Metastatic disease or locally advanced disease that is not resectable.
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
Locally advanced or metastatic disease; locally advanced disease is defined as disease not amenable to local therapy such as surgery and/or radiation
Patients must have either metastatic (stage IVC) or locally advanced unresectable disease (stage IVB)
No prior chemotherapy or targeted systemic therapy for inoperable locally advanced or metastatic TNBC
Chemoradiation and/or surgery should be considered prior to study entry for those patients with locally advanced disease if those therapies are considered to be in the best interest of the patient.
Must have failed at least 1 prior treatment regimen for locally advanced or metastatic disease or be intolerant to treatment or refuse standard treatment
In the dose escalation phase, the trial will be open for patients with stage IV or locally advanced unresectable gastrointestinal adenocarcinomas (gastric, cholangiocarcinoma, pancreatic, colorectal) who have failed at least one prior therapy; subjects must have received, and then progressed or been intolerant to, at least 1 standard treatment regimen in the advanced or metastatic setting
In the dose expansion phase, Arm A will be open for 25 patients with pancreatic adenocarcinoma; patients must have histologic diagnosis and either locally advanced unresectable or metastatic disease and have not received prior irinotecan; patients must have received at least one prior line of standard treatment for locally advanced or metastatic disease
In dose expansion phase, Arm B will be open for 25 patients with colorectal adenocarcinoma; patients must have histologic diagnosis and metastatic disease and have not received prior irinotecan; patients must have received at least one prior line of standard treatment for locally advanced or metastatic disease
Disease that is unresectable, locally advanced, or metastatic (not amendable to curative therapy)
Metastatic or locally advanced angiosarcoma, treated with at least one prior systemic therapy where no standard of care curable therapy is available OR metastatic or locally advanced malignant and progressive epithelioid hemangioendothelioma (EHE)\r\n* A maximum of 5 EHE patients will be accrued on this study
Histologically or cytologically confirmed locally advanced unresectable or metastatic adenocarcinoma of gastric or gastroesophageal junction; (for the 1L Cohort: no prior systemic therapy for the locally advanced or metastatic disease; for the 2L Cohort: disease progression during or following a first-line platinum-containing or fluoropyrimidine-containing chemotherapy regimen);
RASMUT/BRAFMUT NSCLC: Subject must have a locally confirmed diagnosis of RAS (NRAS, KRAS, HRAS) or BRAF mutated non-small cell malignancies of the lung. Subject must have received at least 1 prior approved regimen for locally advanced or metastatic disease followed by documented progressive disease.
SCCHN: Subject must have a locally confirmed diagnosis of SCCHN. Subject must have received at least 1 prior approved agent for advanced or metastatic disease followed by documented progressive disease.
Locally advanced unresectable or metastatic disease that has progressed since last treatment.
Locally advanced, unresectable or metastatic disease
Metastatic disease or locally advanced, unresectable disease
Locally advanced or metastatic NSCLC
Patient with histological proven metastatic GIST or non-operable locally advanced GIST
Refractory or intolerant to at least one prior standard therapy(ies) for metastatic or locally advanced disease.
Patients must have locally advanced, metastatic or refractory leiomyosarcoma or dedifferentiated liposarcoma
Patients must have metastatic disease or locally advanced unresectable disease
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
Locally advanced unresectable or metastatic stage 4 (i.e. T4 or N3 or M1) penile squamous cell carcinoma (PSCC)
The patient 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).
Patients with metastatic (lymph node or distant metastasis, i.e. N+ or M1) or locally advanced unresectable PSCC
Patients with metastatic (lymph node or distant metastasis, i.e. N+ or M1) or locally advanced unresectable (T4b) TCC
Patient has only locally advanced disease.
Advanced stage III, IV (N2C, N3) or surgically unresectable disease or disease that cannot be fully resected, obvious radiologic extracapsular spread (ECS), supraclavicular or matted metastatic disease, > 3 cervical nodes; (these patients will be placed on the quarterback trial due to advanced state of disease and poor prognostic features)
Patients must have pathologically?confirmed, non-metastatic locally/regionally advanced squamous cell carcinoma of the head and neck, stage III/IV, referred for definitive chemo?RT, and meet one of the following criteria:\r\n* Primary tumor (T4) with or without metastatic lymph nodes; tumor or nodes are: unresectable, resection is considered by the treating surgeon or patient to result in unacceptable functional or oncological results, patient refuses surgery, or surgery is not possible due to co-morbidities\r\n* Human papillomavirus (HPV)(?) or p16(-) locally/regionally advanced (T3?4 or N2?3) oropharyngeal cancer\r\n* HPV(+) or p16(+) locally/regionally advanced (T4 or N3) oropharyngeal cancer\r\n* T3 or T4 laryngeal or hypopharyngeal cancer that is locally advanced, bulky (> 40 cc), unresectable, or patient declines surgery\r\n* Stage III/IV oral cavity or paranasal sinus cancers in patients who refuse surgery or are unfit for surgery\r\n* Locally/regionally advanced (stage T3?4 and/or N3) nasopharyngeal cancer which is EBV (-) (Epstein?Barr virus)
Locally advanced or metastatic disease\r\n* Patients with locally advanced or metastatic disease must have disease deemed not amenable to surgical and/or locoregional therapies or patients who have progressed following surgical and/or locoregional therapies\r\n* Measurable disease, as defined as lesions that can accurately be measured in at least one dimension according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 at least 1 cm with contrast enhanced dynamic imaging (magnetic resonance imaging or computed tomography)
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
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
Locally advanced or metastatic solid tumors that have exhausted standard of care therapy
Patients should have had either progression during or after at least two HER2-targeting treatment regimens for locally advanced or metastatic disease or progression during or after (ado-)trastuzumab emtansine treatment for locally advanced or metastatic disease;
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 (5-FU), mitomycin plus 5-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) 1.1 measurable, untreated progression of disease component
Stage IV disease or locally advanced/unresectable tumors
Locally advanced/unresectable disease as determined by site attending urologic oncologist or metastatic disease
Previously treated, pathologically confirmed, locally advanced or metastatic solid tumors with measurable disease;
Must have histologically or cytologically documented rare tumor as defined per protocol that is metastatic or locally advanced and unresectable. Patients with locally advanced cutaneous squamous cell carcinoma that are technically resectable but in whom surgery is expected to lead to substantial function impairment or disfigurement are eligible
Evidence of locally advanced or metastatic disease;
Stage III unresectable locally advanced pancreatic carcinoma
Pathologically confirmed adenocarcinoma of the pancreas; patients with either initially diagnosed or recurrent locally advanced disease; the maximum dimension of the treatment target must be =<10 cm; locally advanced disease defined as: T 1-2N+MO or T3-4 NxMo, or borderline resectable and unresectable adenocarcinoma without distant metastatic disease or resectable T3-4 NxMo disease or M1 with controlled distant disease
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)=12\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 CD56, synaptophysin, chromogranin and/or presence of a detectable serum or urine biomarker (3-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 2 systemic therapies (e.g. lanreotide, sunitinib, or everlimus); patients with small cell carcinomas will not be included in this clinical trial; N=12
Locally advanced disease that is not resectable or metastatic disease.
Locally advanced unresectable or metastatic disease with no standard curative therapy available
Patients with borderline resectable, locally advanced or metastatic disease
Metastatic or unresectable locally advanced
For Part I (Arms A, B): Patients can have either locally advanced or metastatic pancreas adenocarcinoma for which no prior therapy has been administered for either locally advanced or metastatic disease; prior adjuvant therapy is permissible if gemcitabine or a fluoropyrimidine was administered with or without radiation and if disease recurrence has been documented at least 6 months after completion of adjuvant therapy
That is relapsed or refractory after treatment with an approved therapy(ies), defined as metastatic or non-resectable, locally advanced disease that has previously been treated with and progressed following approved therapy(ies) (Cohort 2)
Subjects who were previously treated with carboplatin and paclitaxel for locally advanced and/or metastatic disease and who received the last dose of the drug(s) ? 12 months prior to the first dose of the study treatment may be enrolled
Subjects who were not previously treated with carboplatin and paclitaxel for locally advanced and/or metastatic disease and for whom, in the opinion of the Investigator, this chemotherapy regimen is appropriate may be enrolled
Subjects who were not previously treated with paclitaxel for locally advanced and/or metastatic disease and for whom, in the opinion of the Investigator, this chemotherapy regimen is appropriate may be enrolled
Patients eligible for this study should have locally and/or regionally advanced melanoma that is considered potentially surgically resectable and with biopsiable tumor at baseline
Locally advanced or metastatic CRC
Disease progression after prior therapy in locally advanced or metastatic setting
In the phase Ib portion, must have locally advanced or metastatic GIST and have progressed on imatinib
Stage IV or locally advanced cancers for which no alternative therapies with proven survival advantage are available
Have an unresectable, locally advanced pancreatic cancer (AJCC stage III). (Excluded: resectable and borderline resectable patients are ineligible per NCCN criteria)
Presence of locally advanced, inoperable or metastatic disease
Previously treated with one or more regimens of systemic therapy for locally advanced or metastatic disease.
Previously treated with one or more regimens of systemic therapy for locally advanced or metastatic disease.
Previously treated with one or more regimen of systemic therapy for locally advanced or metastatic disease.
Previously treated with one or more regimens of systemic therapy for locally advanced or metastatic disease.
Subject has radiologically confirmed locally advanced unresectable or metastatic disease within 28 days prior to the first dose of study treatment.
Locally advanced (T4b, any N; or any T, N 2?3) or metastatic disease (any T, any N and M1). Locally advanced bladder cancer must be unresectable i.e. invading the pelvic or abdominal wall (stage T4b) or presenting with bulky nodal disease (N2-3).
Retroperitoneal/hilar adenopathy concerning for locally advanced disease
Locally advanced (including unresectable or borderline resectable) pancreatic cancer based on computed tomography (CT) imaging, as determined by the principal investigator (PI)
Locally advanced/unresectable (as determined by local surgeon) OR metastatic disease
Locally advanced (T4b, any N; any T, N2-3) or metastatic (M1) disease as determined by the treating investigator
Have locally advanced (unresectable) or metastatic small bowel adenocarcinoma
PSTAT3 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
No evidence of locally advanced or metastatic disease
Must have locally advanced or distant metastatic disease that is not surgically curable
Locally advanced or metastatic malignancy
Metastatic or locally advanced disease
Subjects with histological confirmation of locally advanced unresectable or metastatic MSI high CRC.
Use of taxanes as adjuvant therapy or to treat locally advanced disease is permitted, if given more than 6 months prior to C1D-2
unresectable locally advanced recurrent BC or metastatic BC
For dose escalation, locally advanced and/or metastatic gastrointestinal (GI) solid tumor in participants who have progressed on a standard therapy, are intolerant to SOC, and/or are non-amenable to SOC and other solid tumors expressing CEA. Only locally advanced and/or metastatic colorectal cancer participants should be included in the scheduled comparison expansion
nab-Paclitaxel and Nivolumab: Subjects must have received 1 prior systemic chemotherapy regimen for locally advanced or metastatic disease.
Subject must have locally advanced or metastatic solid tumor;
Phase 2 only: Previous treatment with >3 chemotherapy regimens for locally advanced or metastatic disease
VLA009A: Locally advanced and/or metastatic disease for which curative surgery and/or radiation therapy is not possible and judged not to be a candidate for the current standard of care treatment. VLA009B: locally advanced and/or metastatic disease and judged to be a candidate for pembrolizumab to be used in combination with CVA21.
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)
Progression must have occurred during or after most recent treatment for locally advanced/metastatic BC or within 6 months after completing adjuvant therapy
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 3 months of the past dose of systemic therapy are eligible
Receipt of prior systemic anti-cancer therapy for unresectable, locally advanced or metastatic melanoma
Previously received more than 1 regimen of systemic anticancer therapy for locally advanced or metastatic disease.
Metastatic disease or locally advanced, unresectable disease.
Inclusion Criteria - Cohort Expansion Phase:\n\n          -  Histologically-proven, unresectable, locally advanced or metastatic melanoma or NSCLC\n\n               -  Melanoma: Advanced or metastatic melanoma patients may be systemic therapy naïve\n                  or may have received systemic treatment for unresectable locally advanced or\n                  metastatic disease. A patient who previously received systemic therapy must have\n                  had progression on a checkpoint inhibitor (e.g., anti-PD-L1, anti-PD-1,\n                  anti-CTLA-4) as the most recent prior therapy.\n\n               -  NSCLC: NSCLC that has progressed during or following 1 or more prior systemic\n                  therapies for unresectable locally advanced or metastatic disease. Patients who\n                  are intolerant of, or have refused treatment with standard first line cancer\n                  therapy, will be allowed to enroll. Patients must not have had more than 5 prior\n                  systemic regimens (excluding experimental therapies) for unresectable locally\n                  advanced or metastatic disease.\n\n          -  B7-H3 expression is not required for eligibility in this study; however, tumor\n             expression of B7-H3 will be evaluated for all patients.\n\n          -  Measurable disease per RECIST 1.1 criteria\n\n          -  ECOG performance status 0 or 1\n\n          -  Acceptable laboratory parameters and adequate organ reserve.\n\n        Exclusion Criteria - Cohort Expansion Phase:\n\n          -  Patients with a history of symptomatic central nervous system metastases, unless\n             treated and asymptomatic\n\n          -  Patients with history of autoimmune disease with certain exceptions\n\n          -  History of allogeneic bone marrow, stem cell, or solid organ transplant\n\n          -  Treatment with systemic cancer therapy or investigational therapy within 4 weeks;\n             radiation within 2 weeks; trauma or major surgery within 4 weeks\n\n          -  History of clinically-significant cardiovascular disease; gastrointestinal\n             perforation; gastrointestinal bleeding, acute pancreatitis or diverticulitis within 4\n             weeks;\n\n          -  Active viral, bacterial, or systemic fungal infection requiring parenteral treatment\n             within 7 days; positive for human immunodeficiency virus or AIDS, hepatitis B or C.\n\n          -  Known hypersensitivity to recombinant proteins, polysorbate 80, or any excipient\n             contained in the drug or vehicle formulation for MGA271 or ipilimumab.
Radiographic and pathologic staging consistent with pancreatic cancer, locally advanced, unresectable (per NCCN criteria)
Laparoscopic confirmation that PDAC is locally advanced. Biliary stents are permitted
The subject has metastatic disease or has locally advanced disease that is not amendable to curative treatment
Previous systemic therapy for locally advanced or metastatic disease is not allowed.
In the phase Ib portion, must have locally advanced or metastatic GIST and have progressed on imatinib
Stage IV or locally advanced cancers for which no alternative therapies with proven survival advantage are available
Locally advanced and/or metastatic disease
Locally advanced (T4b, any N; any T, N2-3) or metastatic (M1) disease as determined by the treating investigator
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).
Melanoma that has progressed during or following at least 1 and up to 5 prior systemic treatments for unresectable locally advanced or metastatic disease, or melanoma patients who are intolerable of or have refused standard cancer therapy. Pre- and on-study biopsy required.
In the phase I dose escalation study, must have locally advanced, unresectable or metastatic GIST and have progressed on imatinib
Concurrent active inoperable locally advanced or metastatic malignancy (other than malignancies, which the investigator determines are unlikely to interfere with treatment and safety analysis or are less of a treatment priority than their diagnosis of advanced GIST)
Unresectable locally advanced or metastatic MPM after locally confirmed progression on 1st line treatment with platinum in combination with pemetrexed.
Measurable metastatic disease or locally advanced and unresectable disease
Locally advanced (clearly unresectable) or metastatic disease
Must have locally advanced or distant metastatic disease that is not surgically curable
The participant received >1 line of prior therapy for the treatment of locally advanced and unresectable or metastatic gastric or GEJ (Siewert Types I-III) adenocarcinoma.
Subjects can be treatment naive for metastatic or incurable locally advanced HPV-16 positive solid tumors or can have one prior line of treatment
Confirmed metastatic or locally advanced, unresectable disease (by computed tomography [CT] scan or clinical evidence)
Metastatic or locally advanced (unresectable) colorectal cancer with histological confirmation of adenocarcinoma
Phase I: patients with any locally advanced or metastatic gastrointestinal malignancy which mFOLFOX6 is indicated for treatment
Locally advanced or metastatic NSCLC
Patients must have an unresectable locally advanced or metastatic adenocarcinoma
Documented evidence of NSCLC (locally advanced, unresectable, Stage III)
Cohort 1: Patients must have had a minimum of 1 and a maximum of 4 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 2: Patients must have had a minimum of 1 and maximum of any number of prior chemotherapy regimens for recurrent/metastatic disease or locally advanced/unresectable disease; Cohort 3: 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 28 days prior to initiation of therapy; patients receiving carmustine (BCNU) or mitomycin C must have received their last dose at least 6 weeks prior to initiation of therapy
Patients must have received previous treatment with crizotinib for the treatment of locally advanced or metastatic NSCLC.
Naïve 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.
Patients with borderline resectable, locally advanced or metastatic disease.
Written consent from Female or male patients aged 18 years and over. Previously confirmed histological diagnosis of unresectable, locally advanced or metastatic, hereditary or sporadic MTC Objective disease progression within the previous 14 months prior to enrolment, and/or
Dose Expansion phase: Metastatic melanoma (locally advanced or metastatic melanoma)
Patients must have measurable or non-measurable stage III/locally advanced or metastatic carcinoma of the breast where surgery is not possible; lesions must be evaluated within 4 weeks prior to registration
Patients must not have had more than 2 lines of non-hormonal treatment in the locally advanced or metastatic setting, including trastuzumab (Herceptin), bevacizumab, or other agents; treatment in the locally advanced or metastatic setting must have been completed at least 2 weeks prior to study registration
Prior aromatase inhibitors (e.g. anastrozole, letrozole, exemestane, aminoglutethamide) are allowed in the locally advanced or metastatic setting
Prior tamoxifen is not allowed in the locally advanced or metastatic setting
Has locally advanced esophageal carcinoma that is resectable or potentially curable with radiation therapy (as determined by local investigator)
Only locally advanced disease
Patients must have a clinical diagnosis of Birt-Hogg-Dube syndrome (clinical features consistent with BHD and /or a germline FLCN mutation) and the presence of localized, locally advanced or advanced, renal tumor(s)
No more than three prior anticancer regimens (BRAF/MEK inhibitors, IL-2 or investigational agents) including no more than one chemotherapy-containing regimen for advanced (recurrent, locally advanced or metastic) disease.
Failed more than 3 treatment regimens for locally advanced or metastatic NSCLC.
Patients with locally advanced BCC are required to have disease that is considered inoperable due to significant functional compromise or to have a medical contraindication to surgery
No prior chemotherapy for locally advanced or metastatic disease
Subjects greater than or equal to (>=) 18 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:
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
Metastatic disease as documented by CT scan or MRI (locally advanced disease only NOT eligible)
Previous chemotherapy for locally advanced or metastatic disease
Locally advanced or metastatic solid tumors;
No prior systemic therapy for inoperable locally advanced or metastatic UC
Subjects must have metastatic or unresectable locally advanced malignant solid tumor.
Diagnosis of NSCLC with locally advanced or metastatic disease
Metastatic or locally advanced disease
Locally advanced or metastatic disease
Inoperable metastatic or locally advanced unresectable disease
Presence of locally advanced or metastatic disease with at least one measurable lesion.
Stage IV disease or inoperable locally advanced disease.
Subject with more than 2 prior cytotoxic therapies (not including treatment administered for locally curable disease) for unresectable or metastatic gastroesophageal adenocarcinoma.
Presence of locally advanced or metastatic disease with at least one measurable lesion.
Prior hormonal therapy for locally advanced or metastatic disease is allowed but this must have been discontinued prior to enrollment; no washout period will be required
More than 1 prior chemotherapy given for locally advanced or metastatic disease
Documented evidence of advanced (locally recurrent, locally advanced and/or metastatic) adipocytic (restricted to subtypes listed in Inclusion 1) or leiomyosarcoma, incurable by surgery and/or radiotherapy.
Unresectable locally advanced or metastatic HCC;
Patients must have “advanced disease”; usually, this will mean metastatic disease; this may also be multiply recurrent disease or locally advanced disease; locally advanced disease is defined for this study as disease where a mutilating surgery is required and the patient is more likely than not to die of their disease despite an aggressive operation; patients with metastatic disease that has been resected or radiated are allowed to participate; Response Evaluation Criteria in Solid Tumors (RECIST) evaluable disease is not necessary for participation
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
Patients with only locally advanced disease
Pathologically confirmed locally advanced or metastatic disease per the treating institution's standard of care of the following tumor types: \r\n* Subjects with histologically confirmed locally advanced/unresectable or metastatic melanoma who meet all of the following criteria: \r\n** Subjects have received any number of prior lines of therapy or may be treatment naive \r\n** If the subject has been treated with a prior line of therapy, they must have had disease progression or be refractory to treatment OR \r\n* Subjects with histologically or cytologically confirmed locally advanced/unresectable or metastatic urothelial carcinoma (including mixed histologies of urothelial carcinoma with elements of other subtypes) of the renal pelvis, ureter, bladder or urethra (referred to broadly in this protocol as “bladder cancer”) who meet the following criteria: \r\n** Subjects must have disease progression or refractory disease after their prior line of therapy; subjects must have had at least 1 platinum based chemotherapy regimen for the treatment of metastatic or locally advanced unresectable disease; subjects may have received any number of prior lines of therapy OR \r\n** Subjects with disease recurrence within 1 year of a platinum based neoadjuvant or adjuvant therapy for bladder cancer OR \r\n** The subject actively refuses chemotherapy for the treatment of metastatic or locally advanced disease considered as standard treatment for this disease stage (i.e. a patient who has relapsed > 1 year after treatment with neoadjuvant or adjuvant chemotherapy), despite being informed by the investigator about the treatment options; the subject’s refusal must be documented
Unresectable, locally advanced or metastatic disease; diagnosed within 6 weeks prior to screening
No prior systemic treatment in the advanced (metastatic or locally advanced) setting with the exception of treatment with letrozole for a maximum of one month prior to starting study treatment.
Locally advanced disease which is unresectable, or resectable but suitable for an organ sparing approach
Documented disease recurrence or disease progression of: (a) locally advanced disease that is not considered curable by surgery and/or radiation; or (b) metastatic disease.
Patients presenting with locally advanced disease in the breast (cT4) and/or in the nodes (cN2/N3) as assessed by clinical exam and imaging
Patients who have known metastatic disease or other locally advanced disease in the thoracic or cervical regions
Locally advanced or metastatic, unresectable sarcoma that has progressed after treatment with 150 mg/m2 or less of doxorubicin or anthracycline equivalent
No prior chemotherapy for inoperable locally advanced or mUC