Metastatic and/or unresectable (cTb) disease
Primary unresectable rectal cancer; a tumor is considered unresectable when invading adjacent organs and an en bloc resection will not achieve negative margins
Patients must have measurable disease that is metastatic or locally advanced and unresectable; imaging used to assess all disease per RECIST . must have been completed within  days prior to step  randomization; all disease must be assessed and documented on the Baseline Tumor Assessment Form
Locally advanced/unresectable or metastatic disease
Re-registration: locally advanced/unresectable or metastatic disease
Patients must have a locally advanced and unresectable or metastatic gastroenteropancreatic neuroendocrine carcinoma that is either known or suspected to be of gastrointestinal (GI) origin; primary tumors arising from the lung, gynecologic organs or prostate are not permitted
Patients must have either metastatic (stage IVC) or locally advanced unresectable disease (stage IVB)
Patient must have unresectable disease
Disease that is unresectable, locally advanced, or metastatic (not amendable to curative therapy)
Must have unresectable or inoperable stage IIIA or IIIB disease; subjects must be considered unresectable or inoperable based on the judgment of the treating physician
Has cSCC that is either metastatic defined as disseminated disease, and/or unresectable disease that is not curable by surgery, radiation, or systemic therapy.
Subject has a locally advanced unresectable or metastatic, relapsed and/or refractory, non-hematological malignancy for which treatment with an approved agent that is considered standard of care in the indication either does not exist or has proven ineffective.
Locally advanced unresectable or metastatic disease that has progressed since last treatment.
Patients who have received prior immunotherapy for unresectable or metastatic disease
Locally advanced, unresectable or metastatic disease
Extent of disease\r\n* Unresectable
Metastatic disease or locally advanced, unresectable disease
Patients with unresectable disease are eligible
Unresectable or metastatic GIST
Patients must have metastatic disease or locally advanced unresectable disease
Pathologically confirmed diagnosis of breast cancer with radiographic evidence of incurable, unresectable, locally advanced or metastatic disease (LA/MBC)
Metastatic or unresectable solid tumor malignancy
Disease must be locally advanced and unresectable or metastatic; disease which may be resected but with an associated level of morbidity deemed unacceptable by the treating clinician is considered eligible
Part C: Have advanced unresectable cancer (dose escalation) and advanced/unresectable/metastatic NSCLC carrying BRAF or RAS mutation and colorectal cancer carrying RAS mutation (dose expansion)
Locally advanced unresectable or metastatic stage  (i.e. T or N or M) penile squamous cell carcinoma (PSCC)
Patients must be considered unresectable or inoperable
Patients with metastatic (lymph node or distant metastasis, i.e. N+ or M) or locally advanced unresectable PSCC
Patients with metastatic (lymph node or distant metastasis, i.e. N+ or M) or locally advanced unresectable (Tb) TCC
Patients may be potentially resectable or unresectable
Locally advanced/unresectable or metastatic disease.
Patients must have had disease progression on or following their most recent treatment regimen or on presentation for the first time with locally advanced unresectable or metastatic disease
Deemed to have unresectable disease by surgeon
Patients with inflammatory breast cancer, widespread locally advanced unresectable disease involving the chest wall/nodal basins in which a curative surgical resection cannot be performed, or those in whom de novo metastatic disease is suspected or confirmed
Unresectable thymoma or thymic carcinoma.
Locally advanced, unresectable disease, as defined by NCCN criteria
Stage IV or locally advanced unresectable cancers for which no alternative therapies with proven survival advantage are available
Patients with recurrent unresectable locally advanced or metastatic urothelial carcinoma (also known as [aka] transitional cell carcinoma) previously NOT treated with systemic chemotherapy for current stage of disease\r\n* Low-dose chemotherapy (e.g., low-dose cisplatin, cisplatin plus fluorouracil (-FU), mitomycin plus -FU, or cisplatin plus paclitaxel) given concurrently with radiation to the primary tumor site is not considered systemic chemotherapy; in that clinical setting, chemotherapy is given with the purpose of sensitizing the tumor to local radiation; it is not administered at doses with any systemic efficacy\r\n* Surgery is not considered first-line therapy following diagnosis of advanced/metastatic disease\r\n* If unresectable locally advanced urothelial cancer, could have been previously radiated, but must have Response Evaluation Criteria in Solid Tumors (RECIST) . measurable, untreated progression of disease component
Patients must have metastatic or unresectable disease, including those with HER+ disease
Stage IV disease or locally advanced/unresectable tumors
Locally advanced/unresectable disease as determined by site attending urologic oncologist or metastatic disease
Stage III unresectable locally advanced pancreatic carcinoma
Diagnosed with advanced (metastatic or unresectable) leiomyosarcoma or liposarcoma
Unresectable metastases
Subjects must have unresectable, recurrent, locally advanced, or metastatic neuroendocrine tumor including\r\n* Cohort A; unresectable, recurrent, locally advanced, or metastatic pheochromocytoma-paraganglioma (PC-PG) who have failed or are refractory to available therapies; sample size (N)=\r\n* Cohort B will include only patients with unresectable, locally advanced or metastatic tumors who have failed or are refractory to available therapy; other neuroendocrine cancer varieties as characterized by expression of neuroendocrine markers on tumor tissue including CD, synaptophysin, chromogranin and/or presence of a detectable serum or urine biomarker (-methoxytyramine, normetanepherine, metanepherines, homovanillic acid [HVA], vanillylmandelic acid [VMA], and dopamine), varieties will include neuroblastoma, Ewing sarcoma, neuroectodermal tumor, clear call sarcoma, myoepithelial tumor, primitive neuroectodermal tumor [PNET], desmoplastic small round cell tumor, round cell sarcoma, and unresectable, metastatic or locally advanced , well-differentiated neuroendocrine tumors who have relapsed or are refractory to at least  systemic therapies (e.g. lanreotide, sunitinib, or everlimus); patients with small cell carcinomas will not be included in this clinical trial; N=
PRE-SCREENING: Unresectable locally advanced or metastatic pancreatic cancer, confirmed by histology, and at least one but not more than two prior chemotherapy regimens with progression (neoadjuvant chemotherapy would not be counted as a line of therapy)
FULL STUDY INCLUSION CRITERIA: Unresectable locally advanced or metastatic pancreatic cancer and at least one but not more than two prior chemotherapy regimens with progression (neoadjuvant chemotherapy would not be counted as a line of therapy)
Locally advanced unresectable or metastatic disease with no standard curative therapy available
Advanced, unresectable hepatocellular carcinoma (unsuitable for resection, transplant or ablation)
Have metastatic or unresectable sarcoma
Histologic proof of metastatic or locally advanced, unresectable breast cancer
Patients with unresectable tumor
Metastatic or unresectable disease documented on diagnostic imaging studies
Metastatic or unresectable locally advanced
Patients must be considered unresectable or inoperable
Unresectable tumor
Have an unresectable, locally advanced pancreatic cancer (AJCC stage III). (Excluded: resectable and borderline resectable patients are ineligible per NCCN criteria)
Patient must have disease that is unresectable or borderline resectable with < % liver involvement by cancer
The cancer must be unresectable
The cancer must be unresectable
Subject has radiologically confirmed locally advanced unresectable or metastatic disease within  days prior to the first dose of study treatment.
Tumor progression during or after first-line treatment for advanced unresectable / metastatic ESCC
Receipt of  or more prior systemic treatments for advanced/metastatic unresectable ESCC
Has a pathologically documented advanced/unresectable or metastatic breast cancer
Advanced (clinical stage Tb, unresectable) or metastatic disease
Surgically unresectable rectal cancer
Locally advanced/unresectable (as determined by local surgeon) OR metastatic disease
Have locally advanced (unresectable) or metastatic small bowel adenocarcinoma
PSTAT SCREENING: Participants must have histologically or cytologically confirmed invasive breast cancer (testing of either the primary tumor or in the metastatic setting), with either metastatic disease or unresectable locally advanced disease (including inflammatory breast cancer); patients without pathologic or cytologic confirmation of metastatic disease (or unresectable locally advanced disease) should have unequivocal evidence of metastasis (or unresectable locally advanced disease) by physical examination or radiologic study
Participants must have histologically or cytologically confirmed invasive breast cancer with either metastatic disease or unresectable locally advanced disease; patients without pathologic or cytologic confirmation of metastatic disease (or unresectable locally advanced disease) should have unequivocal evidence of metastasis (or unresectable locally advanced disease) by physical examination or radiologic study
Unresectable disease
Subjects with histological confirmation of locally advanced unresectable or metastatic MSI high CRC.
unresectable locally advanced recurrent BC or metastatic BC
Patient has histologically proven advanced (unresectable) or metastatic cancer as outlined below according to study phase and disease type:
Must have colorectal cancer with unresectable metastatic disease to the liver (unresectable unilobar or bilobar disease) who have disease progression in the liver with oxaliplatin or irinotecan based first line chemotherapy
is unresectable or metastatic
Subjects with recurrent, locally advanced unresectable or metastatic adenocarcinoma of the pancreas who have progressed after primary therapy with FOLFIRINOX or FOLFIRINOX-like regimen or were intolerant of it.
Prior treatment for BC in the: adjuvant; unresectable locally advanced; or metastatic settings; which must include both, a taxane and trastuzumab (alone or in combination with another agent)
Prior systemic therapy and chemoradiotherapy for treatment of resectable, borderline resectable or locally advanced unresectable disease is allowed and does not count toward prior therapy for metastatic disease
Patients who received systemic therapy with gemcitabine/nab-paclitaxel for resectable or borderline/locally advanced unresectable disease and progressed with metastatic disease within  months of the past dose of systemic therapy are eligible
Receipt of prior systemic anti-cancer therapy for unresectable, locally advanced or metastatic melanoma
Metastatic disease or locally advanced, unresectable disease.
Radiographic and pathologic staging consistent with pancreatic cancer, locally advanced, unresectable (per NCCN criteria)
A diagnosis of metastatic or unresectable sarcoma
Histologic or cytologic evidence of a malignant solid tumor or lymphoma (any histology) and must have advanced disease, defined as cancer that is either metastatic or locally advanced and unresectable (and for which additional radiation therapy or other locoregional therapies are not considered feasible).
In the phase I dose escalation study, must have locally advanced, unresectable or metastatic GIST and have progressed on imatinib
Locally advanced unresectable pancreatic cancer by National Comprehensive Cancer Network (NCCN) criteria
Locally unresectable or metastatic carcinoid or pNET
Measurable metastatic disease or locally advanced and unresectable disease
Locally advanced (clearly unresectable) or metastatic disease
Patients may have received up to one prior line of chemotherapy for metastatic or unresectable locally advanced breast cancer
Metastatic or unresectable disease documented on diagnostic imaging studies
Confirmed metastatic or locally advanced, unresectable disease (by computed tomography [CT] scan or clinical evidence)
Must have unresectable or inoperable stage IIIA or IIIB disease. Patients are considered unresectable or inoperable based on the judgment of the treating physician
Metastatic or locally advanced (unresectable) colorectal cancer with histological confirmation of adenocarcinoma
Patients must have an unresectable locally advanced or metastatic adenocarcinoma
Documented evidence of NSCLC (locally advanced, unresectable, Stage III)
Unresectable disease or subject refused surgery.
Men with metastatic or unresectable breast cancer are eligible
Cohort : Patients must have had a minimum of  and a maximum of  prior chemotherapy regimens for recurrent/metastatic disease or locally advanced/unresectable disease; it will be up to the investigator to determine what constitutes a regimen in each case; Cohort : Patients must have had a minimum of  and maximum of any number of prior chemotherapy regimens for recurrent/metastatic disease or locally advanced/unresectable disease; Cohort : Patients may have had any number of prior therapies for recurrent/metastatic or locally advanced/unresectable disease; there are no restrictions; all cohorts: The last dose of systemic therapy much have been given at least  days prior to initiation of therapy; patients receiving carmustine (BCNU) or mitomycin C must have received their last dose at least  weeks prior to initiation of therapy
Locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC)
Metastatic or locally advanced unresectable breast cancer (includes metastatic or locally advanced unresectable breast cancer which is diagnosed while on adjuvant letrozole or exemestane)
Locally unresectable or metastatic carcinoid tumors
Subjects must have metastatic or locally advanced, unresectable cancer; cancer must be active (i.e. demonstrable by physical examination, blood tests, or radiographical procedures)
Nave untreated patients or patients who have progressed on or after any number of prior lines of immunotherapy for unresectable locally advanced or metastatic melanoma
Previous systemic chemotherapy for unresectable locally advanced or metastatic melanoma.
Unresectable or metastatic sporadic or NF associated high-grade MPNST
Patients may have received up to one prior line of chemotherapy for metastatic or unresectable locally advanced breast cancer
Patients must have metastatic or unresectable disease
Written consent from Female or male patients aged  years and over. Previously confirmed histological diagnosis of unresectable, locally advanced or metastatic, hereditary or sporadic MTC Objective disease progression within the previous  months prior to enrolment, and/or
Locally advanced/unresectable or metastatic breast cancer
Indication A - ASPS: Histologically proven, unresectable, locally advanced or metastatic alveolar soft part sarcoma.
Indication B - LMS: Histologically proven, unresectable, recurrent, locally advanced or metastatic leiomyosarcoma (of soft tissue, cutaneous origin, vascular origin and of the bone).
Indication C - SS: Histologically proven, unresectable, recurrent, locally advanced or metastatic synovial sarcoma.
Confirmed diagnosis of unresectable, locally advanced or metastatic hereditary or sporadic Medullary Thyroid Cancer.
Subjects greater than or equal to (>=)  years of age with locally advanced unresectable or metastatic pancreatic adenocarcinoma proven by histology or cytology and previously untreated with chemotherapy or systemic therapy other than:
Received at least two prior systemic cytotoxic chemotherapy regimens for unresectable, locally advanced or metastatic disease.
At least one of the prior systemic cytotoxic chemotherapy regimens for unresectable, locally advanced or metastatic disease must have contained gemcitabine and have met the following criteria:
Patient has borderline resectable, locally advanced unresectable or advanced metastatic disease; patients with adenocarcinoma of the distal pancreatic body or tail are ineligible; patients with endocrine tumors, lymphoma of the pancreas, or ampullary cancer are also ineligible
Patient has localized resectable, locally advanced unresectable or advanced metastatic disease; patients with adenocarcinoma of the pancreatic body or tail are ineligible
Unresectable or metastatic disease
Metastatic or recurrent disease that is deemed partially resectable or unresectable based on preoperative imaging
Subjects must have metastatic or unresectable locally advanced malignant solid tumor.
A diagnosis of a metastatic or unresectable sarcoma
Must have unresectable metastatic disease, and have tumor(s) present that is (are) evaluable by the RECIST, v.; may have spinal-associated metastases but must have concluded dexamethasone therapy and be evaluated by the Investigator to have stable CNS disease.
Patients must have unresectable or metastatic disease
Inoperable metastatic or locally advanced unresectable disease
Unresectable disease or subject refused surgery.
Treatment with at least two prior systemic therapies for advanced (unresectable locoregional or metastatic) disease
Subject with more than  prior cytotoxic therapies (not including treatment administered for locally curable disease) for unresectable or metastatic gastroesophageal adenocarcinoma.
Unresectable disease or patient refused surgery.
Tumor deemed unresectable or metastatic
Disease must be considered unresectable at the time of preoperative evaluation
Surgically unresectable or metastatic disease.
Unresectable locally advanced or metastatic HCC;
technically unresectable HGG
Patients with obvious unresectable disease prior to signing informed consent
Have borderline resectable or unresectable locally advanced disease or metastatic disease
Intraoperative evidence of metastatic or locally-unresectable disease
Patients with locally advanced surgically unresectable PDAC
Participants with advanced or metastatic and/or unresectable HCC
Advanced unresectable or metastatic disease
Unresectable, locally advanced or metastatic disease; diagnosed within  weeks prior to screening
Patients with obvious unresectable disease prior to signing informed consent
Locally advanced disease which is unresectable, or resectable but suitable for an organ sparing approach
Unresectable or metastatic SCCHN.
Locally advanced or metastatic, unresectable sarcoma that has progressed after treatment with  mg/m or less of doxorubicin or anthracycline equivalent
Patients with metastatic or locally unresectable PDAC* (resectability is as defined by MSKCC pancreatic surgeon)
Diagnosed with advanced (metastatic or unresectable) sarcoma
Is unresectable or metastatic