[c09aa8]: / clusters / 9knumclustersv2 / clust_270.txt

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Patients must have pathologically confirmed melanoma that is either stage IV or unresectable stage III; patients may have primaries of cutaneous, mucosal or unknown origin; patients with uveal (ocular) primary are not eligible
Patients with unresectable or metastatic stage III B/C or IV melanoma. Patients enrolled under this version of the protocol must also have progressed on prior anti-PD- therapy, according to RECIST . criteria. Patients who progressed within months of treatment start are excluded.
Stage IV melanoma for which surgery is not recommended.
Histologically-confirmed diagnosis of advanced (unresectable Stage III) or metastatic (Stage IV) melanoma excluding mucosal, or ocular melanoma (or a histologically or cytologically-documented locally-advanced or metastatic solid malignancy in Parts and )
Participants must have histologically or cytologically confirmed stage IV melanoma or recurrent stage IIIc melanoma following primary treatment of surgery and prior treatment or consideration of adjuvant therapy
Has a histologically confirmed diagnosis of unresectable stage III or metastatic melanoma not amenable to local therapy
Have histologically- or cytologically-confirmed unresectable stage III or stage IV melanoma not amenable to local therapy
Histologically confirmed Stage IV (metastatic) or unresectable Stage IIIc (locally advanced) melanoma
Histologically confirmed unresectable stage III or stage IV melanoma (American Joint Committee on Cancer [AJCC] th edition classification); cutaneous melanoma and mucosal melanoma will be eligible
Patients must have histologically or cytologically confirmed breast cancer with stage IV or unresectable stage III disease
American Joint Committee on Cancer (AJCC) () stage IV cutaneous melanoma or stage III cutaneous or acral melanoma that is judged inoperable; patients with a history of uveal or mucosal melanoma are not eligible
Histologic or cytologic diagnosis of cutaneous melanoma that is considered unresectable (stage III) or metastatic (stage IV); ocular and mucosal melanoma is excluded
Unresectable Stage III or Stage IV melanoma.
All patients must be either stage IIIb/c or stage IV melanoma according to the American Joint Committee on Cancer (AJCC) (th edition) and have histologically confirmed melanoma that is felt to be surgically unresectable in order to be eligible\r\n* All melanomas, except ocular/uveal melanoma, regardless of primary site of disease will be allowed; mucosal melanomas are eligible\r\n* Patients must not have received prior anticancer treatment for metastatic disease (for example, but not limited to, systemic, local, radiation, radiopharmaceutical)\r\n* Exceptions: Surgery for melanoma and/or post-resection brain radiotherapy (RT) if central nervous system (CNS) metastases and/or prior treatment with adjuvant IFN\r\n* All patients must have their disease status documented by a complete physical examination and imaging studies within weeks prior to the first dose of study drug; imaging studies must include computerized tomography (CT) scan of neck, chest, abdomen, pelvis, and all known sites of resected disease in the setting of stage IIIb/c or stage IV disease, and brain magnetic resonance imaging ([MRI], brain CT allowable if MRI is contraindicated)\r\n* The complete set of baseline radiographic images must be available before treatment initiation
Participants must have histologically confirmed Stage III (unresectable) or Stage IV melanoma, per the AJCC staging system
Patients with histologically confirmed unresectable stage III or stage IV metastatic melanoma, who have not been previously treated with a SEMAD antibody and have had prior anti-PD/PDL inhibitors with documented progression; patient may have or not have prior anti-CTLA treatments
Participants must be newly diagnosed, treatment-naive with histologically confirmed stage IIIC unresectable melanoma or stage IV melanoma
Have a histologically or cytologically confirmed diagnosis of unresectable stage III or IV melanoma; patient may not have a diagnosis of uveal or mucosal melanoma
Histologically or cytologically confirmed diagnosis of unresectable stage III or metastatic melanoma (stage IV) not amenable to curative local therapy
Have unresectable (stage III) or advanced (stage IV) melanoma
Have unresectable stage III or stage IV melanoma
Histologically or cytologically confirmed malignant melanoma at Screeningthat is unresectable/unresected Stage IIIB, IIIC, IIID or IV. Patients with unresectable mucosal melanoma may be enrolled after consultation with the Medical Monitor.
Patients must have received and failed or refused available therapy for unresectable/unresected Stage III or IV melanoma.
Diagnosis of unresectable stage III or metastatic melanoma (stage IV) not amenable to local therapy
Histologic or cytologic confirmation of unresectable stage III or metastatic melanoma (stage IV) not amenable to local therapy
Failure to confirm histologically or cytologically unresectable stage III or metastatic melanoma (stage IV) not amenable to local therapy
Subjects who are ipilimumab naive with progressive unresectable stage III or stage IV melanoma; eligible patients may have had prior adjuvant therapy, but not including ipilimumab, and been treated with up to prior treatments for metastatic melanoma (eg, chemotherapy, other biologic or targeted therapy or IL-)
Histologic or cytologic confirmation of stage III or stage IV melanoma
Patients who have unresectable stage III through stage IV metastatic melanoma that have not received prior PD- directed therapy (Arm A) or that have progressed despite prior PD- directed therapy (Arm B)
Patients must have stage IV melanoma, with newly identified brain or spine metastases
CAPMATINIB INCLUSION CRITERIA: Unresectable stage III or stage IV melanoma by clinical or radiographic criteria
CERITINIB INCLUSION CRITERIA: Unresectable stage III or stage IV melanoma by clinical or radiographic criteria
REGORAFENIB INCLUSION CRITERIA: Unresectable stage III or stage IV melanoma by clinical or radiographic criteria
ENTRECTINIB INCLUSION CRITERIA: Unresectable stage III or stage IV melanoma by clinical or radiographic criteria
Subjects with metastatic or unresectable stage IIIb/c of IV melanoma for whom treatment with pembrolizumab is indicated and who have at least one cutaneous, subcutaneous tumor or palpable lymph node amenable to intratumoral injection.
AJCC stage III or IV completely resectable melanoma identified before surgery
Patients must have metastatic melanoma or stage III in-transit, subcutaneous, or regional nodal disease
The subject must have clinical stage III or resectable stage IV MEL; subjects may not have a diagnosis of uveal or mucosal melanoma
Patient must have a histologically or cytologically confirmed diagnosis of unresectable stage III or IV melanoma; patient may not have a diagnosis of uveal melanoma
Participants must have histologically confirmed unresectable stage III or stage IV melanoma
Treatment of unresectable stage III or stage IV melanoma with a tyrosine kinase inhibitor within prior months; sorafenib for purposes of eligibility will not be considered acceptable prior therapy
More than prior systemic therapies for unresectable stage III or stage IV melanoma
Histologically confirmed locally advanced unresectable (stage III) or stage IV pancreatic ductal adenocarcinoma (PDAC)
Patients must have unresectable stage III or stage IV melanoma; patients must have histological or cytological confirmation of melanoma that is metastatic or unresectable and clearly progressive
Diagnosis of stage IV melanoma
Melanoma cohort only: histologic proof of surgically unresectable stage IV malignant melanoma
Histologic or cytologic diagnosis of cutaneous melanoma, mucosal melanoma, or melanoma of unknown primary that is considered unresectable (stage III) or metastatic (stage IV)
Patients must have primary cutaneous melanoma that belong to one of the following American Joint Commission on Cancer (AJCC) stages ( AJCC Melanoma Staging System):\r\n* Stage IIIB\r\n** T-b Na M\r\n** T-b Na M\r\n** T-b Nb M\r\n** T-b Nb M\r\n** T-b Nc M\r\n* Stage IIIC\r\n** T-b Nb M\r\n** T-b Nb M\r\n** T-b Nc M\r\n** Any T N M\r\n* Stage IV \r\n** Ma\r\n** Mb\r\n** NOTE: patients with stage IV melanoma must have normal lactate dehydrogenase (LDH) and either distant skin, subcutaneous, lymph node, or lung metastases, but no other visceral metastases in order to be eligible; for patients with resected stage IV melanoma, LDH within the institutional upper limit of normal (ULN) must be documented within weeks prior to randomization
Unresectable stage III or IV validated by clinical criteria (including recurrent melanoma), or patients with multiple skin/soft tissue metastases of melanoma that may be resectable but are judged to have a future recurrence risk exceeding % (e.g., large adenopathy, distant skin metastases or multiple in-transit melanoma metastases); tumor deemed amenable to biopsy (excisional, incisional, or core, with at least mm^ tumor volume per biopsy date) and fine-needle aspiration (FNA) biopsy\r\n* NOTE: optimally, patients will have tumor approachable for three serial biopsies during the trial; for patients with only one or two tumors approachable for biopsy, available tumor blocks from prior biopsies can serve as the pretreatment sample, but only if formalin-fixed tumor tissue is available and adequate to provide at least unstained slides with sufficient tumor for analysis\r\n* NOTE: patients with unresectable advanced stage III or IV melanoma (including recurrent melanoma) are only eligible if they have failed at least one other first-line systemic therapy (other than adjuvant therapy); exceptions to this requirement are those patients who have refused and/or are ineligible for other systemic therapies\r\n* NOTE: v-raf murine sarcoma viral oncogene homolog B inhibitor (BRAFi) should be considered for all unresectable or metastatic melanoma with BRAFVE mutation; for low burden in-transit disease patients may enter trial without prior systemic therapy\r\n** Stage IV no evidence of disease (NED) is excluded by this criterion
Patients must have histological or cytological confirmed melanoma that is metastatic or that is unresectable stage III and clearly progressive
Patients must have unresectable stage III or stage IV melanoma, either initial presentation or recurrent, that is of cutaneous origin or unknown primary origin and that is histologically diagnosed
Patients must have unresectable metastatic stage IV melanoma or stage III intransit or regional nodal disease, and in the opinion of the institutional Principal Investigator (PI) is an acceptable candidate for ACT with high dose IL- (aldesleukin)
Patients must have unresectable metastatic stage IV melanoma or stage III in-transit or regional nodal disease and in the opinion of the principal investigator (PI) or treating co-investigator is an acceptable candidate for ACT
Histologic diagnosis of unresectable stage III or IV melanoma\r\n* All melanomas regardless of primary site of disease will be allowed
Have unresectable Stage III or Stage IV melanoma, as per AJCC staging system not amenable to local therapy
Have advanced, unresectable (Stage III) or metastatic (Stage IV) melanoma;
Untreated or previously received one treatment regimen for measurable unresectable stage III or stage IV melanoma (American Joint Committee on Cancer [AJCC] ) (for BRAF wild-type, and regardless of human leukocyte antigen [HLA] type); untreated or previously received up to two treatment regimens for measurable unresectable stage III or stage IV melanoma (AJCC ) (for BRAF mutant, and regardless of HLA type; If prior regimens, one should be a BRAF inhibitor); this does not include any therapies given in the adjuvant setting
Unresectable Stage III or Stage IV melanoma (AJCC )
Failure, ineligible or intolerant of approved therapies; any number of prior systemic therapeutic regimens for unresectable stage III or stage IV melanoma; this includes chemotherapy, immunotherapy, pathway inhibitors, biochemotherapy, or investigational treatments; patients may also have received therapies in the adjuvant setting
Subjects who are ipilimumab nave with progressive unresectable stage III or stage IV melanoma who are either treatment nave or may have been treated with up to prior treatments for melanoma (e.g. chemotherapy, biologic or targeted therapy or interleukin [IL]-)
Histologic or cytologic confirmation of stage III or stage IV melanoma
Stage IV melanoma or stage III melanoma that is unlikely to be cured by surgery
Participants with BRAFV mutation-positive, cutaneous melanoma (either pathologic Stage IIC or Stage III according to AJCC Staging Criteria version that has been completely resected
Histologically confirmed Stage IIb, IIc, III melanoma
Histologically confirmed melanoma that is considered surgically incurable with either: \r\n* Stage IIIc melanoma including locally relapsed, satellite, in-transit lesions or bulky draining node metastasis\r\n* Stage IV melanoma (Ma, Mb, or Mc)
Histologic diagnosis of unresectable III or stage IV metastatic melanoma
The patient must have a pathologically confirmed (by histology or cytology) diagnosis of melanoma, which is currently Stage (unresectable) or Stage disease.
Naive or any number of prior systemic therapeutic regimens for unresectable stage III or stage IV melanoma, except prior BRAF or MEK inhibitor agents; this includes chemotherapy, immunotherapy, biochemotherapy, or investigational treatments; patients may also have received therapies in the adjuvant setting
Completely resected Stage III melanoma
Patients must have Stage IIIB, IIIC or IV melanoma, which is unresectable/unresected or histologically confirmed diagnosis of metastatic malignant melanoma.
Histologic or cytologic proof of surgically unresectable stage IV malignant melanoma - including that of uveal and mucosal origin\r\n* Note: biopsy can be of locoregional disease in setting of clinically evident stage IV disease; a biopsy of the primary tumor alone does not fulfill this requirement
Diagnosis of locally advanced, unresectable or metastatic cutaneous melanoma or unknown primary melanoma (AJCC Stage IIIB, IIIC, or IV)
Histologically confirmed stage III (unresectable) or stage IV melanoma
Patients with histologically documented diagnosis of advanced stage IV or unresectable stage III mucosal or cutaneous melanoma are eligible
Diagnosis of locally advanced, unresectable or metastatic cutaneous or melanoma of unknown primary AJCC Stage IIIC or IV (uveal and mucosal melanoma are excluded)
Unresectable stage III/IV melanoma
Histologically confirmed Stage III (unresectable)/Stage IV melanoma
Patients with a history of stage III melanoma (any primary melanoma with locoregional nodal/subcutaneous disease) treated with surgical resection who subsequently have disease recurrence meeting the criteria for stage IIIC disease
Patients must have histologically or cytologically confirmed melanoma stage III/IV, unresectable
For Melanoma Subjects: Have histologically or cytologically confirmed diagnosis of unresectable Stage III or metastatic (Stage IV) melanoma not amenable to local therapy, and irrespective of PD-L status
Patient must have histologically or cytologically confirmed diagnosis of stage III melanoma inoperable/not amenable to local treatment or stage IV melanoma.
Histologically confirmed surgically incurable and unresectable Stage IIIC or Stage IV (AJCC) melanoma
Patients with histologically documented diagnosis of advanced stage IV or unresectable stage III melanoma are eligible
Patients with histologically proven melanoma with metastasis that is unresectable Stage III or Stage IV. This will include bulky stage III and M-. Patients with melanoma with documented metastases to the brain are eligible.
Previously treated or untreated, unresectable Stage III or Stage IV malignant melanoma
Patients must have histologically confirmed recurrent stage III or stage IV melanoma (AJCC th edition classification); cutaneous melanoma, ocular or mucosal melanoma will be eligible
Histologically confirmed stage IV or unresectable stage III melanoma with documented BRAF V mutation
Unresectable Stage III or Stage IV melanoma
Unresectable stage III or stage IV Ma/Mb/Mc melanoma including patients with uveal melanoma
Histologic diagnosis of unresectable stage IIIC or stage IV melanoma that is BRAF V mutation positive
Patients must have pathologically confirmed stage IV or unresectable stage III melanoma; patients must not have disease that is suitable for local therapy, administered with curative intent
Phase I: Diagnosis of primary pathologic stage III cutaneous malignant melanoma
Phase II: Diagnosis of primary pathologic stage III cutaneous malignant melanoma
Participants must have histologically confirmed malignancy that is metastatic or currently unresectable; eligible malignancies include:\r\n* Adenocarcinoma of the pancreas (locally advanced or metastatic)\r\n* Colorectal (stage IV)\r\n* Non-small cell lung cancer (currently unresectable stage III or stage IV)
Patients must have histologically or cytologically confirmed diagnosis of unresectable, stage III or metastatic melanoma
Subjects must be diagnosed with histologically proven stage IV (metastatic) melanoma or stage III with bulky disease which may or may not be amenable for surgery and are receiving therapy at present
Subjects with unresectable Stage III or IV melanoma who are either refractory or intolerant to, or have refused standard therapy for treatment of metastatic melanoma