Patients must have histologically or cytologically confirmed alveolar soft part sarcoma that is not curable by surgery; diagnosis of malignancy must be confirmed by the department of pathology at the institution where the patient is enrolled prior to patient enrollment
Histologically- or cytologically-confirmed CRC that is metastatic
Histologically or cytologically confirmed cholangiocarcinoma.
Patients must have a biopsy with histologically confirmed diagnosis of recurrent endometrial cancer confined to the pelvis and/or vagina and no evidence of extrapelvic disease
Histologically or cytologically confirmed diagnosis of limited or extensive stage SCLC which failed one prior platinum-containing regimen and with a chemotherapy-free interval (CTFI, time from the last dose of first-line chemotherapy to the occurrence of progressive disease) ? 30 days. Small-cell carcinoma of unknown primary site with or without neuroendocrine features confirmed in histology test(s) performed on metastatic lesion(s) are eligible, if Ki-67/MIB-1 is expressed in >50% of tumor cells.
Patients must have histologically or cytologically confirmed non-rhabdomyosarcoma of soft tissue or bone at any site
Histologically confirmed advanced malignant melanoma, regardless of subtype (for screening and treatment phases)
Have histologically or cytologically confirmed SCLC that meets:
Phase 1: Subjects must have a histologically or cytologically confirmed diagnosis of metastatic (AJCC stage IV) NSCLC that carries an ALK rearrangement with CNS metastases, as determined by FISH, RT-PCR, immunohistochemistry (IHC), or NGS via a CLIA-certified LDT
Have a histologically-confirmed diagnosis of MB, NB, ES, or ARMS
Histologically or cytologically confirmed SCLC (either limited or extensive disease) or LCNEC, that has relapsed from the most current treatment or was refractory to treatment
Patients must have persistent or recurrent histologically confirmed USC
The diagnosis must be histologically confirmed by a gynecologic pathologist as containing >= 10% uterine papillary serous (UPSC) adenocarcinoma in the specimen
Part 1: A confirmed diagnosis of FL Grade 1, 2, or 3a, which has relapsed after, or been refractory to ? 1 prior therapy for FL, or subjects who have not previously received systemic anticancer therapy for FL., and which requires treatment. Part 2:Histologically confirmed MZL including splenic, nodal, and extranodal sub- types
Histologically confirmed metastatic or recurrent Type II EC (serous, clear cell, carcinosarcoma, adenosquamous and mixed histologies).
Epithelial Endometrial Cancer: histologically confirmed diagnosis (by either primary surgical specimen or biopsy for recurrence) of recurrent previously treated EEC.
Histologically or cytologically confirmed limited or extensive disease stage of SCLC. The disease should be progressing during or relapsing after the previous treatment.
Patients must have cytologically or histologically confirmed relapsed or refractory extensive-disease small-cell lung cancer (ES-SCLC) or non-progressing ES-SCLC after first line chemotherapy, or advanced or inoperable grade I-II pulmonary NETs
New diagnosis of brain metastases from a histologically or cytologically confirmed primary or metastatic NSCLC tumor within 5 years of registration on the study. If the original histological proof of malignancy is greater than 5 years, then pathological confirmation is required (i.e.: from extra-cranial or intracranial disease).
Histologically or cytologically confirmed metastatic UM
Histologically confirmed lymphoma (WHO classification), or confirmed MM (IMWG), that is relapsed and/or refractory.
Histologically or cytologically confirmed AML according to the WHO classification
Patients must have histologically or cytologically confirmed metastatic or recurrent RCC (any histologic subtype)
Part 2: HNSCC, with confirmed p53 mutations
(Part 2 only) Cohort 2: Have histologically or cytologically confirmed diagnosis of nonresectable, recurrent, or metastatic biliary tract carcinoma (intrahepatic or extrahepatic cholangiocarcinoma, gallbladder cancer, or ampullary carcinoma) and have not received prior systemic anticancer therapy for advanced or metastatic disease.
Participants must have histologically confirmed malignant tumor
Histologically confirmed CAH or grade 1 EC
Part B5 only: Participants must have histologically confirmed diagnosis of B-cell iNHL, with histological subtype; prior treatment with ?2 prior chemotherapy- or immunotherapy-based regimens for iNHL
Histologically confirmed neurotropic primary melanoma
Patients must have must have histologically or cytologically confirmed SCLC
Histologically confirmed classical HCL by the enrolling institution
Histologically or cytologically confirmed BRAFV600 wild-type melanoma
Prior diagnosis of Langerhans cell histiocytosis (strata A and B) or LCH-related disorder (stratum C) established by standard diagnostic criteria and confirmed histologically
Histologically or cytologically confirmed ovarian epithelial cancer
Have histologically or cytologically confirmed diagnosis of SCCHN irrespective of PD-L1 status, which is either inoperable and recurrent, or metastatic
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)
Histologically confirmed advanced TET (thymoma or thymic carcinoma)
Patients must have histologically or cytologically confirmed non-mucinous, epithelial stage 3 or 4 carcinoma of the ovary, fallopian tube or peritoneum
Patients must have histologically or cytologically confirmed metastatic/recurrent adenoid cystic carcinoma (ACC) or non-adenoid cystic carcinomas (non-ACC) of major or minor salivary glands
Patients with chemo-sensitive histologically confirmed NHL will be eligible for this treatment protocol contingent on histologic sub-classification
Histologically confirmed malignancy of the bladder
Histologically- or cytologically- confirmed CRC
Must have a histologically or cytologically confirmed, incurable malignancy, for which further standard treatment is not currently available.
Histologically confirmed FL.
Histologically or cytologically confirmed hematologic malignancy
Patients must have histologically or cytologically confirmed epithelial endometrial carcinoma; all histologies are accepted; patients with diagnosis of endometrial carcinosarcoma will be enrolled in the exploratory cohort (arm C) and will receive combination of cabozantinib and nivolumab
Subjects with histologically or cytologically confirmed extensive stage disease SCLC
Phase I portion of the study: Patients with histologically confirmed classical hairy cell leukemia (HCL)
Histologically or cytologically confirmed malignant secretory or non-secretory pheochromocytoma or paraganglioma that is unresectable and deemed inappropriate for alternative local regional therapeutic approaches
Patients must have histologically confirmed diagnosis of chordoma; the pathologic confirmation may be from another metastatic site
Patients with histologically or cytologically confirmed, resectable colon cancer and other resectable cancers without distant metastases, who are candidates for surgical resection of the tumor
Patients must be diagnosed with relapse of previously histologically confirmed PFEPN
Diagnosis of histologically or cytologically confirmed metastatic or non-resectable synovial sarcoma
Have histologically- or cytologically- confirmed unresectable or metastatic ACC that is considered incurable by local therapies
Patients must have a histologically confirmed diagnosis of endometrial cancer and no clinical evidence of extra-uterine disease on preoperative evaluation
Histologically confirmed diagnosis of CD20 positive iNHL with histological subtype limited to:
CAPMATINIB INCLUSION CRITERIA: Histologically or cytologically confirmed invasive melanoma
REGORAFENIB INCLUSION CRITERIA: Histologically or cytologically confirmed invasive melanoma
ENTRECTINIB INCLUSION CRITERIA: Histologically or cytologically confirmed invasive melanoma
Patients must have histologically confirmed diagnosis of osteosarcoma or Ewing sarcoma by central review, except if the diagnosis was already confirmed by the RRePS (Réseau de Référence en Pathologie des Sarcomes et des Tissus Mous et des Viscères) network
Histologically confirmed metastatic or recurrent HER2-negative (via IHC or FISH per ASCO/CAP guidelines 2013) breast cancer or histologically confirmed metastatic solid tumor
Histologically confirmed cancer by a Mount Sinai pathologist
Histologically- or cytologically-confirmed CRC
Patients with histologically or cytologically confirmed metastatic clear cell RCC who are eligible for cytoreductive nephrectomy, metastasectomy or post-treatment biopsy; diagnosis must be confirmed by pathologist review of screening biopsy; the determination of resectability will ultimately lie in the clinical judgment of the urologist and medical oncologist involved in the care of the patient
Patients must have pathologically confirmed GIST
Patients must have histologically or cytologically-confirmed diagnosis of progressive or recurrent malignancy as follows:
Participants must have histologically confirmed primary cancer of the uterus or cervix with histologically confirmed metastasis to one or more parametrial, pelvic, or para-aortic nodes prior to enrollment; participants diagnosed at other institutions must have pathology reviewed and confirmed at Massachusetts General Hospital (MGH) or another Dana-Farber (DF)/Harvard Cancer Center (HCC) institution
Patient must have suspected intrahepatic or hilar cholangiocarcinoma with minimal extrahepatic disease; diagnosis must be histologically or cytologically confirmed for continued treatment on study after pump placement
Patients must have histologically confirmed malignancy with brain metastases and are being recommended palliative WBRT
Pathologically (histologically or cytologically) confirmed diagnosis of esophageal squamous cell carcinoma (ESCC)
Histologically or cytologically confirmed (patients with mixed histologies are required to have a dominant transitional cell pattern.)
Histologically or cytologically confirmed metastatic or recurrent tumor types
Histologically or cytologically confirmed malignancy or lymphoproliferative disorder known to over express CK2 which has failed standard therapies (surgery, radiotherapy, endocrine therapy, chemotherapy) or for which effective therapy is not available, including the following types: (examples)
Histologically confirmed diagnosis of ACC according to Weiss system by a national reference pathologist who has to be nominated before study initiation.
Histologically or cytologically confirmed diagnosis of Ewing sarcoma and have progressed on or after standard therapies.
Histologically-confirmed T1b, T2 or T3 gallbladder cancer discovered incidentally at the time of or following routine cholecystectomy for presumed benign disease
Patients with histologically-confirmed Tis, T1a, or T4 tumors
Histologically- or cytologically-confirmed mCRC.
Women with biopsy confirmed high grade cervical intraepithelial lesions (diagnosis confirmed by\r\npositive p16 immunohistochemistry staining) within 12 weeks of baseline visit
Histologically-confirmed metastatic CRC
Histologically confirmed plasmacytoma amenable for biopsy
Patients must have histologically or cytologically confirmed metastatic endometrial cancer; eligible histologies for the experimental cohort are: endometrioid or serous; eligible histologies for the exploratory cohort are: carcinosarcoma, clear cell, mixed, adenosquamous and any other rare sub-type of endometrial cancer
Patients with histologically or cytologically confirmed metastatic NETs of any origin of low or intermediate grade (Part 1)
Histologically or cytologically confirmed diagnosis of biliary tract adenocarcinoma/ cholangiocarcinoma (including primary intra- and extrahepatic diseases); pathologic confirmation may be made from the primary or a metastatic site
Patients without histologically or cytologically confirmed node metastases or any other metastases
Study participants must have histologically or cytologically confirmed unresectable or metastatic malignant melanoma
Patients must have histologically or cytologically confirmed peritoneal surface malignancies from primary appendiceal tumors
Patients with chemotherapy (chemo)-sensitive histologically confirmed NHL will be eligible for this treatment protocol contingent on histologic subclassification
The diagnosis must be histologically confirmed by a gynecologic pathologist as containing >= 10% UPSC adenocarcinoma in the specimen
Age ? 18 years with histologically confirmed diagnosis of melanoma and stage IIIB to IVM1c for whom surgery is not recommended.
Has one of the following histologically confirmed tumors:
Part 2: histologically confirmed disease in specific tumor types
Subjects with histologically or cytologically confirmed NSCLC, MEL (including I/O relapsed MEL or I/O refractory MEL), CRC, SCCHN, ovarian cancer, recurrent B cell NHL or HL, or glioblastoma
Histologically or cytologically confirmed transitional cell carcinoma of the genitourinary tract
Have histologically or cytologically confirmed melanoma
Pathologically confirmed HER2-positive MBC
Patients with histologically confirmed intrahepatic, perihilar or extra-hepatic CCA.
has HER2 positive expression confirmed per protocol
Histologically or cytologically confirmed melanoma.
Based on RECIST v1.1 criteria on current nivolumab treatment (prior to initiation of this study), has a best response of confirmed stable disease (SD) or confirmed progressive disease (PD). Confirmed SD or confirmed PD refers to a response that is confirmed by a 2nd scan which is at least 4 weeks apart from the previous scan.
Histologically confirmed non-keratinizing differentiated NPC or undifferentiated NPC
Patients must have histologically-confirmed stage IV TNBC (patients who had metastatic disease within 6 months of lumpectomy or mastectomy for treatment of TNBC may be excused from repeat biopsy)
Specific eligibility criteria for Part 2 CRPC expansion cohort: Histologically or cytologically confirmed diagnosis of prostate adenocarcinoma, surgically castrated or continuously medically castrated (for >=8 weeks prior to pre-screening).
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 or cytologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group [VALG] staging system)
Histologically or cytologically confirmed advanced fibrolamellar carcinoma (FLC).
Inclusion Criteria:\n\n        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please\n        visit www.BMSStudyConnect.com\n\n          -  Patients with metastatic or advanced solid tumors\n\n          -  Women with histologically or cytologically confirmed triple negative breast carcinoma\n\n          -  Participants with histologically or cytologically confirmed pancreatic adenocarcinoma\n\n          -  Participants with histologically or cytologically confirmed Non Small Cell Lung Cancer\n             (NSCLC)\n\n        Exclusion Criteria:\n\n          -  Active brain metastases or leptomeningeal metastases.\n\n          -  Any serious or uncontrolled medical disorder\n\n          -  Prior malignancy active within the previous 3 years\n\n        Other protocol defined inclusion/exclusion criteria could apply
Histologically confirmed diagnosis of R/R AITL (eligibility needs to be confirmed by central pathological review).
Pathologically confirmed MCL.
Have a histologically or cytologically confirmed diagnosis of non-resectable, recurrent, or metastatic biliary tract adenocarcinoma (intrahepatic or extrahepatic cholangiocarcinoma, gallbladder cancer, or Ampulla of Vater) .
A histologically or cytologically confirmed cancer that is metastatic, unresectable, or recurrent and for which treatment with ipilimumab, or nivolumab, or pembrolizumab is a reasonable therapeutic option in the opinion of the investigator.
Patients must have pathologically confirmed GIST
Participants must have histologically confirmed B-cell NHL
Patients must have histologically or cytologically confirmed evidence of pancreatic carcinoma
Histologically confirmed melanoma of cutaneous origin
Confirmed or suspected endocarditis
Confirmed HER2 positive status
Patients must have pathologically confirmed GIST
Patients must have histologically-confirmed endometrial carcinoma (endometrioid and mixed endometrioid tumors, any grade).
Histologically or cytologically confirmed metastatic PDAC, no more than 1 prior chemotherapy regimen or treatment-naïve patients
Histologically- or cytologically- confirmed CRC
Patients must have histologically or cytologically confirmed gastrointestinal (GI) malignancies or ovarian cancer prior to entering this study
Histologically confirmed diagnosis of indolent B-cell NHL, with histological subtype limited to the following:
Histologically confirmed recurrent or metastatic SCCHN
Patients must have histologically or cytologically confirmed thyroid carcinoma of follicular origin (including papillary, follicular, or poorly differentiated subtypes and their respective variants)
Histologically or cytologically confirmed diagnosis of pancreatic carcinoma (dose escalation and MTD expansion components).
Histologically confirmed papillary serous adenocarcinoma or endometrioid type of endometrial carcinoma (histological documentation of recurrence is not required);
Participants must have histologically or cytologically confirmed cervical cancer which is now recurrent or metastatic and is refractory to curative therapy or established treatments; histologic or cytologic confirmation of the original primary tumor is required; all histologic types of cervical origin are permitted
Pathologically or cytologically confirmed esophagogastric cancer
Histologically confirmed squamous cell carcinoma of the cervix (any grade) or histologically confirmed grade 1 or 2 adenocarcinoma of cervix
Histologically confirmed AML with >20% blasts
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
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
Histologically confirmed diagnosis of mycosis fungoides (MF) or Sezary Syndrome (SS)
Histologically confirmed AL or LCDD (from any time prior to screening)
histologically-confirmed diagnosis according to REAL/WHO classification, of the following B-cell lymphomas :
Patients must have histologically or cytologically confirmed renal cell carcinoma except medullary or collecting duct subtypes; sarcomatoid differentiation will be allowed
Histologically confirmed diagnosis of indolent B-cell NHL, with histological subtype limited to the following:
Patients must have a histologically confirmed diagnosis of endometrial cancer and no clinical evidence of extra-uterine disease on preoperative evaluation
Subjects must have histologically-confirmed chordoma
Patients’ biopsies must be histologically confirmed CD30 positive within 36 months of enrollment
Histologically-confirmed HL
Histologically confirmed diagnosis of B-cell iNHL, with histological subtype limited to the following:
Histologically confirmed MCL
Patients must have histologically or cytologically confirmed cancer
Histologically confirmed CD20 positive primary B-cell CNS lymphoma (PCNSL) confirmed by one of the following:
Patients must be males with histologically confirmed and clinically localized low-grade and low-volume prostate cancer demonstrated at the time of initial diagnosis
Patient has histologically/cytologically-confirmed HNSCC.
Patients with histologically confirmed viral related hepatocellular, SCLC, non-cutaneous/ non-uveal melanoma, ovarian, TNBC, Sarcoma, Bladder and RCC.
Histologically confirmed diagnosis of osteosarcoma with lung metastasis, who have progressed on the prior line of therapy, or relapsed
Patients with histologically/cytologically-confirmed HNSCC
Histologically confirmed non-squamous histologies are not allowed; an exception is made for WHO type I-III nasopharynx histologies
Histologically confirmed uterine leiomyosarcoma with disease limited to the uterus (determined by surgical staging or radiologic imaging).
Histologically or cytologically confirmed disease;
Patient with histologically/cytologically confirmed Primary Central Nervous System Lymphoma (PCNSL)
Histologically confirmed diagnosis of B-cell iNHL, with histological subtype limited to the following:
Patients must have histologically or cytologically confirmed thyroid carcinoma of follicular origin (including papillary, follicular, or poorly differentiated subtypes and their respective variants).
Subjects with a histologically or cytologically confirmed acute leukemia who are refractory to or have exhausted all available therapies
Histologically documented leiomyosarcoma
Participants must have histologically confirmed intrahepatic cholangiocarcinoma (IHC) without evidence of extrahepatic metastasis within 3 months prior to study registration
Subjects with histologically or cytologically confirmed mCRC, Kirsten rat sarcoma wild-type (KRAS WT) at initial diagnosis
Histologically confirmed cutaneous metastatic melanoma of V600 E, K, D or R.
Histologically confirmed endometrial cancer
Histologically confirmed HCC that is inoperable (where surgery is not indicated due to disease extension, co-morbidities, or other technical reasons), and not eligible for local therapy
DOSE EXPANSION COHORT: subjects must have histologically or cytologically confirmed GIST that is metastatic or unresectable
Histologically or cytologically confirmed melanoma
Histologically or cytologically confirmed locally residual or recurrent cancer of the rectum or anus
Histologically confirmed angiosarcoma
Patients must have histologically confirmed metastatic alveolar soft part sarcoma that is not curable by surgery; diagnosis of malignancy must be confirmed by the department of pathology at the institution where the patient is enrolled prior to patient enrollment
Histologically- or cytologically-confirmed MPeM; epithelial, sarcomatoid, biphasic, multi-cystic, or well-differentiated papillary subtypes are allowed
SCLC pathologically confirmed at MSKCC
Histologically or cytologically confirmed salivary gland carcinoma.
Histologically confirmed medulloblastoma located in the posterior fossa            \r\n* Standard-risk disease
Patients must have histologically confirmed diagnosis of recurrent, persistent or advanced (stage IVB) squamous, adenocarcinoma or adenosquamous cervical cancer
Patients must have histologically or cytologically confirmed malignant melanoma and clinical evidence of metastatic disease to the brain; mucosal and ocular melanomas are included
Have histologically confirmed organ-confined prostate cancer - Clinical Stage T1 or T2a,
Have histologically or cytologically-confirmed malignant disease in an advanced incurable stage
Pathologically confirmed NHL
Adolescents and young adults (AYA) with histologically confirmed cancer who have completed primary treatment
Patients must have histologically confirmed T3-T4 and N0-N2, M0 adenocarcinoma of the rectum with the inferior margin within 16 cm from the anal verge
Adult men of all races and body size with histologically confirmed localized PCa on AS
CANCER PATIENT GROUP: Histologically confirmed non-metastatic PCa
Adult patients > 18 years with histologically or cytologically confirmed Peripheral T-cell lymphoma (PTCL)
Histologically-confirmed high grade dysplasia (HGD), cancer, or polyp burden that is not quantifiable
Naïve or non-naïve patient with histologically, and/or cytologically (or imaging in the case of brain tumors) confirmed malignant disease.
Histologically-confirmed chronic multifocal atrophic gastritis (MAG) and/or gastric intestinal metaplasia (GIM)
Age >= 18 years, with histologically confirmed diagnosis of Barrett's Esophagus without dysplasia
Subject must have histologically confirmed at last relapse aggressive B-cell NHL according to \The 2016 revision of the WHO classification of lymphoid neoplasms\ defined as:
If, based on surgeon’s assessment, the patient is recommended to undergo surgical staging for histologically confirmed endometrial cancer or if IB1 cervical cancer is deemed eligible for surgical treatment of disease
Histologically confirmed diagnosis of malignant primary brain tumor or known metastatic cancer with brain lesion presumed to be metastatic
Pathologically or cytologically confirmed diagnosis of metastatic (stage IV) RAS wildtype CRC
Patients must have histologically or cytologically confirmed thyroid carcinoma of follicular origin (including papillary and its respective variants)
History of histologically confirmed melanoma as assessed per medical record review
Have histologically or cytologically confirmed small bowel carcinoid tumor
Participants must have histologically confirmed intracranial meningioma, grade II-III, that has recurred or progressed after previous treatment
a primary brain tumor that has been histologically confirmed
Patients must have either \r\n* 1) histologically/cytologically-confirmed borderline resectable pancreatic cancer and be prescribed neoadjuvant gemcitabine-plus-Abraxane as part of their standard of care, or \r\n* 2) histologically/cytologically-confirmed locally advanced unresectable pancreatic cancer and be prescribed neoadjuvant gemcitabine-plus-Abraxane as part of their standard of care
Patients must have histologically-confirmed HNSCC with surgically resectable disease
Histologically or cytologically-confirmed advanced or metastatic GIST with a D842V mutation in the PDGFRA gene as determined by central laboratory testing
Age ? 18 years with histologically- or cytologically-confirmed, extensive-stage, chemotherapy-naïve SCLC
Participants must have histologically or cytologically confirmed diagnosis of one of the following differentiated thyroid cancer (DTC) subtypes:
Histologically or cytologically confirmed diagnosis of Ewing sarcoma (including ESFT) in subjects with relapsed or refractory disease who have failed standard therapy
Patients must have a histologic diagnosis of pancreatic adenocarcinoma
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
Procurement: Any patient with biopsy proven pancreatic adenocarcinoma
Any patient with biopsy-proven pancreatic adenocarcinoma:\r\n* Group A: Patients with locally advanced or metastatic pancreatic adenocarcinoma who experienced a documented best response of investigator-assessed confirmed partial response (PR) or stable disease (SD) per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1\r\n* Group B: Patients with locally advanced or metastatic pancreatic adenocarcinoma who experienced progressive disease following first line chemotherapy or who are judged by the investigator as being ineligible to receive standard of care chemotherapy\r\n* Group C: Patients with potentially resectable pancreatic cancer who have completed planned preoperative neo-adjuvant chemotherapy, radiotherapy or combination chemoradiation
Pancreatic ductal adenocarcinoma (PDAC)
Histologically or cytologically-confirmed metastatic pancreatic ductal adenocarcinoma.
Must have histologically or cytologically confirmed advanced pancreatic ductal adenocarcinoma (PDAC) that is metastatic. The definitive diagnosis of metastatic PDAC will be made by integrating the histopathological data within the context of the clinical and radiographic data. Patients with islet cell neoplasms are excluded.
Confirmed diagnosis of borderline resectable or locally advanced pancreatic adenocarcinoma
The patient has a histologically or cytologically confirmed metastatic pancreatic adenocarcinoma.
Pancreatic adenocarcinoma.
EXPANSION COHORT: No more than one line of prior systemic therapy for advanced pancreatic adenocarcinoma allowed
Patients must have a histologically or cytologically confirmed pancreatic adenocarcinoma that is metastatic, unresectable, or recurrent
Histologically or cytologically proven pancreatic adenocarcinoma (subjects with endocrine or acinar pancreatic carcinoma are not eligible)
Cytologic or biopsy confirmed adenocarcinoma of the pancreatic head, body or tail
Have histologically or cytologically confirmed diagnosis of pancreatic ductal adenocarcinoma
Histologically confirmed pancreatic adenocarcinoma with initial diagnosis within 6 weeks of consent
Histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma; mixed histology will be included as long as the predominant histology is adenocarcinoma
Histologically or cytologically confirmed, previously treated, locally-advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) or other CA19-9 positive malignancies
Histologically or cytologically confirmed metastatic pancreatic adenocarcinoma that has progressed on one or more chemotherapy regimens.
Patient must have pathologically confirmed, locally advanced or metastatic pancreatic ductal adenocarcinoma (PDA) deemed surgically unresectable by a surgeon with expertise in pancreatic cancer
The presence of metastatic pancreatic adenocarcinoma
Patients must have metastatic histologically or cytologically confirmed pancreatic adenocarcinoma or sarcoma (soft tissue or bone) for which progression was documented for at least one line of therapy
Pancreatic ductal adenocarcinoma: 1) pancreatic ductal adenocarcinoma patient with KRAS point mutation at codon G12 or G13; in addition to the above inclusion criteria, first 5 patients from both non-small cell lung cancer and pancreatic ductal adenocarcinoma patients will need to agree to mandatory pre- and post-treatment tumor biopsies
Have histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma based on pathology report
Histologically or cytological confirmed diagnosis of metastatic or locally advanced, unresectable pancreatic adenocarcinoma (excluding other pancreatic malignancies for example, acinar cell carcinomas, adenosquamous carcinomas, and neuroendocrine islet cell neoplasms).
Pancreatic Cancer Cohort: Patients must have a diagnosis of locally advanced or metastatic pancreatic adenocarcinoma previously treated with or not a candidate for standard of care systemic therapy.
Histologically confirmed, locally-advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) or other CA19-9 positive malignancies
Patients with histologically proven, surgically unresectable, locally advanced pancreatic adenocarcinoma (at diagnosis) or with mixed cell type with predominant histology of adenocarcinoma (by NCCN guidelines)
Patients must have metastatic pancreatic ductal adenocarcinoma (PDA) or metastatic colorectal cancer (CRC) to be eligible; (PDA patients with an elevated tumor marker following a primary pancreatic surgery would be eligible)
ARM A COHORT 1: Patients must have advanced pancreatic adenocarcinoma (unresectable or metastatic)
Any prior therapy (chemotherapy, radiation or surgery) for pancreatic adenocarcinoma other than biliary decompression
Pathologic or cytologic documentation of pancreatic adenocarcinoma
Biopsy proven pancreatic adenocarcinoma
Any pancreatic adenocarcinoma that does not meet criteria for borderline resectable disease
Group 5: Pancreatic Ductal Adenocarcinoma (Part B)
Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma.
Histologically or cytologically confirmed locally advanced or borderline resectable pancreatic ductal adenocarcinoma. Patients with clinical suspicion of pancreatic adenocarcinoma can be enrolled for pre-treatment biopsy, and must be histologically confirmed to have adenocarcinoma before being treated on study. Patients with squamous carcinoma, adenosquamous carcinoma or neuroendocrine tumor will be excluded
Cytologically confirmed pancreatic adenocarcinoma
Metastatic colorectal, pancreatic, gastroesophageal or biliary tract adenocarcinoma not amenable to curative resection
Have localized pancreatic ductal adenocarcinoma (PDA)s at the time of original diagnosis without any definitive evidence of distant metastatic disease
Histologically documented diagnosis of pancreatic adenocarcinoma
Patients must have histologically or cytologically confirmed pancreatic adenocarcinoma that is metastatic or unresectable; in the dose expansion phase, the tumor must express AR by immunohistochemistry; if >= 1% of the tumor cells express AR, it will be considered positive for this trial
Patients must have histologically or cytologically-confirmed pancreatic adenocarcinoma
Cytologically or histologically confirmed pancreatic adenocarcinoma (excluding islet cell or ampullary tumors) that is metastatic or unresectable
Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma
Patients must have histologically or cytologically proven pancreatic adenocarcinoma; histologies other than adenocarcinoma, or any mixed histologies, will NOT be eligible
Patients must have histologically or cytologically documented pancreatic adenocarcinoma; patients with pancreatic neuroendocrine tumors, lymphoma of the pancreas, or ampullary cancer are not eligible
Patients must have newly diagnosed, untreated metastatic histologically or cytologically documented pancreatic adenocarcinoma; patients must not have known history of brain metastases
Part B: Pancreatic Adenocarcinoma
Presence of histologically confirmed inoperable locally advanced or metastatic pancreatic adenocarcinoma
Histologically confirmed (either previously or newly biopsied) metastatic unresectable pancreatic adenocarcinoma, including with intraductal papillary mucinous neoplasm.
Patients with locally advanced unresectable pancreatic ductal adenocarcinoma are excluded.
Histologically proven diagnosis of pancreatic ductal adenocarcinoma (PDAC)
Subjects must have histologically or cytologically confirmed metastatic pancreatic adenocarcinoma; subjects with islet cell neoplasms are excluded
Histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma.
Histologically or cytologically confirmed locally advanced or metastatic pancreatic adenocarcinoma, gastric adenocarcinoma, cholangiocarcinoma, gall bladder adenocarcinoma, ampullary carcinoma, adenocarcinoma of unclear primary (with a gastrointestinal primary suspected), or other primary gastrointestinal malignancy for which the treating physician feels that FOLFIRABRAX is a reasonable therapeutic option
Subjects must have histologically or cytologically confirmed untreated metastatic pancreatic adenocarcinoma; subjects with islet cell neoplasms are excluded; subjects with mixed histology will be excluded
Prior therapy for pancreatic adenocarcinoma
Histologically confirmed cancer (one of the following):\r\n* Metastatic pancreatic adenocarcinoma
Patients must have histologically or cytologically diagnosed pancreatic adenocarcinoma; documentation of disease extent by computed tomography (CT) scan is required; radiologically measurable disease is not required
Patients must have histologically or cytologically confirmed metastatic pancreatic adenocarcinoma (or any mixed pathology if adenocarcinoma is predominant)
Patients must have histopathological confirmation of pancreatic adenocarcinoma prior to entering this study
Histologically or cytologically confirmed locally advanced or metastatic pancreatic ductal adenocarcinoma. Patients with acinar cell carcinoma may also be included.
Received and failed, or were intolerant to, at least 1 prior systemic therapy for locally advanced or metastatic pancreatic ductal adenocarcinoma.
Histologically or cytologically confirmed metastatic solid tumor, including but not limited to pancreatic adenocarcinoma, breast cancer, melanoma, renal cell carcinoma (RCC), colorectal adenocarcinoma, non-small cell lung cancer, and others approved by the principal investigator
Patients with any type of recurrent pancreatic adenocarcinoma
Histologically or cytologically confirmed pancreatic adenocarcinoma
Histologically confirmed pancreatic adenocarcinoma
Patients must have histologically or cytologically confirmed metastatic pancreatic adenocarcinoma (or any mixed pathology if adenocarcinoma is predominant)
Histologically or cytologically confirmed advanced pancreatic ductal adenocarcinoma that is unresectable or metastatic
Histologically or cytologically proven metastatic or inoperable pancreatic adenocarcinoma
Histologically or cytologically confirmed non-resectable pancreatic adenocarcinoma with or without metastases
Patients with metastatic pancreatic adenocarcinoma not treated with chemotherapy for metastatic disease
Eligibility for the expansion cohort: histologically or cytologically confirmed metastatic or unresectable pancreatic adenocarcinoma for which curative treatment does not exist
Non metastatic pancreatic ductal adenocarcinoma
Histologically and cytologically confirmed metastatic pancreatic adenocarcinoma
Histologically or cytologically confirmed locally advanced or metastatic pancreatic adenocarcinoma, colorectal adenocarcinoma, gastric adenocarcinoma, cholangiocarcinoma, gall bladder adenocarcinoma, ampullary carcinoma, adenocarcinoma of unclear primary (with a gastrointestinal primary suspected), or other primary gastrointestinal malignancy for which the treating physician feels that mFOLFIRINOX is a reasonable therapeutic option
The patient has histologically or cytologically confirmed pancreatic adenocarcinoma.
Histologically or cytologically confirmed diagnosis of an advanced nonhematological malignancy (Part A) or advanced pancreatic adenocarcinoma (Part B) that is not surgically resectable
The presence of metastatic pancreatic adenocarcinoma plus 1 of the following:
Histological diagnosis of pancreatic adenocarcinoma confirmed pathologically, OR
Presence of metastatic pancreatic adenocarcinoma plus 1 of the following:
Histological diagnosis of pancreatic adenocarcinoma confirmed pathologically, OR
A history of resected pancreatic adenocarcinoma
Histologically or cytology proven pancreatic ductal carcinoma
Confirmed pancreatic ductal adenocarcinoma
Histologically or cytologically confirmed diagnosis of inoperable colorectal adenocarcinoma, pancreatic, hepatocellular, cholangiocarcinoma, small bowel, gastric or esophageal adenocarcinoma that carries an activated ALK or ROS1 pathway
Histologic documentation of incurable, locally advanced, or metastatic pancreatic ductal adenocarcinoma consisting of unresectable pancreatic ductal adenocarcinoma (i.e., participants who are not considered eligible for surgical resection with curative intent), including recurrence of previously resected disease
Patients must have a histologically confirmed, unresectable pancreatic adenocarcinoma
Histologically or cytologically proven pancreatic carcinoma or adenocarcinoma; histologies other than carcinoma/adenocarcinoma will not be eligible
Non- metastasis, unresectable, adenocarcinoma pancreatic cancer patients
Subjects must have histologically confirmed metastatic pancreatic ductal adenocarcinoma.. Prior chemotherapy and/or radiotherapy either in the adjuvant or neoadjuvant setting or for metastatic disease is not allowed.
Histologically or cytologically confirmed solid tumor (Part 1) or pancreatic adenocarcinoma (Part 2)
Resectable pancreatic adenocarcinoma
Pathologic diagnosis of pancreatic adenocarcinoma
Phase II: Patients with histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma that have not received systemic chemotherapy for advanced or metastatic disease; the definitive diagnosis of metastatic pancreatic adenocarcinoma will be made by integrating the histopathological data within the context of the clinical and radiographic data
Phase II: Patients that previously received systemic chemotherapy for metastatic or advanced pancreatic adenocarcinoma are not eligible
Pancreatic adenocarcinoma, biopsy-proven or suspected
Histologically confirmed resectable or borderline resectable pancreatic adenocarcinoma; pathology report form
Personal history of pancreatic adenocarcinoma
History of pancreatic adenocarcinoma (at any time)
Patient to undergo pancreaticoduodenectomy for pancreatic ductal adenocarcinoma at the Johns Hopkins Hospital
Pancreaticoduodenectomy for an indication that is not pancreatic ductal adenocarcinoma (PDAC)
Clinically suspected or biopsy-confirmed diagnosis of pancreatic adenocarcinoma
Patients with histologically confirmed pancreatic adenocarcinoma (borderline resectable or locally advanced disease at presentation) are eligible for the study
Patients should not have any type of curative or palliative therapy for pancreatic adenocarcinoma before enrolling in the study
Subjects who had prior chemotherapy or radiotherapy for pancreatic adenocarcinoma cannot participate in the study
Histologically confirmed, locally-advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) or other malignancies known to express CA19-9 positive malignancies
GROUPS 1, 2, AND 3: Group 3 participants must have pathologically- confirmed pancreatic adenocarcinoma and have been determined to have the need for neoadjuvant chemotherapy prior to surgical resection
Clinically suspected or biopsy-confirmed diagnosis of pancreatic adenocarcinoma
Prior resection for pancreatic adenocarcinoma
Subject must be expected to undergo a clinically indicated surgical resection of histologically confirmed or suspected pancreatic ductal adenocarcinoma
Histologically-confirmed diagnosis of pancreatic adenocarcinoma, mesothelioma,\r\nmesothelin-positive ovarian cancer, or NSCLC; a new biopsy is not required; the diagnostic biopsy sample will be sufficient; IHC confirmation of mesothelin positivity is not necessary for pancreatic adenocarcinoma and mesothelioma; mesothelin expression in ovarian cancer and NSCLC will be tested by IHC, and any degree of positivity (1+, 2+, or 3+) will be accepted
Histologically or cytologically confirmed pancreatic ductal adenocarcinoma
Patients must have histologically confirmed malignancy that is metastatic or unresectable and for which standard Food and Drug Administration (FDA)-approved systemic curative or palliative antitumor therapies do not exist or are no longer effective or for which MK-3475 (pembrolizumab) is FDA-approved as standard of care therapy
Histologically confirmed solid tumor malignancy that is metastatic or unresectable and have progressed on at least 1 prior therapy and for whom standard curative or palliative measures do not exist or are associated with minimal subject survival benefit. Evaluable or measurable disease, defined as by Response Evaluation Criteria in Solid Tumors (RECIST).
Histologically or cytologically confirmed solid tumor that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective
Histologically or pathologically confirmed malignancy (hematologic or solid tumor) that is metastatic or unresectable and for which standard of care therapy does not exist or is no longer effective
Patients must have histologically or cytologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective
Participant must have histologically or cytologically confirmed advanced malignancies, except all forms of leukemia and lymphoma, for which standard curative or palliative measures do not exist, are no longer effective, or are not acceptable to the participant
Part 1: any histologically-confirmed metastatic or unresectable solid tumor for which standard curative or palliative measures do not exist or are no longer effective
Part 2, Cohort 4, Any histologically-confirmed metastatic or unresectable solid tumor for which standard curative or palliative measures do not exist or are no longer effective. Must have accessible tumor tissue and be willing to undergo tumor tissue sampling (biopsies/aspirates) pre- and post-treatment
DOSE ESCALATION COHORT: Histologically or cytologically confirmed diagnosis of advanced extracranial solid tumor for which standard curative or palliative measures do not exist or are no longer effective
Cancer that is recurrent, metastatic, or unresectable and for which no effective or curative measures exist.
Histologically or cytologically confirmed solid tumor that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective.
Patients must have histologically confirmed melanoma that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective
COHORT 3: ENDOMETRIAL CANCER: Patients must have histologically or cytologically confirmed persistent or recurrent advanced or metastatic invasive endometrial cancer (EC) for which standard curative measures do not exist or are no longer effective
Patients must have histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective
Patients must have histologically confirmed HER2-positive breast cancer for which standard curative measures do not exist or are no longer effective; HER2 testing must have been performed in a laboratory accredited by the College of American Pathologists (CAP) or another accrediting entity
Patients must have histologically confirmed neuroendocrine tumor (grades 1-3) that is metastatic or unresectable, and for which standard curative or palliative measures do not exist or are no longer effective
Patients must have a histologically confirmed solid tumor that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective; additionally, in the opinion of the investigator the primary site of the metastatic or unresectable tumor must have arisen within a previously irradiated site and be considered a radiation-induced tumor
Histologically or cytologically confirmed solid tumors or lymphomas that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective
Patients with histologically confirmed, advanced or metastatic cancer for which standard curative or palliative measures do not exist or are no longer effective
Patients must have histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective\r\n* Subject must have undergone at least 2 prior regimens for treatment of recurrent or metastatic disease
Patients with advanced or metastatic cancer that is refractory to standard therapy or relapsed after standard therapy; patients must have histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective
Patients must have histologically or cytologically confirmed (at original diagnosis or subsequent recurrence or progression) solid tumor that is metastatic, unresectable, progressive, or recurrent, and for which standard curative or palliative measures do not exist or are no longer effective
Patients must have histologically- or cytologically-confirmed diagnosis of KRAS or NRAS mutation-positive malignancy that is metastatic or unresectable and for which standard curative measures do not exist or are no longer effective; patients must have activating mutations affecting codons 12, 13, 61, or 146 as determined in a Clinical Laboratory Improvement Amendments (CLIA)-certified lab to be eligible for this study
Participants must have histologically or cytologically confirmed endometrial, ovarian (including ovarian, fallopian tube, primary peritoneal), cervical, vaginal, or vulvar cancer that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective
Patients must have histologically confirmed progressive brain metastases from melanoma, or recurrent/progressive malignant glioma (glioblastoma, anaplastic glioma), for which standard curative or palliative measures do not exist or are no longer effective
For Dose Escalation Cohort: Patients must have histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective
For the dose escalation cohort, patients must have histologically or cytologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective
Standard, curative or palliative measures do not exist or are no longer effective
Patients must have histologically confirmed malignancy that is radiologically evaluable and metastatic or unresectable, for which standard curative or palliative measures do not exist or are no longer effective, and for which there is expectation of response to the combination of carboplatin/paclitaxel (i.e., lung, ovarian, breast, melanoma, head and neck, endometrial, urothelial, testicular, esophageal, carcinoma of unknown primary); for indications not listed, eligibility based on disease must be verified by the principal investigator before they are considered
PHASE I: Adult patients with histologically confirmed solid tumor malignancy that is metastatic or unresectable and for which standard curative measures or other therapy definitely capable of extending life expectancy does not exist
Patients must have histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective
Malignancy that is incurable and for which standard (FDA approved or established standard clinical practice) curative, or palliative measures do not exist or are no longer effective
Subjects having histologically and/or cytologically confirmed non-haematological\n             malignancy that is metastatic or unresectable and for which standard curative or\n             palliative treatment does not exist or is no longer effective
Patients must have a histologically/cytologically confirmed diagnosis of recurrent glioblastoma or an advanced solid tumor in which bevacizumab has shown benefit in specific disease population and for which standard or curative measures do not exist or are no longer effective
Patients must have histologically confirmed malignancy that is metastatic or unresectable and for which standard curative measures do not exist or are no longer effective
Subjects with advanced refractory cancer for which standard curative or palliative\n             measures do not exist or are no longer effective. There is no limitation on the\n             number or types of prior therapy.
Histologically- or cytologically-confirmed malignancy that is metastatic or unresectable and for which standard measures do not exist or are no longer effective (DEP) or a histologically confirmed diagnosis of PTCL based on pathology review at the local institution, using the most recent edition of the WHO Classification, relapsed or refractory disease after at least one prior systemic anticancer regimen (EXP in PTCL)
Patients must have histologically or cytologically confirmed diagnosis of malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective or for whom CPT-11 treatment would be a viable therapy regimen; patients with solid hematologic malignancies (Hodgkin’s and non-Hodgkin’s lymphomas) may be included as long as a bone marrow has been performed within 6 weeks of treatment
Patients enrolled on the dose escalation for intermittent ABT-888 portion of the study must histologically or cytologically confirmed diagnosis of malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective or for whom CPT-11 treatment would be a viable therapy regimen; patients with solid hematologic malignancies (Hodgkin’s and non-Hodgkin’s lymphomas) may be included as long as a bone marrow has been performed within 6 weeks of treatment
A histologically or cytologically confirmed solid tumor that is metastatic, unresectable, or recurrent and for which standard therapies do not exist or are no longer effective a. Patients must not be considered eligible for a potentially curative resection
Multiple myeloma (MM), limited to those patients for whom standard curative or palliative treatments do not exist or are no longer effective
Non-Hodgkin's lymphoma (NHL), limited to those patients for whom standard curative or palliative treatment do not exist or are no longer effective,
Hodgkin's lymphoma (HL), limited to those patients for whom standard curative or palliative treatment do not exist or are no longer effective
Patients must be HLA-A2+ and have histologically confirmed melanoma that is metastatic (stage IV) or unresectable stage IIIB/C and for which standard curative or palliative measures do not exist or are no longer effective
Patients must have histologically confirmed gastrointestinal malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective, or for whom FOLFOX would be an appropriate therapy
PHASE I: Participants must have histologically confirmed breast cancer that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective
Participants must have histologically or cytologically confirmed MCC that is metastatic or unresectable and for which standard curative measures do not exist or are no longer effective
Participants must have histologically confirmed malignancy with a RAS mutation (via any Clinical Laboratory Improvement Amendments [CLIA]-certified method) that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective
Eligibility for dose escalation cohort: histologically or cytologically confirmed metastatic or unresectable solid tumor for which standard curative or palliative measures do not exist or are no longer effective
Eligibility for dose escalation cohort: Histologically or cytologically confirmed metastatic or unresectable solid tumor for which standard curative or palliative measures do not exist or are no longer effective OR solid tumor for which irinotecan monotherapy is considered standard
Patients must have a diagnosis and documented disease progression of a solid tumor malignancy, excluding primary brain tumor, for which standard, curative, or life prolonging treatment does not exist or is no longer effective
A histologically or cytologically confirmed solid tumor that is metastatic, unresectable, or recurrent and for which standard curative or palliative therapies do not exist or are no longer effective.
Patients must have histologically confirmed solid malignancy that is metastatic or unresectable or lymphoma, for which standard curative or palliative measures that improve survival by at least three months do not exist or are no longer effective; for the purpose of this study patients with leukemia are not eligible
Patient must have a histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective (dose-escalation cohorts only)
Patients must have histologically confirmed (by the National Cancer Institute [NCI] Pathology Department) solid tumor malignancy or lymphoma that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are associated with minimal patient survival benefit (as defined the Lymphoid Malignancies Branch physicians or if the patient refuses standard of care treatment); enrollment of patients with tumors that can be safely biopsied is encouraged
Subjects must have a histologically or cytologically confirmed solid tumor that is metastatic, unresectable or recurrent and for which standard curative or palliative measures do not exist or are no longer effective
Phase I: Participants must have histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective (or who are intolerant of such therapy)
Dose escalation phase: patients must have histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective; OR safety dose expansion phase: patients must have histologically or cytologically confirmed relapsed or refractory small cell lung cancer
Patients must have a histologically or cytologically confirmed adenocarcinoma of the colon or rectum that is metastatic to the liver and unresectable and for which standard curative measures do not exist or are no longer effective
Histologically or cytologically confirmed solid tumor that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective OR\r\n* Histologically or cytologically confirmed solid tumor for which single agent capecitabine is an appropriate treatment option
Patients must have histologically confirmed solid tumor that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective
Patients must have prostate cancer that is advanced or recurrent and for which standard curative or reliable palliative therapies do not exist or are no longer effective
Subjects must have histologically or cytologically confirmed solid tumor malignancy that is unresectable/locally advanced and/or metastatic and for which standard curative or palliative measures are not available or are no longer effective (for all subjects, histologic or cytologic proof of malignancy based on prior primary cancer pathology is acceptable).
Histologically or cytologically confirmed metastatic and/or advanced solid tumors or lymphomas for which standard curative or life-prolonging treatment does not exist or is no longer effective or tolerable.
Histologically or cytologically confirmed solid tumor that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective.
Patients must have histologically or cytologically confirmed soft tissue sarcoma that is metastatic or unresectable and for which standard treatment that prolongs survival does not exist or is no longer effective
Patients must have histologically confirmed solid malignancy (excluding lymphoma) that is metastatic or unresectable and for which standard curative or palliative systemic therapies (such as chemotherapy, targeted therapies or immunotherapy) do not exist or are no longer effective
Patients must have a histologically or cytologically confirmed lymphoid malignancy (like Hodgkin lymphoma or one of the mature B- or T-cell non-Hodgkin lymphomas as classified by World Health Organization [WHO]) for which standard curative or palliative measures do not exist or are no longer effective
Diagnosis of systemic anaplastic large-cell lymphoma (sALCL), or HL for which standard, curative, life-prolonging, or palliative treatment does not exist or is no longer effective
Patients must have histologically confirmed solid tumor malignancy or lymphoma that is metastatic or unresectable and for which effective therapy does not exist or is no longer effective
For the dose escalation cohort, patients must have histologically or cytologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective
Patients must have histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective
Participants must have disease that is relapsed or refractory and for which standard curative or palliative measures do not exist or are no longer effective
Dose escalation: patients must have histologically or cytologically confirmed solid tumor malignancy that is metastatic or unresectable and for whom either standard curative or palliative measures do not exist or are no longer effective, or for whom anti-PD-L1/cytotoxic T-lymphocyte antigen (CTLA)-4 is appropriate
Histologically or cytologically confirmed solid tumor that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective
Histologically or cytologically confirmed solid malignancy or lymphoma that is metastatic or unresectable, and for which standard curative or palliative measures do not exist, or are no longer effective. In case of hepatocellular carcinoma, the diagnosis should be based on at least one of the following:
The patient has a histologically confirmed solid tumor that is metastatic or unresectable for which standard measures do not exist or are no longer effective. (Patients with primary brain cancer or lymphoma are permitted. Patients with brain metastases are allowed if whole brain radiation was performed and is documented stable for ? 6 weeks)
Must have a histologically or cytologically confirmed metastatic and/or advanced solid tumor and/or lymphoma for which standard curative or life-prolonging treatment does not exist, or is no longer effective or tolerable.
Histologically or cytologically confirmed solid tumor that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective
Histologically confirmed metastatic colorectal cancer, not amenable to curative resection
Histologically or cytologically confirmed GI malignancy for which mFOLFOX6 is considered an appropriate treatment (e.g., gastric cancer [GC], colorectal carcinoma, pancreatic adenocarcinoma)
In dose expansion (part 2), patients must have histologically or cytologically confirmed unresectable or metastatic melanoma, renal cell carcinoma, ovarian cancer, or colorectal cancer
Measurable, histologically/cytologically confirmed metastatic colorectal cancer (mCRC).
Histologically confirmed unresectable metastatic colorectal adenocarcinoma
Have a pathologically confirmed diagnosis of colorectal cancer, which is metastatic or otherwise unresectable
Histologically confirmed colorectal adenocarcinoma
Patients must have histologically or cytologically confirmed metastatic colorectal cancer.
Histologically confirmed diagnosis of colorectal adenocarcinoma
Patients must have histologically and or cytologically confirmed metastatic colorectal cancer
Histologically or cytologically-confirmed diagnosis of metastatic KRAS wildtype colorectal cancer (CRC)
Participants must have histologically or cytologically confirmed adenocarcinoma of colorectal or pancreatic origin
Histologically confirmed colorectal cancer
Have a diagnosis of histologically confirmed metastatic colorectal cancer to the liver (no other sites of metastatic disease)\r\n* Histologic confirmation of a colorectal primary tumor is acceptable if accompanied by radiographic evidence of metastatic disease
Patients with histologically confirmed KRAS positive metastatic colorectal cancer
Histologically or cytologically confirmed metastatic colorectal adenocarcinoma (colon, rectal, colorectal, appendiceal cancer) or small bowel that is not resectable
Patients must have a histologically documented peritoneal carcinomatosis from either colorectal or appendiceal adenocarcinoma
Histologically or cytologically confirmed colorectal adenocarcinoma.
Histologically or cytologically confirmed colorectal adenocarcinoma
Histologically confirmed unresectable metastatic colorectal adenocarcinoma
Histologically or cytologically confirmed colorectal adenocarcinoma, with metastatic disease documented on diagnostic imaging studies
Histologically confirmed stage IV colorectal adenocarcinoma without any prior systemic treatment
In dose escalation, patients must have histologically or cytologically confirmed metastatic disease from any solid tumor; in dose expansion, patients must have histologically or cytologically confirmed metastatic melanoma, renal cell carcinoma, ovarian cancer, or colorectal cancer
Patients must have histologically or cytologically confirmed peritoneal surface malignancies from primary colorectal and appendiceal tumors
Histologically confirmed recurrent or metastatic colorectal cancer
Histologically proven colorectal adenocarcinoma
Patients with histologically confirmed metastatic colorectal cancer, who have received and/or progressed on a prior oxaliplatin-based chemotherapy regimen
Histologically and/or cytologically confirmed and radiographically evaluable refractory metastatic colorectal adenocarcinoma for which regorafenib would be considered a therapeutic option
A histologically or cytologically confirmed colorectal cancer that is metastatic, unresectable, or recurrent.
History of histologically confirmed colorectal adenocarcinoma metastatic to the liver with no clinical or radiographic evidence of extrahepatic disease; confirmation of diagnosis must be performed by the enrolling institution
Histologically or cytologically confirmed advanced metastatic or unresectable advanced colorectal cancer (CRC) or gastric cancer that is relapsed, refractory, or progressive after:
Histologically or cytologically confirmed diagnosis of metastatic colorectal cancer with a product related mutation in Ras (G12V, G12C, G12D, G12R, Q61L, Q61R, Q61H)
Patients with histologically proven, unresectable, evaluable metastatic colorectal cancer, by RECIST criteria
Histologically confirmed colorectal cancer with at least one measurable metastatic lesion by RECIST v 1.1, that is considered unresectable at baseline
Histologically confirmed colorectal cancer
Histologically or cytologically confirmed refractory colorectal cancer
Histologically or cytologically confirmed colorectal adenocarcinoma
Patient must have histologically or cytologically confirmed refractory colorectal cancer (CRC)
Histologically/cytologically proven colorectal carcinoma
Participants with histologically or cytologically confirmed advanced metastatic or unresectable colorectal cancer (CRC) that is relapsed, refractory, or progressive following at least 2 prior systemic regimens in the metastatic setting.
Patients must have histologically or cytologically confirmed colorectal or pancreatic carcinoma
Histologically confirmed diagnosis of colorectal adenocarcinoma
Patient must have stage I-III malignant pleural mesothelioma that is deemed resectable and must be planning to undergo pleurectomy decortication (P/D) or extrapleural pneumonectomy (EPP)
Patient must not have had prior immunotherapy or chemotherapy for malignant pleural mesothelioma
Histologically confirmed pleural malignant mesothelioma not eligible for curative surgery
Prior chemotherapy for pleural mesothelioma
Histologically or cytologically confirmed unresectable or medically inoperable malignant pleural mesothelioma
Mesothelioma
Mesothelioma.
Patients with a histologic diagnosis of malignant pleural mesothelioma (MPM), epithelioid subtype, who in the opinion of the attending thoracic surgeon can receive a macroscopically complete resection of tumor
Part B3 only: Participants must have malignant pleural or peritoneal mesothelioma
Part B4 only: Participants must have malignant pleural or peritoneal mesothelioma and appropriate candidate for treatment with cisplatin/pemetrexed; no prior systemic chemotherapy
COHORT B, GROUP 5: MESOTHELIOMA: Patients must have histologically or cytologically proven diagnosis of malignant mesothelioma; both pleural and peritoneal mesothelioma are allowed
Patients with sarcomatoid mesothelioma as mesothelin is not expressed in this type of mesothelioma
Patients must have histologically or cytologically malignant mesothelioma confirmed by the National Cancer Institute (NCI) Laboratory of Pathology. Patients with pleural, peritoneal, pericardial or tunica vaginalis mesothelioma are eligible
Arm A 14-patients expansion cohort: patients with histologically or cytologically proven chemotherapy naive unresectable malignant pleural or peritoneal mesothelioma
Arm B (first stage of phase II of TRC102 and pemetrexed): patients with malignant pleural or peritoneal mesothelioma who had progressed while being treated with or had recurred within 6 months of being treated with pemetrexed and cisplatin or carboplatin frontline; intervening treatment is allowed
Pathologic diagnosis of malignant mesothelioma (any primary site is acceptable, any histology is acceptable)
Have unresectable malignant mesothelioma (any histology)
Patients must have a histologic diagnosis of malignant pleural mesothelioma
Patients who have received pleurectomy with decortication (P/D) or EPP for mesothelioma
Histologically proven malignant pleural mesothelioma MPM that is considered resectable according to the following criteria:\r\n* Confined to one pleural space\r\n* No chest wall invasion\r\n* No transdiaphragmatic involvement\r\n* No invasion of mediastinal structures
Histologically or cytologically confirmed pleural malignant mesothelioma, epithelial or biphasic subtypes
Histologically confirmed epithelioid predominantly (> 70%) subtype malignant pleural mesothelioma
Patients must have histologically or cytologically confirmed malignant pleural mesothelioma (MPM)
Surgically resectable malignant pleural mesothelioma (MPM) with no disease extension beyond the ipsilateral hemithorax
Patients must have a pathologically confirmed diagnosis, either at MSKCC or at the participating site, of stage I-III malignant pleural mesothelioma
Prior nephrectomy on the contralateral side of malignant pleural mesothelioma (MPM)
Measurable disease as defined by RECIST v1.1 or disease-specific criteria for prostate cancer and malignant pleural mesothelioma
Patients must have histologically or cytologically confirmed malignant mesothelioma for which they have received pemetrexed in combination with cisplatin as part of chemotherapeutic regimen.
Patients must not have received any other chemotherapeutic treatment for malignant mesothelioma other than pemetrexed and a platinum agent such as cisplatin.
Patient must have histologically or cytologically confirmed diagnosis of malignant pleural mesothelioma; surgical resection must not be planned
Has mesothelioma (pleural, peritoneal, pericardial, tunica vaginalis) of any histology that is relapsed or refractory after treatment with at least one pemetrexed-containing regimen
Peritoneal mesothelioma basket \r\n* Refractory or intolerant to platinum and pemetrexed systemic therapy\r\n* Any number of prior therapies
Peritoneal mesothelioma basket:\r\n* None
Pleural mesothelioma basket:\r\n* None
predominantly epithelial (?50% tumor component) pleural or peritoneal mesothelioma
Currently have mesothelioma of the sarcomatous type, mixed histologic disease, or have malignant peritoneal mesothelioma
Pathologic diagnosis of malignant mesothelioma (any primary site is acceptable)
Have unresectable malignant mesothelioma (any histology)
Malignant pleural mesothelioma (histologically confirmed epithelial)
Sarcomatoid malignant pleural mesothelioma (MPM) histology which is known in the literature to not express mesothelin; biphasic MPM is also excluded
Histologically confirmed malignant pleural mesothelioma (MPM) (Epithelioid or biphasic subtype for Phase II patients; epithelioid subtype only for Phase III patients)
Histological documentation of malignant pleural mesothelioma (MPM) overexpressing mesothelin
Patients must have histologically confirmed diagnosis of unresectable malignant pleural mesothelioma
ELIGIBILITY FOR ENROLLMENT/SCREENING (ARMS 1 AND 2): Histopathological documentation of NSCLC or mesothelioma
Histologically or cytologically confirmed pleural or peritoneal malignant mesothelioma, epithelial, sarcomatoid, or biphasic subtypes
Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for peritoneal mesothelioma, and modified RECIST for pleural mesothelioma
Histologically confirmed malignant pleural mesothelioma that is not metastatic or unresectable
Histologically or cytologically confirmed malignant pleural or peritoneal mesothelioma (MPM)
Patients must have a histologically confirmed diagnosis of epithelioid, sarcomatoid, or mixed-type malignant pleural or peritoneal mesothelioma that is not amenable to surgery
Patients must have measurable disease according to the modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria for pleural mesothelioma, or standard RECIST for peritoneal mesothelioma; patients must have adequate tissue sample available for molecular profiling with Memorial Sloan-Kettering (MSK)-IMPACT (archived tissue block or 15-20 unstained slides); patients will sign a separate informed document (Institutional Review Board [IRB] #12-245) to allow this to be performed
Histologically documented malignant pleural mesothelioma, epithelial, sarcomatoid or mixed type, not amenable to surgical resection
Patients with unresectable, malignant pleural or peritoneal mesothelioma who have progressed on first-line pemetrexed-based chemotherapy
Histologically proven malignant pleural or peritoneal mesothelioma of epithelioid or biphasic histology
Patients with only one kidney that is ipsilateral to the mesothelioma
Histopathologically-confirmed diagnosis of malignant mesothelioma (pleural or peritoneal). Must have disease that has relapsed following at least one prior line of chemotherapy.
Mesothelin-positive refractory/recurrent solid tumors, other than malignant pleural mesothelioma (MPM) and pancreatic ductal adenocarcinoma (PDA) (Group 1 only)
Assessment by the attending thoracic surgeon that radical pleurectomy can be safely achieved in pts with malignant pleural mesothelioma
6. Have completed baseline quality of life evaluation as assessed by LCSS modified for mesothelioma
Pathologic diagnosis of malignant pleural mesothelioma (MPM) confirmed at participating institution
Histologically confirmed peritoneal carcinomatosis from appendiceal, colorectal, ovarian, or primary mesothelioma, with no systemic metastases