Histological or cytological evidence of urothelial cancer of the bladder, urethra, ureter, or renal pelvis; differentiation with variant histologies (e.g., squamous cell differentiated) will be permitted provided that the predominant histology is urothelial carcinoma
Maximal diameter of any one hepatocellular carcinoma > 15 cm
Histologically documented urothelial carcinoma (squamous differentiation or mixed cell types allowed).
Must have a histologically confirmed transitional cell carcinoma (TCC, also known as urothelial carcinoma), locally advanced or metastatic
Histologically confirmed muscle-invasive urothelial carcinoma of the bladder or upper tract; variant histology allowed as long as urothelial carcinoma is predominant (> 50%); pure small-cell carcinoma is excluded
Patients must have histologically or cytologically confirmed papillary histology renal cell carcinoma which is metastatic or locally advanced disease not amenable to surgical resection; (NOTE: a designation of type I or type II should be made by the local pathologist if possible); mixed histologies containing type I or type II will be allowed provided that they contain >= 50% of the papillary component
Pathologically confirmed non-squamous non-small cell lung carcinoma (NSCLC)
Predominant non-squamous histology (patients with NSCLC not otherwise specified [NOS] are eligible); mixed tumors will be categorized by the predominant cell type; if small cell elements are present the patient is ineligible
Pathologically proven diagnosis of squamous cell carcinoma (including variants such as verrucous carcinoma, spindle cell carcinoma, carcinoma not otherwise specified [NOS]) of the head/neck (oral cavity, oropharynx, hypopharynx or larynx); pathologic stage III or IVA (American Joint Committee on Cancer [AJCC] 8): T3-T4a, N0-3, M0 or T1-T2, N1-3, M0
Patients must not have poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, goblet cell carcinoid and small cell carcinoma
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 must have endometrial carcinoma including endometrioid adenocarcinoma, adenocarcinoma with squamous differentiation, mucinous adenocarcinoma, squamous cell carcinoma, mixed carcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, and serous adenocarcinoma histologies
Preoperative biopsy for confirmation of renal cell carcinoma (RCC) must be performed within four (4) months prior to randomization\r\n* If biopsy was performed as part of patients standard care, and will not be performed during step 0 proceed directly to randomization
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 have histologically proven Ta, carcinoma in situ (CIS) or T1 stage urothelial cell carcinoma of the bladder within 90 days prior to registration
Patients must not have pure squamous cell carcinoma or adenocarcinoma
Upper age limit of =< 18 years of age for medullary thyroid carcinoma (MTC), renal cell carcinoma (RCC) and hepatocellular carcinoma (HCC)
Patients with known active cutaneous squamous cell carcinoma (includes keratoacanthoma or mixed keratoacanthoma subtype) are not eligible; patients who have fully excised lesions with dermatologic confirmation of absence of disease are eligible
Patients must be newly diagnosed with histologically-proven primary pediatric hepatic malignancies including hepatoblastoma or hepatocellular carcinoma, except as noted below; note that rapid central pathology review is required in some cases; please note: all patients with histology as assessed by the institutional pathologist consistent with pure small cell undifferentiated (SCU) HB will be required to have testing for INI1/SMARCB1 by immunohistochemistry (IHC) according to the practices at the institution
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)
Patients with two or more active malignancies (synchronous multiple cancers, or metachronous multiple cancers with a disease-free period of ? 5 years, with the exception of carcinoma in situ, mucosal carcinoma, or other carcinomas that have been curatively treated with local therapy)
Biliary tract carcinoma.
Endometrial carcinoma.
Carcinoma of unknown primary site.
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.
Patients must have histologically confirmed well-differentiated islet cell carcinoma (PNET) not amenable to surgical resection
Histologically confirmed diagnosis of urothelial carcinoma of the bladder. Variant histology is acceptable if there is a predominant urothelial component.
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.
Prior CAR T-cell or other genetically-modified T-cell therapy
Cohort A2: Transitional cell carcinoma of the urothelium including the bladder, urethra, renal pelvis, and ureter.
Cytologically- or histologically-confirmed pancreatic adenocarcinoma or poorly differentiated pancreatic carcinoma that is metastatic to distant sites\r\n* Other histologies such as neuroendocrine and acinar cell carcinoma are excluded
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
Dose Escalation Cohort: must have breast cancer, colorectal cancer, adrenocortical carcinoma, chromophobe renal cell carcinoma.
Have a histologically proven locally advanced or metastatic high grade neuroendocrine carcinoma (NEC)\r\n* Includes small cell and large cell neuroendocrine carcinoma of unknown primary or any extrapulmonary site\r\n* Includes neuroendocrine prostate cancer (de novo or treatment-emergent) of prostate if small cell or large cell histology\r\n* Mixed tumors, e.g. mixed adenoneuroendocrine carcinoma (MANEC) or mixed squamous or acinar cell NEC are allowed if the high grade (small or large cell) NEC component comprises > 50% of the original sample or subsequent biopsy
Has Merkel cell carcinoma, small cell lung carcinoma, or large cell NEC of lung \r\n* Intermediate grade neuroendocrine tumors are excluded\r\n* Well differentiated grade 3 neuroendocrine tumors are excluded\r\n* Metastatic high-grade prostate carcinoma with evidence of focal neuroendocrine differentiation on prostate biopsy (e.g., positive chromogranin staining by immunohistochemistry) without small cell or large cell NEC morphology are excluded, as are neuroendocrine prostate cancers with phenotype intermediate between adenocarcinoma and small cell\r\n* Atypical bronchial carcinoid and well differentiated G2 gastro-entero-pancreatic neuroendocrine tumors (GEP-NET) are excluded
T0-3, N0 to N2c, M0 squamous cell carcinoma of the oropharynx
Biopsy proven squamous cell carcinoma that is HPV and/or p16 positive
Urothelial carcinoma
Gastric/gastroesophageal junction/esophageal carcinoma (G/GEJ/E)
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
Malignancy of squamous histology. In cases of mixed histology, squamous must be the predominant histology.
Histologic confirmation of non-muscle invasive bladder cancer of the transitional cell carcinoma high-grade subtype
Evidence of muscle-invasive or regional and/or distant metastatic bladder cancer, or high grade urothelial carcinoma in the prostate or upper urinary tract
Diagnosis of anal or small bowel carcinoma.
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.
Histopathologically confirmed melanoma, Merkel cell carcinoma or other solid tumor malignancy
Patients with histologically or serologically confirmed relapsed/refractory nonseminoma germ cell tumor, (i.e., embryonal carcinoma, choriocarcinoma, or yolk sac tumors) including female germ cell tumors (GCT) and primary mediastinal NSGCT
Merkel Cell Carcinoma (MCC)
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).
Non-small cell lung adenocarcinoma or squamous cell carcimona
Histologically or cytologically confirmed incurable HNSCC of the oral cavity, oropharynx, larynx, hypopharynx, and/or level 1-3 neck node with non-skin squamous cell carcinoma (SCC) and unknown primary; “incurable” is defined as metastatic disease or a local or regional recurrence in a previously irradiated site that is unresectable (or patient declines resection)
Presence of lobular carcinoma
Histological or cytological diagnosis of renal cell cancer with a clear-cell component
Poorly differentiated carcinoma, high grade neuroendocrine tumor or small cell carcinomas are excluded from this study
Pancreatic neuroendocrine tumors (islet cell carcinoma) will be excluded from this study; all non functional and functional islet cell carcinomas such as insulinoma, glucagonoma, gastrinoma, vasoactive intestinal peptide (VIP)oma will be excluded
Patients must have recurrent or persistent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma; histologic documentation of the original primary tumor is required via the pathology report; the following histologic epithelial cell types are eligible:\r\n* Serous, endometrioid, mucinous, or clear cell adenocarcinoma\r\n* Undifferentiated, mixed epithelial or transitional cell carcinoma\r\n* Brenner’s tumor\r\n* Adenocarcinoma not otherwise specified (N.O.S)
Eligible disease sites include the following\r\n* Breast\r\n* Prostate\r\n* Gastrointestinal (GI) (including colorectal, anal, esophagus, pancreas, gastric with the exception of patients with colon cancer and liver-only metastatic disease)\r\n* Head and neck\r\n* Skin (melanoma and squamous cell carcinoma)\r\n* Lung (both small cell and non-small cell)\r\n* Sarcoma (both soft tissue and bone)\r\n* Gynecologic (endometrial, cervical, ovarian, vaginal, vulvar)
Eligible disease sites include the following\r\n* Breast\r\n* Prostate\r\n* Gastrointestinal (GI) (including colorectal, anal, esophagus, pancreas, gastric with the exception of colon cancer with resectable liver-only lesions)\r\n* Head and neck\r\n* Skin (melanoma and squamous cell carcinoma)\r\n* Lung (both small cell and non-small cell)\r\n* Sarcoma (both soft tissue and bone)\r\n* Gynecologic (endometrial, cervical, ovarian, vaginal, vulvar)
Patients with recurrent squamous cell carcinoma or a second primary arising in a previously irradiated field
Hepatocellular carcinoma;
Urothelial carcinoma;
Renal cell carcinoma (clear cell predominant type);
Microsatellite instability-high or mismatch repair deficient colorectal carcinoma or endometrial carcinoma;
Non-small cell lung carcinoma;
Histologically confirmed metastatic or recurrent Type II EC (serous, clear cell, carcinosarcoma, adenosquamous and mixed histologies).
For papillary thyroid carcinoma patients:
For endometrial carcinoma patients, a diagnosis of epithelial endometrial carcinoma is required. Stromal tumors and carcinosarcoma (mixed malignant Mullerian tumor) are excluded.
For papillary renal cell carcinoma patients, the following are required:
Documented local confirmation of renal cell carcinoma with a predominantly papillary growth pattern.
Bladder urothelial carcinoma
Patients with nasopharyngeal carcinoma, salivary gland or skin primaries
Biopsy-proven squamous cell carcinoma of the oral cavity or oropharynx without distant organ metastases
Histological or cytological confirmation of predominant clear cell renal cell carcinoma (RCC) (original tissue diagnosis of RCC is acceptable)
Must have histologically confirmed squamous cell carcinoma or adenosquamous cell carcinoma of esophagus
Nasopharyngeal carcinoma
Participants with previously untreated T1/T2 N0 squamous cell carcinoma of the oral cavity with or without extension to the oropharynx
Histologically confirmed squamous cell carcinoma of the target tumor(s)
Histologically proven (squamous cell or adenocarcinoma) esophageal or gastro- esophageal junction cancer (core biopsy required)
Histologically confirmed muscle-invasive UC (also termed transitional cell carcinoma) of the bladder or upper urinary tract (i.e., renal pelvis or ureters)
Institutional confirmation of Mullerian epithelial adenocarcinoma on core biopsy (not cytology or fine needle aspiration) or laparoscopic biopsy; (for phase II of the study formalin-fixed paraffin-embedded [FFPE] tissue should be available for laboratory analysis); patients with the following histologic epithelial cell types are eligible: high grade serous carcinoma, high grade endometrioid carcinoma, clear cell carcinoma, or a combination of these
Patients with mucinous carcinoma, low grade endometrioid carcinoma, low grade serous carcinoma or carcinosarcoma
Anal Squamous Cell Carcinoma
Endometrial Carcinoma (sarcomas and mesenchymal tumors are excluded)
Cervical Squamous Cell Carcinoma
Vulvar Squamous Cell Carcinoma
Small Cell Lung Carcinoma
Thyroid Carcinoma
Pathologic findings consistent with small-cell or neuroendocrine carcinoma of the prostate
Subject has histologically confirmed diagnosis of any one of the following cancers: (A) urothelial cancer (transitional cell cancer of the bladder, ureter or renal pelvis), (B) melanoma, or (C) squamous cell carcinoma of the head and neck.
Pathologically confirmed squamous cell carcinoma of the oral cavity; clinical stage >= T2 (primary tumor greater than 2 cm in size) and/or evidence of regional nodal involvement by clinical exam or imaging
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
Adequately treated urothelial papillary non-invasive carcinoma or carcinoma in situ
Histological confirmation of human papillomavirus (HPV) positive (+) squamous cell carcinoma of the oropharynx; HPV positivity will be defined as positive staining for p16 on immunohistochemistry (IHC)
Patients must have histologically proven urothelial carcinoma of the bladder; those with mixed histology, including a component of urothelial carcinoma, are eligible; pure small cell carcinoma, pure adenocarcinoma, and pure squamous cell carcinoma are excluded
Baseline skin exam is required for all patients; Note: cutaneous squamous cell carcinoma (SCC) lesions identified at baseline must be excised
Has non-squamous histology NSCLC.
Patient has disease of nasopharyngeal carcinoma histology
Histologically-confirmed renal cell carcinoma (any histologic subtype) without evidence of distant metastatic disease
High grade and/or invasive and/or carcinoma in situ disease
Concomitant upper tract urothelial carcinoma
Nasopharyngeal or sinonasal carcinoma
Histologic proof or unequivocal cytologic proof (fine needle aspiration, biopsy or two positive sputa) of SCLC within 250 days prior to Step 1 registration;\r\n* High-grade neuroendocrine carcinoma or combined SCLC and non-small cell lung cancer (NSCLC) is permitted
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.
Colorectal carcinoma (CRC).
Histologic features: (a) Neuroendocrine tumors of lung origin are considered high grade if in any part of the tumors, there are >10 mitoses/2mm2 or 10 high power field (HPF). Large zones of necrosis are usually present. This includes small cell lung carcinoma and large cell neuroendocrine lung carcinoma. [SCLC will not enroll in the HGNEC cohort.] (b)Neuroendocrine tumors of gastroenteropancreatic origin are considered high grade if in any part of the tumors there are either >20 mitoses/2mm2 or 10 high power field (HPF) OR Ki67.
Patients must have pathologically or cytologically proven transitional cell carcinoma (TCC) of the urothelium
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
Recurrent, persistent, or progressive epithelial ovarian, fallopian tube, or primary peritoneal cancer after treatment with bilateral oophorectomy and either cisplatin or carboplatin and either paclitaxel, albumin-bound paclitaxel, or docetaxel; histologic confirmation of the primary tumor is required; eligible histologies include serous, endometrioid, clear cell, mucinous, transitional cell, undifferentiated, or mixed carcinoma
Histologic evidence of predominantly squamous cell NSCLC
Patients with HPV-positive or p16-positive oropharyngeal squamous cell carcinoma (SCCA)
Histologic evidence of urothelial carcinoma of the bladder
Diagnosis of urothelial carcinoma involving the prostatic urethra or upper urinary tract
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)
Pathologically confirmed squamous cell carcinoma, undifferentiated carcinoma, or poorly differentiated carcinoma of the oropharynx, larynx, or hypopharynx with no evidence of distant metastasis; biopsy sampling of primary tumor with pathology report documenting diagnostic tissue type is required
Patients must have histologically or cytologically confirmed urothelial tract carcinoma; patients with urothelial carcinoma of the bladder, upper tract, or urethra are eligible
Participants must have histologically or cytologically confirmed and identified resectable primary squamous cell carcinoma of the oropharynx that is HPV 16 positive or positive for any high risk HPV subtype (i.e., 18, 33, 35, etc.) as determined by PCR at the central laboratory. Patients must have p16+ status as determined by IHC performed or reviewed at the central laboratory. Both p16 and HPV status must be determined prior to post-surgical adjuvant treatment assignment. Tissue from the primary site must be available for biomarker studies after surgery
p16 or HPV negative oropharyngeal squamous cell carcinoma (OPSCC) as determined by immunohistochemistry (IHC) and polymerase chain reaction (PCR), respectively
Available allogeneic activated peripheral blood T cell products with ? 15% expression of CD19.CAR-CD28zeta determined by flow cytometry (cell dose is based on total cell numbers and not individual anti-leukemic cell numbers)
Mixed histology including clear cell, serous, undifferentiated or sarcomatous elements
Patients with concurrent upper urinary tract (i.e. ureter, renal pelvis) non-invasive urothelial carcinoma
Biopsy/pathology-proven clear cell renal cell carcinoma (CCRCC) with metastases
COHORT B, GROUP 6: HEPATOCELLULAR CARCINOMA: Patients are not required to have failed sorafenib
Histologically confirmed metastatic renal cell carcinoma with predominantly clear cell histology
Measurable metastatic (stage IV) gastric, gastroesophageal, pancreatic, hepatocellular carcinoma, cholangiocarcinoma, gallbladder, colorectal, urothelial, breast, ovarian/endometrial carcinoma, or glioblastoma  with at least one lesion that is resectable for TIL generation with minimal morbidity preferentially using minimal invasive laparoscopic or thoracoscopic surgery for removal of superficial tumor deposit, plus one other lesion that can be measured by Response Evaluation Criteria In Solid Tumors (RECIST) criteria
Cohort D: unresectable or metastatic urothelial carcinoma (urethra, bladder, ureters, or renal pelvis)
Predominant histologic component (> 50%) must be urothelial (transitional cell) carcinoma
Biopsy-proven non-hematopoietic malignancy, except for germ cell cancer. Small cell lung carcinoma is eligible for this study.
Patients with histologically confirmed, potentially curable squamous-cell carcinoma, adenocarcinoma, or large-cell undifferentiated carcinoma of the esophagus
Diagnosis of cervical esophageal carcinoma
Histologically or cytologically documented adenocarcinoma or squamous cell carcinoma of the cervical or thoracic esophagus or gastroesophageal junction or cardia of stomach
INCLUSION - ENROLLMENT: Diagnosis of invasive ductal carcinoma
Localized clear cell renal carcinoma without evidence of distant metastases
Non-clear cell histology
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
Localized urothelial cancer of bladder with presence of transitional cell carcinoma (TCC) component; mixed histologies are allowed
Subjects with poorly differentiated or small cell carcinoma histology
Measurable solid cancer with at least one lesion that is resectable for tumor infiltrating lymphocytes (TIL) generation with minimal morbidity plus at least one other lesion that can be measured that falls into one of four cohorts:\r\n* Gastrointestinal and genitourinary cancers\r\n* Breast and ovarian, and other solid cancers\r\n* Lung cancer (Non-small cell lung cancer ([NSCLC])\r\n* Glioblastoma\r\n** Note: Metastatic disease is required for cohorts 1-3, but not required for cohort 4\r\n** Note: NSCLC includes but is not limited to squamous cell carcinoma, adenosquamous carcinoma or adenocarcinomas; neuroendocrine tumors are not eligible
Histological proof of non-metastatic muscle-invasive urothelial cell carcinoma of the bladder.
STUDY TREATMENT: Histology consistent with high-grade epithelial ovarian cancer (excluding mucinous carcinoma, clear cell carcinoma, and carcinosarcoma).
GENERAL: Mucinous, low-grade histology, clear cell carcinoma, or carcinosarcoma.
Histologic demonstration of transitional cell carcinoma of the urothelium. Minor components ( less than [<] 50 percent [%] overall) of variant histology such as glandular or squamous differentiation, or evolution to more aggressive phenotypes such as sarcomatoid or micropapillary change are acceptable
Larynx squamous cell carcinoma (SCC), hypopharynx SCC, or oral cavity SCC; HPV-unrelated oropharyngeal squamous cell carcinoma (OPSCC) (defined as p16^INK4a negative by immunohistochemistry [IHC] [staining in < 70% of cells] or HPV high risk [type 16 or 18] negative by in situ hybridization [ISH]); P16^INK4a positive larynx SCC, hypopharynx SCC, and oral cavity SCC are eligible
Carcinoma in situ (CIS) in the past in the urinary tract.
Patient has a history of invasive urothelial carcinoma in the urinary tract during the past 5 (Five) years.
Patient has a history of high grade papillary urothelial carcinoma in the urinary tract during the past 2 (Two) years.
Dose Escalation, Renal insufficiency and CPI-Treated Expansion cohorts: Histologically confirmed Transitional Cell Carcinoma of the Urothelium (TCCU) (i.e., cancer of the bladder, renal pelvis, ureter, or urethra). Subjects with Urothelial Carcinoma with squamous differentiation or mixed cell types are eligible.
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).
Advanced Renal Cell Carcinoma
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.
p16-positive squamous cell carcinoma of the pharynx, larynx or oral cavity
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
Confirmed unresectable or metastatic hepatocellular carcinoma; confirmation either by histologic confirmation or accepted radiographic criteria
Patients must have histologically or cytologically confirmed squamous cell carcinoma of oral cavity, oropharynx, paranasal sinuses, hypopharynx, or larynx; squamous cell carcinoma of unknown primary in cervical lymph node can be included only if p16 status is positive
Histologic diagnosis of prostate adenocarcinoma\r\n* Pure small cell carcinoma will be excluded; however, component of neuroendocrine /small cell differentiation will be allowed provided that adenocarcinoma constitutes majority of the tissue specimen
Histologically confirmed invasive carcinoma or ductal carcinoma in situ (DCIS) of the breast
Primary nasopharyngeal carcinoma
Pathological diagnosis of squamous cell carcinoma of the lung
Patients with the following histologic epithelial cell types are eligible:\r\n* Serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, or adenocarcinoma not otherwise specified
Unresectable thymoma or thymic carcinoma.
Patients must have recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal carcinoma, diagnosed within 6 months of completing their most recent platinum-containing chemotherapy; histologic documentation of the original primary tumor is required via a pathology report; \r\n* Patients with the following histologic cell types are eligible: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's Tumor, or adenocarcinoma not otherwise specified (N.O.S.)
Patients must have a diagnosis endometrial carcinoma on a tissue sample obtained at MSK (biopsy); patients with the following histologic epithelial cell types are eligible: endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified (N.O.S.), mucinous adenocarcinoma, squamous cell carcinoma, transitional cell carcinoma
Diagnosis of hepatocellular carcinoma
Patients must have histologically or cytologically confirmed by National Cancer Institute (NCI) Laboratory of Pathology as high grade non-muscle invasive urothelial (transitional cell carcinoma) of the bladder as follows:\r\n* Carcinoma-in-situ (CIS) with or without papillary tumors\r\n* High-grade Ta or T1 disease based on a biopsy/Transurethral Resection of Bladder Tumor (TURBT) performed within 12 weeks of the initial dose of study treatment; if multiple bladder biopsies/TURBTs are required to confirm eligibility, the timing of the last bladder biopsy to the initial dose of study treatment must be within 12 weeks\r\n* Patients with persistent T1 high grade disease on TURBT following a single induction course of BCG (at least 5 of 6 doses) may also be eligible for this trial provided that the patient is surgically unfit for cystectomy as deemed by the investigator or the patient declines cystectomy
Evidence of non-bladder urothelial (transitional cell) carcinoma by biopsy, cytology, or radiological imaging within the past 2 years of treatment (e.g. upper tract transitional cell carcinoma, urethral urothelial carcinoma)
Has any evidence of small cell histology, or combined small cell and non-small cell histology, in original tumor biopsy or in screening biopsy performed since progression.
Histological or cytologically proven urothelial carcinoma; mixed urothelial/non-urothelial cell histologies are allowed but pure non-urothelial cell carcinoma is NOT allowed
Colorectal cancer/carcinoma (CRC), glioblastoma (GBM), squamous cell carcinoma of the head and neck (HNSCC), or squamous non-small cell lung cancer (sqNSCLC)
Biopsy proven diagnosis of squamous cell carcinoma of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal walls). Clinical evidence should be documented, and may consist of imaging, endoscopic evaluation, palpation, and should be sufficient to estimate the size of the primary for purposes of T staging.
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
Patients must have histologically or cytologically confirmed thyroid carcinoma of follicular origin (including papillary, follicular, Hurthle cell or poorly differentiated subtypes and their respective variants)
The subject must not have had diagnosis, detection, or treatment of another type of cancer =< 2 years prior to randomization (except basal or squamous cell carcinoma of the skin that has been definitively treated); questions regarding the inclusion of individual subjects should be directed to the principal investigators, Dr. Isaacs and Dr. Pishvaian
Subjects must have a histologic diagnosis of urothelial carcinoma with radiologic, histologic or cytologic evidence of metastatic disease
Patient has histologically confirmed locally recurrent or metastatic predominantly clear cell renal cell carcinoma.
Renal cell carcinoma without any clear (conventional) cell component
Histologically proven mRCC with a clear cell component
Neuroendocrine-like prostate cancer, based on histology OR based on clinical presentation as defined by meeting one of the two below criteria; all subjects must submit their primary tumor or metastatic biopsy pathology specimens to the Duke Cancer Institute where they will be centrally reviewed by Duke Pathology (Dr. Jiaoti Huang); central Duke pathologic review is not required for screening but rather for confirmation of histologic subtype; local pathologic review is sufficient for eligibility determination\r\n* Criterion 1: presence of 1 of 3 histologically proven diagnoses:\r\n** Primary small cell carcinoma of the prostate, defined by classic histologic features such as small tumor cells with scanty cytoplasm, darkly stained nuclei with homogeneous chromatin pattern; the tumor cells do not form glandular structure but grow as solid sheets with frequent mitotic figures and necrosis\r\n** Intermediate atypical carcinoma of the prostate, which has histologic features distinct from small cell carcinoma or adenocarcinoma; the tumor grows as solid sheets or vague glandular structures; the tumor cells have moderate amounts of cytoplasm and centrally located, round and regular nuclei with fine, granular and homogeneous chromatin; mitosis and necrosis are absent\r\n** Mixed histology tumors of the prostate, containing both adenocarcinoma and neuroendocrine or small cell components\r\n* Criterion 2: presence of histologically proven adenocarcinoma of the prostate without any sign of neuroendocrine or small cell histology that is radiographically progressing despite castrate levels of testosterone (< 50 ng/mL) with the following poor risk features:\r\n** Prior progression despite therapy with either abiraterone acetate and/or enzalutamide\r\n** At least one of the following:\r\n*** Liver metastases\r\n*** Bulky radiographic progression (>= 2 cm short axis lymph nodes or >= 1 cm long axis visceral metastases) combined with low serum PSA (< 10 ng/mL)\r\n*** High serum LDH (> 1 X upper limit of normal)
Histological documentation of adenocarcinoma of the prostate reviewed at MD Anderson Cancer Center. Patients with small cell, neuroendocrine, or transitional cell carcinomas are not eligible.
PRE-CHEMORADIATION SAMPLE COLLECTION: Patients must have histologically proven primary carcinoma of the bladder or urethra or lower ureter (adenocarcinoma or transitional or squamous-cell carcinoma)
STUDY TREATMENT: Patients must have histologically proven primary carcinoma of the bladder or urethra or lower ureter (adenocarcinoma or transitional or squamous-cell carcinoma)
Histologically proven squamous cell carcinoma, adenocarcinoma or undifferentiated carcinoma of the esophagus or gastroesophageal (GE) junction
Suspected or histologically/cytologically confirmed oropharyngeal squamous cell carcinoma (OPSCC), stage II, III, or IVA (according to the American Joint Committee on Cancer [AJCC] 7th edition), or patients with loco-regional recurrence from an OPSCC primary, if time of recurrence is at least 6 months after completion of initial curative intent treatment (surgery or radiotherapy +/- chemotherapy or cetuximab). Patients with a suspected lesion may be enrolled and a baseline biopsy will be obtained as part of the study. If squamous cell histology is not confirmed, patients will be discontinued from the study
Histology other than squamous cell carcinoma
Subjects must not have invasive lobular carcinoma
Histological or cytological evidence urothelial (transitional cell) carcinoma of the renal pelvis, ureter, bladder or urethra
Subject has histologically confirmed diagnosis of any one of the following cancers: urothelial cancer (transitional cell cancer of the bladder, ureter, urethra or renal pelvis), melanoma, squamous cell carcinoma of the head and neck, ovarian cancer, NSCLC (squamous, adenosquamous, or large cell), esophageal (squamous and adenocarcinoma) or gastric cancer, synovial sarcoma or MRCLS.
Histological confirmation of renal cell carcinoma (RCC) (any histology)
Patients must have measurable stage IVA, stage IVB (with or without measurable disease) or recurrent (with or without measurable disease) endometrial carcinoma; largest tumor diameter =< 5 cm\r\n* NOTE: histologic confirmation of the original primary tumor is required; patients with the following histologic epithelial cell types are eligible: Endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, carcinosarcoma, adenocarcinoma not otherwise specified (NOS)\r\n* NOTE: measurable disease is defined by Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1)
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
Histologically confirmed renal cell carcinoma (RCC)
For individual baskets: Appendiceal adenocarcinoma: Must not have clinically symptomatic malignant bowel obstruction; Cutaneous squamous cell carcinoma: none; Small bowel adenocarcinoma: must not have clinically symptomatic malignant small bowel obstruction
Histological or cytological evidence of transitional cell carcinoma or carcinoma in situ of the urothelium involving the bladder or prostatic urethra following treatment with BCG with the recommendation to proceed for cystectomy; minor histologic variants (< 50% overall) are acceptable; diagnosis must be within 1 year of study entry
Patients with high risk muscle invasive urothelial carcinoma (hydronephrosis, palpable mass on examination under anesthesia, muscle invasive urothelial carcinoma with lymphovascular invasion on pathologic specimen, > T3 disease) or those with lymph node positive or metastatic disease are to be excluded
Patients must have histologically confirmed metastatic or recurrent endometrial cancer; eligible histologies include but are not limited to endometrioid, serous, clear cell, carcinosarcoma, adenosquamous, and mixed histologies
Histological confirmation of renal cell carcinoma (RCC) with a predominantly (> 50%) clear cell component
Subjects must have a histologically confirmed diagnosis of small cell lung carcinoma
Presence of primary hepatobiliary malignancy, including cholangiocarcinoma or hepatocellular carcinoma, gallbladder carcinoma, cancer of ampulla of Vater.
Pathologically-proven diagnosis of squamous cell carcinoma of the oropharynx or larynx; squamous cell carcinoma of unknown primary is not allowed
Histological confirmation of renal cell carcinoma (RCC) with a clear-cell component
For the window phase: Patients must have histologically confirmed invasive lobular carcinoma or invasive ductal carcinoma; no central confirmation of histological subtype is necessary for enrollment; patients with mixed invasive ductal and lobular carcinoma are eligible and will be stratified as ductal
Histologically or cytologically documented transitional cell carcinoma of the urothelium (squamous differentiation or mixed cell types allowed).
Diagnosis of pancreatic islet neoplasm, acinar cell carcinoma, non- adenocarcinoma (i.e., lymphoma, sarcoma), adenocarcinoma originating from the biliary tree, or cystadenocarcinoma
Histologic or cytologic diagnosis of endometrial carcinoma (including endometrioid, serous, mixed adenocarcinoma, clear-cell carcinoma, or carcinosarcoma).
Patients with neuroendocrine or small cell features are not eligible
Any patient eligible for internal implantation without MR guidance will be considered eligible for this protocol; standard criteria for internal implantation include:\r\n* Carcinoma of the cervix: stage I-IVA or vaginal recurrence\r\n* Carcinoma of the uterus: stage IIIB (vaginal involvement), inoperable, or vaginal recurrence\r\n* Carcinoma of the vagina: stage I-IVA or vaginal recurrence\r\n* Carcinoma of the vulva: stage I-IVA or recurrence\r\n* Carcinoma of the urethra based on treating physician’s discretion
Pathologically confirmed diagnosis of squamous cell carcinoma of the oropharynx, larynx, hypopharynx, or oral cavity with clinical or pathologic high-risk features for whom cisplatin and radiation would be considered appropriate care.
Advanced, unresectable hepatocellular carcinoma (unsuitable for resection, transplant or ablation)
Any one hepatocellular carcinoma > 15 cm
Subjects must have a histologic diagnosis of clear cell renal cell carcinoma (pure or mixed) with radiologic or histologic or cytologic evidence of metastatic disease
An archived tissue block with the subject’s renal cell carcinoma must be identified prior to registration
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
Adequately treated urothelial papillary noninvasive carcinoma or carcinoma in situ.
Participants must have histologically confirmed small cell lung carcinoma not amenable to initial concurrent radiotherapy (extensive-stage disease)
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
Muscle invasive (T2 or above) urothelial carcinoma or urothelial carcinoma outside the bladder
Primary lesions with the following histologies: small cell carcinoma, germ-cell tumors, lymphoma, leukemia, and multiple myeloma
Histology showing mucinous or low-grade epithelial ovarian carcinoma
Pathologically–confirmed small cell carcinoma of any primary site
Histologically confirmed muscle-invasive urothelial carcinoma of the bladder defined as T2-T4 stage; mixed histologies are acceptable provided urothelial carcinoma is the predominant histology (? 50%); patients with > 50% non- urothelial carcinoma histologies or any component of small cell carcinoma are not eligible; resectable clinical node-positive (N1) patients are eligible provided the lymph nodes are confined to the true pelvis and are within the planned surgical lymph node dissection template
Patients with concurrent upper urinary tract (i.e. ureter, renal pelvis) invasive urothelial carcinoma; (NOTE: Patients with history of non-invasive [Ta, Tis] upper tract urothelial carcinoma that has been definitively treated with at least one post-treatment disease assessment [i.e. cytology, biopsy, imaging] that demonstrates no evidence of residual disease are eligible)
Diagnosis of metastatic squamous cell carcinoma and/or adenocarcinoma of the esophagus, gastroesophageal junction, or stomach in need of palliative radiotherapy to the primary tumor or a single metastatic site for symptoms such as pain, dysphagia, and/or gastrointestinal bleeding\r\n* Patients with adenocarcinoma histology and known human epidermal growth factor receptor 2 (HER2) overexpressing disease are permitted to participate if the progressed or are intolerant of prior trastuzumab-containing therapy
Any evidence of metastatic urothelial carcinoma
Patients must have a histologically documented recurrence of non-muscle-invasive bladder carcinoma (T1HG, T1HG after repeat transurethral resection [reTUR]) or BCG refractory; if patient has received BCG they can be Ta, Tis, or T1)\r\n* Note: Gross disease is not allowed, however positive urine cytology and carcinoma in situ is permitted
Patients must have a histologically confirmed diagnosis of metastatic, progressive urothelial carcinoma of the bladder, urethra, ureter, or renal pelvis
Patients must have pathologically-confirmed, previously untreated, p16-positive oropharyngeal squamous cell carcinoma
Patients with imaging findings consistent with renal 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
Pathologic diagnosis of metastatic renal cell carcinoma (RCC) with clear cell component with progression or intolerance to at least one prior systemic anti-angiogenic therapy (if a previous biopsy of metastatic site within the last 12 months exists and a review of stained slides shows it to be adequate then a pretreatment biopsy is not required)
Patients must have histologically-confirmed head and neck squamous cell carcinoma with no evidence of distant metastasis; the primary site may be the oral cavity, oropharynx, larynx, or hypopharynx; patients with squamous cell carcinoma of unknown primary, metastatic to cervical lymph nodes, are permitted to enroll
UROTHELIAL CARCINOMA EXPANSION COHORT: Patients must have a histologically confirmed diagnosis of urothelial carcinoma of the bladder, urethra, ureter, or renal pelvis from a CLIA-certified laboratory, with measurable disease by RECIST (version 1.1) including lymphadenopathy and visceral metastatic disease
UROTHELIAL CARCINOMA EXPANSION COHORT: ECOG 0–2
UROTHELIAL CARCINOMA EXPANSION COHORT: Platelets >= 100,000/mcL without growth factor support
All subjects must have a diagnosis of ALL of either B-cell, T-cell, or mixed (i.e., B/T lineage)
Cohort A – T2, Transitional cell carcinoma (TCC) muscle invasive bladder cancer, (patients who are cisplatin ineligible, decline neoadjuvant and/or ineligible for neoadjuvant chemotherapy); must have histological proof of T2, muscle-invasive transitional cell carcinoma of the bladder with no evidence of metastatic; patient with any degree of fixation of the pelvic sidewall are not eligible
Cohort C – Renal cell carcinoma (> pT1b); must have radiologic suspicion or histological proof of clear cell renal cell carcinoma >= 4 cm with no evidence of metastatic disease; patient with any degree of tumor extension into the renal vein are not eligible; patients must be candidates for contrast-enhanced ultrasound (CEUS) imaging and agree to undergo this additional imaging technique
Diagnosis of germ cell tumor, small cell carcinoma or hematologic malignancy
Histology showing mucinous or low grade epithelial carcinoma
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
The subject has a history of unrelated neoplastic disease, which has been deemed active within thirty-six (36) months of the screening evaluation, with the exception of the following:\r\n* Non-invasive non-melanoma skin cancer such as superficial basal cell carcinoma or squamous cell carcinoma\r\n* In female subjects: high-grade or low-grade squamous intraepithelial lesions or equivalent cervical lesions\r\n* In male subjects: tumors of the prostate with a combined Gleason score =< 7
Primary tumors of radiosensitive histology (lymphoma, multiple myeloma, small cell carcinoma, germ cell tumors), as conventional radiation is likely to be effective in such cases
Primary urothelial or predominantly urothelial carcinoma of the bladder
Any component of small cell histology
Patients must have histological confirmation of metastatic urothelial carcinoma; patients must have sufficient tumor tissues for future MTAP testing and research; histological variants such as glandular, squamous, sarcomatoid, micropapillary, plasmacytoid, and small cell changes will not be allowed for this trial unless these tumors are MTAP-deficient
Has histologically confirmed urothelial carcinoma of the bladder; those with mixed histology, including a component of urothelial carcinoma, are eligible; pure small cell carcinoma, pure adenocarcinoma, and pure squamous cell carcinoma are excluded
Clinical suspicion of active carcinoma in situ (CIS)
Evidence of upper tract urothelial carcinoma
Small-cell lung cancer/mixed NSCLC with small cell component or other neuroendocrine lung cancers (typical and atypical carcinoids, large-cell neuroendocrine carcinomas). Large-cell carcinoma.
NSCLC that is predominantly squamous cell carcinoma, and patient had docetaxel as part of his prior chemotherapy.
Patients with squamous cell histology or non-squamous cell histology previously treated by pemetrexed and with a contraindication for docetaxel with grade ? 2 neuropathy or hypersensitivity reaction to medications formulated with polysorbate 80 (Tween 80) as they could be randomly assigned to Arm B.
Diagnosis of hepatocellular carcinoma, cholangiocarcinoma, or liver metastasis from any histology
Histologic evidence of neuroendocrine or small cell carcinoma of the prostate
Patients must have histologically or cytologically confirmed clear cell renal cell carcinoma (RCC)
Prior systemic therapy for renal cell carcinoma
Patients with histologic evidence of small cell carcinoma of the prostate will not be eligible
Squamous cell histology or mixed, predominantly squamous adenosquamous carcinoma
Patients with histologically or cytologically documented, unresectable, Stage IV transitional cell carcinoma of the urothelium who have not been previously treated with first-line chemotherapy.
Documented pathologic diagnosis of RCC; all subtypes eligible including but not limited to clear cell, papillary, chromophobe, collecting duct carcinoma, medullary carcinoma, and unclassified categories; sarcomatoid and rhabdoid differentiation are allowed
Histologically-confirmed diagnosis of high risk non-muscle-invasive (T1, high grade Ta and / or carcinoma in situ [CIS]) transitional cell carcinoma of the bladder (mixed histology tumors allowed if transitional cell histology is predominant histology).
Concurrent extra-vesical (i.e., urethra, ureter, or renal pelvis) non-muscle invasive transitional cell carcinoma of the urothelium
Patients with histologic diagnosis of epithelial ovarian carcinoma, primary peritoneal carcinoma, or fallopian tube carcinoma that has recurred > 6 months since platinum-based chemotherapy (first recurrence) and who are scheduled for secondary surgical evaluation/cytoreduction
Histologic epithelial cell types include serous, endometrioid, clear cell, or undifferentiated carcinomas, transitional cell carcinoma, mixed epithelial carcinoma, malignant Brenner's tumor, or adenocarcinoma not otherwise specified (NOS)
Histology other than adenocarcinoma (neuroendocrine or acinar cell)
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 and/or cytologically confirmed, non-small cell lung cancer (NSCLC) of adenocarcinoma histology at the time of initial diagnosis.\r\na) Mixed tumors will be categorized by the predominant cell type; (Note: If small cell elements are present the patient is ineligible)\r\nb) Known mutational status of KRAS and BRAF oncogenes.\r\nc) For patients in whom mutational testing result is unknown or unavailable from a prior test, KRAS and BRAF testing will be performed (at a CLIA-certified laboratory) using an archived or fresh biopsy as per Standard of Care, prior to enrollment.
All patients with Surgical Stage III or IVA endometrial carcinoma per FIGO 2009 staging criteria, including clear cell and serous papillary and undifferentiated carcinomas.
Patients with FIGO 2009 surgical Stage I or II endometrial clear cell or serous carcinoma and with positive peritoneal cytology.
Patients with positive pelvic washings as the only extra-uterine disease are NOT eligible if the histology is other than clear cell or papillary serous carcinoma.
Pathologically confirmed diagnosis of high-grade serous ovarian, primary peritoneal, or fallopian tube carcinoma
Patients with any component of small cell lung carcinoma
Histology consistent with primary peritoneal mesothelioma rather than primary peritoneal serous carcinoma
Women with a biopsy proven diagnosis of ductal carcinoma in situ or invasive carcinoma of the breast; biopsy tissue (either slides or block) from outside institutions will be reviewed to confirm diagnosis
Women with a biopsy proven diagnosis of ductal carcinoma in situ or invasive carcinoma of the breast\r\n* Biopsy tissue (either slides or block) from outside institutions will be reviewed to confirm diagnosis
Clinical T1N0M0 invasive carcinoma or ductal carcinoma in situ (DCIS) < or equal to 2 cm
For subjects in the every 2 week and every 1 week dosing cohorts histologically or cytologically documented diagnosis of urothelial carcinoma, melanoma, squamous cell carcinoma of the head and neck, non-small cell lung cancer, or any solid tumor with high microsatellite instability status (MSI-high)
Histological/cytological diagnosis of non-small cell lung cancer (NSCLC). Squamous cell (epidermoid), adenocarcinoma, bronchoalveolar carcinoma and large cell anaplastic lung carcinoma histologies are eligible. Mixed histologies of NSCLC (i.e., adenosquamous) are eligible. Mixed NSCLC/small cell lung carcinoma (SCLC), and variant large and small cell lung cancer are NOT eligible for this study.
Cohort 2A: Differentiated Thyroid Cancer (DTC) with one of the following histological subtypes: i) Papillary thyroid cancer (PTC). i.a) Follicular variant. i.b) Other variants (including but not limited to tall cell, columnar cell, cribriform-morular, solid, oxyphil, Warthin's-like, trabecular, tumor with nodular fasciitis-like stroma, Hurthle cell variant of papillary carcinoma, or poorly differentiated carcinomas). ii) Follicular thyroid cancer (FTC). ii.a) Hurthle cell. ii.b) Clear cell. ii.c) Insular. c) Cohort 2B, 3A, and 3B: Relapsed or refractory osteosarcoma.
Patients whose pathology has squamous cell features unless there is an unequivocal determination of non-squamous pathology
All patients must have histologic demonstration of metastatic or locally unresectable transitional cell carcinoma of the urothelium; variant histology is allowed as long as there is an urothelial component present; the principal investigator (PI), will serve as the final arbiter of eligibility
High-grade peritoneal carcinomatosis from appendiceal adenocarcinoma\r\n* Moderate or poorly-differentiated adenocarcinoma, signet ring cell carcinoma or “high-grade” carcinoma as designated by University of California San Diego (UCSD) pathologic testing\r\n* May be initially determined from pre-CRS/HIPEC tumor pathology (for screening purposes), but must be confirmed with UCSD pathology from resected tumors as part of CRS/HIPEC
Primary lesion with radiosensitive histology that includes the following: small cell carcinoma, germ cell tumors, lymphoma, leukemia, or multiple myeloma
Histologically or cytologically confirmed incurable HNSCC of the oral cavity, oropharynx, larynx, hypopharynx, and/or level 1-3 neck node with non-cutaneous squamous cell carcinoma (SCC) and unknown primary; “incurable” is defined as metastatic disease or a local or regional recurrence in a previously irradiated site that is unresectable (or patient declines resection)
Histologically confirmed diagnosis of primary non-small cell carcinoma of the lung. according to WHO Classification of Tumours (WHO Classification of Tumours of the Lung, Pleura, Thymus and Heart. WHO/IARC Classification of Tumours, 4th Edition, Volume 7). Patients with large-cell neuroendocrine carcinomas are not eligible.
A combination of small cell and non-small cell lung cancer, pulmonary carcinoid tumour or large-cell neuroendocrine carcinoma (LCNEC).
If a previous biopsy of mass has been done, pathology must be consistent with renal cell carcinoma (RCC)
Histologically confirmed diagnosis of squamous cell carcinoma of the larynx, stages III, IVa, or IVb, p16-negative on immunohistochemistry
Patients for whom the diagnosis of high-grade serous or undifferentiated carcinoma of ovarian, peritoneal, or fallopian tubal origin is confirmed at surgery
Papillary serous, endometrioid, clear cell, undifferentiated and mixed histologies
Previous or concurrent malignancies at other sites within the last 5 years, with the exception of in situ carcinoma of the cervix and adequately treated basal cell carcinoma or squamous cell carcinoma of the skin; in addition, patients with prior or concomitant, based on hysterectomy, stage IA endometrial adenocarcinoma with less than 3 mm depth on invasion, absence of lymphovascular space invasion and absence of grade 3, papillary serous or clear cell histology are allowed
Proven multicentric carcinoma (invasive or ductal carcinoma in situ [DCIS]) in more than one quadrant or separated by > 4 centimeters
RENAL CELL CARCINOMA (RCC) COHORT EXCLUSION CRITERIA: Pregnancy (as determined by point of care test administered in accordance with the policies of the Department of Nuclear Medicine)
RENAL CELL CARCINOMA (RCC) COHORT EXCLUSION CRITERIA: History of other malignancy with concern for renal metastasis and known allergy to technetium or sestamibi
Histologically confirmed diagnosis of squamous cell carcinoma of the oropharynx, stage IVa, p16-positive on immunohistochemistry (determination of HPV status using p16 as surrogate is standard of care)
Patients must have histologically or cytologically confirmed thyroid carcinoma of follicular origin (including papillary, follicular, or poorly differentiated subtypes and their respective variants); confirmation of thyroid carcinoma will be done at Memorial Sloan-Kettering (MSK)
Largest papillary thyroid carcinoma < 1 cm in size on ultrasound
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)
The following histologic epithelial cell types are eligible: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner’s tumor, or adenocarcinoma not otherwise specified (NOS)
Patients with histologic evidence of small cell carcinoma of the prostate will not be eligible
Ductal carcinoma in-situ with microinvasions (T1mic)
Pathologic diagnosis of urothelial or squamous cell carcinoma of the bladder
Patients with known (biopsy proven) invasive carcinoma in a potential study polyp
Pathologic evidence of clear cell RCC
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
Newly diagnosed stage I to III breast cancer and carcinoma in situ (including lobular carcinoma in situ [LCIS] and ductal carcinoma in situ [DCIS])
Must have pathology proven invasive ductal carcinoma (lobular is not allowed) and/or ductal carcinoma in situ (DCIS).
cT2/T3-N0-M0 urothelial carcinoma of the bladder
Patients must have pathologically confirmed, previously untreated, resectable, squamous cell carcinoma of the larynx or hypopharynx
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
Patients are excluded from this trial if they have melanoma, small cell carcinoma, lymphoma/leukemia, or germ cell histology (note, melanoma patients will be eligible for the sister trial to this trial which will be open simultaneously)
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
Histologically-proven, invasive primary carcinoma of the cervix
Histologically documented adenocarcinoma or squamous cell carcinoma of the cervical or thoracic esophagus or gastroesophageal junction or cardia of stomach
Pathological finding consistent with small cell carcinoma of the prostate
Histologically documented metastatic or surgically unresectable urothelial carcinoma; may include primary site from ureters, upper tract, renal pelvis, and bladder.
Poorly differentiated or high grade carcinoma, or patients with neuroendocrine tumors not of lung origin are excluded
Histological diagnosis of cholangiocarcinoma, hepatocholangiocarcinoma, fibrolamellar carcinoma and hepatoblastoma
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.
Histological or cytological confirmation of thyroid carcinoma of follicular origin (including papillary, follicular, or poorly differentiated subtypes and their respective variants); NOTE: medullary and anaplastic thyroid cancers are excluded; Hurthle cell carcinomas are excluded (defined as having an invasive tumor composed of > 75% oncocytic [Hurthle] cells lacking the nuclear features of papillary carcinoma, tumor necrosis, and marked mitotic activity); patients with oncocytic (Hurthle cell) variants of papillary thyroid carcinoma (defined as a tumor composed of a majority of oncocytic [Hurthle] cells having the nuclear features of papillary carcinoma) are eligible to participate
ELIGIBILITY CRITERIA FOR REGISTRATION: subjects must have histologically confirmed carcinoma consistent with ovarian, fallopian tube, or primary peritoneal carcinoma (any of these three are referred to in this protocol as “ovarian cancer [OvCA]” OR a cytological diagnosis of carcinoma); the following histologic subtypes are included: serous, endometrioid, undifferentiated, clear cell, mixed, transitional, malignant Brenner tumor or adenocarcinoma not otherwise specified (NOS); subjects eligible for this study may be in one of three surgical categories: status post primary debulking surgery; undergoing neoadjuvant chemotherapy at a site not participating in correlative tissue collection sub study OR undergoing neoadjuvant chemotherapy at a site participating in correlative tissue collection sub study
Biopsy-proven, unresected stage IB-IVA invasive carcinoma of the cervix
Patients with biopsy-proven small cell or sarcomatoid histology
Patients with hepatocellular carcinoma will be excluded from this study
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
Histologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma
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
American Joint Committee on Cancer (AJCC) stage 0-IIIa (pathologic stage Tis, T1N0, T2N0, T1N1a, T2N1a, T1N2a, T2N2a, M0) histologically confirmed ductal carcinoma in-situ or invasive carcinoma of the breast with a lesion =< 5 cm treated with lumpectomy and either sentinel node biopsy or axillary dissection (if invasive carcinoma is present)
Since small cell tumors of the bladder are often associated with other variant histology including TCC and adenocarcinoma, the presence of variant histology will be allowed
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.
Pathological finding consistent with small cell, neuroendocrine carcinoma of the prostate or any other histology different than adenocarcinoma
Histologic demonstration of transitional cell carcinoma of the urothelium. Minor components (less than [<] 50 percent [%] overall) of variant histology such as glandular or squamous differentiation, or evolution to more aggressive phenotypes such as sarcomatoid or micropapillary change are acceptable
Documented urothelial carcinoma (transitional cell carcinoma) including urinary bladder, renal pelvis, ureters, urethra meeting all of the following criteria
Patients must have histologically confirmed disease that is unresectable and not amenable to curative intent therapy: \r\n* Cohort A: salivary gland cancers (mucoepidermoid carcinoma, adenocarcinoma, adenoidcystic carcinoma, acinic cell carcinoma, or other histology) originating in salivary glands \r\n* Cohort B: thyroid cancer, radioactive iodine (RAI)-refractory and after failure, intolerance to or refusal of anti-antiangiogenic therapy, or with evidence of dedifferentiated or anaplastic histology
Pathologically-confirmed squamous cell carcinoma of the oral cavity, oropharynx or hypopharynx or HPV-positive unknown primaries presumed to be of oropharyngeal origin
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
Pathologically confirmed diagnosis of squamous cell carcinoma of the mouth, oropharynx, hypopharynx or nasopharynx
Diagnosis of anal or small bowel carcinoma.
Prior malignancy (other than basal cell carcinoma and cervical in situ carcinoma) unless treated with a curative intend and without evidence of malignant disease for 1 year before screening. Patients with prior hematologic malignancies that have progressed to AML (such as Myelodysplastic syndrome, myeloproliferative neoplasms, bi-phenotypic leukemias, AcuteLymphocyticLeukemia) or AML that has relapsed are eligible;
Histological confirmation of non-clear cell renal cancer (including chromophilic [papillary], chromophobic, oncocytic, sarcomatoid, collecting duct [Bellini's duct]), translocation-type carcinoma or medullary renal cell carcinoma
Up to one prior treatment for metastatic non clear cell carcinoma is allowed prior to registration as long as the agent used to treat was not pazopanib
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.
Histological or cytological proof of urothelial carcinoma of the urethra, bladder, ureters, or renal pelvis
Participants must have histologically or cytologically confirmed squamous cell carcinoma of the oropharynx or unknown primary that is high risk human papillomavirus (HPV) positive as determined by p16 immunohistochemistry (IHC) testing and/or HPV in situ hybridization (ISH) / polymerase chain reaction (PCR)
Histologically confirmed diagnosis of urothelial carcinoma of the bladder, urethra, ureter, or renal pelvis
Atypical endometrial or glandular cells or evidence of invasive cervical carcinoma on cervical biopsy;
Histological proof of muscle-invasive urothelial carcinoma of the bladder (stage cT2-cT3b, N0-1, M0). Subjects with mixed histology are required to have documented dominant transitional cell pattern with no more than 10% squamous differentiation and 10% glandular differentiation. Micropapillary/sarcomatoid/adenocarcinoma/plasmacytoid variants are not allowed.
Prior systemic chemotherapy for urothelial cell carcinoma of the bladder.
Patients must have histologically or cytologically documented locally advanced/inoperable or metastatic urothelial bladder carcinoma (UBC), including renal pelvis, ureters, urinary bladder, and urethra\r\n* Note: mixed histology tumors allowed if predominant histology is urothelial carcinoma\r\n* Note: small cell or neuroendocrine carcinoma is not allowed if predominant
Pathologically (histologically or cytologically) proven diagnosis of recurrent/persistent ovarian, or peritoneal endometrioid/clear cell carcinoma, OR recurrent/persistent low grade (grade 1 or 2) endometrioid endometrial adenocarcinoma; primary ovarian tumors must be at least 50% endometrioid/clear cell morphology, or have histologically documented recurrence with at least 50% endometrioid/clear cell morphology; appropriate tissue sections must be available for histologic evaluation for central pathology review by National Research Group (NRG) Oncology
ORAL CAVITY SQUAMOUS CELL CARCINOMA COHORT: Pathologically confirmed (histology or cytology) stage III or IVA squamous cell cancer of the oral cavity (excluding lip)
ORAL CAVITY SQUAMOUS CELL CARCINOMA COHORT: Disease is surgically resectable with curative intent
ORAL CAVITY SQUAMOUS CELL CARCINOMA COHORT: Hemoglobin > 9 g/dL
ORAL CAVITY SQUAMOUS CELL CARCINOMA COHORT: Lymphocyte count > 500 x 10^9/mL
ORAL CAVITY SQUAMOUS CELL CARCINOMA COHORT: Neutrophil count > 1500 × 10^9/mL
ORAL CAVITY SQUAMOUS CELL CARCINOMA COHORT: Platelet count > 100,000 x 10^9/mL
ORAL CAVITY SQUAMOUS CELL CARCINOMA COHORT: Serum albumin > 3.0 g/dL
ORAL CAVITY SQUAMOUS CELL CARCINOMA COHORT: Willing and able to give informed consent and adhere to protocol therapy
ORAL CAVITY SQUAMOUS CELL CARCINOMA COHORT: Prior surgery, radiation therapy, or chemotherapy other than biopsy or emergency procedure required for supportive care
ORAL CAVITY SQUAMOUS CELL CARCINOMA COHORT: Prior treatment with cetuximab or EGFR inhibitors in any treatment setting
ORAL CAVITY SQUAMOUS CELL CARCINOMA COHORT: Clinical status of either subject or tumor such that administration of 10 day neoadjuvant IRX-2 1 or 2 before surgery would be medically inappropriate
ORAL CAVITY SQUAMOUS CELL CARCINOMA COHORT: Primary tumor of the oropharynx
ORAL CAVITY SQUAMOUS CELL CARCINOMA COHORT: Any investigational agent within the previous 30 days
ORAL CAVITY SQUAMOUS CELL CARCINOMA COHORT: Daily administration of systemic immunosuppressive therapy or corticosteroids (except in physiological doses for hormone deficiency) during the previous 30 days
ORAL CAVITY SQUAMOUS CELL CARCINOMA COHORT: Myocardial infarction within the last 3 months
ORAL CAVITY SQUAMOUS CELL CARCINOMA COHORT: Evidence of distant metastases (M1 disease) or other concurrent primary malignancy
ORAL CAVITY SQUAMOUS CELL CARCINOMA COHORT: Stroke or other symptoms of cerebral vascular insufficiency within the last 3 months
ORAL CAVITY SQUAMOUS CELL CARCINOMA COHORT: Allergy to ciprofloxacin (or other quinolones), acetylsalicylic acid
ORAL CAVITY SQUAMOUS CELL CARCINOMA COHORT: Prior axillary dissection
HPV-ASSOCIATED OROPHARYNX SQUAMOUS CELL CARCINOMA: Carcinoma of the oropharynx associated with HPV as determined by p16 protein expression using immunohistochemistry (IHC) performed by a Clinical Laboratory Improvement Act [CLIA] approved laboratory; using p16 antibody obtained from Roche mtm laboratories AG (CINtec, clone E6H4) is recommended
HPV-ASSOCIATED OROPHARYNX SQUAMOUS CELL CARCINOMA: No prior radiation above the clavicles
HPV-ASSOCIATED OROPHARYNX SQUAMOUS CELL CARCINOMA: Patients must not have evidence of extensive or “matted/ fixed” pathologic adenopathy on preoperative imaging
HPV-ASSOCIATED OROPHARYNX SQUAMOUS CELL CARCINOMA: Hemoglobin > 9 g/dL
HPV-ASSOCIATED OROPHARYNX SQUAMOUS CELL CARCINOMA: Lymphocyte count > 500 x 10^9/mL
HPV-ASSOCIATED OROPHARYNX SQUAMOUS CELL CARCINOMA: Neutrophil count > 1500 x 10^9/mL
HPV-ASSOCIATED OROPHARYNX SQUAMOUS CELL CARCINOMA: Platelet count > 100,000 x 10^9/mL
HPV-ASSOCIATED OROPHARYNX SQUAMOUS CELL CARCINOMA: Serum albumin > 3.0 g/dL
HPV-ASSOCIATED OROPHARYNX SQUAMOUS CELL CARCINOMA: Willing and able to give informed consent and adhere to protocol therapy
HPV-ASSOCIATED OROPHARYNX SQUAMOUS CELL CARCINOMA: ECOG performance status < 2
HPV-ASSOCIATED OROPHARYNX SQUAMOUS CELL CARCINOMA: Prior surgery, radiation therapy, or chemotherapy other than biopsy or emergency procedure required for supportive care
HPV-ASSOCIATED OROPHARYNX SQUAMOUS CELL CARCINOMA: Any medical contraindications or previous therapy that would preclude treatment with either nivolumab or IRX-2 or the surgery, reconstruction or adjuvant therapy required to treat the oropharynx tumor appropriately
HPV-ASSOCIATED OROPHARYNX SQUAMOUS CELL CARCINOMA: Clinical status of either subject or tumor such that administration of neoadjuvant nivolumab or IRX-2 before surgery would be medically inappropriate
HPV-ASSOCIATED OROPHARYNX SQUAMOUS CELL CARCINOMA: Tumor of the oral cavity
HPV-ASSOCIATED OROPHARYNX SQUAMOUS CELL CARCINOMA: Any investigational agent within the previous 30 days
HPV-ASSOCIATED OROPHARYNX SQUAMOUS CELL CARCINOMA: Daily administration of systemic immunosuppressive therapy or corticosteroids (except in physiological doses for hormone deficiency) during the previous 30 days
HPV-ASSOCIATED OROPHARYNX SQUAMOUS CELL CARCINOMA: Myocardial infarction within the last 3 months
HPV-ASSOCIATED OROPHARYNX SQUAMOUS CELL CARCINOMA: Evidence of distant metastases (M1 disease) or other concurrent primary malignancy
HPV-ASSOCIATED OROPHARYNX SQUAMOUS CELL CARCINOMA: Stroke or other symptoms of cerebral vascular insufficiency within the last 3 months
HPV-ASSOCIATED OROPHARYNX SQUAMOUS CELL CARCINOMA: Allergy to ciprofloxacin (or other quinolones), acetylsalicylic acid
HPV-ASSOCIATED OROPHARYNX SQUAMOUS CELL CARCINOMA: Prior axillary dissection
Absence of concomitant upper tract urothelial carcinoma (i.e. cancer within the kidney or ureter) as evidenced on computed tomography (CT) urogram and no visible lesion and/or biopsy proven evidence of urothelial carcinoma within the prostatic urethra (i.e. biopsy proven presence of cancer within the prostatic urethra)
Predominantly squamous cell histology NSCLC. Mixed tumors will be categorized by the predominant cell type; if small cell elements are present, the participant is ineligible.
Women scheduled for unilateral or bilateral mastectomy for breast cancer therapy, pathology confirmed stage 0-III (including ductal carcinoma in situ), or prophylaxis (BRCA1/2 mutation carriers, women with strong family history or lobular carcinoma in situ or other conditions where prophylactic mastectomy has been elected)
Histological or cytological diagnosis of metastatic squamous or non-squamous NSCLC.
Have histologic confirmation of RCC with a clear cell component
Patients with neuroendocrine or small cell carcinoma of the prostate
Pathologically proven (either histologic or cytologic) diagnosis of urothelial carcinoma
RENAL COHORT: Histological documentation of renal cell carcinoma with a clear cell component in the metastatic renal cell carcinoma cohort
The subject has a histologic or cytologic diagnosis of squamous cell carcinoma of the oral cavity, oropharynx, paranasal sinuses, hypopharynx, or larynx; squamous cell carcinoma of unknown primary in cervical lymph node can be included only if human papillomavirus (HPV) status is positive
Localized, muscle invasive urothelial carcinoma (T2-4, N0-1, M0) (mixed histology acceptable) ineligible for cystectomy
Upper tract urothelial carcinoma
Endocrine or acinar pancreatic carcinoma
Basal cell carcinoma (BCC)
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
Histologically confirmed urothelial carcinoma of the bladder, ureter, urethra, or renal pelvis by the enrolling institution; patients with mixed histologies are required to have a predominant urothelial component as reviewed by the pathologist at the enrolling institution
Have histological diagnosis of squamous cell cancer of the head & neck with confirmation of HPV positivity or squamous, non-squamous, adenosquamous, carcinoma or adenocarcinoma of the cervix which HPV positivity is not required
Subjects with neuroendocrine and/or small cell CRPC
Histological confirmation of RCC with a clear-cell component, including participants who may also have sarcomatoid features
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)
Multicentric invasive or in situ carcinoma
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 with active malignancies in addition to urothelial carcinoma
Primary nasopharyngeal carcinoma
Histological or cytological confirmed squamous or non-squamous non-small cell lung cancer.
Participants must have stage IV, locally advanced or metastatic (T4b, any N; or any T, N2-3) urothelial bladder cancer or TCC arising in another location of the urinary tract, including urethra, ureter, and renal pelvis; the diagnosis must be histologically or cytologically confirmed; mixed histologies are permitted as long as TCC is the major component (i.e. > 50% of the pathologic specimen); pure or predominant squamous cell carcinomas or adenocarcinomas are not permitted
Patients with measurable inoperable, histologically confirmed non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), esophageal carcinoma, thymic epithelial neoplasms, germ cell tumors, malignant pleural mesotheliomas or chest wall sarcomas, as well as patients with gastric, colorectal, pancreas or renal cancers, germ cell tumors and sarcomas metastatic to thorax are eligible
Patients must have recurrent or persistent endometrial cancer (endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, mixed epithelial carcinoma or adenocarcinoma not otherwise specified [NOS]); histologic confirmation of the primary tumor is required
Patients who have the following histologies: mucinous, squamous, sarcomas, carcinosarcomas, clear cell
Histologically proven squamous cell carcinoma of the oropharynx, hypopharynx or larynx
Gynecologic cancer cohort only: histologic proof of epithelial cervical, endometrial, ovarian, fallopian, or primary peritoneal cancers; allowable histologies for cervical cancer include squamous cell carcinoma, adenocarcinoma, and mixed/adenosquamous carcinoma; allowable histologies for endometrial cancer include endometrioid, serous, clear cell, mucinous, squamous, transitional cell, undifferentiated, mixed, and carcinosarcoma (this is considered a poorly differentiated epithelial tumor); allowable histologies for ovarian, fallopian, and peritoneal cancer include serous, clear cell, endometrioid, mucinous, transitional cell, undifferentiated, mixed, and carcinosarcoma
Radiosensitive or non-solid (eg. small cell lung carcinomas, germ cell tumors, leukemias, or lymphomas) or unknown tumor histologies
Participants must have pathology-confirmed epithelial ovarian, fallopian tube, or\n             primary peritoneal carcinoma.
Concurrent malignancy requiring therapy (excluding non-invasive carcinoma or\n             carcinoma in situ).
Subjects with any kind of non-small cell lung carcinoma (NSCLC) histology documented by histology or cytology from bronchial brushing or washing, or needle aspiration of a defined lesion but not from sputum cytology alone
On histologic examination, the tumor must be ductal carcinoma in situ (DCIS) and/or invasive breast carcinoma
Multicentric carcinoma (DCIS or invasive)
Cytologically or histologically confirmed evidence of transitional cell carcinoma of bladder, renal pelvis, ureter or urethra
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)
Patients must have histologically or cytologically confirmed neuroendocrine carcinoma of the gastrointestinal (GI) tract; patients with unknown origin for the neuroendocrine carcinoma in which a gastroenteropancreatic origin is suspected (per pathologist or investigator discretion) will be eligible for the study
Patients with a secondary primary cancer (excluding baso/squamous cell carcinoma of skin) within 1 year will be excluded
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 a histologically or cytologically confirmed, previously untreated squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx
Patients must have histologically confirmed squamous cell carcinoma, undifferentiated carcinoma, or poorly differentiated carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx with no evidence of distant metastasis; biopsy sampling of primary tumor with pathology report documentation of confirmed diagnostic tissue type is required; patients should be evaluated by a radiation oncologist, medical oncologist and otolaryngologist prior to enrolling on study
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
Pathologically (histologically or cytologically) proven diagnosis of stage IIIA or IIIB non-small cell lung cancer within 84 days of registration; eligible histologies include adenocarcinoma, adenosquamous, large cell carcinoma, squamous carcinoma, non-lobar and non-diffuse bronchoalveolar cell carcinoma or non-small cell lung cancer not otherwise specified [NOS])
Patients with mixed small cell and non-small cell histologies
Solid tumor patients in stage 2 must have a diagnosis of papillary serous, endometrioid or clear cell endometrial carcinoma or, high grade serous, clear cell, endometrioid or mucinous ovarian, fallopian or primary peritoneal carcinoma
Patients must have histologically confirmed localized high grade (G3) transitional cell carcinoma (urothelial carcinoma) of the bladder that is stage Ta, T1, and/or carcinoma in situ (CIS) confirmed by the Laboratory of Pathology, National Cancer Institute (NCI) 90 days prior to study entry; this can be obtained at an outside hospital prior to entry into the study or at the NCI; however, all outside pathology specimens will require that the formalin-fixed paraffin embedded tissues be re-read by the Laboratory of Pathology, NCI; for patients enrolled at collaborating trial sites, diagnosis must be confirmed by the Department of Pathology at the institution where the patient is enrolled on the trial; pathology can also be reviewed by the Laboratory of Pathology at the NCI if the participating trial site prefers another pathologic evaluation
Patients must have recurrent or persistent endometrial carcinoma, which is refractory to curative therapy or established treatments; histologic confirmation of the original primary tumor is required\r\n* Patients with the following histologic epithelial cell types are eligible: endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, mixed epithelial carcinoma, uterine clear cell carcinoma, and adenocarcinoma not otherwise specified (N.O.S.)
American Joint Committee on Cancer (AJCC) stage III/IVB, excluding T1N1, histologically or cytologically confirmed squamous cell carcinoma or undifferentiated carcinoma of the head and neck; patients should not have distant metastasis; primary sites include: oropharynx, hypopharynx, larynx
Histologically or cytologically confirmed (from the primary lesion and/or regional lymph nodes) squamous cell carcinoma of the oropharynx, hypopharynx, or larynx that has not been previously treated or resected; patients with unresectable oral cavity cancers are also eligible; human papilloma virus (HPV) testing is required, although both HPV-positive and -negative patients are eligible
Patients who are treatment naïve, high risk, stage IVa/IVb (all other sites) and histologically proven squamous cell carcinoma of the head and neck (SCCHN) with no definitive evidence of metastatic disease, excluding patients with oropharynx human papillomavirus (HPV)-positive tumors; in summary, those patients eligible are newly diagnosed and treatment naive: \r\n* Stage IVa-b squamous cell carcinoma other than oropharyngeal cancer (OPC), or\r\n* Oropharyngeal cancer (OPC) HPV-negative, stage IVa-b
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 must have pathologically-confirmed, previously untreated, stage III-IV (excluding N3 or T4) squamous cell carcinoma of the oropharynx, without evidence of distant metastasis
Patients with any component of small cell lung carcinoma are excluded
Radiosensitive (eg. small cell lung carcinomas, germ cell tumors, leukemias, or lymphomas) or unknown tumor histologies
Patients with cervical esophageal carcinoma
Patients must have histologically confirmed renal cell carcinoma (of any subtype) containing any sarcomatoid features; there must be histologic confirmation by the treating center of either the primary or metastatic lesion
Patients must not have collecting duct or medullary carcinoma
Patients with the following histologic cell types are eligible: \r\n* Serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial adenocarcinoma, transitional cell carcinoma, malignant Brenner's tumor, adenocarcinoma not otherwise specified (N.O.S.) or carcinosarcoma
Histologic proof of non-small cell histology (adenocarcinoma, adenosquamous, large cell carcinoma, squamous carcinoma, non-lobar and non-diffuse bronchoalveolar cell carcinoma or non-small cell lung cancer not otherwise specified [NOS]) within 12 weeks of registration; note: mixed small cell and non-small cell histologies are not eligible for this study
Patients with nasopharyngeal carcinoma
Patients with nasopharyngeal carcinoma
Endometrioid adenocarcinoma, carcinosarcoma, undifferentiated carcinoma, mixed epithelial adenocarcinoma, adenocarcinoma not otherwise specified, mucinous adenocarcinoma, clear cell adenocarcinoma, low-grade serous adenocarcinoma, or malignant Brenner's tumor.
Absence of concomitant upper tract urothelial carcinoma or urothelial carcinoma within the prostatic urethra. Freedom from upper tract disease (if clinically indicated) as indicated by no evidence of upper tract tumor by either intravenous pyelogram, retrograde pyelogram, computed tomography (CT) scan with or without urogram, or MRI with or without urogram performed within 6 months of enrollment
Myoepithelial carcinoma
Renal medullary carcinoma
Myoepithelial carcinoma
Renal medullary carcinoma
Patients must have histologic diagnosis of epithelial ovarian carcinoma, peritoneal primary or fallopian tube carcinoma, which is now recurrent
Patients with the following histologic epithelial cell types are eligible: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's tumor, or adenocarcinoma not otherwise specified (N.O.S.)
History of small-cell or neuroendocrine prostate carcinoma
In situ carcinoma of the cervix or other noninvasive carcinoma or in situ neoplasm.
Patients must have histologically proven urothelial carcinoma of the bladder; those with mixed histology, including a component of urothelial carcinoma, are eligible; small cell carcinoma, pure adenocarcinoma, and pure squamous cell carcinoma are excluded
Histologically-confirmed non muscle-invasive urothelial carcinoma (transitional cell carcinoma) of the bladder as follows:
Histologically-diagnosed advanced (unresectable and/or metastatic) Non-small Cell Lung Cancer (Phase l only), Melanoma (Phase l only), Colorectal, Head and Neck SCC (squamous cell carcinoma), Ovarian Cancer, Glioblastoma or Renal Cell Carcinoma.
1b. Ovarian Recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal carcinoma requiring original or subsequent relapse histologic documentation. A platinum-taxane based chemotherapy regimen as frontline therapy must have been completed. Any histologic diagnosis of borderline, low malignant potential epithelial carcinoma are excluded.
1e. Renal Cell Carcinoma Have histologically confirmed diagnosis of predominant clear cell renal cell 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.
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).
For Phase 2 expansion cohorts: Subjects with NSCLC, melanoma (checkpoint inhibitor naïve, primary refractory melanoma, relapsed melanoma), transitional cell carcinoma of the GU tract, SCCHN, ovarian cancer, MSI high CRC, RCC, DLBCL, and TNBC.
Phase 2 expansion: Transitional cell carcinoma of the GU tract
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.
Borderline, low-malignant-potential epithelial carcinoma per histopathology is excluded.
Subjects with histological or cytological confirmation of clear cell RCC.
Histologically confirmed, advanced, predominantly clear cell renal cell carcinoma (RCC).
Chronic hepatitis (except for subjects with hepatocellular carcinoma)
Histological diagnosis of squamous cell carcinoma, adenocarcinoma or adenosquamous cell carcinoma of the cervix
Carcinoma of the nasopharynx, salivary gland, unknown primary origin, or nonsquamous histologies as primary tumors.
Has a histologically or cytologically confirmed diagnosis of advanced/unresectable (inoperable) or metastatic urothelial carcinoma of the renal pelvis, ureter [upper urinary tract], bladder, or urethra. Both transitional cell and mixed transitional/non- transitional cell histologies are allowed, but transitional cell carcinoma must be the predominant histology.
Fibrolamellar carcinoma or mixed hepatocellular cholangiocarcinoma.
Patient must have pathologically confirmed renal cell carcinoma with a clear cell component; pure papillary and chromophobe histologies are excluded; there must be pathologic confirmation of metastatic disease in the resected metastasectomy specimen
Patient must have undergone nephrectomy or partial nephrectomy to remove primary renal cell carcinoma (at any time in the past)
RCC (clear cell), urothelial carcinoma (transitional cell), gastric or gastro-esophageal junctional (GEJ) adenocarcinoma, or K-RAS or N-RAS wild-type EGFR expressing CRC
For urothelial carcinoma:
For urothelial carcinoma, gastric or GEJ adenocarcinoma, and CRC, platelet count ?100,000 cells/mm3
For RCC, urothelial carcinoma, and gastric or GEJ adenocarcinoma, hemoglobin ?8.0 g/dL
For urothelial carcinoma, prior treatment with any taxane
Carcinoma of the neck of unknown primary site origin (regardless of HPV/p16 status) is eligible
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
Concurrent malignancy requiring therapy (excluding non-invasive carcinoma or carcinoma in situ)
Concomitant bladder urothelial carcinoma is acceptable if it is organ confined and surgically resectable
Presence or history of carcinoma in situ (CIS)
Documented histological or cytological diagnosis of renal cell carcinoma with a clear-cell component.
Patients with the following tumors are included in the study:\r\n* Patients initially diagnosed with low-grade serous ovarian or peritoneal carcinoma that recur as low-grade serous carcinoma (invasive micropapillary serous carcinoma or invasive grade I serous carcinomas as defined by GOG, Federation of Obstetricians and Gynecologists [FIGO], World Health Organization [WHO] or Silverberg)\r\n* Patients initially diagnosed with serous borderline ovarian or peritoneal carcinoma that recur as low-grade serous carcinoma (invasive micropapillary serous carcinoma or invasive grade I serous carcinomas as defined by GOG, FIGO WHO or Silverberg)
Patients must have documented low-grade serous carcinoma; confirmation must occur by prospective pathology review prior to study entry; the prospective pathology review can be done on tissue from the recurrent carcinoma or from original diagnostic specimen
Patients must have measurable stage III, measurable stage IVA, stage IVB (with or without measurable disease) or recurrent (with or without measurable disease) endometrial carcinoma\r\n* Histologic confirmation of the original primary tumor is required; patients with the following histologic epithelial cell types are eligible:\r\n** Endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified (N.O.S.)
Patients must have histologically or cytologically-proven new diagnosis of unresectable stage IIIA/IIIB*, non-small cell lung cancer (adenocarcinoma, bronchioloalveolar cell carcinoma, large cell carcinoma, squamous cell carcinoma, or mixed)\r\n* Per the American Joint Committee on Cancer (AJCC) 7th edition, pleural and pericardial are now considered stage M1a disease; when pleural fluid is visible on the computed tomography (CT) scan or on a chest x-ray, a thoracentesis is required to confirm that the pleural fluid is cytologically negative; patients with exudative pleural effusions are excluded, regardless of cytology; patients with effusions that are minimal (i.e. not visible on chest x-ray) that are too small to safely tap are eligible; a small effusion that has positive fludeoxyglucose F 18 (FDG) uptake on positron emission tomography (PET) has to be proven to be malignant per standard of care diagnostic procedures for the patient to be excluded
Patients must have histologically or cytologically confirmed renal cell carcinoma (clear cell or non-clear cell allowed, but collecting duct or medullary carcinomas excluded); patients must be considered pathologically either intermediate high risk or very high risk; patients must not have a history of distant metastases; patients with microvascular invasion of the renal vein of any grade or stage (as long as M0) are also eligible
Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx.
Subjects with urothelial carcinoma:
Histologically or cytologically confirmed urothelial carcinoma of the renal pelvis, ureter, urinary bladder, or urethra that is transitional cell or mixed transitional/nontransitional (predominantly transitional) cell type.
Histologically confirmed diagnosis of Renal Cell Carcinoma with a documented clear cell component (ccRCC)
Cohort A (clear cell RCC cohort) participant must have histologically confirmed diagnosis of clear cell RCC or RCC with clear cell component (with or without sarcomatoid features).
Cohort B (non-clear cell RCC cohort) participant must have histologically confirmed diagnosis of non-clear cell RCC (with or without sarcomatoid features). Participants with tumors that have a component of clear cell histology are not eligible for inclusion in Cohort B.
Has predominantly squamous cell histology NSCLC.
Histologically confirmed Transitional Cell Carcinoma of the Urothelium (TCCU) (i.e., cancer of the bladder, renal pelvis, ureter, or urethra). Subjects with Urothelial Carcinoma with squamous differentiation or mixed cell types are eligible.
cervical carcinoma in situ on biopsy or squamous intraepithelial lesion on Pap smear; and
Diagnosis of ovarian carcinoma with mucinous histology
Pathologically (histologically) proven diagnosis of squamous cell carcinoma (including variants such as verrucous carcinoma, spindle cell carcinoma, carcinoma not otherwise specified [NOS], etc.) of the head/neck (oral cavity, oropharynx or larynx); note: hypopharynx primaries are excluded
Inclusion Criteria:\n\n        Part A Escalation Cohorts:\n\n        o Histologically or cytologically confirmed advanced malignant solid tumor, limited to\n        melanoma, castrate resistant prostate cancer (CRPC), ovarian cancer (OVCA), renal cell\n        carcinoma, colorectal carcinoma (CRC), pancreatic carcinoma or non-small cell lung\n        carcinoma (NSCLC) that is refractory to, intolerant of, for which no standard of therapy is\n        available or where the patient refuses existing therapies\n\n        Part A Expansion Cohorts, Part B and C Escalation and Expansion Cohorts:\n\n          -  Tumors with all histological diagnosis or tissue origin may be enrolled\n\n          -  Patients must have failed prior standard curative chemotherapy for their disease,\n             refuse existing therapies OR the proposed chemotherapy regimen to which AM0010 is\n             added represents an acceptable standard treatment for their disease.\n\n               -  Measurable or evaluable disease according to irRC or bone metastatic disease\n                  evaluable by Prostate Cancer Working Group 2 criteria (PCWG2) for\n                  castration-resistant prostate cancer (CRPC)\n\n               -  At least 18 years of age\n\n               -  Performance Status of 0 or 1\n\n               -  Adequate organ function\n\n        Exclusion Criteria:\n\n          -  Hematologic malignancies\n\n          -  Pregnant or lactating\n\n          -  Present or history of neurological disorders such as Multiple Sclerosis and Guillain\n             Barre or inflammatory central nervous system/peripheral nervous system (CNS/PNS)\n             disorders\n\n          -  Myocardial infarction within the last 6 months\n\n          -  Unstable angina, or unstable cardiac arrhythmia requiring medication\n\n          -  Surgery within the last 28 days\n\n          -  Systemic fungal, bacterial, viral, or other infection\n\n          -  History of bleeding diathesis within the last 6 months\n\n          -  Positive for human immunodeficiency virus (HIV), hepatitis C, or hepatitis B
Cohort 5: Participants must have a mature T cell, B cell, or natural killer (NK) cell neoplasm.
Adequately treated urothelial papillary non-invasive carcinoma or carcinoma in situ
Patients must have histologically or cytologically confirmed metastatic, high grade NET (Ki67 > 20%), excluding any high grade NETs of large or small cell type of lung/thymus origin and Merkel cell carcinoma
Histologically confirmed diagnosis of advanced or metastatic clear cell or papillary renal cell carcinoma or histologically confirmed clear cell ovarian carcinoma.
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 with neuroendocrine or small cell features are not eligible
Histologically or cytologically confirmed RCC with a clear cell component (subjects with pure papillary cell tumor or other non-clear cell histologies, including collecting duct, medullary, chromophobe, and unclassified RCC are excluded).
Histologically or cytologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx, not amenable for salvage surgery or radiotherapy.
Pathological finding consistent with small cell, ductal or neuroendocrine carcinoma of the prostate
Has histopathologically confirmed transitional cell carcinoma of the urothelium (bladder, urethra, or renal pelvis) with documented disease progression after 1-3 prior lines of systemic therapy
Patients with hepatocellular carcinoma may be eligible provided they have AST and ALT that are ? 5.0 x ULN.
Poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, goblet cell carcinoma, or small cell carcinoma
Subjects with squamous cell carcinoma of the lung
Histologically or cytologically documented non-small cell lung cancer (NSCLC), including squamous cell carcinoma, adenocarcinoma (including bronchioloalveolar carcinoma), and large cell anaplastic carcinoma (including giant and clear cell carcinomas) and poorly differentiated (not otherwise specified, NOS) non-small cell lung cancer; totally resected tumors are excluded\r\n* Patients must be M0;\r\n* Patients with T1 or T2 disease with N2 or T3N1-2 disease (stage IIIA) are eligible\r\n* Patients with T4 with any N or any T with N3 disease are eligible (stage IIIB)\r\n* Measurable disease is required
Histologically-confirmed diagnosis of urothelial carcinoma of the renal pelvis, ureter, bladder, or urethra, that is transitional cell, or mixed transitional/non-transitional (predominantly transitional) cell type.
Urothelial carcinoma that is suitable for local therapy with curative intent.
Merkel cell carcinoma basket:\r\n* None
Neuroendocrine tumors, pancreatic basket:\r\n* Grade 3, poorly differentiated neuroendocrine carcinoma\r\n* Large cell or small cell histology
Neuroendocrine tumors, extrapancreatic basket:\r\n* Grade 3, poorly differentiated neuroendocrine carcinoma\r\n* Large cell or small cell histology
Advanced Renal Cell Carcinoma
Patients with predominant (> 30%) non-endometrioid histology (such as serous, clear cell, or carcinosarcoma)
Histologically confirmed and documented disease to include: adenocarcinoma NOS (not otherwise specified), clear cell adenocarcinoma, endometrioid adenocarcinoma, malignant Brenner’s tumor, mixed epithelial carcinoma, mucinous adenocarcinoma, serous adenocarcinoma, transitional cell carcinoma, and undifferentiated carcinoma
non-small-cell adenocarcinoma of the lung
Thymic carcinoma
Histologically confirmed renal cell carcinoma (RCC) with a clear-cell component.
Evidence that the renal cell carcinoma is advanced or metastatic.
Metastatic renal cell carcinoma (clear cell or non clear cell)\r\n* One metastatic site amenable to cryoablation\r\n* Patients with a single metastatic site may be enrolled if that site is amenable to ablation; however these patients will not be counted in secondary measures of response unless there is new disease detected during follow up\r\n* Eligible for cytoreductive surgery, metastasectomy, or repeated biopsy; biopsy site cannot be lung, mediastinal lymph node, or bone (unless soft tissue component)
Patient’s with an International Metastatic Renal Cell Carcinoma Database Consortium (IMDC or Heng) score of 3 or less will be included; score greater than 4 will be excluded; 1 point each: requirement of systemic treatment for metastatic disease less than 1 year of original diagnosis of renal cell carcinoma, a serum calcium greater than 10, anemia, neutrophilia, thrombocytosis, ECOG performance status >= 2
Any neuroendocrine differentiation including small cell carcinoma on histology or cytology.
Tumors of adenocarcinoma, melanoma, small cell and basal cell histology are excluded
Neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma
Patients with any component of small cell carcinoma are not eligible; other variant histologies are permitted provided the predominant (>= 50%) subtype is urothelial carcinoma
Patients must be able to provide a sufficient biopsy sample to the central pathologist for histopathologically confirmed, transitional cell (urothelial) carcinoma. Urothelial tumors with mixed histology (but with <50% variant) are eligible.
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
Any primary site of urothelial carcinoma including upper tract, renal pelvis, bladder, and ureters
Have a histopathologically confirmed diagnosis of metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. All histologies of nonsquamous cell origin including undifferentiated gastric carcinoma are eligible.
Inclusion criteria:\n\n        Adult patients aged >=18 years with histologically or cytologically confirmed advanced\n        nonsquamous non-small cell lung cancer (nsNSCLC). Mixed tumors should be categorized\n        according to the predominant histology.\n\n        Note: NSCLC should be predominantly nonsquamous. Recurrent or metastatic disease (Stage IV)\n        with an indication for therapy with paclitaxel + carboplatin + Avastin®.\n\n        Patients harboring tumors with unknown or without activating epidermal growth factor\n        receptor (EGFR) / anaplastic lymphoma receptor tyrosine kinase (ALK) mutation maybe\n        included provided chemotherapy is standard of care. At least one measurable lesion\n        according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 based on independent\n        central review.\n\n        Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.\n\n        Adequate hepatic, renal, and bone marrow function:\n\n        Life expectancy > 6 months based on clinical judgment. Further inclusion criteria apply.\n\n        Exclusion criteria:\n\n        Prior therapy with monoclonal antibodies or small molecule inhibitors against Vascular\n        Endothelial Growth Factor (VEGF) or VEGF receptors, including Avastin®.\n\n        Prior systemic therapy for metastatic disease. Prior systemic anticancer therapy or\n        radiotherapy for locally advanced nsNSCLC if completed <12 months prior to Screening.\n\n        Previous malignancy other than NSCLC in the last 5 years except for basal cell cancer of\n        the skin or pre-invasive cancer of the cervix.\n\n        Symptomatic brain metastasis. Diagnosis of small cell carcinoma of the lung, squamous cell\n        carcinoma of the lung, NSCLC not specified (NS) or NSCLC not otherwise specified(NOS).\n\n        Any unresolved toxicity > Common Toxicity Criteria Grade 1 (except alopecia) from previous\n        anticancer therapy (including radiotherapy).\n\n        History or evidence of inherited bleeding diathesis or coagulopathy with the risk of\n        bleeding. Thrombotic or hemorrhagic event =< 6 months prior to Screening. Further exclusion\n        criteria apply.
Patients with small cell or neuroendocrine tumours.
benign basal cell carcinoma
benign low grade transitional cell carcinoma of the bladder
Patients must not have any of the following: acinar cell carcinoma, neuroendocrine carcinoma, cystadenocarcinoma, carcinosarcoma
Patients must have a histologically confirmed diagnosis of urothelial carcinoma of the bladder, urethra, ureter, or renal pelvis; confirmation may be obtained from any CLIA certified lab
Patient must have a histologically confirmed diagnosis of non-transitional cell carcinoma of the bladder, urethra, ureter, or renal pelvis including but not limited to squamous cell, neuroendocrine, adenocarcinoma including urachal and sarcomatoid; confirmation may be obtained from any CLIA certified lab
Pathologically proven diagnosis of carcinoma of the bladder within 105 days prior to registration\r\n* Operable patients whose initial tumor is a primary high grade urothelial carcinoma of the bladder exhibiting histologic evidence of invasion into the lamina propria (disease clinical stage T1) or a high grade stage Ta urothelial carcinoma without hydronephrosis; patients who have involvement of the prostatic urethra with urothelial carcinoma and have no evidence of stromal invasion of the prostate remain eligible; if the patient’s initial tumor was a high grade stage Ta urothelial carcinoma then his/her recurrent tumor must be a high grade stage T1 urothelial carcinoma to be eligible
Transitional cell, small cell, or squamous cell carcinoma of the prostate
Have mixed small cell and non-small cell histologic features.
Histologically or cytologically confirmed urothelial carcinoma (confirmed at the enrolling institution) of the bladder, ureter, urethra, or renal pelvis; patients with mixed histologies are required to have a predominant urothelial component as reviewed by the pathologist at the treating institution
Muscle invasive urothelial carcinoma of the bladder histologically confirmed at the enrolling institution; (urothelial carcinoma invading into the prostatic stroma with no histologic muscle invasion is allowed provided the extent of disease is confirmed via imaging and/or EUA)
Ovarian Carcinoma
Renal Cell Carcinoma
Urothelial Carcinoma
The patient must have a pathologically confirmed (by histology or cytology) diagnosis of epithelial ovarian, fallopian tube or primary peritoneal carcinoma, which is currently recurrent or persistent Stage 3 or Stage 4 disease. A histologic diagnosis of borderline, low malignant potential epithelial carcinoma is not permitted.
The patient must have a pathologically confirmed diagnosis of clear cell (renal cell) carcinoma, which is currently Stage 4 disease.
A patient with urothelial carcinoma with variant histologic differentiation (e.g. squamous cell differentiation, glandular differentiation, neuroendocrine differentiation) will be eligible provided that the predominant histology is urothelial carcinoma.
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
Patients with grade 2-3 endometrioid, uterine serous, clear cell, mucinous, squamous, transitional cell, sarcomas, or carcinosarcoma histology
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
Patients must have histologically-confirmed endometrial carcinoma (endometrioid and mixed endometrioid tumors, any grade).
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.
Patients must have pathologically or cytologically confirmed adenoid cystic carcinoma; cancers arising from non-salivary gland primary sites are allowed
Poorly differentiated histology, uterine papillary serous carcinoma, clear cell carcinoma or carcinosarcoma is acceptable as long as the predominant metastatic component is epithelial (versus sarcomatous)
Presence of islet-cell or pancreatic neuroendocrine tumor or mixed adenocarcinoma-neuroendocrine carcinoma
Histologically confirmed, locally recurrent or metastatic clear cell renal cell carcinoma
Non clear cell renal cell carcinoma (RCC)
High grade NET or small cell neuroendocrine carcinoma
Patient must have a diagnosis with urothelial carcinoma of the bladder with clinically apparent tumor Ta, G1-G2.
Upper tract Transitional Cell Carcinoma (TCC).
Carcinoma in situ (CIS).
Histologically confirmed ovarian epithelial (including fallopian tube and primary peritoneal) carcinoma.
Metastatic or recurrent merkel cell carcinoma (MCC) confirmed by histology
Patients with the following histologic epithelial cell types are eligible: High grade serous adenocarcinoma, endometrioid adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, or adenocarcinoma not otherwise specified (N.O.S.).
Patients with histologically proven squamous cell carcinoma of the larynx
Patients with recurrent or persistent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma
Subjects with histologically- or cytologically-documented incurable human papillomavirus (HPV)-16 positive solid tumors including oropharyngeal squamous cell carcinoma (OPSCC), cervical, vulvar, vaginal, anal, penile cancer; incurable HPV-16 solid tumors are defined as tumors which are not curable by salvage approaches including resection and/or re-irradiation; HPV-16 serotype will be assessed by Cervista assay
Documented pathologic diagnosis of renal cell carcinoma (RCC); all subtypes eligible including but not limited to clear cell, papillary, chromophobe, collecting duct carcinoma, medullary carcinoma, and unclassified categories; sarcomatoid and rhabdoid differentiation are allowed
Histologically documented adenocarcinoma or squamous cell carcinoma of the cervical esophagus, thoracic esophagus, or gastroesophageal junction
Evidence of metastatic or surgically unresectable transitional cell carcinoma of the urothelium involving the bladder,urethra,ureter or renal pelvis
Patient has carcinoma primary to the intra- or extra-hepatic biliary system or gall bladder.
Participants with any concomitant or prior invasive malignancies are ineligible with the following exceptions:\r\n* Treated limited-stage basal cell or squamous cell carcinoma of the skin\r\n* Carcinoma in situ of the breast or cervix\r\n* Primary endometrial cancer meeting the following conditions: stage not greater than IA, grade 1 or 2, no more than superficial myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated subtypes, including papillary serous, clear cell, or other International Federation of Gynecology and Obstetrics (FIGO) grade 3 lesions\r\n* Prior cancer treated with curative intent with no evidence of recurrent disease 3 years following diagnosis and judged by the investigator to be at low risk of recurrence
Histologically- or cytologically-confirmed diagnosis of advanced/unresectable (inoperable) or metastatic urothelial cancer of the renal pelvis, ureter, bladder, or urethra (transitional cell and mixed transitional/non-transitional cell histologies)
A retrospective review of all patients entered will be performed to confirm clear cell histology; patients must have recurrent or, progressive clear cell ovarian cancer not solely based on cancer antigen (CA)-125; primary tumors must be at least 50% clear cell histomorphology in order to be eligible or have a histologically documented recurrence with at least 50% clear cell histomorphology; recurrence should be biopsy proven unless the tumor is located in an area deemed unsafe to biopsy by the surgeon; if a biopsy can be obtained without significant risk, then biopsy should be obtained
The trial is open only to women with recurrent, progressive clear cell carcinoma of the ovary
Patients with pathologic diagnosis of lung NSCLC or squamous cell carcinoma
Patients with nasopharyngeal carcinoma are not eligible
Patients must have histologically confirmed HNSCC, from any primary site; nasopharyngeal carcinoma, World Health Organization [WHO] type I (keratinizing), will be included; squamous cell carcinoma of unknown primary, clearly related to the head and neck, will be included
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
Histologically confirmed adenocarcinoma of the prostate without histological variants (including overt neuroendocrine differentiation, small cell neuroendocrine carcinoma features, sarcomatoid features, pure ductal adenocarcinoma, squamous or transitional cell carcinoma)
Patients must have pathologically confirmed HPV-positive squamous cell carcinoma
Small cell or neuroendocrine carcinoma of the prostate
Histologically- or cytologically-confirmed diagnosis of urothelial cancer of the renal pelvis, ureter, bladder, or urethra, that is transitional cell or mixed transitional/non-transitional (predominantly transitional) cell type
Histological confirmation of renal cell carcinoma (RCC) with a clear-cell component
Pathology consistent with small cell carcinoma of the prostate
Patients must have a histologically confirmed diagnosis of non- muscle invasive urothelial carcinoma of the bladder at the study institution prior to the beginning of the study; this includes patients with:\r\n* High grade Ta papillary lesion(s)\r\n* High or low grade T1 papillary lesion(s) \r\n* Carcinoma in situ (CIS), with or without Ta or T1 papillary tumor(s) of any grade
Patients must have histologically confirmed predominantly urothelial carcinoma of the bladder, ureter, or urethra
Patients with a small cell component in their histology are excluded
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).
Pathological finding consistent with small cell carcinoma of the prostate
Subjects with histologic diagnosis of epithelial ovarian carcinoma, primary peritoneal carcinoma, or fallopian tube carcinoma, following initial surgery; all subjects must have had appropriate surgery for ovarian, primary peritoneal, or fallopian tube carcinoma with appropriate tissue available for histologic evaluation to confirm diagnosis and stage; pathology must be verified at Memorial Sloan-Kettering Cancer Center; patients with initial cytoreduction surgery performed at outside hospitals will be eligible for this protocol
Patients with the following histologic cell types are eligible: \r\n* High grade serous adenocarcinoma\r\n* Endometrioid adenocarcinoma \r\n* Undifferentiated carcinoma\r\n* Clear cell adenocarcinoma \r\n* Mixed epithelial adenocarcinoma \r\n* Adenocarcinoma not otherwise specified (N.O.S.) \r\n* Carcinosarcoma
Non-small cell lung adenocarcinoma
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
Patients must have pathologically or cytologically confirmed adenoid cystic carcinoma; cancers arising from non-salivary gland primary sites are allowed
Pathologic evidence of chemo-resistant Small Cell Lung cancer (relapse <90 days after 1st line), chemo-sensitive Small Cell Lung Cancer (relapse >90 days after first line), locally advanced metastatic neuroendocrine tumor of gastro-entero, pancreatic, pulmonary (other than Small Cell Lung) or thymic origin, or advanced renal cell carcinoma for which everolimus is indicated.
Histologically or cytologically-confirmed metastatic renal cell carcinoma of clear cell histology; prior nephrectomy is not a requirement for eligibility
Pathological finding consistent with small cell carcinoma of the prostate
Diagnosis of RCC with clear-cell or predominant clear-cell histology (? 50% other histologic features)
Biopsy proven squamous cell carcinoma histology or squamous cell variants (sarcomatoid, verrucous, basaloid, and papillary subtypes) involving the true vocal cord
Non-squamous histology including lymphoma, neuroendocrine carcinoma, adenocarcinoma, or other histology
Histologically or cytologically documented squamous cell carcinoma of the oropharynx, larynx or hypopharynx; human papillomavirus (HPV) status will not be assessed for eligibility
Pathologic finding consistent with small cell carcinoma of the prostate
Diagnosis of anal or small bowel carcinoma.
Histopathologic diagnosis of basal or squamous cell carcinoma
Clear cell, neuroendocrine, adenosquamous, serous carcinoma or other high-risk histologies
Pathologically (histologically or cytologically) proven diagnosis of HPV associated squamous cell carcinoma of the oropharynx (tonsil, base of tongue, or oropharyngeal walls) from surgical resection or excisional biopsy regardless of margin status\r\n* Squamous cell carcinoma of the neck of unknown primary is allowed with excision biopsy of a lymph node (or core biopsy) and consent from the principal investigator (PI) or co-PIs (Dr. Nancy Lee, Dr. Eric Sherman, or Dr. Nadeem Riaz)
Pathological finding consistent with small cell carcinoma of the prostate
Histologically confirmed intrahepatic cholangiocarcinoma (also variously reported as peripheral cholangiocarcinoma, cholangiolar carcinoma or cholangiocellular carcinoma) (ICC); confirmation of the diagnosis must be made at MSKCC or at the participating institution prior to initiating protocol therapy
Mixed small cell and non-small cell lung cancer histology.
Histological confirmation of HPV+ squamous cell carcinoma of the oropharynx; HPV positivity will be defined as positive staining for p16 on immunohistochemistry (IHC)
Suspected or histologically/cytologically confirmed head and neck squamous cell carcinoma (HNSCC) of the oral cavity, stage III, IVA or IVB (according to the American Joint Committee on Cancer [AJCC] 7th edition); patients with a suspected lesion may be enrolled and a baseline biopsy will be obtained as part of the study; if squamous cell histology is not confirmed, patients will be discontinued from the study
Histology other than squamous cell carcinoma
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
Patients with a diagnosis of intrathoracic lung carcinoma of squamous cell histology are not eligible for participation
Diagnosis of LGS carcinoma of the ovary, fallopian tube or primary peritoneum (invasive micropapillary serous carcinoma or invasive grade 1 serous carcinoma), confirmed histologically and verified by central pathology review.
Endocrine or acinar pancreatic carcinoma
Adenocarcinoma histology (including poorly differentiated non-small cell lung cancer [NSCLC], favor adenocarcinoma) of any variant, including adenosquamous histology
Histologically/cytologically verified, non-resectable, recurrent, or metastatic biliary tract carcinoma including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma and gallbladder carcinoma; combined cholangiocarcinoma and hepatocellular carcinoma is allowed
Histologically or cytologically confirmed clear cell renal cell carcinoma (ccRCC); pathology report from the original diagnosis of renal cell carcinoma is acceptable; the component of conventional clear cell type > 50% is mandatory only if there is more than one cell type identified in the tumor tissue
Non-clear cell or predominantly (> 50%) sarcomatoid histology
Patient must have histologically or pathologically confirmed locally unresectable or metastatic low or intermediate grade pancreatic neuroendocrine tumor, excluding small cell carcinoma
Patients must have histologically-confirmed advanced or recurrent endometrial carcinoma (endometrioid and mixed tumors, any grade) that is refractory to curative therapy or established treatments
Poorly differentiated neuroendocrine carcinoma or small cell carcinoma
Histological diagnosis of non-small cell lung cancer (NSCLC). Squamous cell (epidermoid), adenocarcinoma, bronchoalveolar carcinoma, and large cell anaplastic lung carcinoma histologies are eligible as are mixed histologies of NSCLC (i.e., adenosquamous). Mixed NSCLC/small cell lung carcinoma (SCLC), and variant large and small cell lung cancer are not eligible.
Small cell carcinoma of the prostate
Mixed small cell and non-small cell lung cancer histology
Patient must have histologically confirmed p16 positive squamous cell carcinoma of the oropharynx (OPSCC)
Histologic confirmation of renal cell carcinoma (RCC) with clear-cell component
Patients must have histologically or cytologically confirmed renal cell carcinoma except medullary or collecting duct subtypes; sarcomatoid differentiation will be allowed
Pathologic subtypes other than pure adenocarcinoma; acinar cell carcinoma, squamous cell carcinoma, spindle cell carcinoma, neuroendocrine cancer, and mixed types are not eligible.
Histologically or cytologically confirmed non-small cell lung cancer; mixed tumors will be categorized by the predominant cell type unless small cell elements are present, in which case the patient is ineligible; cytologic or histologic elements can be established on metastatic tumor aspirate or biopsy; sputum cytology alone is not sufficient
Muscle invasive urothelial carcinoma of the bladder histologically confirmed at Memorial Sloan Kettering Cancer Center (MSKCC) or participating site; (urothelial carcinoma invading into the prostatic stroma with no histologic muscle invasion is allowed, provided the extent of disease is confirmed via imaging and/or endoscopic ultrasonic aspiration [EUA])
Histologically-confirmed ovarian epithelial (including fallopian tube and primary peritoneal) carcinoma
Mixed, non-small cell and small cell tumors or mixed adenosquamous carcinomas with a predominant squamous component
Suspected preoperative diagnosis of invasive epithelial ovarian cancer, primary peritoneal carcinoma, fallopian tube cancer based on imaging and cancer antigen (Ca) 125; histologic epithelial cell types are eligible: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell carcinoma, mixed epithelial carcinoma, or adenocarcinoma not otherwise specified; patients with primarily carcinoma histology but mixed features can be included; the surgically confirmed histologic features must be compatible with primary Mullerian epithelial adenocarcinoma
Metastases to the ovaries from other organs except fallopian tube or primary peritoneal carcinoma
Locally unresectable or metastatic, histologically-confirmed, carcinoid or pancreatic neuroendocrine tumor; tumors must be considered well- or moderately-differentiated; patients with poorly differentiated neuroendocrine carcinoma are excluded from the study
Any patient eligible for internal implantation without MR guidance will be considered eligible for this protocol; standard criteria for internal implantation include:\r\n* Carcinoma of the cervix: stage I-IVA or vaginal recurrence\r\n* Carcinoma of the uterus: stage IIIB (vaginal involvement), inoperable, or vaginal recurrence\r\n* Carcinoma of the vagina: stage I-IVA or vaginal recurrence\r\n* Carcinoma of the vulva: stage I-IVA or recurrence\r\n* Carcinoma of the urethra/bladder
Primary germ cell tumor, small cell carcinoma, or lymphoma
Women with clinical stage IB2-IVA cervical squamous cell carcinoma, adenosquamous, or adenocarcinoma
Radiographic evidence of nonmetastatic renal cell carcinoma
Histological verification of clear cell renal cell carcinoma (note: this will be confirmed post informed consent)
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
Have histologically confirmed carcinoma of the prostate that is metastatic or otherwise incurable, and a BMI defined as obese (i.e. > 30 kg/m^2); any histologic variant is acceptable other than small cell carcinoma
Patients must have histologically-proven (T2, T3, or T4a) urothelial carcinoma of the bladder (UCB) that requires primary radical cystectomy for definitive treatment; patients must not have clinical stage consistent with a low-risk of node metastasis (carcinoma in situ [CIS] only, T1); patients with a T4b (fixed lesion) are not eligible for this study; NOTE: Patients with predominant urothelial carcinoma with elements of adenocarcinoma, squamous cell carcinoma, micropapillary or minor components of other rare phenotypes are eligible; patients with predominantly small cell, squamous cell, or adenocarcinoma histologies are not eligible; patients with other non-urothelial cancers are not eligible (e.g., sarcoma, lymphoepithelial, nested variant); clinical stage is based on all of the following: transurethral resection of bladder tumor(s) (TURBT[s]) that determined the need for cystectomy, bimanual exam and cross sectional imaging
COHORT 1 ONLY: Patients must have pathologically or cytologically confirmed adenoid cystic carcinoma; cancers arising from non-salivary gland primary sites are allowed
COHORT 2 ONLY: Patients must have pathologically or cytologically confirmed salivary gland cancer of any histology except for adenoid cystic carcinoma
Subjects with RCC (clear cell, non-clear cell histology) with or without prior systemic anticancer therapy
Subjects must have recurrent, unresectable, or metastatic cervical cancer and have relapsed after a platinum-containing doublet administered for treatment of advanced (recurrent, unresectable, or metastatic) disease. Subjects must have persistent, recurrent, or metastatic squamous cell carcinoma, adenosquamous carcinoma or adenocarcinoma of the cervix, with documented disease progression (disease not amenable 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 pathology report. Subjects must have had one prior systemic chemotherapeutic regimen for management of persistent, recurrent, or metastatic carcinoma of the cervix (e.g., paclitaxel/cisplatin, paclitaxel/cisplatin/bevacizumab). Chemotherapy administered concurrently with primary radiation (e.g., weekly cisplatin) is not counted as a systemic chemotherapy regimen. Adjuvant chemotherapy given following completion of radiation therapy (or concurrent chemotherapy and radiation therapy) is not counted as a systemic chemotherapy regimen (e.g., paclitaxel and carboplatin for ?4 cycles). Note: Subjects who have received >1 prior regimen are not eligible.
Subjects must have recurrent or persistent endometrial carcinoma (including: endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, dedifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified [N.O.S.], mucinous adenocarcinoma, squamous cell carcinoma, and transitional cell carcinoma) or endometrial carcinosarcoma; histologic documentation of diagnosis of carcinoma is required; microsatellite instability (MSI)-high patients will be identified based on immunohistochemistry or MSI testing of archival tumor specimens by department of pathology or via known mutations found in mismatch repair genes via the Integrated Mutation Profiling of Actionable Cancer Targets (IMPACT) assay through Memorial Sloan Kettering Cancer Center (MSKCC) Institutional Review Board (IRB)# 12-245
Histologic diagnosis of squamous cell carcinoma of the oral cavity including the lip, floor of mouth, anterior 2/3 of tongue, alveolus and gingiva, buccal mucosa, hard palate and retromolar trigone
Histological or cytological confirmation of renal cell carcinoma (RCC) with a clear-cell component
Histologically confirmed primary (non-recurrent) adenocarcinoma (AC) or squamous cell carcinoma of the esophagus or AC of the gastroesophageal (GE) junction
The histologic features of the tumor must be compatible with a primary Müllerian epithelial adenocarcinoma. Patients with the following histologic epithelial cell types are eligible: Serous adenocarcinoma, Endometrioid adenocarcinoma, Mucinous adenocarcinoma, Undifferentiated carcinoma, Clear cell adenocarcinoma, Mixed epithelial carcinoma, Transitional cell, Malignant Brenner's Tumor, Adenocarcinoma N.O.S. Patients may have co-existing fallopian tube carcinoma in-situ so long as the primary origin of invasive tumor is ovarian, peritoneal or fallopian tube.
Biopsy-proven squamous cell carcinoma (SCC) of the oropharynx (tonsil, base of tongue, pharyngeal wall or palate)
Histology other than squamous cell carcinoma
Subjects must have a pathologic diagnosis of advanced renal cell carcinoma (RCC) and must have progressed on treatment with a TORC1 inhibitor (such as temsirolimus or everolimus).
Patients must have pathological diagnosis of renal cell carcinoma that is metastatic or surgically unresectable; the histology must be clear cell carcinoma or predominant clear cell carcinoma
Core biopsy should definitively demonstrate invasive carcinoma
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.
Has a solid tumor likely to exhibit elevated levels of EGFR (e.g. head and neck squamous cell carcinoma, non-small cell lung cancer, triple negative breast cancer ,colorectal carcinoma and glioblastoma multiforme).
Islet cell or acinar cell carcinoma or cystadenocarcinoma
Biopsy-proven, invasive carcinoma of the cervix
Initial histological diagnosis of muscle invasive urothelial carcinoma
Patients with a previously untreated, T1 or T2, N0-N2b transorally resectable (as determined by the treating surgeon), histologically proven HPV positive, squamous cell carcinoma (SCC) of the oropharynx
Diagnosis of small cell carcinoma of the lung, squamous cell carcinoma of the lung or NSCLC NOS
Advanced colorectal carcinoma.
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
Diagnosis of advanced urothelial carcinoma, cervical cancer, cholangiocarcinoma or carcinomas of the biliary tree or squamous cell carcinoma of the head and neck.
Diagnosis of pancreatic islet neoplasm, acinar cell carcinoma, non-adenocarcinoma (eg, lymphoma, sarcoma), adenocarcinoma originating from the biliary tree or cystadenocarcinoma
Patients must have a diagnosis of a metastatic renal cell carcinoma with a >= 50% clear cell component
Receipt of at least two line of prior therapy for metastatic renal cell carcinoma (RCC)
Known or suspected neuroendocrine/small cell feature.
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
Patients with non-squamous cell histology
Histologically confirmed diagnosis of predominant clear cell renal cell carcinoma.
Patients must have pathologically-confirmed, resectable, squamous cell carcinoma of the oral cavity, oropharynx, larynx or hypopharynx
Pathologically proven (histologically or cytologically) diagnosis of squamous cell carcinoma (including histological variants like papillary squamous cell carcinoma and basaloid squamous cell carcinoma)
Patients with tumors that have a component of small 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
Previous muscle-invasive (i.e., stage T2 or higher) transitional-cell carcinoma of the bladder
Have localized non-metastatic renal cell carcinoma (RCC) (< pT2, NO, MO), as per the American Joint Committee on Cancer (AJCC) seventh (7th) edition criteria; patients who have not had a biopsy must have a solid renal mass suggestive of RCC with confirmation of RCC at screening biopsy
Patients with renal cell carcinoma less than 4 cm in maximum diameter, who are poor surgical candidates are eligible for randomization between SBRT and RFA\r\n* Renal cell carcinoma must be pathologically proven
Patients with renal cell carcinoma less than 8 cm in maximum diameter, patients with metastatic RCC who require local palliation or are progressing through systemic disease, patients who are poor surgical candidates and have tumor location not amenable to RFA, or patients who would prefer a noninvasive means of treatment are eligible for the non-randomized SBRT cohort\r\n* Renal cell carcinoma must be pathologically proven
Patients with bilateral renal cell carcinoma
Currently or previously treated with biologic, small molecule, immunotherapy, chemotherapy, or other agents for metastatic pancreatic carcinoma
Diagnosis of pancreatic islet neoplasm, acinar cell carcinoma, non-adenocarcinoma, adenocarcinoma originating from the biliary tree or cystadenocarcinoma
Histologically confirmed recurrent squamous cell carcinoma of the oral cavity, pharynx, (oropharynx, larynx) and neck
Histologically confirmed carcinoma of the kidney (clear-cell predominance)
Have had at least 2 prior systemic treatments for renal cell carcinoma (RCC)
Histologically confirmed muscle invasive transitional cell carcinoma of the bladder at Memorial Sloan-Kettering Cancer Center (MSKCC); (Note: urothelial carcinoma invading into the prostatic stroma with no histologic muscle invasion is allowed, provided the extent of disease is confirmed via imaging and/or exam under anesthesia [EUA])
Histologically or cytology proven pancreatic ductal carcinoma
Pancreatic tumor histology other than carcinoma (e.g. islet cell, lymphoma, etc.)
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
Core needle biopsy (e.g. Mammotome, core, stereotactic, ultrasound guided) showing invasive mammary cancer (with or without concomitant ductal carcinoma or lobular carcinoma in situ) or ductal carcinoma in situ; acceptable histologic types of invasive mammary cancer include ductal, tubular, mucinous, papillary, cribriform and \NOS\ (not otherwise specified); invasive lobular cancer is excluded
Patients must have histologically or cytologically confirmed non-squamous cell, non small cell carcinoma of the lung
Mixed histology or undifferentiated small cell carcinoma, any stage
Histologically confirmed NSCLC (adenocarcinoma, squamous cell carcinoma, large cell carcinoma, undifferentiated carcinoma or other)
Patients must have a histologically confirmed diagnosis of urothelial carcinoma of the bladder, urethra, ureter, or renal pelvis; confirmation may be obtained from any Clinical Laboratory Improvement Amendments (CLIA) certified lab or
Patient must have a histologically confirmed diagnosis of non-transitional cell carcinoma of the bladder, urethra, ureter, or renal pelvis including but not limited to squamous cell, neuroendocrine, adenocarcinoma including urachal and sarcomatoid; confirmation may be obtained from any CLIA certified lab
Has recurrent or metastatic carcinoma of the colon or rectum with documented histological or cytological confirmation;
Histologically confirmed non-muscle-invasive transitional cell carcinoma (TCC) of the bladder with carcinoma in-situ (CIS)
Patients must have pathologically confirmed non-small cell lung cancer, including squamous, non-squamous, mixed histology, or large cell
Patients with the following histologies of endometrial cancer are not eligible for enrollment: papillary serous adenocarcinoma, clear cell carcinoma, adenosquamous carcinoma, mucinous adenocarcinoma, carcinosarcoma, sarcoma
Have a histologically confirmed diagnosis of predominant clear cell (conventional) Renal Cell Carcinoma (ccRCC).
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.
Patients must have recurrent or persistent endometrial carcinoma; patients with the following histologic epithelial cell types are eligible: endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified (N.O.S.), mucinous adenocarcinoma, squamous cell carcinoma, transitional cell carcinoma, and carcinosarcoma
Patients in the expansion portion must have:\r\n* Histologically confirmed diagnosis of metastatic:\r\n** Urothelial carcinoma of the bladder, urethra, ureter, renal pelvis, OR\r\n** Clear cell renal cell carcinoma OR\r\n** Adenocarcinoma of the bladder OR\r\n** Non-resectable squamous cell carcinoma of the penis OR\r\n** Squamous cell carcinoma of the bladder AND\r\n* Patients with urothelial cancer or renal cell carcinoma must have progressive metastatic disease defined as new or progressive lesions on cross-sectional imaging; patients must have at least:\r\n** One measurable site of disease (according to RECIST criteria) or bone disease by NaF PET/CT
Merkel Cell Carcinoma
Nasopharyngeal Carcinoma
Squamous cell carcinoma of the cervix, vagina, or vulva
Squamous cell carcinoma of the anal canal and penile
Pathological finding consistent with small cell carcinoma of the prostate.
Carcinoma in situ of the bladder.
Patients (except those with hepatocellular carcinoma) must have histologically or cytologically confirmed (at original diagnosis or subsequent recurrence or progression) solid tumor or lymphoma that is metastatic, unresectable, progressive, or recurrent, and for which standard curative or palliative measures do not exist or are no longer effective; patients with hepatocellular carcinoma do not require biopsy confirmation; a liver mass with raised alpha-fetoprotein level (>= 500 ng/mL), consistent radiographic changes, and serology and viral deoxyribonucleic acid (DNA)/ribonucleic acid (RNA) measurements consistent with chronic hepatitis will be sufficient to identify hepatocellular carcinoma without the need for pathologic confirmation of the diagnosis; patients with hepatocellular carcinoma must still, however, have disease that has failed standard therapy; having chronic hepatitis B or C will not exclude patients from participating
Non-epithelial ovarian carcinoma, including malignant mixed Mullerian tumors
Histologically or cytologically documented, advanced, mixed non-small cell and small cell tumors or mixed adenosquamous carcinomas
Part B2: Hepatocellular cancer (excluding fibrolamellar carcinoma)
Part B3: Renal cell carcinoma (any histology)
Part B4: Non-small cell lung cancer (squamous or non-squamous)
Ductal carcinoma in situ (DCIS) or Stage I-III, primary invasive carcinoma of the breast
Malignant germ cell tumors with mixed histology such as embryonal carcinoma, choriocarcinoma, yolk sac tumor or seminoma. Note - this refers to the histology at the time of enrollment, not the histolgy at the time of initial presentation.
Adenocarcinoma or carcinoma of unknown primary site
Evidence of mixed NSCLC with a predominance of the squamous cell type
Patients with variant histologies (e.g., ductal or small cell carcinoma)
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
Patients must have histological or cytological confirmed primary non-small cell lung cancer (adenocarcinoma, large cell carcinoma, squamous, or unspecified); disease must be stage IV non-small cell lung cancer (NSCLC); disease may be either newly diagnosed or recurrent after previous surgery and/or irradiation; primary or metastatic site for biopsy is allowed
Mixed small cell and NSCLC histology
Positive for KRAS mutation or Squamous cell histology
Histologically confirmed non-small cell lung cancer (NSCLC), who are deemed to be surgical candidates by standard criteria; patients with all types of NSCLC (e.g., adenocarcinoma, squamous cell carcinoma) will be allowed to enroll
Oligometastatic or unresectable primary disease planned for SBRT with biopsy-proven primary disease histology of solid tumor categorization with the exception of small cell cancers; hepatocellular carcinoma does not need to be biopsy proven if imaging and clinical findings are consistent with the diagnosis
Ineligible histology including non-adenocarcinomas, adenosquamous carcinoma, islet cell carcinomas, cystadenomas, cystadenocarcinomas, carcinoid tumors, duodenal carcinomas, distal bile duct and ampullary carcinomas
Diagnosis of urothelial carcinoma
Must have histologically confirmed renal cell carcinoma of any pathologic subtype.
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;
Inclusion Criteria:\n\n        Patient has a confirmed diagnosis of a select solid tumor (except with a primary diagnosis\n        of Urothelial cell carcinoma, Cholangiocarcinoma, Endometrial cancer, and Glioblastoma\n        multiforme) or hematologic malignancies and is in need of treatment because of progression\n        or relapse.\n\n        Patient's tumor has been evaluated and pre-identified as having a tumor with a FGFR genetic\n        alteration. The qualifying alteration must be assessed and reported by a CLIA-certified\n        laboratory.\n\n        Patient must have received at least one prior treatment for recurrent, metastatic and /or\n        locally advanced disease and for whom no standard therapy options are anticipated to result\n        in a durable remission.\n\n        Patient must have progressive and measurable disease per RECIST 1.1. or other appropriate\n        hematological response criteria.\n\n        Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ? 1\n\n        Exclusion Criteria:\n\n        Patient has received prior treatment with BGJ398\n\n        Patients with Central Nervous System (CNS) metastasis or leptomeningeal carcinomatosis\n\n        Patient has received chemotherapy or other anticancer therapy ? 4 weeks (6 weeks for\n        nitrosourea, antibodies or mitomycin-C) prior to starting study drug.\n\n        Patients with acute or chronic pancreatitis\n\n        Patients with impaired cardiac function or clinically significant cardiac diseases\n\n        History and/or current evidence of extensive tissue calcification\n\n        Use of medications that increase serum levels of phosphorus and/or calcium\n\n        Current evidence of corneal or retinal disorder/keratopathy\n\n        History and/or current evidence of renal or endocrine alterations of calcium/phosphate\n        homeostasis\n\n        Patients with another primary malignancy within 3 years prior to starting study treatment,\n        with the exception of adequately treated basal cell carcinoma, squamous cell carcinoma or\n        other non-melanomatous skin cancer, or in-situ carcinoma of the uterine cervix
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
Histologically documented hepatocellular carcinoma
Biopsy-confirmed Merkel cell carcinoma with metastatic or loco-regional disease.
Biopsy-proven non-metastatic squamous cell carcinoma of the mouth or oropharynx and is planned to receive a standard course of concomitant CRT.
Squamous, small cell, carcinoid, adenosquamous, large-cell neuroendocrine, or mixed histology containing small-cell or squamous-cell NSCLC
Patients must have a histologically-confirmed ovarian, fallopian, or peritoneal malignancy with a component of high-grade papillary serous carcinoma; (example: a patient with ovarian carcinosarcoma with a component of high-grade papillary serous carcinoma will be eligible)
Subjects with the following histologic epithelial cell types are eligible: Serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's Tumor, or adenocarcinoma N.O.S.
Non-epithelial ovarian carcinoma, including malignant mixed Mullerian tumors.
Histologically or cytologically confirmed stage IV non-small cell lung carcinoma (NSCLC), according to 7th Tumor/Node/Metastasis (TNM) classification (cytological specimens obtained by bronchial washing or brushing, or fine-needle aspiration are acceptable)
Patients with advanced histologically proven squamous cell carcinoma of the lung
Histologically or cytologically confirmed carcinoma of the bladder of all histologies except neuroendocrine differentiation or squamous cell histology
The female subject has a diagnosis of one of the following: a) low-grade serous ovarian or peritoneal carcinoma, or grade 1 serous ovarian or peritoneal carcinoma or well-differentiated serous ovarian or peritoneal carcinoma or b) serous borderline ovarian or peritoneal tumor, ovarian or peritoneal tumor of low-malignant potential, ovarian or peritoneal atypical proliferative serous tumor that recurs as low grade serous carcinoma or has invasive peritoneal implants.
Histologically confirmed esophageal squamous cell carcinoma (ESCC)
Histopathologic confirmation that at least one of the three target lesions is basal cell carcinoma
Prior pathology consistent with small cell carcinoma or prostate cancer with predominantly neuroendocrine differentiation
Participants must have histologically documented metastatic or locally inoperable advanced urothelial carcinoma (bladder, urethra, ureter and renal pelvis) (T4b, N2, N3, or M1 disease. NOTE: Aberrant differentiation such as squamous, glandular (adenocarcinoma), and micropapillary are eligible unless the tumor is considered a pure histological variant according to the pathology report. Participants with small cell histology are not eligible.
Patients with islet cell tumors or other non-epithelial cell malignancies of the pancreas.
Controlled, superficial bladder carcinoma
Subjects in the Phase 2 portion must have squamous cell Non-Small Cell Lung Cancer (NSCLC)
Patients with histologic evidence of small cell carcinoma of the prostate will not be eligible
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
Dose determination cohorts: Histologically confirmed diagnosis of metastatic RCC of either clear cell or non-clear histology.
Tumors with clear cell histology: subject must have progressed after at least one anti-VEGFR therapy
Patients with the following histologic cell types are eligible: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial adenocarcinoma, transitional cell carcinoma, malignant Brenner's tumor, or adenocarcinoma not otherwise specified
Histologically confirmed intrahepatic cholangiocarcinoma (also variously reported as peripheral cholangiocarcinoma, cholangiolar carcinoma or cholangiocellular carcinoma) (ICC); confirmation of the diagnosis at the Memorial Sloan-Kettering Cancer Center (MSKCC) or at the enrolling institution must be obtained prior to initiation of protocol therapy
The subject has a pathologic diagnosis of non-small cell lung carcinoma that is metastatic or unresectable
Documented histological or cytological diagnosis of renal cell carcinoma with a clear-cell component
Diagnosis of high-grade (WHO Grade 3) or poorly differentiated NET; high-grade neuroendocrine carcinoma; large cell neuroendocrine carcinoma, small cell carcinoma, or mixed small and large cell carcinoma.
Renal cell carcinoma (RCC) Cohort: Participants with histologically confirmed incurable, advanced RCC with component of clear cell histology and/or component of sarcomatoid histology not previously treated with anti-PD-L1/PD-1 and/or anti-CTLA-4 (investigational or approved)
Participants must have one of the following tumor types: NSCLC, UC, HNSCC, TNBC, RCC, melanoma, cervical cancer, anal cancer, Merkel-cell carcinoma, microsatellite instability (MSI)-High tumors, squamous cell carcinoma of the skin, hepatocellular carcinoma (non-viral), and CRC including microsatellite stable (MSS) and MSI-Low
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
Up to 12 patients with incurable Squamous cell cancers as follows:
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)
Participants with carcinoma of the cervical stump
Patients must have histologically confirmed metastatic or unresectable renal cell carcinoma; predominant clear cell component is required; pure papillary and chromophobe renal cell carcinoma, collecting duct tumors and transitional cell carcinoma are not eligible
Tumors with squamous cell histology
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
Patients with histologic evidence of small cell carcinoma of the prostate will not be eligible
Subjects with hepatocellular carcinoma
Diagnosis of early stage, invasive ductal carcinoma (for which a lumpectomy or mastectomy is planned prior to systemic therapy)
Small cell carcinoma of the prostate
Radiosensitive or non-solid (eg. small cell lung carcinomas, germ cell tumors, leukemias, or lymphomas) or unknown tumor histologies
Mixed, non-small cell and small cell tumors or mixed adenosquamous carcinomas with a predominant squamous component
Patient has a history of other malignancies unless has undergone definitive treatment more than 5 yrs prior to study and without evidence of recurrent malignant disease (excluding basal cell carcinoma of the skin; superficial carcinoma of the bladder; carcinoma of the prostate with a current prostate-specific antigen <0.1 ng/mL; or cervical intraepithelial neoplasia).
Renal Cell Carcinoma (RCC): --Histologic diagnosis of either clear-cell or papillary RCC (metastatic and unresectable, or bilateral, multifocal, unresectable RCC localized to kidneys).
Histologically proven recurrent urothelial carcinoma of the bladder or prostatic urethra, Stage Tis, Ta
Histologically confirmed non-small cell lung cancer (NSCLC) or metastasis from another known or unknown primary by biopsy, or recurrent tumors in the setting of prior RFA/microwave or cryotherapy; eligible histological subtypes include: squamous cell carcinoma, adenocarcinoma, large cell neuroendocrine, and non-small cell carcinoma not otherwise specified
Histological or cytological proof of component (any percent) of clear cell RCC (renal cell carcinoma).
Patients must have a tissue diagnosis of low, intermediate or high grade ductal carcinoma in situ or ductal carcinoma in situ with microinvasion.
Patients with ductal carcinoma in situ undergoing either lumpectomy/radiation or mastectomy.
Diagnosis of metastatic renal cell carcinoma, either clear cell type or non-clear cell type; the diagnosis must be confirmed by the Laboratory of Pathology of National Cancer Institute (NCI) (there will be no central pathology review)
Subject must have progressive disease after therapy consisting of one of the Food and Drug Administration (FDA)-approved agents for therapy of metastatic renal cell carcinoma, including but not limited to: sorafenib, sunitinib, or temsirolimus
The participant has well-differentiated or moderately-differentiated, histologically confirmed neuroendocrine carcinoma, including carcinoid of any location and islet cell tumors
predominant clear cell histology
Subjects must have melanoma or lung cancer or renal cell carcinoma and received ipilimumab or nivolumab as a single treatment or in combination
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.
Patients with pre-operative histologic confirmation of a bladder lesion other than transitional cell carcinoma
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
Histologically or cytologically confirmed diagnosis of metastatic clear-cell renal cell carcinoma (ccRCC)
Histological documentation of adenocarcinoma of the prostate reviewed at MD Anderson Cancer Center; patients with small cell, neuroendocrine, or transitional cell carcinomas are not eligible
Centrally located non-small cell lung cancers and squamous cell lung cancers
Pathologically confirmed metastatic unresectable well differentiated (low grade and intermediate grade) neuroendocrine tumors (Ki-67 < 20% and mitotic rate < 2 per 10 high power field) that demonstrate progressive disease (by serial computed tomography [CT] or magnetic resonance imaging [MRI] scans) in past 12 months including\r\n* Carcinoid tumors originating anywhere in the body including the gastrointestinal (GI) tract or bronchial tree or thymus\r\n* Pancreatic neuroendocrine tumors (including functional and non-functional islet cell, insulinomas and glucagonomas)\r\n* Pheochromocytomas\r\n* Gastrinomas (Zollinger-Ellison syndrome)\r\n* Multiple endocrine neoplasia (MEN type I/II),\r\n* Adrenal carcinomas with NET markers by immunohistochemistry (IHC) or serum\r\n* Somatostatinoma\r\n* VIPoma (vasoactive intestinal peptide)\r\n* Merkel cell tumors\r\n* Medullary thyroid carcinoma\r\n* Neuroendocrine tumors of unknown primary site
Pure small cell histologic variant or other pure non-urothelial carcinomas
Patients with recurrent or metastatic squamous cell carcinoma of the lung – diagnosis must be histologically confirmed
Patient has a pathologically confirmed diagnosis of clear cell RCC
Patients with Tl/T2 squamous cell carcinoma of the oral cavity with or without extension to the oropharynx
Histologically confirmed squamous cell carcinoma of the target tumor(s)
Histologically confirmed invasive carcinoma of the breast of any of the following histologies (ductal, lobular, mammary, medullary, or tubular); in-situ disease alone is not allowed
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
Patients with clear cell or neuroendocrine cell types
Histologically confirmed serous carcinoma or endometrioid type of endometrial carcinoma (histological documentation of recurrence is not required);
Mixed histology of the tumor or evidence of tumor histology other than serous carcinoma or endometrioid type of endometrial carcinoma;
Carcinoma in-situ and tumors determined to be T1-2N0
Participants with histologically confirmed non clear cell renal cell carcinoma (nccRCC) who have not received any chemotherapy for advanced disease. Participants must have one of the following subtypes of nccRCC: papillary, chromophobe, collecting duct carcinoma (CDC), renal medullary carcinoma (RMC), or unclassified.
Predominant clear cell renal cell carcinoma (RCC)
Histologically confirmed adenocarcinoma of the prostate without histological variants comprising > 50% of the sample as determined by academic center central review (including neuroendocrine differentiation, small cell, sarcomatoid, ductal adenocarcinoma, squamous or transitional cell carcinoma)
Unresectable advanced or metastatic non-clear cell RCC to include but not limited to:\r\n* Papillary RCC, any type\r\n* Unclassified RCC\r\n* Translocation RCC\r\n* Chromophobe RCC\r\n* Collecting duct RCC\r\n* Medullary RCC\r\n* Clear cell RCC or any histology with >= 20% sarcomatoid features will be eligible\r\n* Other non-clear cell histologies that are not included above need to be discussed with the principal investigator (PI)
Cytologically or pathologically verified diagnosis of renal cell carcinoma (RCC)
PATIENT: Biopsy and/or radiograph proven diagnosis of hepatocellular carcinoma, cholangiocarcinoma, gallbladder carcinoma or breast, ovarian, or colorectal cancer with liver metastases with a life expectancy of at least one year
Ductal carcinoma in situ (DCIS) diagnosis
Men with small cell neuroendocrine tumors or features of small cell disease
RENAL CANCER: Histologically confirmed renal cell carcinoma (RCC)
Histologically or cytologically-proven non squamous cell NSCLC; mixed histology with small cell lung carcinoma (SCLC) component not allowed
Squamous cell NSCLC
Have histologically confirmed adenocarcinoma of the pancreas (including adenocarcinoma subtypes such as signet ring carcinoma, adenosquamous carcinoma, undifferentiated/poorly differentiated carcinoma, and mucinous carcinoma)
If biopsy of mass has been done, pathology must be consistent with renal cell carcinoma (RCC)
Has a new or recurrent American Joint Committee on Cancer (AJCC) stage I-IV squamous cell carcinoma of the upper aerodigestive tract (including lip/oral cavity, nasopharynx, salivary gland, oropharynx, hypopharynx, paranasal sinus, and larynx cancers)
Patients with the following histologic epithelial cell types are eligible:\r\n* Serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's Tumor, or adenocarcinoma not otherwise specified (N.O.S.) \r\n* However, the histologic features of the tumor must be compatible with a primary Müllerian epithelial adenocarcinoma; if doubt exists, it is recommended that the investigator should have the slides reviewed by an independent pathologist prior to entry \r\n* Patients may have co-existing endometrial cancer so long as the primary origin of invasive tumor is  ovarian or peritoneal for clarification of synchronous primary endometrial cancer
Patients with brain metastases from primary germ cell tumors, small cell carcinoma, unknown primary, or lymphoma
Patients with squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx will be eligible
Head and neck cancers of non-squamous histology (e.g., adenoid cystic carcinoma, acininc cell carcinoma, adenocarcinoma, sarcoma)
Histological proof of muscle-invasive transitional cell carcinoma of the bladder (stage II-III). Subjects with evidence of metastatic nodal disease to the obuturator or presacral lymph nodes only may be included (N1 M0). Subjects with any degree of fixation of the pelvic sidewall are not eligible.
Prior systemic chemotherapy for transitional cell carcinoma of the bladder. Any other prior systemic chemotherapy for a non-urothelial carcinoma must have been completed > 5 years prior to initiation of study.
Fibrolamellar carcinoma or mixed hepatocellular cholangiocarcinoma
Neuroendocrine or acinar pancreatic carcinoma
Histology showing mucinous or low grade epithelial ovarian carcinoma
Fibrolamellar carcinoma or mixed hepatocellular cholangiocarcinoma.
Stage IV, locally advanced or metastatic urothelial bladder cancer or transitional cell carcinoma arising in another location of the urinary tract, including urethra, ureter, and renal pelvis
T0-3, N0 to N2c, M0 squamous cell carcinoma of the oropharynx
Biopsy proven squamous cell carcinoma that is HPV and/or p16 positive
Diagnosis of: invasive breast cancer (stage I-III), ductal carcinoma in situ, lobular carcinoma in situ, lobular carcinoma
History of rectal cancer or neoplastic polyp (i.e. intramucosal carcinoma, carcinoma in situ)
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
Have recently diagnosed (within previous 6 months) pathologically confirmed, non-metastatic squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or supraglottic larynx that will be treated with CRT therapy as first line non-surgical treatment. Scans (CT, PET, and/or MRI) obtained within 120 days prior to consent for screening can be used to determine the subject's eligibility.
Patients must be diagnosed with oropharyngeal squamous cell carcinoma (SCC) that are surgical candidates
Histologic proof of squamous cell carcinoma of the oral cavity, oropharynx, nasopharynx, hypopharynx, or larynx
For pre-surgical patients\r\n* Suspected diagnosis of resectable non-small cell lung cancer; cancers with a histology of “adenosquamous” are considered a type of adenocarcinoma and thus a “nonsquamous” histology; patients with squamous cell carcinoma are eligible only if the registering site has\r\nEA5142 Institutional Review Board (IRB) approved\r\n* Suspected clinical stage of IIIA, II (IIA or IIB) or large IB (defined as size >= 4cm); Note: IB tumors < 4cm are NOT eligible; stage IB cancer based on pleural invasion is not eligible unless the tumor size is >= 4cm
For post-surgical patients\r\n* Completely resected non-small cell lung cancer with negative margins (R0); patients with squamous cell carcinoma are eligible only if the registering site has EA5142 IRB approved\r\n* Pathologic stage IIIA, II (IIA or IIB) or large IB (defined as size >= 4 cm); Note: IB tumors < 4cm are NOT eligible; stage IB cancer based on pleural invasion is not eligible unless the tumor size is >= 4cm
Completely resected NSCLC with negative margins (R0); cancers with a histology of “adenosquamous” are considered a type of adenocarcinoma and thus a “nonsquamous” histology; patients with squamous cell carcinoma are eligible only if the registering site has EA5142 IRB approved
Known advanced squamous cell carcinoma of the distal esophagus, or dysplastic/suspected malignant esophageal lesion ? 2 cm in size not amenable to endoscopic therapy
Have had a prior biopsy diagnosed atypical lobular hyperplasia, atypical ductal hyperplasia, lobular carcinoma in situ, or ductal carcinoma in situ in the last 10 years; or have had multiple prior breast biopsies, regardless of histology
Have small cell carcinoma or neuroendocrine component > 50%
Subjects with known esophageal cancer diagnosed by previous endoscopy\r\n* Adenocarcinoma\r\n* Squamous cell carcinoma
Patients with the following histologic epithelial cell types are eligible: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner’s tumor or adenocarcinoma not otherwise specified (N.O.S.); however, the histologic features of the tumor must be compatible with a primary Mullerian epithelial adenocarcinoma
Prior lobular carcinoma in situ (LCIS) is allowed
Prior known or suspected hepatocellular carcinoma
H/L: Without a personal history of melanoma and without a personal history of more than one squamous cell carcinoma (SCC) and/or basal cell carcinoma (BCC).
Pure small cell carcinoma of the prostate
Patients must have histologically or cytologically confirmed squamous cell carcinoma of the nasopharynx, oropharynx, larynx, hypopharynx, oral cavity
DCIS or previous invasive ductal carcinoma.
A prior biopsy indicating proliferative breast disease, atypical hyperplasia, ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS)
Participants with premalignant lesions (mild dysplasia, moderate dysplasia, severe dysplasia, or carcinoma in situ) of the head and neck, as confirmed by biopsy within the 4 months prior to study entry or a treated primary T1N0 or T2N0 squamous cell carcinoma will be eligible
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)
Participants with hyperplasia, in absence of dysplasia or carcinoma in situ, will be excluded
New diagnosis of carcinoma
History of invasive carcinoma =< 5 years (except subjects with Dukes A/B1 carcinoma =< 5 years prior to pre-registration or any stage of colon cancer if >= 3 years post surgical resection)
New diagnosis of invasive carcinoma
Lung carcinoma:
Pancreatic carcinoma:
Hepatocellular carcinoma
History of baseline findings of: diabetes mellitus requiring insulin therapy; pancreatitis; hepatitis B, hepatitis C or HIV; malabsorption syndrome or inability to swallow or retain oral medicine; major surgery ? 28 days prior to enrollment; ECOG performance status ? 2; or another cancer within 3 years except for basal carcinoma of the skin or cervical carcinoma in situ; any clinically significant and uncontrolled major morbidity
Currently being treated for metastatic transitional cell carcinoma
Subject must have biopsy-proven invasive ductal carcinoma or ductal carcinoma in situ of the breast
Biopsy proven diagnosis of small superficial oral cavity squamous cell carcinoma (SCC) (stage T1N0) requiring resection without the need for neck dissection
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
Patients with small cell carcinoma must have progressed after at least one prior systemic therapy; patients with squamous cell carcinoma or adenocarcinoma may be previously untreated or have progressed after prior systemic therapy; chemotherapy administered in conjunction with primary radiation as a radio-sensitizer WILL be counted as a systemic chemotherapy regimen; NOTE: There is no maximum number of prior treatments allowed
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
Diagnosis of pre-B cell or T cell ALL and in continuous first remission; at least 3 months into maintenance up until the first year off therapy
Recently-diagnosed (within the last 6 months), histologically-documented, non-metastatic squamous cell carcinoma of the oral cavity and/or oropharynx amenable to radiotherapy with concurrent chemotherapy as the definitive treatment modality.
Patients with invasive lobular carcinoma
The study population will include women with stage IB1 cervical cancer (any histologic subtype) deemed eligible for surgery, and women with a clinical stage I high-grade endometrial cancer planning to undergo surgical staging; high grade is defined by the following:\r\n* Uterine serous carcinoma \r\n* Clear cell endometrial carcinoma  \r\n* Grade 3 endometrioid carcinoma \r\n* Endometrial carcinosarcoma
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
Patients with small cell/neuroendocrine cervical carcinoma
Patients with suspected or histologically documented new non-small cell carcinoma that have agreed to undergo a thoracotomy for segmentectomy, lobectomy, bilobectomy or pneumonectomy as recommended by their thoracic surgeon for treatment
Patient must have epithelial ovarian, fallopian tube, or primary peritoneal cancer; this includes high-grade serous ovarian cancer, endometroid, clear cell, mixed epithelial, undifferentiated carcinoma, transitional cell carcinoma histologies\r\n* Patients with carcinosarcoma, non-epithelial, low grade tumors, or tumors with low malignant potential are excluded
Any male or female patient diagnosed with incident or recurrent Urothelial Cell Carcinoma and undergoing surveillance at 3 month intervals.
Has had all urothelial cell carcinoma tumor resected within the past 12 months
Planning to undergo radical cystectomy or chemotherapy-radiation for Urothelial Cell Carcinoma
Patients with early non-small cell lung carcinoma, or clinically-diagnosed early stage lung cancer, or pulmonary metastases
Histologically confirmed renal cell carcinoma
Pathology proven diagnosis of colon or colorectal carcinoma.
Histologically or cytologically proven squamous cell carcinoma of the oral cavity or pharynx (OSCC)
Subjects with known esophageal cancer (adenocarcinoma or squamous cell carcinoma)
Patient is planning to undergo radiation therapy for primary or recurrent carcinomas of the lung or oligo-metastatic carcinoma of the lung
33 consecutive consenting patients presenting to The Ohio State University James Cancer Hospital Otolaryngology Department with a suspicious oral lesion or prior biopsy-confirmed epithelial dysplasia (mild, moderate, severe), carcinoma in situ (CIS), or squamous cell carcinoma (SCC) will be recruited; adult patients presenting for initial evaluation for treatment planning and/or presenting for follow-up appointments monitoring for recurrence will be eligible to participate
Diagnosis of unresectable and/or metastatic clear cell renal cell carcinoma; 10 patients will be enrolled who have had no prior anti-angiogenic therapy; 10 patients will be enrolled who have had one prior anti-angiogenic therapy
Possible or suspicious sebaceous gland carcinoma of the eyelid
Planned standard of care surgery with curative intent for squamous cell carcinoma
Prior history of carcinoma
Patient with sinonasal carcinoma
Patient with nasopharyngeal carcinoma
Planned standard of care surgery with curative intent for squamous cell carcinoma
Patients undergoing Mohs surgery for basal cell carcinoma (BCC) or squamous cell carcinoma (SCC)
Has any evidence of small cell histology, or combined small cell and non-small cell histology, in original tumor biopsy or in Screening biopsy performed after progression
Nasal, paranasal sinus, or nasopharyngeal carcinoma, aside from WHO Type I and II (keratinizing, non-EBV positive) nasopharyngeal carcinoma which will be allowed.
Dose and Disease Expansion Cohorts: histologically confirmed renal cell carcinoma, gastric carcinoma (including gastro-esophageal junction adenocarcinoma), and a biomarker driven cohort of tumors with evidence of c-MET dysregulation (amplification, mutation)
Locally recurrent and unresectable and/or distant metastatic differentiated thyroid cancer (DTC), histologically or cytologically confirmed; the diagnosis of DTC includes the following subtypes: papillary thyroid cancer (PTC) (including but not limited to variants such as follicular variant, tall cell, columnar cell, Hurthle cell variant of papillary carcinoma, and poorly differentiated), follicular thyroid cancer (FTC), including insular variant, Hurthle cell carcinoma and poorly differentiated thyroid cancer
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
Advanced small cell lung cancer (SCLC) or large cell neuroendocrine carcinoma (LCNEC) of lung progressed after at least 1 line of anticancer chemotherapy
Advanced paraganglioma, pheochromocytoma, medullary thyroid carcinoma, Merkel cell carcinoma, or high grade extrapulmonary neuroendocrine carcinoma having progressed after 1 or more lines of anticancer chemotherapy (unless no standard treatments available or such treatments are deemed not appropriate)
Histologically confirmed clear cell carcinoma (conventional) with advanced and/or metastatic disease
Patients must have metastatic renal cell carcinoma (RCC)
Patients who have histologically proven transitional cell carcinoma (TCC); or
Histologic or imaging evidence of urothelial carcinoma of the bladder
Participants must have histologically or cytologically confirmed hepatocellular carcinoma OR have an imaging study that demonstrates a focal hepatic lesion with imaging features diagnostic of hepatocellular carcinoma
Squamous cell, large cell undifferentiated, neuroendocrine or small cell undifferentiated carcinoma of the lung
A known other currently active malignancy; (benign tumors and benign polyps, basal cell carcinomas of skin, superficial papillary bladder tumors, and pre-invasive carcinoma of the cervix are permitted)
No prior therapy for high-grade serous ovarian, fallopian tube, or primary peritoneal carcinoma
Preoperative fine needle aspiration cytology classified as papillary thyroid carcinoma or suspicious for papillary thyroid carcinoma.
No prior therapy for high-grade serous ovarian, fallopian tube, or primary peritoneal carcinoma
Ductal carcinoma in situ
Have a history of carcinoma-in-situ (CIS)
Have variant histology (micropapillary, nested variant, non-urothelial cell carcinoma elements)
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 prior diagnosis of non-muscle invasive, ?T1, urothelial cell\n             carcinoma of the bladder scheduled to undergo surveillance cystoscopy.
Patients with a diagnosis of small cell carcinoma, adenocarcinoma or squamous cell\n             carcinoma of the bladder
Germ cell tumors (GCTs).
Adenocarcinoma or carcinoma of unknown primary site (UKPS).
Cervix carcinoma.
Advanced or Metastatic renal cell carcinoma (RCC)
Predominant clear cell histology:
Primary nasopharyngeal carcinoma.
Part 2: Subjects with advanced or metastatic adenocarcinoma of the endometrium, ovarian cancer, renal cell carcinoma, melanoma, and non-small cell lung cancer.
Histologically confirmed recurrent or metastatic squamous cell carcinoma of unknown primary or nonsquamous histologies (example, mucosal melanoma) are not allowed.
Histologically documented, locally advanced (T4b, any N; or any T, N2-3) or metastatic urothelial carcinoma (mUC) (M1, Stage IV) (also termed transitional cell carcinoma [TCC] or urothelial cell carcinoma [UCC] of the urinary tract; including renal pelvis, ureters, urinary bladder, and urethra)
Malignancies other than urothelial carcinoma within 5 years prior to Cycle 1, Day 1
B-cell ALL
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)
Clear cell
Anaplastic or medullary carcinoma of the thyroid.
Part 2: Subjects with advanced or metastatic adenocarcinoma of endometrium, melanoma, non-small cell lung cancer, and renal cell carcinoma
Histologically or cytologically-confirmed, HPV (+) or HPV (-) squamous cell carcinoma of the nasopharynx (WHO Type 1), oropharynx, hypopharynx, larynx (supraglottis, glottis, subglottis) or oral cavity,