIENTS: Diagnosis of metastatic cancer < 3 months from the date of hospital admission Focus on one of the following disease categories: non-small cell lung cancer, colon cancer, breast cancer, prostate cancer, kidney cancer, lymphoma Patients must know their cancer diagnosis Patients with non-cancer diagnoses, as CALL only provides services for cancer or pre-cancer diagnoses. Patients with a separate non-cutaneous cancer diagnosis for which the patient has not been without evidence of disease for at least 5 years Patients with a history of other malignancies except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for > 3 years. Patients with second primary malignancy, EXCEPTIONS are: \r\n* Adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS) of the breast, stage 1 grade 1 endometrial carcinoma\r\n* Other solid tumors and lymphomas (without bone marrow involvement) diagnosed >= 5 years prior to randomization and treated with no evidence of disease recurrence and for whom no more than one line of chemotherapy was applied Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for >= 5 years History of other malignancies, with the exception of: adequately treated non-melanoma skin cancer, adequately treated superficial bladder cancer, stage 1 or 2 solid tumor malignancies who are without evidence of disease, or other solid tumors curatively treated with no evidence of disease for >= 5 years from enrollment Other malignancy within the last 5 years except: adequately treated non-melanoma skin cancer; curatively treated in situ cancer of the cervix; ductal carcinoma in situ (DCIS); stage 1, grade 1 endometrial carcinoma; or, other solid tumors including lymphomas (without bone marrow involvement) curatively treated with no evidence of disease for ? 5 years Curatively treated Stage I uterine cancer Solid tumor treated curatively more than 5 years previously without evidence of recurrence Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for >= 5 years Patients with a history of other malignancies except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated by surgery alone or surgery plus radiotherapy with no evidence of disease continuously for > 5 years. Patients with other malignancy within the last 5 years except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS), stage 1, grade 1 endometrial carcinoma, or other solid tumors including lymphomas (without bone marrow involvement) curatively treated with no evidence of disease for >= 5 years Must not have a history of other malignancies, except for adequately treated nonmelanoma skin cancer, curatively treated in-situ cancer of the cervix, curatively-treated thyroid cancer, or other solid tumors curatively treated with no evidence of disease for ? 3 years Has multiple primary malignancies, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, or other solid tumors curatively treated, with no evidence of disease for ?3 years curatively treated non-melanomatous skin cancer A malignancy [other than the one treated in this study] which required radiotherapy or systemic treatment within the past 5 years, or has a >= 30% probability of recurrence within 24 months (except for adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the Ta urothelial carcinomas). Curatively treated in situ disease Patients who have a history of another type of cancer diagnosed within the past 5 years, with the exception of adequately treated non-melanoma skin cancer curatively treated cervical cancer or ductal carcinoma in situ (DCIS) of the breast. History of other malignancies except curatively excised carcinoma in situ of the cervix, non-melanoma skin cancer or superficial bladder cancer or other solid tumors curatively treated with no evidence of disease for ? 5 years; other cases will be reviewed and possibly allowed if discussed with and approved by medical monitor No active malignancy except for nonmelanoma skin cancer or in situ cervical cancer; patients surviving a cancer that was curatively treated and without evidence of disease for more than 3 years before the trial are allowed Has a diagnosed additional malignancy within 3 years prior to first dose of study treatment with the exception of curatively treated in-situ cancer History of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer, or other malignancies curatively treated with no evidence of disease for ? 2 years. History of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer, or other solid tumours curatively treated with no evidence of disease for > 5 years following the end of treatment. curatively treated in-situ cancer, or Other malignancy within 5 years, except curatively treated non-melanomatous skin cancer, curatively treated carcinoma in situ of the uterine cervix, or early stage (stage I or IIa) prostate cancer Other malignancy (including MDS and MGUS) within the last 5 years except: adequately treated non-melanoma skin cancer or other solid tumors curatively treated with no evidence of disease for ?5 years. any cancer curatively treated > 3 years before randomization History of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ? 5 years. History of other malignancies except: (i) adequately treated basal or squamous cell carcinoma of the skin; (ii) curatively treated, a) in situ carcinoma of the uterine cervix, b) prostate cancer, or c) superficial bladder cancer; or (iii) other curatively treated solid tumor with no evidence of disease for ?5 years Other malignancy within the last 5 years except: adequately treated non-melanoma skin cancer, or other solid tumors including lymphomas (without bone marrow involvement) curatively treated with no evidence of disease for >= 5 years. Other malignancy within the last 5 years except: adequately treated non-melanoma skin cancer or other solid tumors including lymphomas (without bone marrow involvement) curatively treated with no evidence of disease for ? 5 years Other malignancy within the last 5 years except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS), stage 1, grade 1 endometrial carcinoma, or other solid tumors. Patients may have received chemotherapy or radiation for a previous, curatively treated non-HNSCC malignancy, provided at least 2 years have elapsed without evidence of recurrence Participant has a history of active malignancies other than SCLC within the past 2 years prior to study entry, with the exception of in situ cancer which was curatively treated. Other malignancy within the last 5 years except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS), stage 1, grade 1 endometrial carcinoma, or other solid tumors including lymphomas (without bone marrow involvement) curatively treated with no evidence of disease for >= 5 years; patients with a history of localized triple negative breast cancer may be eligible, provided they completed their adjuvant chemotherapy more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for >= 5 years Patients with an active second primary cancer will not be eligible; patients curatively treated for a second cancer > 5 years prior to enrollment without a recurrence are eligible; patients curatively treated for a second primary cancer within the last 5 years with a =< 5% risk of recurrence are eligible; patients with a history of curatively treated basal cell carcinoma or intraepithelial neoplasia of the uterine cervix will be allowed on study a) Curatively treated non-melanoma skin cancer or b) Solid tumor treated curatively more than 5 years previously without evidence of recurrence or Other prior malignancies, except for cured non-melanoma skin cancer, curatively treated in situ carcinoma of the cervix, adequately treated malignancies for which there has been no evidence of activity for more than 3 years, or indolent tumors for which observation over three years is a reasonable option History of previous or concurrent cancer other than HCC unless treated curatively 5 or more years prior to entry History of prior cancer except for non-melanoma skin cancer, breast cancer curatively > 3 years ago, curatively treated solid tumor (>5 years ago without evidence of recurrence), and synchronous endometrial cancer (Stage 1A) with ovarian cancer. No second primary malignancy within 2 years of study entry other than adequately treated non-melanoma skin or superficial bladder cancer, curatively treated carcinoma in situ of the cervix or other curatively treated solid tumor deemed by the investigator to be at low risk for recurrence. Past or current history of neoplasm other than Non-small Cell Lung Cancer (NSCLC), except for curatively treated non-melanoma skin cancer, in situ carcinoma of the cervix, or other cancer curatively treated and with no evidence of disease for at least 5 years Other malignancy curatively treated with no known active disease present and no systemic treatment administered for 3 years before the first dose of study drug History of another active malignancy within the previous 5 years other than curatively treated nonmelanomatous skin cancer and superficial bladder cancer; participants treated for malignancy with no relapse within two years are eligible to participate in the study Prior malignancy unless curatively treated and disease-free for > 5 years prior to study entry. Prior adequately treated non-melanoma skin cancer, in situ cancer of the cervix, DCIS or stage I grade 1 endometrial cancer allowed. Other malignancy within the last 5 years except: adequately treated non-melanoma skin cancer or other solid tumours including lymphomas (without bone marrow involvement) curatively treated with no evidence of disease for ?5 years. Other malignancy within the last 5 years except: adequately treated non-melanomatous skin cancer, curatively treated in situ cervical cancer, ductal carcinoma in situ (DCIS), International Federation of Gynecology and Obstetrics (FIGO) Grade 1 endometrial carcinoma, or other solid tumours including lymphomas (without bone marrow involvement) curatively treated with no evidence of disease for >= 5 years. Patients with a history of localised triple negative breast cancer may be eligible, provided they completed their adjuvant chemotherapy more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease. History of another primary malignancy, with the exception of (i) curatively resected non-melanoma skin cancer, (ii) curatively treated in situ cervical cancer, or (iii) other malignancy curatively treated with no evidence of disease and no anticancer therapy administered for 3 years prior to randomization, with the exception of adjuvant hormonal therapy for breast cancer Patients with second primary cancer (except adequately treated nonmelanoma skin cancer, curatively treated in-situ carcinoma of the cervix or superficial bladder cancer, or other solid tumors including lymphoma without bone marrow involvement curatively treated with no evidence of disease for >= 5 years) History of another primary cancer within 3 years prior to enrollment with the exception of curatively treated skin cancer (other than melanoma) or curatively treated cervical carcinoma in-situ History of another primary cancer within 3 years prior to day 1 with the exception of curatively treated skin cancer (other than melanoma) or curatively treated cervical carcinoma in-situ History of other malignancies, with the exception of adequately treated non-melanoma skin cancer or adequately treated superficial bladder cancer or other solid tumors curatively treated with no evidence of disease for >= 5 years from enrollment History of other malignancies, except for other solid tumors curatively treated with no evidence of disease for > 3 years prior to enrollment History of any prior cancer curatively treated within the last two years except:\r\n* Any non-melanoma skin cancer\r\n* Any cancer excised, not treated with chemotherapy and with less than a 30% chance of recurrence within the next 2 years from registration History of other malignancies, except adequately treated non-melanoma skin cancer, curatively treated in-situ disease, or other solid tumors curatively treated with no evidence of disease for greater or equal to 5 years History of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for greater than 2 years Other cancer curatively treated with no evidence of disease for at least 5 years Current requirement for anti-coagulation therapy that prolongs PT or aPTT 7. History of prior malignancy except: Curatively treated non-melanoma skin cancer; Solid tumor treated curatively >5 years previously without evidence of recurrence; or History of other malignancy that in the Investigator's opinion would not affect the determination of study treatment effect (e.g., superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast); Second primary malignancy within 2 years of study entry other than adequately treated non-melanoma skin or superficial bladder cancer, curatively treated carcinoma in situ of the cervix or other curatively treated solid tumor deemed by the investigator to be at low risk for recurrence History of other malignancies except curatively excised carcinoma in situ of the cervix, non-melanomatous skin carcinoma or superficial bladder cancer or other solid tumors curatively treated with no evidence of disease for >= 3 years; other cases will be reviewed and possibly allowed if discussed with and approved by the principal investigator History of other malignancies except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for ? 3 years. History of other malignancies except adequately treated non melanoma skin cancer, curatively treated in-situ cancer, or other solid tumors curatively treated with no evidence of disease for ?2 years For solid tumor-History or presence of hematological malignancies unless curatively treated with no evidence of disease for greater than or equal to 5 years A history of another invasive malignancy (other than non-melanoma skin cancer or curatively treated in situ carcinoma) with evidence of disease within the past 3 years History of other malignancies except: \r\n* Adequately treated basal or squamous cell carcinoma of the skin\r\n* Curatively treated in situ carcinoma of the uterine cervix, prostate cancer, or superficial bladder cancer; OR\r\n* Other curatively treated solid tumor with no evidence of disease for >= 3 years History of other malignancy, unless curatively treated with no evidence of disease for at least 5 years, subjects with adequately treated DCIS or LCIS, adequately treated non-melanoma skin cancer or curatively treated in-situ cancer of the cervix are eligible; History of other malignancies, except adequately treated non-melanoma skin cancer, curatively treated in-situ disease, or other solid tumors curatively treated with no evidence of disease for at least 2 years; No history of any malignancy except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for >= 5 years History of other malignancies except: adequately treated non-melanoma skin cancer, curatively treated in situ carcinoma of the cervix, or other solid tumours curatively treated with no evidence of disease for ? 5 years. Prior in situ cancer of the breast is not a reason for exclusion. Curatively treated in situ disease History of other malignancy(ies), except adequately treated non-melanoma skin cancer, curatively treated in situ disease, or other solid tumors curatively treated, with no evidence of disease for ? 3 years. Any cancer that was curatively treated at least 3 years before entry into this study History of another primary malignancy except for \r\n* Malignancy treated with curative intent and with no known active disease >= 5 years before the first dose of study drug and of low potential risk for recurrence \r\n* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease \r\n* Adequately treated carcinoma in situ without evidence of disease (e.g., cervical cancer in situ) ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C): No evidence of prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical carcinoma, or any surgically- or radiation-cured malignancy continuously disease free for >= 5 years so as not to interfere with interpretation of radiographic response ELIGIBILITY CRITERIA - PHASE II (ARM D): No evidence of prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical carcinoma, or any surgically- or radiation-cured malignancy continuously disease free for >= 5 years so as not to interfere with interpretation of radiographic response No history of prior or synchronous malignancy, except\r\n* Prior malignancy was treated with curative intent and there is no known active disease present for greater than or equal to 3 years prior to study entry\r\n* Participants with adequately treated non-melanoma skin cancers, cervical carcinoma in situ, or prostatic intraepithelial neoplasia without evidence of prostate cancer are eligible History of another malignancy within 5 years prior to randomization, except for either adequately treated non-melanomatous carcinoma of the skin, adequately treated melanoma in situ, adequately treated non-muscle-invasive urothelial carcinoma of the bladder (Tis, Ta, and low grade T1 tumors), or other malignancies where the patient has undergone potentially curative therapy with no evidence of disease and are deemed by the treating physician to have a recurrence rate of <5% at 5 years Adequately treated non-melanoma skin cancer or lentigo maligna History of another primary malignancy except for:\r\n* Malignancy treated with curative intent and with no known active disease >= 5 years before the first dose of ipilimumab (IP) and of low potential risk for recurrence.\r\n* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\r\n* Adequately treated carcinoma in situ without evidence of disease. History prior malignancy except:\r\n* Malignancy treated with curative intent and no known active disease present for ? 2 years prior to initiation of therapy on current study;\r\n* Adequately treated non-melanoma skin cancer or lentigo maligna (melanoma in situ) without evidence of disease;\r\n* Adequately treated in situ carcinomas (e.g., cervical, esophageal, etc.) without evidence of disease;\r\n* Asymptomatic prostate cancer managed with “watch and wait” strategy;\r\n* Myelodysplastic syndrome which is clinically well controlled and no evidence of the cytogenetic abnormalities characteristic of myelodysplasia on the bone marrow at screening Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease. History of prior malignancy, with the exception of adequately treated non-melanoma skin cancer, malignancies treated with curative intent and with no evidence of active disease for more than 3 years, or adequately treated cervical carcinoma in situ without current evidence of disease History of another primary malignancy within the past 2 years except for:\r\n* Basal cell skin cancer\r\n* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\r\n* Adequately treated carcinoma in situ without evidence of disease (e.g., cervical cancer in situ) History of another primary malignancy except for:\r\n* Malignancy treated with curative intent and with no known active disease >= 2 years\r\n* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\r\n* Non-metastatic prostate adenocarcinoma, or treated superficial non-invasive bladder cancer\r\n* Adequately treated carcinoma in situ without evidence of disease (eg, cervical cancer in situ) History of another primary malignancy except for: 1) Malignancy treated with curative intent and with no known active disease >= 5 years before the first dose of study drug and of low potential risk for recurrence. 2) Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease. 3) Adequately treated carcinoma in situ without evidence of disease (e.g., superficial bladder cancer). History of another primary malignancy except for:\r\n* Malignancy treated with curative intent and with no known active disease >= 5 years before the first dose of study treatment and low potential for risk of recurrence\r\n* Adequately treated non-melanoma skin cancer of lentigo maligna without evidence of disease\r\n* Adequately treated carcinoma in situ without evidence of disease History of another primary malignancy except for: A) malignancy treated with curative intent and with no known active disease >= 3 years before the first dose of study drug and of low potential risk for recurrence; B) adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; C) adequately treated carcinoma in situ without evidence of disease, e.g. cervical cancer in situ; D) synchronous endometrial and ovarian cancer is allowed, provided the endometrial cancer is presumed stage IA/B grade 1/2 History of another primary malignancy except for:\r\n* Malignancy treated with curative intent and with no known active disease\r\n* >= 5 years before the first dose of study drug and of low potential risk for recurrence\r\n* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\r\n* Adequately treated carcinoma in situ without evidence of disease e.g., cervical cancer in situ History of another primary malignancy except for: (i) OPSCC with loco-regional recurrence after 6 months of curative-intent treatment and amenable to salvage surgery; (ii) malignancy treated with curative intent and with no evidence of active disease >= 2 years before the first dose of study drug and of low potential risk for recurrence; (iii) non-melanoma, skin cancer or lentigo maligna; in situ cervical, breast, prostate or bladder carcinoma History of another primary malignancy except for: \r\n* Malignancy treated with curative intent and with no known active disease >= 5 years before the first dose of study drug and of low potential risk for recurrence\r\n* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\r\n* Adequately treated carcinoma in situ without evidence of disease e.g., cervical cancer in situ History of other malignancy within the past 3 years with the following exceptions:\r\n* Malignancy treated with curative intent and with no known active disease present and has not received chemotherapy for >3 years before randomization and felt to be at low risk for recurrence by the treating physician\r\n* Adequately treated non-melanoma skin cancer without evidence of disease at the time of randomization\r\n* Adequately treated cervical carcinoma in situ without evidence of disease at the time of randomization\r\n* Adequately treated breast ductal carcinoma in situ without evidence of disease at the time of randomization\r\n* Prostatic intraepithelial neoplasia without evidence of prostate cancer at the time of randomization\r\n* Adequately treated superficial or in situ carcinoma of the bladder without evidence of disease at the time of randomization History of another primary malignancy except for:\r\n* Malignancy treated with curative intent and with no known active disease >= 5 years before the first dose of study drug and of low potential risk for recurrence\r\n* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\r\n* Adequately treated carcinoma in situ without evidence of disease e.g., cervical cancer in situ History of another primary malignancy except for: malignancy treated with curative intent and with no known active disease >= 5 years before the first dose of study drug and of low potential risk for recurrence; adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; or adequately treated carcinoma in situ without evidence of disease, e.g., cervical cancer in situ. History of another primary malignancy except for:\r\n* Malignancy treated with curative intent and with no known active disease >= 5 years before the first dose of study drug and of low potential risk for recurrence\r\n* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\r\n* Adequately treated carcinoma in situ without evidence of disease e.g., cervical cancer in situ History prior malignancy except:\r\n* Malignancy treated with curative intent and no known active disease present for >= 2 years prior to initiation of therapy on current study\r\n* Adequately treated non-melanoma skin cancer or lentigo maligna (melanoma in situ) without evidence of disease\r\n* Adequately treated in situ carcinomas (e.g., cervical, esophageal, etc.) without evidence of disease\r\n* Asymptomatic prostate cancer managed with “watch and wait” strategy\r\n* Myelodysplastic syndrome which is clinically well controlled and no evidence of the cytogenetic abnormalities characteristic of myelodysplasia on the bone marrow at screening History of another primary malignancy except for: \r\n* Malignancy treated with curative intent and with no known active disease >= 2 years before the first dose of study drug and of low potential risk for recurrence \r\n* Adequately treated non-melanoma skin cancer or lentigo maligns without evidence of disease\r\n* Adequately treated carcinoma in situ without evidence of disease eg, cervical cancer in situ Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease. Adequately treated cervical carcinoma in situ without evidence of disease. History of another primary malignancy except for:\r\n* Malignancy treated with curative intent and with no known active disease >= 5 years before the first dose of study drug and of low potential risk for recurrence\r\n* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease (e.g. basal cell or squamous cell carcinoma of the skin)\r\n* Adequately treated carcinoma in situ without evidence of disease (e.g., breast and cervical cancer in situ) History of another primary malignancy except for:\r\n* Malignancy treated with curative intent and with no known active disease >= 5 years before the first dose of study drug and of low potential risk for recurrence\r\n* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\r\n* Adequately treated carcinoma in situ without evidence of disease e.g., cervical cancer in situ Patients with a history of active malignancy within 3 years prior to registration; note: exceptions to this requirement include adequately treated non-melanoma skin cancer or lentigo maligna or carcinoma in situ without evidence of disease or prostate cancers with a Gleason score < 8 and with prostatectomy and no lymph node involvement Diagnosed or treated for malignancy other than MCL, except:\r\n* Malignancy treated with curative intent and with no known active disease present for >= 2 years before randomization\r\n* Adequately treated non-melanoma skin cancer or melanoma in situ without evidence of disease\r\n* Adequately treated cervical carcinoma in situ without evidence of disease\r\n* Asymptomatic prostate cancer managed with “active surveillance” History of another primary malignancy except for: malignancy treated with curative intent and with no known active disease >= 5 years before the first dose of study drug and of low potential risk for recurrence; adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; or adequately treated carcinoma in situ without evidence of disease e.g., cervical cancer in situ No evidence of prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical carcinoma or any surgically- or radiation-cured malignancy continuously disease free for >= 5 years so as not to interfere with interpretation of radiographic response RANDOMIZED PHASE II (ARMS K AND L): No evidence of prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical carcinoma or any surgically- or radiation-cured malignancy continuously disease free for >= 5 years so as not to interfere with interpretation of radiographic response History of another primary malignancy except for:\r\n* Malignancy treated with curative intent and with no known active disease >= 5 years before the first dose of study drug and of low potential risk for recurrence\r\n* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\r\n* Adequately treated carcinoma in situ without evidence of disease (e.g., cervical cancer in situ) 213 History of malignancy other than B-NHL within the past 3 years with the exception of: Malignancy treated with curative intent and with no known active disease present for ? 3 years before enrollment and felt to be at low risk for recurrence by the treating physician. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease. Adequately treated cervical carcinoma in situ without evidence of disease. Adequately treated breast ductal carcinoma in situ without evidence of disease. Prostatic intraepithelial neoplasia without evidence of prostate cancer. Adequately treated urothelial papillary noninvasive carcinoma or carcinoma in situ. Other primary malignancy (EXCEPT adequately treated non-melanomatous carcinoma of the skin, germ cell tumour, or other malignancy treated at least 5 years previously with no evidence of recurrence) History of another malignancy except for:\r\n* Malignancy treated with curative intent and with no known active disease >= 5 years before the first dose of study drug and of low potential risk for recurrence\r\n* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\r\n* Adequately treated carcinoma in situ without evidence of disease e.g., cervical cancer in situ History prior malignancy except:\r\n* Malignancy treated with curative intent and no known active disease present for >= 2 years prior to initiation of therapy on current study\r\n* Adequately treated non-melanoma skin cancer or lentigo maligna (melanoma in situ) without evidence of disease\r\n* Adequately treated in situ carcinomas (e.g., cervical, esophageal, etc.) without evidence of disease\r\n* Asymptomatic prostate cancer managed with “watch and wait” strategy\r\n* Myelodysplastic syndrome which is clinically well controlled and no evidence of the cytogenetic abnormalities characteristic of myelodysplasia on the bone marrow at screening History of another primary malignancy except for: malignancy treated with curative intent and with no known active disease >= 2 years before the first dose of IP and of low potential risk for recurrence, adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease, or adequately treated carcinoma in situ without evidence of disease. History of another primary malignancy except for:\r\n* Malignancy treated with curative intent and with no known active disease >= 3 years before the first dose of study drug\r\n* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease \r\n* Adequately treated carcinoma in situ without evidence of disease eg, cervical cancer in situ\r\n* Controlled, superficial bladder carcinoma\r\n* T1a or T1b or T1c prostate carcinoma treated with radiation >= 1 year prior to study enrollment and prostate specific antigen (PSA) within normal limits (WNL) since treatment \r\n* T2a or b prostate carcinoma treated curatively >= 1 year prior to study enrollment and PSA undetectable since curative treatment\r\n* Other early stage cancers that have a minimal chance of recurrence (i.e stage I endometrial cancer, cervical cancer, etc.) may be cleared by the PI Diagnosed or treated for malignancy other than ALL, except: 1) Malignancy treated with curative intent and with no known active disease present for >= 3 years before treatment; 2) Adequately treated non-melanoma skin cancer or lentigo maligna or carcinoma in situ (e.g. cervical, breast) without evidence of disease; 3) or malignancy that in the opinion of the investigator, with concurrence with the MD Anderson Cancer Center (MDACC) investigational new drug (IND) office, is considered cured with minimal risk of recurrence within 3 years History of another primary malignancy except for: \r\n* Malignancy treated with curative intent and with no known active disease >=5 years before the first dose of study drug and of low potential risk for recurrence;\r\n* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; or \r\n* Adequately treated carcinoma in situ without evidence of disease, e.g. cervical cancer in situ History of another primary malignancy except for:\r\n* Malignancy treated with curative intent and with no known active disease >= 5 years before the first dose of study drug and of low potential risk for recurrence\r\n* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\r\n* Adequately treated carcinoma in situ without evidence of disease e.g., cervical cancer in situ History of prior malignancy except: a) Malignancy treated with curative intent and no known active disease present for ?2 years prior to initiation of current study; b) adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; c) adequately treated in situ carcinomas (e.g., cervical, esophageal, breast, etc.) without evidence of disease; d) asymptomatic prostate cancer managed with \watch and wait\ strategy; e) myelodysplastic syndrome which is clinically well controlled and no evidence of the cytogenetic abnormalities characteristic of myelodysplasia on the bone marrow at screening Adequately treated non-melanomatous skin cancer or lentigo maligna melanoma without current evidence of disease Adequately treated carcinoma in situ without current evidence of disease Diagnosed or treated for malignancy other than multiple myeloma, except: a) Malignancy treated with curative intent and with no known active disease present for more than equal to (>= )3 years before randomization; b) Adequately treated non-melanoma skin cancer, lentigo maligna or in situ malignancies (including but not limited to, cervical, breast) with no evidence of disease Prior malignancy, except for adequately treated lentigo maligna melanoma, non-melanomatous skin cancer, in situ cervical carcinoma or other malignancy treated with no evidence of active disease > 3 years before Screening and at low risk for recurrence. Prior malignancy, except for adequately treated lentigo maligna melanoma, non-melanomatous skin cancer, in situ cervical carcinoma, or other malignancy treated with no evidence of active disease > 3 years before Screening and at low risk for recurrence. Adequately treated non-melanoma skin cancer or lentigo malignancy without evidence of disease Adequately treated cervical carcinoma in situ without evidence of disease No evidence of prior malignancy except: adequately treated non-melanoma skin cancer, adequately treated in situ carcinoma, low grade prostate carcinoma (Gleason grade =< 6) managed with observation that has been stable for at least 6 months, or any malignancy treated with curative intent continuously disease free for >= 3 years so as not to interfere with interpretation of radiographic response Subject has a concurrent active malignancy other than adequately treated nonmelanomatous skin cancer or in situ neoplasm History of another primary malignancy except for:\r\n* Malignancy treated with curative intent and with no known active disease >= 3 years before the first dose of study drug and of low potential risk for recurrence\r\n* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\r\n* Adequately treated carcinoma in situ without evidence of disease (eg, cervical cancer in situ)\r\n* Adequately treated stage 1 breast or stage 1 low grade endometrial cancer No active, second potentially life-threatening cancer; no history of another primary malignancy except for; malignancy treated with curative intent and no known active disease >= 5 years before the first dose of investigation product (IP) and of low potential risk for recurrence; adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; adequately treated carcinoma in situ without evidence of disease Diagnosed or treated for malignancy other than DLBCL, except: malignancy treated with curative intent and with no known active disease present for >=3 years before random assignment; adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; adequately treated carcinoma in situ without evidence of disease History of prior malignancy, except: malignancy treated with curative intent and with no known active disease present for >=3 years before randomization; adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; adequately treated cervical carcinoma in situ without evidence of disease Diagnosed or treated for malignancy other than the indication under study except for\r\n* Malignancy treated with curative intent and with no known active disease present for >= 3 years before the first dose of study treatment\r\n* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\r\n* Adequately treated cervical carcinoma in situ without evidence of disease History of another primary malignancy except for:\r\n* Malignancy treated with curative intent and with no known active disease >= 3 years before the first dose of study drug and of low potential risk for recurrence\r\n* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\r\n* Adequately treated carcinoma in situ without evidence of disease (e.g., cervical cancer in situ)\r\n* Adequately treated stage 1 breast cancer Diagnosed or treated for malignancy other than NHL for which patient will be treated, except: malignancy treated with curative intent and with no known active disease present for >= 3 years before subject registration; adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; adequately treated carcinoma in situ without evidence of disease Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease. Adequately treated carcinoma in situ without evidence of disease. Adequately treated non-melanoma skin cancer or lentigomaligna without evidence of disease. Adequately treated carcinoma in situ without evidence of disease. Second primary malignancy except most situ carcinoma (e.g. adequately treated non-melanomatous carcinoma of the skin) or other malignancy treated at least 5 years previously with no evidence of recurrence History of another primary malignancy except for:\r\n* Malignancy treated with curative intent and with no known active disease >= 5 years before the first dose of study drug and of low potential risk for recurrence\r\n* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\r\n* Adequately treated carcinoma in situ without evidence of disease (e.g., cervical cancer in situ) History of another primary malignancy except for: \r\n* Malignancy treated with curative intent and with no known active disease >= 5 years before the first dose of study drug and or low potential risk for recurrence \r\n* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease \r\n* Adequately treated carcinoma in situ without evidence of disease e.g., cervical cancer in situ Prior malignancy that required treatment, or has shown evidence of recurrence (except for non-melanoma skin cancer or adequately treated cervical carcinoma in situ) during the 5 years prior to randomization. History of prior malignancy, with the exception of adequately treated non-melanoma skin cancer, malignancies treated with curative intent and with no evidence of active disease for more than 3 years, or adequately treated cervical carcinoma in situ without current evidence of disease History of a second primary cancer with the exception of 1) curatively treated non-melanomatous skin cancer, 2) curatively treated cervical or breast carcinoma in situ, or 3) other malignancy with no known active disease present and no treatment administered during the last 2 years. Subjects with history of another primary cancer, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor with no known active disease present that in the opinion of the investigator will not affect patient outcome in the setting of current HCC diagnosis History of another primary cancer within the last 3 years with the exception of non-melanoma skin cancer or curatively-treated cervical carcinoma in-situ Subjects with a history of another primary cancer, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; and c) other primary solid tumors (with no known active disease present) that, in the opinion of the investigator, will not affect patient outcome in the setting of the current diagnosis Subjects with history of another primary cancer, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor with no known active disease present in the opinion of the investigator will not affect patient outcome in the setting of current FLC diagnosis. Subjects with a history of another primary cancer, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; c) localized prostate cancer not requiring systemic therapy; and c) other primary tumors with no known active disease present that, in the opinion of the investigator and medical monitor for the sponsor, will not affect patient outcome in the setting of the current diagnosis. Curatively resected nonmelanomatous skin cancer Subjects with history of another primary cancer, including co-existent second malignancy, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor with no known active disease present in the opinion of the investigator will not affect patient outcome in the setting of current diagnosis. Subjects with history of another primary cancer, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor with no known active disease present in the opinion of the investigator will not affect patient outcome in the setting of current HCC diagnosis Diagnosis of another malignancy, unless the patient was diagnosed at least 3 years earlier and has been disease-free for at least 6 months following the completion of curative intent therapy, specifics as follows:\r\n* Curatively resected non-melanomatous skin cancer \r\n* Curatively treated cervical carcinoma in situ\r\n* Patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease based on prostate-specific antigen (PSA) values are also eligible for this study if hormonal therapy has been initiated or a radical prostatectomy has been performed.\r\n* Other primary solid tumor curatively treated with no known active disease present and no treatment administered for the last 3 years The patient has history of another primary malignancy, with the exception of\r\n* Curatively treated non-melanomatous skin cancer;\r\n* Curatively treated cervical carcinoma in situ; \r\n* Non-metastatic prostate cancer\r\n* Other primary non-hematologic malignancies or solid tumor treated with curative intent, no known active disease, and no treatment administered during the last 3 years prior to registration History of another primary cancer, except:\r\n* Curatively treated cervical carcinoma in situ, or\r\n* Curatively resected non-melanomatous skin cancer, or\r\n* Other primary solid tumor curatively treated with no known active disease present and no treatment administered for >= 3 years prior to enrollment Other primary solid tumor with no known active disease presents that in the opinion of the investigator that will not affect patient outcome in the setting of current prostate cancer diagnosis. History of second or other primary cancer with the exception of: 1) curatively treated non-melanomatous skin cancer; 2) curatively treated cervical or breast carcinoma in situ; or 3) other primary solid tumor treated with curative intent and no known active disease present and no treatment administered during the last 3 years. Subjects with history of another primary cancer, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor with no known active disease present in the opinion of the investigator will not affect patient outcome in the setting of current HCC diagnosis. Other primary solid tumor with no known active disease in the opinion of the investigator that will not affect patient outcome in the setting of current HCC diagnosis. Subjects with history of another primary cancer, including co-existent second malignancy, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor with no known active disease present in the opinion of the Investigator will not affect subject outcome in the setting of breast cancer diagnosis. Subjects with history of another primary cancer, including co-existent second malignancy, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor with no known active disease present in the opinion of the investigator will not affect patient outcome in the setting of current cancer diagnosis. Subjects with a history of another primary cancer, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor with no known active disease present that, in the opinion of the investigator, will not affect patient outcome in the setting of current hepatocellular carcinoma diagnosis. The participant has a history of another primary cancer, with the exception of the following: curatively resected nonmelanomatous skin cancer, curatively treated carcinoma in situ, or other primary solid tumor treated with curative intent and no known active disease present and no treatment administered during the last 5 years. The participant has a history of another primary cancer, with the exception of: a) curatively resected nonmelanomatous skin cancer; b) curatively treated cervical carcinoma in-situ; or c) other primary solid tumor curatively resected or treated with no known active disease present and no treatment administered for the last 3 years Subjects with history of another primary cancer, with the exception of: \r\n* Curatively resected non-melanoma skin cancer\r\n* Curatively treated cervical carcinoma in situ\r\n* Other primary solid tumor with no known active disease present in the opinion of the investigator will not affect patient outcome in the setting of current HCC History of, or current active cancer other than NSCLC, with the exception of curatively resected non-melanomatous skin cancer, curatively treated cervical carcinoma in situ, or other primary solid tumors curatively treated with no known active disease present and no curative treatment administered for the last 3 years. Subjects with any previously untreated or concurrent cancer that is distinct in primary site or histology except cervical cancer in-situ, treated basal cell carcinoma, or superficial bladder tumor; subjects surviving a cancer that was curatively treated and without evidence of disease for more than 3 years before registration are allowed; all cancer treatments must be completed at least 3 years prior to study registration Previous or concurrent cancer within 3 years prior to treatment start EXCEPT for curatively treated cervical cancer in situ, non-melanoma skin cancer, superficial bladder tumors (Ta [non-invasive tumor], Tis [carcinoma in situ] and T1 [tumor invades lamina propria]) Subjects with any previously untreated or concurrent cancer that is distinct in primary site or histology from breast cancer except cervical cancer in-situ, treated localized basal cell carcinoma, Gleason score 6 prostate cancer or superficial bladder tumor; subjects surviving a cancer that was curatively treated and without evidence of disease for more than 3 years before randomization are allowed; all cancer treatments for another malignancy must be completed at least 3 years prior to study entry (i.e., signature date of the informed consent form) Subjects with any previously untreated or concurrent cancer that is distinct in primary site or histology from breast cancer except cervical cancer in-situ, treated basal cell carcinoma, or superficial bladder tumor; subjects surviving a cancer that was curatively treated and without evidence of disease for more than 3 years before randomization are allowed; all cancer treatments must be completed at least 3 years prior to study entry (i.e., signature date of the informed consent form) Subjects with any previously untreated and concurrent cancer that is distinct in primary site or histology from HCC except cervical cancer in-situ, treated nonmelanoma skin cancers, localized prostate cancer not requiring systemic therapy undergoing surveillance, or superficial bladder tumor; subjects surviving a cancer that was curatively treated and without evidence of disease for more than 2 years before enrollment are allowed provided that cancer therapy was completed at least 2 years prior to study entry (date of the informed consent form) Previous or concurrent cancer within 3 years prior to treatment start EXCEPT for curatively treated cervical cancer in situ, non-melanoma skin cancer, superficial bladder tumors (Ta [non-invasive tumor], Tis [carcinoma in situ] and T1 [tumor invades lamina propria]) History of a second primary cancer is allowed in the event the cancer is curatively resected and there is no evidence of recurrence/metastatic disease x 1 year; subjects who have a history of cervical or breast carcinoma in situ, localized prostate cancer, adequately treated basal cell or squamous cell carcinoma of the skin, or superficial bladder tumors (Ta, Tis & T1) are also allowed Patients with any previously untreated or concurrent cancer that is distinct in primary site or histology except cervical cancer in-situ, treated ductal carcinoma in situ of the breast, curatively treated nonmelanoma skin carcinoma, noninvasive aerodigestive neoplasms, or superficial bladder tumor; subjects surviving a cancer that was curatively treated and without evidence of disease for more than 3 years before registration are allowed; all cancer treatments must be completed at least 3 years prior to registration Previously untreated or concurrent cancer that is distinct in primary site or histology except cervical cancer in-situ, treated ductal carcinoma in situ of the breast, curatively treated non-melanoma skin carcinoma, noninvasive aerodigestive neoplasms or superficial bladder tumor; subjects surviving a cancer that was curatively treated and without evidence of disease for more than 3 years before registration are allowed; all cancer treatments for concurrent cancers must be completed at least 3 years prior to registration Previous or concurrent cancer that is distinct in primary site or histology within 5 years; exceptions: curatively treated\r\n* Cervical cancer in situ\r\n* Non-melanoma skin cancer\r\n* Superficial bladder tumors (non-invasive tumor [Ta], carcinoma in situ [Tis] and tumor invades lamina propria [T1]) Previous or concurrent cancer within 3 years prior to treatment start EXCEPT for curatively treated cervical cancer in situ, non-melanoma skin cancer and superficial bladder tumors (Ta [non-invasive tumor], Tis [carcinoma in situ] and T1 [tumor invades lamina propria]) Other malignancies diagnosed within the past five years (other than curatively treated cervical cancer in situ), non melanoma skin cancer, superficial bladder tumors Ta (non invasive tumor) and TIS (carcinoma in situ) Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors ( Ta, Tis &T1) or any cancer curatively treated > 5 years prior to study entry. Patients who have a previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study, except\r\n* Cervical carcinoma in situ, non-melanoma skin cancer, superficial noninvasive bladder tumors, ductal carcinoma in situ (DCIS) or any previous cancer curatively treated >3 years before the start of anetumab ravtansine Previous or concurrent cancer that is distinct in primary site or histology from cancer of primary site =< 3 years prior to randomization EXCEPT for curatively treated cervical cancer in situ, melanoma in situ, non-melanoma skin cancer and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor invades lamina propria)]; Note: All cancer treatments for those distinct in a primary site other than cancer of origin must be completed >= 3 years prior to randomization Subjects with any previously untreated or concurrent cancer that is distinct in primary site or histology from carcinoid or pancreatic islet cancer except cervical cancer in-situ, treated basal cell carcinoma, or superficial bladder tumor; subjects surviving a cancer that was curatively treated and without evidence of disease for more than 3 years before randomization are allowed; all cancer treatments must be completed at least 3 years prior to study entry (i.e., signature date of the informed consent form) Previous or concurrent history of malignancies within 5 years prior to study treatment except for curatively treated:\r\n* Cervical carcinoma in situ\r\n* Non-melanoma skin cancer\r\n* Superficial bladder cancer (Ta [non-invasive tumor], Tis [carcinoma in situ] and T1 [tumor invades lamina propria]) Patients with any previously untreated or concurrent cancer that is distinct in primary site or histology from biliary tract cancer except cervical cancer in-situ, treated basal cell carcinoma, or superficial bladder tumor; patients surviving a cancer that was curatively treated and without evidence of disease for more than 3 years prior to registration are allowed; all cancer treatments must be completed at least 3 years prior to prior to registration) Subjects who have a previous or concurrent cancer that is distinct in primary site or histology from lung adenocarcinoma, except cervical carcinoma in situ, treated basal cell carcinoma, superficial noninvasive bladder tumors or any previous cancer curatively treated < 2 years before the start of study treatment Patients with non-HCC malignancy except those with DCIS (ductal carcinoma in situ), cervical cancer in-situ, basal cell or superficial bladder tumor; patients surviving a cancer that was curatively treated and without evidence of recurrence for more than 3 years before randomization are allowed Recent history of prior cancer except cervical cancer in-situ, treated basal cell carcinoma, or superficial bladder tumor; subjects surviving a cancer that was curatively treated and without evidence of disease for more than 3 years before enrollment are allowed Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study, except cervical carcinoma in situ, treated basal cell carcinoma, superficial noninvasive bladder tumors or any previous cancer curatively treated ? 3 years before the start of anetumab ravtansine Subjects with any previously untreated or concurrent cancer that is distinct in primary site or histology from breast cancer except cervical cancer in-situ, treated basal cell carcinoma, or superficial bladder tumor. Subjects surviving a cancer that was curatively treated and without evidence of disease for more than 3 years before randomization are allowed. All cancer treatments must be completed at least 3 years prior to study entry (ie, signature date of the informed consent form). Have a previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study, except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta and Tis [carcinoma in situ]) or any previous cancer curatively treated <3 years ago. Subjects who have a previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study, or any previous cancer curatively treated >3 years before the start of study Treatment. Subjects with any previously untreated or concurrent cancer that is distinct in primary site or histology from pancreatic cancer except cervical cancer in-situ, treated basal cell carcinoma, or superficial bladder tumor; subjects surviving a cancer that was curatively treated and without evidence of disease for more than 3 years before randomization are allowed; all cancer treatments must be completed at least 3 years prior to study entry (i.e., signature date of the informed consent form) Previous or concurrent cancer that is distinct in primary site or histology from colorectal cancer within 3 years prior to randomization EXCEPT for curatively treated cervical cancer in situ, non-melanoma skin cancer and superficial bladder tumors (Ta [non-invasive tumor], Tis [carcinoma in situ] and T1 [tumor invades lamina propria]); note: all cancer treatments for cancers that were distinct in a primary site other than colorectal must be completed at least 3 years prior to randomization (i.e., signature date of the informed consent form) No active malignancy except for nonmelanoma skin cancer or in situ cervical cancer; subjects surviving a cancer that was curatively treated and without evidence of disease for more than 3 years before the trial are allowed; all cancer treatments must be completed at least 3 years prior to study entry (i.e., signature date of the informed consent form) Previous or concurrent cancer other than HCC unless without evidence of disease for 5 or more years prior to entry, except cervical cancer in-situ, treated basal cell carcinoma, or superficial bladder tumor Subjects with any previously untreated or concurrent cancer that is distinct in primary site or histology from breast cancer except cervical cancer in-situ, treated basal cell carcinoma, or superficial bladder tumor; subjects surviving a cancer that was curatively treated and without evidence of disease for more than 3 years before randomization are allowed; all cancer treatments must be completed at least 3 years prior to study entry (i.e., signature date of the informed consent form) Subjects with any previously untreated or concurrent cancer that is distinct in primary site or histology from HCC except cervical cancer in-situ, treated basal cell carcinoma, or superficial bladder tumor; subjects surviving a cancer that was curatively treated and without evidence of disease for more than 3 years before randomization are allowed; all cancer treatments must be completed at least 3 years prior to the first dose of sorafenib except for local treatments for cervical carcinoma in situ (CIS), basal cell carcinoma (BCC), and superficial bladder tumors Previous or concurrent cancer that is distinct in primary site or histology from indolent B-cell NHL within 5 years prior to treatment start EXCEPT for curatively treated cervical cancer in situ, nonmelanoma skin cancer and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor invades lamina propria)]. Previous or concurrent cancer that is distinct in primary site or histology from indolent B-cell NHL within 5 years prior to treatment start EXCEPT for curatively treated cervical cancer in situ, nonmelanoma skin cancer and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor invades lamina propria)]. Presence of an active malignant disease within the last 12 months, with the exception of adequately treated cervical cancer in-situ, non-melanoma skin cancer and superficial bladder tumors (Ta [non-invasive tumor], Tis [carcinoma in situ] and T1 [tumor invades lamina propria]). Other malignancies may be considered after consultation with the Medical Monitor Previous or concurrent cancer that is distinct in primary site or histology from ASPS, LS, or SS within 5 years before enrollment except for curatively treated cervical cancer in situ, non-melanoma skin cancer and superficial bladder tumors (Ta, Tis and T1). Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in the study EXCEPT cervical cancer in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis and T1) or any cancer curatively treated > 3 years prior to study entry Previous or concurrent cancer that is distinct in primary site or histology from colorectal cancer within 3 years prior to randomization EXCEPT for curatively treated cervical cancer in situ, non-melanoma skin cancer and superficial bladder tumors [Ta (Non-invasive tumor), Tis (Carcinoma in situ) and T1 (Tumor invades lamina propria)]. Subjects who have a previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study, except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta and Tis) or any previous cancer curatively treated <3 years before the first dose of study drug Subjects with any previously untreated or concurrent cancer that is distinct in primary site or histology from breast cancer except cervical cancer in-situ, treated basal cell carcinoma, or superficial bladder tumor; subjects surviving a cancer that was curatively treated and without evidence of disease for more than 3 years before enrollment are allowed; all cancer treatments must be completed at least 3 years prior to study entry (i.e., signature date of the informed consent form) Subjects with any previously untreated or concurrent cancer that is distinct in primary site or histology except cervical cancer in-situ, treated basal cell carcinoma, or superficial bladder tumor; subjects surviving a cancer that was curatively treated and without evidence of disease for more than 3 years before randomization are allowed; all cancer treatments must be completed at least 3 years prior to start of study treatment Subjects who are receiving treatment for a concurrent cancer that is distinct in primary site or histology from colorectal carcinoma, except any cancer in-situ, treated basal cell or squamous cell carcinoma, or superficial bladder tumor; subjects surviving a cancer that was curatively treated and without evidence of disease more than 1 year before randomization are allowed; all cancer treatments must be completed at least 1 year prior to start of study treatment Have had prior or concurrent cancer distinct in primary site or histology from CRC within 5 years prior to randomization EXCEPT for curatively treated cervical cancer in situ, nonmelanoma skin cancer, Stage 0 intramucosal gastric cancer after endoscopic complete removal, or superficial bladder tumors classified as noninvasive tumor (Ta), carcinoma in situ (Tis), or tumor invades lamina propria (T1). Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study, EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors [Ta, Tis and T1] or any cancer curatively treated >3 years prior to study entry Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis & T1) or any cancer curatively treated > 3 years prior to study entry Previous or concurrent cancer that is distinct from HCC in primary site or histology, EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, and superficial bladder tumors. Any cancer curatively treated more than 3 years prior to enrollment is permitted. Phase 2 portion only: The subject has previous or concurrent cancer that is distinct in primary site or histology from NSCLC, except cervical carcinoma in situ, non-melanoma carcinoma of the skin or in situ carcinoma of the bladder. Any cancer curatively treated greater than 3 years prior to entry is permitted. Subjects with any previously untreated or concurrent cancer unrelated to angiosarcoma; NOTE: exceptions include cervical cancer in-situ, treated basal cell carcinoma, or superficial bladder tumor; subjects surviving a cancer that was curatively treated and without evidence of disease for more than 3 years before registration are allowed; all treatments must have been completed at least 3 years prior to registration Previous or concurrent cancer that is distinct in primary site or histology from breast cancer within 5 years prior to enrollment EXCEPT cervical cancer in situ, treated basal cell carcinoma, squamous cell carcinoma (SCC), as long as it is other than SCC involving skin of the head and/or neck, and superficial bladder tumors (Ta and Tis) Any previously untreated or concurrent cancer that is distinct in primary site or histology from rectal cancer except cervical cancer in-situ, treated basal cell carcinoma, or superficial bladder tumor; subjects surviving a cancer that was curatively treated and without evidence of disease for more than 3 years before starting study drug are allowed; all cancer treatments must be completed at least 3 years prior to study entry (i.e., signature date of the informed consent form) Patients with any previously untreated or concurrent cancer that is distinct in primary site or histology except cervical cancer in-situ, treated ductal carcinoma in situ of the breast, curatively treated nonmelanoma skin carcinoma, noninvasive aerodigestive neoplasms, or superficial bladder tumor; subjects surviving a cancer that was curatively treated and without evidence of disease for more than 3 years before registration are allowed; all cancer treatments must be completed at least 3 years prior to registration Previous or coexisting cancer(s) distinct in primary site or histology from the cancer evaluated in this study EXCEPT: Subjects with another primary malignancy that has not been in remission for at least 3 years, with the exception of non-melanoma skin cancer, curatively treated localized prostate cancer with non-detectable prostate-specific antigen, cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on Papanicolaou (Pap) smear, and thyroid cancer (except anaplastic). History of another primary malignancy that has not been in remission for at least 2 years. The following are exempt from the 2-year limit: non-melanoma skin cancer, completely resected Stage 1 solid tumor with low risk for recurrence, curatively treated localized prostate cancer, cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on Pap smear, and in situ breast cancer that has been completely resected. History of another primary malignancy that has not been in remission for at least 1 year (the following are exempt from the 1-year limit: non-melanoma skin cancer, curatively treated localized prostate cancer, curatively treated superficial bladder cancer and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on PAP smear) History of another primary malignancy that has not been in remission for at least 3 years (the following are exempt from the 3-year limit: non-melanoma skin cancer, fully excised melanoma in situ [stage 0], curatively treated localized prostate cancer, and cervical or breast carcinoma in situ on biopsy or a squamous intraepithelial lesion on papanicolaou [PAP] smear); History of another invasive malignancy that has not been in remission for at least 3 years. Exceptions to the 3year limit include non-melanoma skin cancer, curatively treated localized prostate cancer, ductal carcinoma in situ, and cervical cancer in situ on biopsy or squamous intraepithelial lesion on PAP smear. History of another primary malignancy that requires intervention beyond surveillance or that has not been in remission for at least 1 year (the following are exempt from the 1 year limit: non-melanoma skin cancer, curatively treated localized prostate cancer, and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on papanicolaou [PAP] smear) History of another primary malignancy that has not been in remission for at least 3 years (the following are exempt from the 3-year limit: non-melanoma skin cancer, fully excised melanoma in situ [stage 0], curatively treated localized prostate cancer, and cervical or breast carcinoma in situ on biopsy or a squamous intraepithelial lesion on papanicolaou [PAP] smear) CRITERIA FOR LEUKAPHERESIS AND PRE-THERAPY EVALUATION: History of another primary malignancy that has not been in remission for at least 2 years with the following exceptions: nonmelanoma skin cancer, curatively treated localized prostate cancer, cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on pap smear, or other malignancy considered by the investigator to have a low risk of relapse or progression History of other primary malignancy not in remission for at least 2 years (The following are exempt from the 2-year limit: nonmelanoma skin cancer, definitively treated stage 1 solid tumor with low risk for recurrence, curatively treated localized prostate cancer, and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on Pap smear) History of another primary malignancy that has not been in remission for at least 3 years; (the following are exempt from the 3-year limit: nonmelanoma skin cancer, fully excised melanoma in situ [stage 0], curatively treated localized prostate cancer, and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on PAP smear) History of another primary malignancy that has not been in remission for at least 3 years (the following malignancies are exempt from the 3 year limit: non-melanoma skin cancer, fully-excised melanoma in situ [stage 0], curatively treated, localized prostate cancer, and cervical carcinoma in situ in biopsy or a squamous intraepithelial lesion on Papanicolau [PAP] smear) Patients with a history of other malignancies during the past three years. (The following are exempt from the three-year limit: non-melanoma skin cancer, Lymphomatoid papulosis, curatively treated localized prostate cancer, curatively treated localized breast cancer, resected thyroid cancer, biopsy proven cervical intraepithelial neoplasia or cervical carcinoma in situ). Known history of another primary malignancy that has not been in remission for at least 5 years. Non-melanoma skin cancer and cervical carcinoma in situ or squamous intraepithelial lesions (e.g., cervical intraepithelial neoplasia [CIN] or prostatic intraepithelial/intraductal neoplasia [PIN]) are allowed. A history of any other primary malignancy that has not been treated with curative intent and that has not been in complete remission for at least 2 years (exempt from the two year limit are non-melanoma skin cancer and cervical carcinoma in-situ on biopsy or a squamous intraepithelial lesion on PAP smear). History of another invasive malignancy that has not been in remission for at least 3 years. Exceptions to the 3 year limit include nonmelanoma skin cancer, curatively treated localized prostate cancer, and cervical cancer in situ on biopsy or squamous intraepithelial lesion on PAP smear Second primary malignancy that has not been in remission for greater than 3 years. Treated non-melanoma skin cancer, cervical carcinoma in situ on biopsy, or squamous intraepithelial lesion on PAP smear, localized prostate cancer (Gleason score < 6), or resected melanoma in situ are exceptions and do not require a 3 year remission. cervical carcinoma in situ on biopsy or squamous intraepithelial lesion on Pap smear; and History of another primary malignancy that has not been in remission for at least 3 years (the following are exempt from the 3-year limit: non-melanoma skin cancer, fully excised melanoma in situ [stage 0], curatively treated localized prostate cancer, and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on Papanicolaou [PAP] smear) History of another primary malignancy that has not been in remission for at least 2 years. (The following are exempt from the 2-year limit: nonmelanoma skin cancer, completely resected stage 1 solid tumor with low risk for recurrence, curatively treated localized prostate cancer, cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on Pap smear, and in situ breast cancer that has been completely resected.) Patient with a history of other malignancies during the past three years; (the following are exempt from the 3-year limit: non-melanoma skin cancer, melanoma in situ, curatively treated localized prostate cancer, and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on Papanicolaou [PAP] smear) Patients with another primary malignancy that has not been in remission for at least 3 years, unless approved by the Idera Medical Monitor. The following are exempt from the 3-year limit: non-melanoma skin cancer, curatively treated localized prostate cancer with non-detectable prostate-specific antigen, cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on Papanicolaou (Pap) smear, and thyroid cancer (except anaplastic). History of another primary malignancy not in clinical remission; except adequately treated patients with completely resected in situ carcinoma, such as nonmelanoma skin cancer and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on Papanicolaou (Pap) smear, or localized prostate cancer with prostate-specific antigen (PSA) < 1 ng/ml History of another invasive malignancy that has not been in remission for at least 1 year. (Exceptions are nonmelanoma skin cancer, curatively treated localized prostate cancer, ductal carcinoma, and cervical carcinoma or a squamous intraepithelial lesion on PAP smear). History of another primary malignancy not in remission for at least 3 years (the following are exempt from the 3-year limit: nonmelanoma skin cancer and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on Pap smear) History of another primary malignancy that has not been in remission for at least 3 years (the following are exempt from the 3-year limit: non-invasive nonmelanoma skin cancer, fully excised melanoma in situ [stage 0], curatively treated localized prostate cancer, and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on Papanicolaou [PAP] smear) History of another primary malignancy that has not been in remission for at least 3 years (the following are exempt from the 3-year limit: non-melanoma skin cancer, fully excised melanoma in situ [stage 0], curatively treated localized prostate cancer, and cervical or breast carcinoma in situ on biopsy or a squamous intraepithelial lesion on Papanicolaou [PAP] smear) Second primary malignancy that has not been in remission for greater than 3 years, with the exception of non-melanoma skin cancer, cervical carcinoma in situ,or squamous intraepithelial lesion on PAP smear, localized prostate cancer (Gleason score <6), or resected melanoma in situ. History of another primary malignancy that has not been in remission for at least 3 years; (Note: The following are exempt for the 3-year limit: nonmelanoma skin cancer, fully excised melanoma in situ [stage 0], curatively treated localized prostate cancer, and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on papanicolaou [PAP] smear) History of another invasive malignancy that has not been in remission for at least 3 years. Exceptions: nonmelanoma skin cancer, curatively treated localized prostate cancer, and cervical cancer in situ on biopsy or squamous intraepithelial lesion on PAP smear.