[c09aa8]: / clusters / 9knumclustersv2 / clust_1511.txt

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Patients must have histological or cytological confirmation of melanoma that is metastatic or unresectable and clearly progressive\r\n* NOTE: Any patient with BRAF V mutant melanoma (whether cutaneous, acral or mucosal primary) who meets the eligibility criteria is eligible for participation in this trial; patients with uveal melanoma are not eligible for this trial
Patients must have melanoma that is metastatic and clearly progressive on prior therapy
Patients must not have received prior systemic treatment for this melanoma
Patients who have received prior ipilimumab treatment for metastatic melanoma are not eligible.
Melanoma after failure of available therapies
Participants must have a clinical indication for resection of metastatic melanoma; patients will be informed about other treatment options for stage IV melanoma including Braf inhibitors and antibodies to CTLA-
Subjects with melanoma or with a history of melanoma, invasive squamous cell carcinomas, or aphakia (due to contraindication for use of methoxsalen).
Patients with melanoma of cutaneous, mucosal or acral-lentiginous origin or of unknown primary
Melanoma
Has received prior systemic treatment for unresectable or metastatic melanoma (except BRAF directed therapy).
Prior radiation to the primary and/or regional radiotherapy for melanoma and/or NSCLC is acceptable
Part B: Have metastatic melanoma carrying NRAS mutation
Metastatic melanoma eligible for {or currently o
Rapidly progressing multi-focal metastatic melanoma
Melanoma
Study subjects previously treated with one of the peptides used in this trial, melanoma protein vaccine, melanoma whole cell vaccines, or with Montanide are not eligible
Prior melanoma vaccinations may be an exclusion criterion in the following circumstances:\r\n* Patients who have received, within the prior years, melanoma vaccines or other vaccines containing an incomplete Freunds adjuvant (IFA; such as montanide ISA-).\r\n* Patients who have received any melanoma vaccine within the past months.\r\n* Patients who have been vaccinated in the past with any of the melanoma peptides in the LPV vaccine included in this study.
Patients must have a diagnosis of metastatic melanoma which is measurable either clinically or radiologically
Patients with a history metastatic melanoma involving the brain will be excluded if they have active disease or have had active disease within the prior six months that was not controlled with surgery or radiotherapy
Treatment directed against the melanoma (eg, chemotherapy, targeted agents, biotherapy, limb perfusion) that is administered after a prior complete resection other than adjuvant radiation after neurosurgical resection and IFN for resected melanoma
Cohort A: unresectable or metastatic melanoma
Metastatic melanoma, gastrointestinal, or genitourinary cancer with at least one lesion that is resectable; only patients with metastatic gastrointestinal cancer will be eligible for enrollment on the phase I portion of the study; patients with metastatic melanoma, gastrointestinal, or genitourinary cancer will be eligible for enrollment on the phase II portion of the study
Participants must not have had prior systemic anticancer therapy for unresectable or metastatic melanoma
Patients must have completely resected (as per standard of care) melanoma of cutaneous origin in order to be eligible for this study; patients must be classified as stage IIB or IIC cutaneous melanoma using the American Joint Committee on Cancer eighth edition; patients with melanoma of mucosal or other non-cutaneous origin are not eligible; patients with melanoma of ocular origin are not eligible
Diagnosis of choroidal melanoma
Melanoma located on face or digits
Histologically or cytologically confirmed malignant melanoma from skin, or mucosal melanoma (i.e. ocular melanoma subjects are not eligible)
Patients must have received at least one prior therapy for metastatic melanoma
Inclusion criteria Part : Safety run-in\n\n - Histologically confirmed, unresectable or metastatic melanoma with BRAF V mutation\n\n - Aspartate transaminase (AST) < . ULN and Alanine transaminase (ALT) < . ULN\n\n - ECOG performance status ? \n\n Part : Biomarker cohort\n\n - Histologically confirmed, unresectable or metastatic melanoma with BRAF V mutation\n\n - At least two cutaneous or subcutaneous or nodal lesions for tumor sample collection\n\n - ECOG performance status ? \n\n Part : Double-blind, randomized, placebo-controlled part\n\n - Histologically confirmed, unresectable or metastatic melanoma with BRAF V mutation\n\n - ECOG performance status ? \n\n Exclusion Criteria:\n\n Part : Safety run-in\n\n - Subjects with uveal or mucosal melanoma\n\n - Any history of CNS metastases\n\n - Prior systemic anti-cancer treatment for unresectable or metastatic melanoma\n\n - Prior loco-regional treatment for unresectable or metastatic melanoma in the last \n month\n\n - Prior neoadjuvant and/or adjuvant therapy for melanoma completed less than months\n\n - Radiation therapy within weeks prior to start of study treatment\n\n - Active, known, suspected or a documented history of autoimmune disease\n\n Parts & : Biomarker cohort & double-blind, randomized, placebo-controlled part\n\n - Subjects with uveal or mucosal melanoma\n\n - Clinically active cerebral melanoma metastasis\n\n - Prior systemic anti-cancer treatment for unresectable or metastatic melanoma\n\n - Prior loco-regional treatment for unresectable or metastatic melanoma in the last \n month\n\n - Prior neoadjuvant and/or adjuvant therapy for melanoma completed less than months\n\n - Radiation therapy within weeks prior to start of study treatment\n\n - Active, known, suspected or a documented history of autoimmune disease\n\n Other protocol-defined Inclusion/Exclusion may apply.
Patients with metastatic, surgically unresectable melanoma or newly diagnosed melanoma patients of any stage unable to receive or complete standard therapy
Histological/cytological diagnosis of melanoma. AJCC stage IV (any T, any N, M), metastatic, progressive, refractory, melanoma.
Primary melanoma arises from the eye or mucus membranes
Second invasive melanoma
Melanoma specific systemic therapy within days of enrollment
Patients are excluded from this trial if they have melanoma, small cell carcinoma, lymphoma/leukemia, or germ cell histology (note, melanoma patients will be eligible for the sister trial to this trial which will be open simultaneously)
Patients with advanced melanoma defined as unresectable stage III or metastatic stage IV disease. Patients with acral or mucosal melanoma or patients with unknown primary melanoma are acceptable in Phase b but are excluded from Phase II. Patients with uveal melanoma are excluded from the study.
Participants in Part E must have melanoma of any subtype.
Histologic diagnosis of stage IV metastatic melanoma, with melanoma lesion that can be safely irradiated in the opinion of the radiation oncologist (note: subjects with primary ocular and mucosal melanoma are permitted). Lesions may include, but are not limited to:
Patient with detectable c-kit JM mutation confirmed by DNA or RNA sequencing, which is expected to be mainly found after screening of mucosal or acral melanoma or melanoma on skin with chronic sun-induced damages (defined by a microscopically marked elastosis involving the skin surrounding their primary melanoma)
Other metastatic melanoma systemic disease allowed
Histologic diagnosis of metastatic melanoma
Histologically confirmed melanoma of cutaneous primary; metastatic melanoma from unknown primary are allowed
Patients for whom there is a plan to receive ipilimumab, vemurafenib, or other treatment for advanced melanoma
Pathologically confirmed, clinically evident (by physical examination or radiographic imaging) stage IIIB, IIIC, and IV Ma and b cutaneous melanoma (anatomic stages T-b Na and T-b Na not included); the current diagnosis may be the patients first diagnosis of melanoma or recurrent melanoma after previous diagnosis of an earlier stage melanoma
Patients with fully resected stage IIb through IV melanoma, with melanoma validated by histology or cytology, who have NOT received prior therapy\r\n* Patients may have had primary cutaneous, mucosal, or ocular melanoma or metastasis from an unknown primary site\r\n* Tissue should be submitted for evaluation of NY-ESO- expression and T-cell infiltrates; however, availability of tissue and/or positivity for NY-ESO- is not mandatory
Positive staining of the most recently resected tumor tissue with antibodies to or more of the following: human melanoma black (HMB) for glycoprotein (gp) , NY-ESO-, and/or melanoma-associated antigen recognized by T cells (MART)-
No prior anti-cancer treatment for melanoma (except surgery for the melanoma lesion(s) and/or except for adjuvant radiation therapy (RT) after neurosurgical resection for central nervous system (CNS) lesions)
For Phase expansion cohorts: Subjects with NSCLC, melanoma (checkpoint inhibitor nave, primary refractory melanoma, relapsed melanoma), transitional cell carcinoma of the GU tract, SCCHN, ovarian cancer, MSI high CRC, RCC, DLBCL, and TNBC.
Has received prior systemic treatment for unresectable or metastatic melanoma (except BRAF directed therapy)
Patients must have completely resected melanoma of cutaneous origin or of unknown primary in order to be eligible for this study; patients must be classified as stage IIIA (Na), IIIB, IIIC, or stage IV melanoma; patients with non-ulcerated Tb Na disease are not eligible; patients with melanoma of mucosal or other non-cutaneous origin are eligible; patients with melanoma of ocular origin are not eligible; patients with a history of brain metastases are ineligible
Subjects with melanoma:
Treatment-nave participants (no prior systemic anticancer therapy for unresectable or metastatic melanoma)
Treatment directed against the resected melanoma that is administrated after the surgery
Subject has not been treated by systemic anticancer therapy for unresectable or metastatic melanoma
Prior adjuvant melanoma therapy is permitted; any number of previous treatments for melanoma is permitted.
Patients must have measurable metastatic melanoma
History of radiotherapy for the treatment of melanoma
Diagnosis of non-cutaneous melanoma or melanoma with unknown primary origin
Mucosal melanoma and uvueal melanoma.
Melanoma that has progressed during or following at least and up to 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.
Histologic diagnosis of unresectable or metastatic BRAF V mutant melanoma
Patients diagnosed with advanced melanoma
Patients with stage I or II, melanoma who are not candidates for ipilimumab
Uncertain diagnosis of melanoma i.e. so-called 'melanocytic lesion of unknown malignant potential'.
Desmoplastic or neurotropic melanoma.
Subungual melanoma
History of previous or concurrent (i.e., second primary) invasive melanoma.
Melanoma-related operative procedures not corresponding to criteria described in the protocol.
No prior therapy for melanoma except surgery for primary melanoma lesions (or previously treated with interferon for thick primary melanomas without evidence of lymph node involvement are eligible)
No more than prior courses of systemic therapy for metastatic melanoma
Patients with unresectable melanoma
Histopathologic documentation of melanoma concurrent with the diagnosis of metastatic disease
Melanoma
Group : Patients with NRAS mutated melanoma
Prior systemic anti-cancer treatment and radiotherapy for melanoma; prior surgery for melanoma is allowed.
Measurable metastatic melanoma with available autologous TIL
Dose Expansion phase: Metastatic melanoma (locally advanced or metastatic melanoma)
Part E: Melanoma that is advanced and/or metastatic
Patients who have a diagnosis for which a PD-(L)- inhibitor has been approved must have previously received treatment with one of these therapies. a. Melanoma Dose Expansion: Patients must have histologically confirmed metastatic melanoma (ocular melanoma not included) which has progressed on or after treatment with a PD-(L) inhibitor.
Histological or cytological confirmed melanoma that is metastatic or unresectable; patients must have measurable disease (at least one measurable lesion) as defined by Response Evaluation Criteria In Solid Tumors (RECIST) criteria; NOTE: all sites of disease must be evaluated within weeks prior to registration to treatment; patients must have a history of melanoma of one of the following subtypes: \r\n* Acral (as defined as occurring on the palms, soles, or subungual sites)\r\n* Melanoma arising from the vagina and/or vulva\r\n* Melanoma arising on other mucosal surface (not vagina or vulva)
The melanoma must harbor a c-KIT mutation determined by PCR and sequencing
Complete and adequate resection of Stage III melanoma with histologically confirmed melanoma metastatic to lymph node
Prior therapy for melanoma except surgery
Histologically documented cutaneous or mucosal malignant melanoma, which is recurrent or metastatic and is not curable by surgical or other means.
Patients must have melanoma that is documented to contain a BRAFVE or BRAFVK mutation by a FDA-approved test.
A single regimen of prior chemotherapy for metastatic melanoma is allowed; patients also may have received other immunotherapy or biologic therapy (including kinase inhibitors, antibodies to checkpoints CTLA, PD, PDL, etc.) for metastatic melanoma and there is a limit of three therapy regimens
Greater than months since melanoma resection;
Prior adjuvant therapy for current melanoma diagnosis;
Treatment directed against the melanoma (eg, chemotherapy, targeted agents, biotherapy, limb perfusion) that is administered after a prior complete resection other than adjuvant radiation after neurosurgical resection and IFN for resected melanoma.
Histologically or cytologically confirmed diagnosis of advanced or metastatic cutaneous melanoma that is determined to be BRAFV wild type and either NRAS wild type or NRAS mutation type. Note: Subjects with a melanoma of unknown primary origin may be allowed to enrol if all other types of melanoma (e.g., uveal, mucosal, or acral) can be reasonably ruled out.
Histologically confirmed cutaneous metastatic melanoma of V E, K, D or R.
Recurrent disease, refractory disease, or progressive disease after having received at least one standard therapy for their disease. Note: Subjects with metastatic (and surgically unresectable) melanoma can be enrolled for first-line treatment; Melanoma subjects with CNS involvement may be enrolled.
Patients with advanced cutaneous or subcutaneous in-transit or metastatic melanoma
Is treatment naive or has received prior treatment for metastatic melanoma.
Primary melanoma with the following Breslow thickness and stage:\r\n* =< mm\r\n* Patients with recent (within weeks) biopsy of primary melanoma that has not been widely resected will be eligible for study according to the above-specified criteria for tumor thickness and stage; if more than one biopsy was done for the primary melanoma, the window of weeks will be counted from the date of the last surgery
WHITE, NON-HISPANIC: Without a personal history of melanoma.
Have a personal history of melanoma and/or family history of melanoma (see definition under child eligibility criteria below)
Are at risk for melanoma due to having a first degree relative with a history of melanoma and/or at least second or third degree relatives on the same side of the family with a history of melanoma and/or
Subjects must not have received any form of systemic antineoplastic treatment for melanoma within the last year from day
Cutaneous melanoma with Breslow depth > mm or melanoma Breslow depth of . . mm in setting of ulceration, extensive regression
AIMS AND : Healthy individuals with pigmented lesions or a partially biopsied melanoma or cutaneous melanoma metastasis whose treatment plan includes excision
Patient must not have melanoma
Histopathologically confirmed diagnosis of metastatic or unresectable malignant melanoma arising from skin. Ocular melanoma subjects are not eligible.
Diagnosis of unresectable or metastatic melanoma
Current or pending participation in a clinical trial examining therapy for the\n treatment of any cancer (including unresectable or metastatic melanoma)
Current use of therapy to treat a primary cancer other than melanoma