Pathologically proven primary cervical cancer I-IIA with squamous cell carcinoma, adenosquamous carcinoma or adenocarcinoma initially treated with a standard radical hysterectomy with pelvic lymphadenectomy
Patients with locally advanced, previously untreated squamous cell carcinoma of the vulva
Pathologically proven diagnosis of a malignant major salivary gland tumor or malignant minor salivary gland tumor of the head and neck of the following histologic subtypes: \r\n* Intermediate-grade adenocarcinoma or intermediate-grade mucoepidermoid carcinoma\r\n* High-grade adenocarcinoma or high-grade mucoepidermoid carcinoma or salivary duct carcinoma\r\n* High-grade acinic cell carcinoma or high-grade (> 30% solid component) adenoid cystic carcinoma\r\n* Patients with diagnoses such as \undifferentiated or poorly differentiated carcinoma\, \carcinoma-ex pleomorphic adenoma\, \carcinoma not otherwise specified (NOS)\ and others should be considered for this trial
Patients with mixed urothelial carcinoma and a glandular and/or squamous component will be eligible for the trial, but the presence of other histologic variants, pure adenocarcinoma, or pure squamous cell carcinoma, will make a patient ineligible
Patients must not have pure squamous cell carcinoma or adenocarcinoma
Phase 1b: Histologically and/or cytologically confirmed metastatic selected solid tumor types that have progressed after treatment with approved therapies or for which there are no standard effective therapies available. If nivolumab or pembrolizumab is an approved therapy for the participant's tumor type, but the participant has not been treated with it, the Investigator may enroll the participant in this study. Phase 2: Histologically and/or cytologically confirmed metastatic selected solid tumor types with 0-2 prior lines of systemic therapy (unless discussed with the sponsor) For the non-small cell lung cancer (NSCLC) and melanoma cohorts, participants must have progressed on or after prior treatment with one anti-PD-1, anti-PD-L1, or anti-PDL2 agent Selected tumor types of both phases: NSCLC, predominantly clear cell renal cell carcinoma, endometrial carcinoma, urothelial carcinoma, squamous cell carcinoma of the head and neck, or melanoma (excluding uveal melanoma)
Endometrial carcinoma.
Patients with any other diagnosis except for adenocarcinoma (squamous cell carcinoma, small cell carcinoma, mixed adenosquamous, lymphoma, sarcoma, etc.) will be ineligible
Histologically proven diagnosis of squamous cell carcinoma of the head and neck, including variants such as spindle cell carcinoma, verrucous carcinoma, carcinoma not otherwise specified (NOS), etc.
Histologically confirmed diagnosis of a locally advanced (not amenable to curative therapy such as surgical resection) metastatic cancer of the following histologies: melanoma (MEL), Merkel cell carcinoma (MCC), triple-negative breast cancer (TNBC), ovarian carcinoma, renal cell carcinoma (RCC), colorectal cancer, urothelial carcinoma, or sarcoma.
Histopathologically confirmed diagnosis of one the following cancer types:\r\n* Squamous cell carcinoma\r\n* Esthesioneuroblastoma\r\n* Adenoid cystic carcinoma\r\n* Adenocarcinoma
Endometrial carcinoma
PART II: participants must have histologically confirmed advanced squamous cell lung cancer, advanced pancreatic cancer, advanced head & neck cancer (specifically non-oropharynx squamous cell carcinoma or human papillomavirus [HPV]-negative oropharynx squamous cell carcinoma), or any tumor with suspected PI3K-pathway dependence (either by mutation or by known biologic rationale, such as endometrial cancer; PI3K dependence includes the presence of a PIK3CA-mutant hotspot mutation (such as E542 [K], E545 [A, G, or K], H1047 [L, R, Y]), PIK3CA copy number gain, or PTEN loss in the archival or fresh tumor tissue specimen identified in a Clinical Laboratory Improvement Act (CLIA)-certified laboratory; all genetic findings must be reviewed by the study principal investigator (PI), prior to study entry
Advanced or recurrent/metastatic solid tumor, including nasopharyngeal carcinoma, castration-resistant prostate cancer, gastric cancer, ovarian clear cell carcinoma and sarcoma, with measurable disease as determined by RECIST 1.1.
Merkel Cell Carcinoma (MCC)
Participants must have any of the following tumor types, confirmed by available pathology records or current biopsy, that is advanced, nonresectable, or recurrent and progressing since last antitumor therapy, and for which no alternative standard therapy exists: pancreatic adenocarcinoma, renal clear cell carcinoma, SCCHN (squamous cell carcinoma of head and neck), NSCLC (non-small cell lung cancer), colorectal cancer (CRC), hepatocellular carcinoma (HCC), ovarian serous epithelial cancer, bladder transitional cancer, cervical cancer, and triple-negative breast cancer
Subjects with the following solid tumors are eligible for screening: Non-small cell lung cancer (NSCLC), Squamous cell carcinoma of the head and neck (SCCHN), Renal cell carcinoma (RCC), melanoma, bladder, Triple-negative breast cancer (TNBC), and Colorectal carcinoma displaying microsatellite instability (MSI CRC).
Patients with recurrent squamous cell carcinoma or a second primary arising in a previously irradiated field
Histologically or cytologically confirmed, treatment-naive esophageal squamous cell carcinoma
Must have histologically confirmed squamous cell carcinoma or adenosquamous cell carcinoma of esophagus
Squamous cell or undifferentiated gastric cancer
Nasopharyngeal carcinoma
Histologically confirmed squamous cell carcinoma of the target tumor(s)
Patients with mucinous carcinoma, low grade endometrioid carcinoma, low grade serous carcinoma or carcinosarcoma
Anal Squamous Cell Carcinoma
Cervical Squamous Cell Carcinoma
Vulvar Squamous Cell Carcinoma
Participant has a newly diagnosed, histologically confirmed, stage I-IV squamous cell carcinoma or squamous cell carcinoma in situ of the oral cavity or oropharynx and will be undergoing definitive surgical, radiotherapy, or chemoradiation treatment; patients who are NOT candidates for localized treatment (surgery, radiation or chemoradiation) with curative intent (i.e.patients with distant metastasis or contra-indication to localized treatment) are not eligible OR
Baseline skin exam is required for all patients; Note: cutaneous squamous cell carcinoma (SCC) lesions identified at baseline must be excised
Nasopharyngeal or sinonasal carcinoma
No known diagnosis of invasive squamous cell carcinoma within the previous 2 years
Patients with invasive squamous cell carcinoma derived from their RRP who are not considered appropriate for surgery, radiation therapy, or chemotherapy by their treating oncology team may be considered eligible for the study
Endometrial carcinoma.
Gastric carcinoma.
Histologically document transitional cell carcinoma with the presence of any of the following stages: carcinoma in situ (CIS), high­grade Ta, any grade T1, or any grade cT2­T4, considered appropriate for radical cystectomy; subjects with mixed histology are required to have a dominant transitional cell carcinoma (TCC) pattern
Measurable metastatic (stage IV) or unresectable non-small cell lung cancer (including but not limited to squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinomas) with at least one lesion that is resectable for TIL generation; (Note: neuroendocrine tumors are not eligible)
Patients with histologically confirmed, potentially curable squamous-cell carcinoma, adenocarcinoma, or large-cell undifferentiated carcinoma of the esophagus
Patients must have histologically confirmed HNSCC from any primary site; basaloid, poorly differentiated, and undifferentiated carcinoma histologies will be accepted; nasopharyngeal carcinoma, World Health Organization (WHO) type I and II (keratinizing, non-Epstein-Barr virus [EBV] positive), will be included; paranasal sinus, lip and external auditory canal sites will be included; squamous cell carcinoma of unknown primary, clearly related to the head and neck, will be included
Stages of endometrial carcinoma other than described
Metastatic or recurrent carcinoma of the nasopharynx, squamous cell carcinoma of unknown primary, squamous cell carcinoma originating from skin and salivary glands or non squamous histologies (eg. mucosal melanoma).
Subjects must have a biopsy confirmed diagnosis of squamous cell, adenocarcinoma, or adenosquamous carcinoma of the cervix. Histologic confirmation of the original primary tumor is required.
Has histologies other than squamous cell, adenocarcinoma, or adenosquamous carcinoma of the cervix.
High-intermediate risk disease, defined as:\r\n* T1-T3 N2 M0 or T3 N1 M0 or any stage III (T4 or N3) p16+ squamous cell carcinoma of the oropharynx (The American Joint Committee on Cancer [AJCC] 8th edition staging system)\r\n* T1-2 N1-3 M0 or T3-4 N0-3 M0 (stage III-IVB) p16+ squamous cell carcinoma of the hypopharynx or larynx\r\n* T1-2 N2-3 M0 or T3-4 N0-3 M0 (stage III-IVB) p16+ squamous cell carcinoma of the nasopharynx\r\n* Inoperable T4 N0-3 M0 (stage IVA-IVB) p16+ squamous cell carcinoma of the oral cavity
Pathological diagnosis of squamous cell carcinoma of the lung
Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma of the oropharynx, which include the sites tonsil, base of tongue, soft palate, or posterior oropharyngeal wall; histologic variants will be included (papillary squamous cell carcinoma and basaloid squamous cell carcinoma); cytologic diagnosis from a cervical lymph node is sufficient in the presence of clinical evidence of a primary tumor in the oropharynx
Histologically proven squamous cell carcinoma of the larynx.
Histological confirmation of non-small cell lung cancer (NSCLC) by either biopsy or cytology will be is required for the primary diagnosis and is recommended for recurrent disease. The following primary cancer types are eligible: squamous cell carcinoma, adenocarcinoma (with or without bronchioloalveolar carcinoma features), large cell carcinoma (with or without neuroendocrine features), neuroendocrine carcinoma (either NSCLC with neuroendocrine features or atypical carcinoids, but not small cell lung carcinoma), bronchioloalveolar cell carcinoma, or non-small cell carcinoma not otherwise specified
Pathologically-proven diagnosis of squamous cell carcinoma of the oropharynx or larynx; squamous cell carcinoma of unknown primary is not allowed
Histologically or cytologically documented transitional cell carcinoma of the urothelium (squamous differentiation or mixed cell types allowed).
All subjects must have cutaneous squamous cell carcinoma that is not curable by surgery or radiation; both locally advanced and metastatic squamous cell carcinoma will be included
History of malignant tumors other than Kaposi sarcoma (KS) or KSHV-associated multicentric Castleman disease (MCD), unless:\r\n* In complete remission for >= 1 year from the time response was first documented or\r\n* Completely resected basal cell carcinoma or\r\n* In situ squamous cell carcinoma of the cervix or anus
Has pancreatic tumor other than adenocarcinoma, including: acinar cell carcinoma, pancreaticoblastoma, malignant cystic neoplasms, endocrine neoplasms, squamous cell carcinoma; vater and periampullary duodenal or common bile duct malignancies
Patients must have pathologically-confirmed, previously untreated, p16-positive oropharyngeal squamous cell carcinoma
Pathologic subtypes other than pure adenocarcinoma; acinar cell carcinoma, squamous cell carcinoma, spindle cell carcinoma, neuroendocrine cancer, and mixed types are not eligible
Have one of the following advanced (unresectable and/or metastatic) solid tumor indications that has progressed following standard therapies, where standard therapies are available:\r\n* Squamous cell carcinoma of the skin \r\n* Small cell malignancies of non-pulmonary origin\r\n* Adrenocortical carcinoma\r\n* Medullary renal cell carcinoma \r\n* Carcinoma of unknown primary\r\n* Penile carcinoma\r\n* Vascular sarcoma\r\n* Germ cell tumor\r\n* Paraganglioma-pheochromocytoma \r\n* Other rare tumors (except those tumor types listed in exclusion)
Is participating in cohort 10 and has melanoma; non-small cell lung cancer; hepatocellular carcinoma; Merkel cell carcinoma; colon or rectal adenocarcinoma; anal canal squamous cell carcinoma; pancreas adenocarcinoma; esophageal squamous cell carcinoma or adenocarcinoma (including gastroesophageal [GE] junction); biliary tract adenocarcinoma (gallbladder and biliary tree but excluding ampulla of vater cancers); carcinoid tumors; neuroendocrine carcinomas (well or moderately differentiated pancreatic neuroendocrine tumor); estrogen receptor (ER)-positive human epidermal growth factor receptor 2 (HER2)-negative breast cancer; triple negative breast cancer; ovarian epithelial, fallopian tube or primary peritoneal carcinoma; endometrial carcinoma; cervical squamous cell cancer; vulvar squamous cell carcinoma; small cell lung cancer; mesothelioma (malignant pleural mesothelioma); thyroid cancer (papillary or follicular subtype); salivary gland carcinoma; nasopharyngeal carcinoma; glioblastoma multiforme; leiomyosarcoma; prostate adenocarcinoma; gastric adenocarcinoma; or small bowel malignancy
The subject must have a histologically or cytological-proven diagnosis of one of the following malignancies:\r\n* Oral, oropharyngeal, hypopharyngeal or laryngeal squamous cell carcinoma\r\n* Non-small cell carcinoma of the bronchus and/or lung\r\n* Ductal or lobular carcinoma of the breast\r\n* Serous carcinoma of the ovary, fallopian tube, or other uterine adnexa\r\n* Urothelial cell carcinoma of renal pelvis, ureter, or bladder\r\n* Cutaneous squamous cell carcinoma
Squamous cell histology or mixed, predominantly squamous adenosquamous carcinoma
Subjects must have histologically or cytologically confirmed breast adenocarcinoma, colorectal adenocarcinoma, gastroesophageal cancer (adenocarcinoma or squamous cell carcinoma), melanoma, non-small cell lung cancer, or clear cell renal cell carcinoma with liver metastases or hepatocellular carcinoma with known disease progression.
Histologically confirmed diagnosis of squamous cell carcinoma of the larynx, stages III, IVa, or IVb, p16-negative on immunohistochemistry
Have a biopsy confirmed basal cell carcinoma (BCC) that measures at least 6 mm in size at the time of the initial evaluation (visit #1)
Patients with a history of carcinoma in remission, on no therapy or on hormonal therapy for the adjuvant treatment of breast carcinoma or prostate carcinoma are included in the study
Cervical cancer participants will be American Joint Cancer Commission (AJCC) stages pT1 ,2, N1, M0 with squamous carcinoma, adenocarcinoma, adenosquamous carcinoma, or glassy cell carcinoma histology
Biopsy proven, within 16 weeks prior to study entry, sinonasal adenoid cystic carcinoma, adenocarcinoma, mucoepidermoid carcinoma, squamous cell carcinoma, including sinonasal carcinoma, sinonasal undifferentiated carcinoma, Schneiderian carcinoma, myoepithelial carcinoma, undifferentiated carcinoma, esthesioneuroblastoma, or melanoma American Joint Committee on Cancer (AJCC) 7th edition stage III - IVA/B tumors, or with skull base or intracranial extension; pathology must be confirmed by review at the treating institution
Patients with adenoid cystic carcinoma, adenocarcinoma, mucoepidermoid carcinoma, myoepithelial carcinoma who have undergone gross total resection who refuse chemotherapy may receive radiation alone
Eligible patients will have pathologically proven primary locally advanced cervical cancer with squamous cell carcinoma, adenosquamous carcinoma or adenocarcinoma histology suitable for primary treatment with chemoradiation with curative intent
Part 1b: Subjects with endometrial cancer, gastric cancer, head and neck squamous cell carcinoma, melanoma, microsatellite unstable colorectal cancer, non-small cell lung cancer, pancreatic ductal adenocarcinoma, renal cell carcinoma, triple negative breast cancer, or transitional cell carcinoma of the genitourinary tract that have had disease progression after available therapies for metastatic disease that are known to confer clinical benefit, been intolerant to treatment, or refused standard treatment.
Histologically confirmed primary non-metastatic NSCLC; eligible histological subtypes include: squamous cell carcinoma, adenocarcinoma, squamous-adeno carcinoma, large-cell carcinoma, and non-small cell carcinoma not otherwise specified
Inclusion Criteria:\n\n        Target Population\n\n          1. Only node-negative patients are eligible: Histological confirmed endometrial carcinoma\n             with no macroscopic remaining tumour after primary surgery and lymph-node negative\n             disease, with one of the following postoperative FIGO 2009 stage and grade:\n\n               1. Stage I grade 3 endometrioid adenocarcinoma\n\n               2. Stage II endometrioid adenocarcinoma\n\n               3. Stage I and II type 2 histology (clear cell, serous, squamous cell carcinoma, or\n                  undifferentiated carcinoma) Prior therapy\n\n          2. Patients have undergone hysterectomy (total abdominal hysterectomy, radical\n             hysterectomy, laparoscopic or robotic hysterectomy) and bilateral\n             salpingo-oophorectomy (BSO) and pelvic lymphadenectomy (LNE).\n\n          3. LNE: minimum 12 pelvic nodes (6 from each side) should be removed. Para-aortic LNE is\n             optional\n\n          4. Omentectomy strongly recommended in clear cell, serous or undifferentiated carcinoma.\n\n          5. Surgery performed within 10 weeks of randomization. If the dates for hysterectomy and\n             lymph node dissection are different, 10 weeks are counted from the last surgery, and\n             in that case the gap between two surgeries should not exceed 8 weeks.\n\n             Other inclusion criteria\n\n          6. Patients must give informed consent according to the rules and regulations of the\n             individual participating centres\n\n          7. Patients have not received any other anticancer therapy other than surgery.\n\n          8. Adjuvant vaginal brachytherapy is permitted in both arms. In chemotherapy arm, timing\n             of VBT should not cause delay in chemotherapy delivery.\n\n          9. Patients must have a WHO performance status of 0-2\n\n         10. Patients must have an adequate bone-marrow, renal and hepatic function (WBC\n             ?3.0x109/L, neutrophils ?1.5x109/L, platelets ?100x109/L, total S-bilirubin <2 x upper\n             normal value, ALAT <2.5 x upper normal value, estimated GFR >50 ml/min (measured or\n             calculated according to Cockroft-Gault or Jeliffe). Up to 5% deviation for\n             hematological values and 10% deviation for s-bilirubin and ALAT are tolerated.\n\n         11. Life expectancy of at least 12 weeks\n\n         12. Patients must be fit to receive combination chemotherapy\n\n         13. Patient's age >18 years\n\n        Exclusion criteria:\n\n        Target Disease Exceptions\n\n          1. Carcinosarcoma, Sarcomas or small cell carcinoma with neuroendocrine differentiation.\n\n             Prohibited Treatments and/or Therapies\n\n          2. External Beam Radiotherapy\n\n          3. Concurrent cancer therapy\n\n          4. Concurrent treatment with an anticancer investigational agent or participation in\n             another anticancer clinical trial Other exclusion criteria\n\n          5. Previous or concurrent malignant disease except for curatively treated carcinoma in\n             situ of the cervix or basal cell carcinoma of the skin\n\n          6. Active infection or other serious underlying medical condition, which might prevent\n             the patient from receiving treatment or to be followed\n\n          7. Whatever reasons which interferes with an adequate follow-up
Patients must have a confirmed (by a MDACC pathologist) cytologic or histological diagnosis of locally advanced squamous cell carcinoma, poorly differentiated carcinoma, or sinonasal undifferentiated carcinoma of the nasal cavity and/or paranasal sinuses.
Pathological and radiographic documented stage IIIB/IV NSCLC (squamous, adenocarcinoma, bronchioloalveolar, large cell, undifferentiated or not otherwise specified non-small cell carcinoma) diagnosed less than two months prior to randomization. Patients must have ECOG performance status of 0-1 and life expectancy >3 months.
There is reasonable expectation of response to pembrolizumab or nivolumab, and one of the drugs is available from the commercial supply; this includes (but is not limited to) the following tumor types: melanoma, non-small cell lung cancer, renal cell carcinoma, squamous cell carcinoma of the head and neck, bladder cancer, and classic Hodgkin lymphoma
Histologically confirmed stage IV NSCLC (adenocarcinoma, squamous cell carcinoma, large cell carcinoma, or not otherwise specified) or recurrent NSCLC not amenable to curative therapy
Patients are excluded if they have a history of metastatic cancer in addition to melanoma or a history of uncontrolled non-metastatic cancer. Patients with localized squamous cell carcinoma and/or basal cell carcinoma are not excluded.
Newly diagnosed, cytologically or histologically confirmed squamous cell carcinoma (and common variants, including poorly differentiated carcinoma; undifferentiated carcinoma; basaloid carcinoma) of the oropharynx; patients must have resectable oropharyngeal and nodal disease, including the following stages according to the American Joint Commission on Cancer Staging 7th edition:\r\n* T1N1-3\r\n* T2N1-3\r\n* T3N0-3\r\n* T4aN0-3; note: eligible T4a tumors may include deep/extrinsic tongue muscle invasion and must be judged resectable by transoral laser microsurgery (TLM) or transoral robotic surgery (TORS), according to the surgeon-investigator; patients with T4a tumors with clear radiologic mandibular, hard palate or medial pterygoid invasion are not eligible
Included tumor types\t\r\n* T cell and NK cell lymphomas, including, but not limited to: cutaneous T-cell lymphomas (CTCL), mycosis fungoides (MF), Sezary syndrome (SS), peripheral T-cell lymphoma (PTCL), ALK-positive and ALK-negative anaplastic large cell lymphoma (ALCL), and NK-cell lymphomas\r\n* Merkel cell carcinoma\r\n* Squamous cell carcinoma of the skin, including keratoacanthomas, vulvar squamous carcinoma, and mixed histology tumors, such as basosquamous carcinoma, and squamous cell carcinoma of unknown primary consistent with skin origin\r\n* Other non-melanoma skin cancers\r\n** Basal cell carcinoma\r\n** Malignant sweat gland tumors, including porocarcinoma, hidradenocarcinoma, spiradenocarcinoma, cylindrocarcinoma, microcystic adnexal carcinoma and related entities, squamoid eccrine ductal carcinoma, cutaneous adenoid cystic carcinoma, digital papillary adenocarcinoma, primary cutaneous mucinous carcinoma, endocrine mucin-producing sweat gland carcinoma, primary cutaneous signet ring cell carcinoma, cutaneous apocrine gland carcinoma, and extraocular sebaceous carcinoma\r\n** Adnexal carcinoma\r\n** Trichilemmal carcinoma\r\n** Extramammary Paget’s disease\r\n** Any other rare tumor of the skin with approval of principle investigator (PI)
Rectal cancer histology other than adenocarcinoma (i.e., sarcoma, lymphoma, squamous cell carcinoma, mucosal melanoma, etc.)
Patients with the following histologies are not eligible for either study cohort:\r\n* Non-small cell lung cancer, squamous cell carcinoma of head and neck, melanoma, renal cell carcinoma, bladder cancer, Hodgkin’s lymphoma, Merkel cell carcinoma, and MSI-H colorectal cancer
Patients must have histologically or cytological confirmed malignancy in the following disease groups: melanoma that is metastatic or unresectable, non-small cell lung carcinoma, renal cell carcinoma, sarcoma, colon carcinoma, non-Hodgkin lymphoma, squamous cell head and neck carcinoma, or cutaneous squamous cell carcinoma, for which standard curative or palliative measures do not exist or are no longer effective; the primary site may be cutaneous or unknown, but mucosal and ocular primaries are excluded\r\n* Note: patients with non-small lung cancer must have had prior epidermal growth factor receptor (EGFR) and anaplastic lymphoma receptor tyrosine kinase (ALK) testing; patients with sensitizing mutations in EGFR or ALK rearrangements should have been treated with prior targeted agents and have had progression or discontinued due to toxicity from these agents
Patients in whom histologic diagnosis is not consistent with ductal adenocarcinoma such as adenosquamous, squamous cell, colloid, islet cell, serous or mucinous cystadenoma or cystadenocarcinoma, carcinoid, small or large cell carcinoma, intraductal oncocytic papillary neoplasms (IOPN), osteoclast-like giant cell tumors, acinar cell carcinoma, pancreatoblastoma, solid pseudopapillary tumors, undifferentiated small cell carcinoma and non-epithelial tumors (sarcomas, gastrointestinal [GI] stromal tumor, lymphoma)
Since p53 mutations occur in a wide variety of tumor types, this is a mixed histology study for incurable tumors; subjects with the following solid tumors are eligible for screening: non-small cell lung cancer, squamous cell carcinoma of the head and neck, hepatocellular carcinoma, renal cell carcinoma, melanoma, bladder, soft tissue sarcoma, triple-negative breast cancer, and colorectal carcinoma displaying microsatellite instability and pancreatic cancer
Patients must have persistent, recurrent or metastatic squamous cell carcinoma, adenosquamous carcinoma or adenocarcinoma of the cervix with documented disease progression (disease not amendable to curative therapy); NOTE: the following cervical tumors are not eligible: minimal deviation/adenoma malignum, gastric type adenocarcinoma, clear cell carcinoma and mesonephric carcinoma; histologic confirmation of the original primary tumor is required via the pathology report
Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma (including the histological variants papillary squamous cell carcinoma and basaloid squamous cell carcinoma) of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal walls); cytologic diagnosis from a cervical lymph node is sufficient in the presence of clinical evidence of a primary tumor in the oropharynx; clinical evidence should be documented, may consist of palpation, imaging, or endoscopic evaluation, and should be sufficient to estimate the size of the primary (for T stage)
Patients must have histologically or cytologically confirmed squamous cell carcinoma of the skin; patients who present with “squamous cell carcinoma of unknown primary lesions” at the time of diagnosis will be eligible if patients have a plausible primary skin site removed in the past; similarly, patients with neck, parotid, or facial lymph nodes positive for squamous cell carcinoma with no identifiable mucosal primary would also be eligible
Endometrial cancer:\r\n* Patients with the following histologic features are eligible for pelvic radiation therapy without weekly cisplatin:\r\n** < 50% myometrial invasion, grade 3 adenocarcinoma without uterine serous carcinoma (USC) or clear cell histology\r\n** >= 50% myometrial invasion, grade 1-2 adenocarcinoma without USC or clear cell histology\r\n* Patients with the following histologic features may be treated with pelvic radiation with or without weekly cisplatin; the decision to add weekly cisplatin for these patients is at the treating physician’s discretion:\r\n** >= 50% myometrial invasion, grade 3 including USC and clear cell carcinoma\r\n** International Federation of Gynecology and Obstetrics (FIGO) 2009 stage II endometrial cancer of any grade including USC and clear cell carcinoma\r\n** FIGO 2009 stage IIIC1 (pelvic lymph node positive only, para-aortic nodes sampled and negative if removed) including USC and clear cell carcinoma; Note: if para-aortic nodes are not removed, CT abdomen or PET CT must demonstrate no evidence of lymphadenopathy
Patients with nasopharyngeal carcinoma
Patients with nasopharyngeal carcinoma
Myoepithelial carcinoma
Myoepithelial carcinoma
Portion A: Histological or cytological diagnosis of advanced/metastatic solid tumor malignancy or B cell lymphoma, for which no curative therapy is available. Portion A expansion includes patients who have documented disease progression on a checkpoint inhibitor (anti CTLA 4, anti PD1/PD L1 antibodies) per RECIST criteria. Tumor types include metastatic melanoma, renal cell carcinoma (RCC), non-small cell lung cancer (NCSLC) and squamous cell carcinoma of the head and neck (SCCHN). Patients in the dose expansion stage are required to provide archival or baseline (obtained during the screening period) tumor biopsies.
Squamous cell or undifferentiated gastric cancer
Subjects with histologically or cytologically NSCLC, melanoma, transitional cell carcinoma of the genitourinary (GU) tract, renal cell cancer, triple negative breast cancer, adenocarcinoma of the endometrium or squamous cell carcinoma of the head and neck (Phase 1).
Histologically confirmed metastatic or recurrent squamous cell carcinoma not amenable to local therapy with curative intent (surgery or radiation with or without chemotherapy). Carcinoma of the nasopharynx, salivary gland, or * *Subjects must have received at least 1 prior systemic chemotherapy regimen that must have included a platinum-based therapy.
Histological diagnosis of squamous cell carcinoma, adenocarcinoma or adenosquamous cell carcinoma of the cervix
Patients with nasopharyngeal carcinoma, skin squamous cell carcinoma (SCC), and salivary gland carcinomas are not eligible
Histologically-proven squamous cell carcinoma of the penis
Squamous carcinoma of the urethra
Has pancreatic tumor other than adenocarcinoma, including: acinar cell carcinoma, pancreaticoblastoma, malignant cystic neoplasms, endocrine neoplasms, squamous cell carcinoma. Vater and periampullary duodenal or common bile duct malignancies.
Subjects with squamous cell carcinoma of the lung
Merkel cell carcinoma basket:\r\n* None
Thymic carcinoma
Histological confirmation of non-small cell cancer will be required by either biopsy or cytology; the following primary cancer types are eligible: squamous cell carcinoma, adenocarcinoma with or without bronchioloalveolar carcinoma (BAC) features, large cell carcinoma with or without neuroendocrine features, neuroendocrine carcinoma, bronchioloalveolar cell carcinoma, or non-small cell carcinoma not otherwise specified
Histologically confirmed cervical cancer\r\n* Histologically confirmed invasive squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix, stages IB2, IIA, IIB, IIIB, and IVA; stage IB1 with positive pelvic or para-aortic nodes based on magnetic resonance imaging (MRI) is also eligible\r\n* No evidence of distant metastases (based on PET/CT done within 4 weeks of start of treatment)\r\n* Recurrent cervical cancer is not eligible
Histologically confirmed non-small cell cancer by biopsy or cytology; squamous cell carcinoma, adenocarcinoma, large cell carcinoma, bronchioalveolar carcinoma, or non-small cell carcinoma (not otherwise specified) are allowed
Patient must have recurrent, persistent or metastatic cervical cancer including squamous cell, adenocarcinoma and adenosquamous histologies; mesonephric carcinoma, minimal deviation/adenoma malignum, clear cell carcinoma and gastric type are excluded
Histologically proven advanced or metastatic solid cancer for which bevacizumab has an indication: renal cell carcinoma, colorectal adenocarcinoma, non-squamous non-small cell lung cancer, platinum-refractory ovarian carcinoma, cervical carcinoma.
Upper tract Transitional Cell Carcinoma (TCC).
Patients with histologically proven squamous cell carcinoma of the larynx
Histologically confirmed recurrent or metastatic NSCLC (adenocarcinoma, large cell, squamous cell, or not otherwise specified) that has either progressed during or after platinum-based chemotherapy
Squamous cell or undifferentiated gastric cancer
Patients must have histologically or cytologically confirmed previously treated metastatic squamous cell carcinoma of the anal canal
Patients with pathologic diagnosis of lung NSCLC or squamous cell carcinoma
Safety expansion: patients with one of the following locally advanced unresectable or metastatic pathologically confirmed diagnosis:\r\n* Colorectal carcinoma and appendiceal adenocarcinoma\r\n* Gastro-esophageal carcinoma; Note: esophageal squamous cell carcinoma is exclusionary\r\n* Biliary tract carcinoma; Note: hepatocellular carcinoma is excluded\r\n* Pancreatic carcinoma
Patients with histologically-confirmed, persistent, metastatic or recurrent squamous or non-squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix with documented disease progression (disease not amenable to surgery or standard radiotherapy).
Histologically confirmed recurrent or metastatic carcinoma of the nasopharynx, squamous cell carcinoma of unknown primary, and salivary gland or non-squamous histologies (eg: mucosal melanoma) are not allowed
Biopsy proven squamous cell carcinoma histology or squamous cell variants (sarcomatoid, verrucous, basaloid, and papillary subtypes) involving the true vocal cord
Patients must have newly diagnosed, histologically or cytologically confirmed squamous cell carcinoma or undifferentiated carcinoma of the oropharynx; patients must have been determined to have resectable oropharyngeal disease; patients with primary tumor or nodal metastasis fixed to the carotid artery, skull base or cervical spine are not eligible
Pathologic subtypes other than pure adenocarcinoma; acinar cell carcinoma, squamous cell carcinoma, spindle cell carcinoma, neuroendocrine cancer, and mixed types are not eligible.
Women with clinical stage IB2-IVA cervical squamous cell carcinoma, adenosquamous, or adenocarcinoma
Patients must have persistent or recurrent squamous or non-squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix with documented disease progression (disease not amenable to curative therapy); histologic confirmation of the original primary tumor is required via the pathology report
Histologically confirmed primary adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma of the uterine cervix;
Any histology other than adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma of the uterine cervix;
For the second stage of the Phase I trial, all patients must have histologic demonstration of metastatic or locally unresectable transitional cell carcinoma of the urothelium. Minor components (<50% overall) of variant such as glandular or squamous differentiation, or evolution to more aggressive phenotypes such as sarcomatoid or small cell change are acceptable. However, when these atypical histologies are dominant, other treatment approaches may be more appropriate, and such patients are not eligible.
Islet cell or acinar cell carcinoma or cystadenocarcinoma
Recurrent or metastatic carcinoma of the nasopharynx, squamous cell carcinoma of unknown primary, squamous cell carcinoma that originated from the skin and salivary gland or paranasal sinus, non-squamous histologies (eg, mucosal melanoma)
Patients with histologically proven invasive squamous cell carcinoma arising from the true vocal cord
T1a and T2a squamous cell carcinoma of the glottic larynx (tumor limited to one vocal cord with normal cord mobility)
Squamous cell carcinoma in-situ of a single vocal cord (Tis) is eligible
The patient must have squamous cell carcinoma, adenocarcinoma or malignant salivary gland cancer (e.g. acinic cell, adenoid cystic, mucoepidermoid, salivary duct carcinoma) proven by histologic diagnosis; both mucosal and cutaneous cancers are eligible
Pathologically proven (histologically or cytologically) diagnosis of squamous cell carcinoma (including histological variants like papillary squamous cell carcinoma and basaloid squamous cell carcinoma)
Subjects with squamous cell carcinoma
Patients with a history of carcinoma in remission (on no therapy or on hormonal therapy for the adjuvant treatment of breast carcinoma or prostate carcinoma) are included in the study
Patients must have histologically or cytologically confirmed incurable malignancy that is surgically unresectable locally advanced, recurrent, or metastatic (stage IIIB/IV) non-small cell lung cancer (NSCLC); patients with adenocarcinoma, squamous cell carcinoma, large cell carcinoma and sarcomatoid carcinoma will be eligible
Histologically confirmed NSCLC (adenocarcinoma, squamous cell carcinoma, large cell carcinoma, undifferentiated carcinoma or other)
For Part 1b: Subjects with histologically or cytologically confirmed advanced or metastatic endometrial cancer, gastric cancer, melanoma, microsatellite unstable (MSI) colorectal cancer or other MMR-deficient tumors, non-small cell lung cancer, renal cell carcinoma, head and neck squamous cell carcinoma, triple negative breast cancer, pancreatic ductal carcinoma, or transitional cell carcinoma of the genitourinary tract that have had disease progression after available therapies for advanced or metastatic disease that are known to confer clinical benefit, been intolerant to treatment, or refused standard treatment.
Merkel Cell Carcinoma
Nasopharyngeal Carcinoma
Squamous cell carcinoma of the cervix, vagina, or vulva
Squamous cell carcinoma of the anal canal and penile
For dose escalation portion of the study: Patients must have a histologically or cytologically confirmed metastatic solid tumor that has shown clinical or pre-clinical evidence of responding to anti-PD-1 therapy or the capacity to up-regulate PD-L1; these tumor types may include but may not be limited to: renal cell carcinoma (RCC), urothelial carcinoma (UC), melanoma, non-small cell lung cancer (NSCLC), small cell lung cancer, squamous cell cancer of the head and neck (SCCHN), ovarian carcinoma, triple negative breast cancer, gastric cancer, microsatellite instability expressing (MSI-high) colon cancer, hepatocellular carcinoma, mesothelioma, gastrointestinal stromal tumors, endometrial carcinoma, liposarcomas, chondrosarcomas, and uterine sarcomas; patients with solid tumor types not listed above may be enrolled at the discretion of the principal investigator
Histological diagnosis of squamous cell carcinoma, adenocarcinoma or adenosquamous cell carcinoma of the cervix. Not accepted are small cell, clear cell and other rare variants of the classical adenocarcinoma;
Patients must have histologically or cytologically proven primary non-squamous non-small cell lung cancer (adenocarcinoma, large cell carcinoma, adenocarcinoma in situ, mixed histology with < 50% squamous or unspecified); patients with tumors having squamous cell components >= 50% are not eligible; disease must be stage IV
Nasopharyngeal carcinoma
Biopsy-confirmed Merkel cell carcinoma with metastatic or loco-regional disease.
Patients with advanced histologically proven squamous cell carcinoma of the lung
Histologically confirmed esophageal squamous cell carcinoma (ESCC)
Patients must have histological or cytological confirmed malignancy in the following disease groups: melanoma, non-small cell lung carcinoma, renal cell carcinoma or squamous cell head and neck carcinoma, for which no standard effective or curative options are available
Recurrent, persistent, and/or metastatic cervical cancer, for which there is not a curative intent option (surgery or radiation therapy with or without chemotherapy). Acceptable histologies are squamous carcinoma, adenocarcinoma, and adenosquamous carcinoma. Sarcomas and neuro-endocrine carcinomas are not eligible histologies.
Patients must have histologically or cytologically documented salivary gland cancers; patients that do not have a salivary gland primary must have one of the following histologies - adenoid cystic carcinoma, mucoepidermoid carcinoma, acinic cell carcinoma
Participants (who have been adequately clinically staged by standard clinical guidelines) with primary, untreated, histologically-confirmed, documented invasive squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix, International Federation of Gynecology and Obstetrics (FIGO) stages IB2, IIA, IIB, IIIA, IIIB, and IVA; (stage IIA tumors must be greater than 4 cm)
Histological confirmation (by biopsy or cytology) or clinically diagnosed primary NSCLC; the following primary cancer types are eligible: squamous cell carcinoma, adenocarcinoma, large cell carcinoma, bronchioloalveolar cell carcinoma, or non-small cell carcinoma not otherwise specified
Histologically document transitional cell carcinoma with the presence of any of the following stages: carcinoma in situ (CIS), high-grade Ta, or any grade T1, detectable at the time of study accrual; combinations of the aforementioned stages are acceptable; subjects with mixed histology are required to have a dominant transitional cell carcinoma (TCC) pattern
Recurrent or metastatic carcinoma of the nasopharynx and paranasal sinuses, squamous cell carcinoma that originated from the skin and salivary gland or non-squamous histologies (e.g., mucosal melanoma) and SCCHN of unknown primary origin.
Histologically confirmed stage IV NSCLC (squamous, adenocarcinoma, or large cell carcinoma) that is stable or has partially responded after four cycles of a platinum doublet; (a complete response is not allowed) there is no restriction on prior lines of therapy; maintenance chemotherapy is not allowed
Patients with recurrent or metastatic squamous cell carcinoma of the lung – diagnosis must be histologically confirmed
Histologically confirmed squamous cell carcinoma of the target tumor(s)
Patients with a histologic diagnosis of squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma of the cervix, stage IA1 (lymph-vascular space invasion [LVSI]+), IA2, and IB1 (tumor size [maximum visible or palpable]) =< 2 cm), any grade
Have histologically confirmed adenocarcinoma of the pancreas (including adenocarcinoma subtypes such as signet ring carcinoma, adenosquamous carcinoma, undifferentiated/poorly differentiated carcinoma, and mucinous carcinoma)
Histologically or cytologically documented NSCLC, including squamous cell carcinoma, adenocarcinoma (including bronchoalveolar cell), and large cell anaplastic carcinoma (including giant and clear cell carcinomas) and poorly differentiated non-small cell lung cancer; totally resected tumors are excluded
Subjects with known esophageal cancer diagnosed by previous endoscopy\r\n* Adenocarcinoma\r\n* Squamous cell carcinoma
For patients with T1N0 or T2N0 treated squamous cell carcinoma they must have been free of disease for a minimum period of 8 weeks, up to a maximum of 3 years following completion of surgery and/or radiotherapy
Patients with a treated T1N0 or T2N0 squamous cell carcinoma may have oral premalignant lesions (i.e., hyperplasia, dysplasia, carcinoma in situ) at the time of study entry (provided their stage I or II disease has been definitively treated)
Currently being treated for metastatic transitional cell carcinoma
Squamous cell carcinoma of the nasopharynx
Histologically or cytologically confirmed small cell carcinoma, squamous cell carcinoma or adenocarcinoma (confirmed at Memorial Sloan Kettering Cancer Center [MSKCC]) of the bladder, ureter, urethra, urachus, or renal pelvis; patients with squamous cell carcinoma and adenocarcinoma are required to have a predominant squamous or adenocarcinoma component as reviewed by the pathologist at MSKCC; however, if any element of small cell or neuroendocrine differentiation is present, the patients will be classified as small cell/neuroendocrine
Carcinoma originating in the nasopharynx or paranasal sinus, squamous cell carcinoma that originated from the skin and salivary gland or non-squamous histology (e.g., mucosal melanoma), squamous cell carcinoma of unknown primary
Patients must have histologically confirmed stage IB2-IVA epithelial carcinoma of the cervix, including squamous cell, adeno-, and undifferentiated carcinoma, and excluding small cell/neuroendocrine carcinoma, who will undergo radiation therapy for cervical cancer with curative intent
Subjects with known esophageal cancer (adenocarcinoma or squamous cell carcinoma)
Prior history of carcinoma
Patient with nasopharyngeal carcinoma
Patients undergoing Mohs surgery for basal cell carcinoma (BCC) or squamous cell carcinoma (SCC)
Nasal, paranasal sinus, or nasopharyngeal carcinoma, aside from WHO Type I and II (keratinizing, non-EBV positive) nasopharyngeal carcinoma which will be allowed.
Histologically confirmed, measurable, unresectable adenocarcinoma or squamous cell carcinoma of the esophagus; for the purposes of this study, undifferentiated carcinomas or adenosquamous carcinomas will be categorized as adenocarcinomas
Squamous cell, large cell undifferentiated, neuroendocrine or small cell undifferentiated carcinoma of the lung
Histologically or cytologically confirmed measurable advanced and/or metastatic solid GI tumor that expresses GCC protein (H-score greater than [>] 10), for which standard treatment is no longer effective or does not offer curative or life-prolonging benefit. For the escalation part of the study (Part A), GI malignancies include, but are not limited to, metastatic colorectal carcinoma (mCRC), gastric carcinoma, esophageal carcinoma, small intestine cancer, and pancreatic cancer. The expansion part of the study (Part B) is limited to participants with CRC.
Patients with a diagnosis of small cell carcinoma, adenocarcinoma or squamous cell\n             carcinoma of the bladder
Histologically confirmed recurrent or metastatic squamous cell carcinoma of unknown primary or nonsquamous histologies (example, mucosal melanoma) are not allowed.
Variants (including but not limited to tall cell, columnar cell, cribriform-morular, solid, oxyphil, Warthin's-like, trabecular, tumor with nodular fasciitis-like stroma, Hürthle cell variant of papillary carcinoma, poorly differentiated)