A Biomarker Study in Advanced Mucosal or Acral Lentiginous Melanoma Receiving Nivolumab in Combination With Ipilimumab

• Status: Active, not recruiting
• Trial end date: 2021-12-01

Summary

Participants with advanced or metastatic mucosal melanoma (cohort A) and acral lentiginous melanoma (cohort B) eligible for treatment with nivolumab in combination with ipilimumab followed by nivolumab therapy will submit tissue blocks from tumors of malignant melanoma for histopathology review and immunohistochemistry analysis at Georgetown University-Lombardi Comprehensive Cancer Center. Pretreatment blood will be drawn and stored in the Melanoma Research Foundation Breakthrough Consortium Virtual Repository at each participating institution. At the end of participation, samples will be sent to Georgetown University-Lombardi Comprehensive Cancer Center for processing and storage. An optional pretreatment biopsy of an accessible tumor lesion will be performed in a subset of enrolled patients. Patients will receive nivolumab in combination with ipilimumab according to the standard FDA approved treatment regimen.

• Phase: Phase 2

Details

• Lead Sponsor: Georgetown University
• Collaborators: Bristol-Myers Squibb; Columbia University; Dana-Farber Cancer Institute; H. Lee Moffitt Cancer Center and Research Institute; M.D. Anderson Cancer Center; Melanoma Research Foundation Breakthrough Consortium; Memorial Sloan Kettering Cancer Center; Northwestern University; University of California, San Francisco; University of Colorado, Denver; University of Pittsburgh; Vanderbilt University; Vanderbilt University Medical Center; Yale University
• Treatments: Antibodies, Monoclonal; Ipilimumab; Nivolumab