SWOG S1512: A Phase II Study of PD-1 Blockade with Pembrolizumab In Patients with Locally Advanced and Metastatic Desmoplastic Melanoma

SWOG S1512 (NCT02775851) was a phase II trial designed to evaluate how well pembrolizumab works in treating patients with desmoplastic melanoma (DM) that can be removed by surgery (resectable; Cohort A) or cannot be removed by surgery (unresectable; Cohort B). Biopsies were collected before (baseline) and during (on-therapy) treatment, as well as resection specimens from patients with resectable disease, for central pathology review and DNA extraction for whole exome sequencing. The data made available through dbGaP for this study version will include the raw, unaligned whole exome sequencing data of DNA isolated from either tumor biopsies or peripheral blood mononuclear cells (to be used as a patient-matched normal for somatic mutation calling) from patients in Cohort B.]]>
Inclusion:Cohort A: Histologically or cytologically confirmed primary desmoplastic melanoma that is deemed resectableResidual disease after initial biopsy which can be measurable or non-measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.Cohort B:Must have histologically or cytologically confirmed primary desmoplastic melanoma that is unresectableMeasurable disease per RECIST 1.1.Exclusion:No known brain metastases, unless brain metastases have been treated and patient is asymptomatic with no residual neurological dysfunction and has not received enzyme-reducing anti-epileptic drugs or corticosteroids for at least 14 days prior to registrationPrior systemic treatment for this melanoma. Planning to receive concomitant other biologic therapy, hormonal therapy, other chemotherapy, anti-cancer surgery or other anti-cancer therapy while on this protocol. Have received radiation therapy, non-cytotoxic agents or investigational agents or systemic corticosteroids within 14 days prior to registration. May have received prior surgery; but all adverse events associated with prior surgery must have resolved to =< grade 1 (per Common Terminology Criteria for Adverse Events [CTCAE] 4.0) prior to registration.Age less than 18 years]]>