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
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

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

Criteria

Inclusion Criteria:

• Patients must have histologically confirmed MCM or ALM that is metastatic or unresectable.

• Patients must be eligible to receive nivolumab in combination with ipilimumab treatment per institutional guidelines.

• Patients must have a tissue block (or 20 unstained slides) available with adequate tumor to perform multiplex immunohistochemistry and nucleic acids analyses ( i.e. whole exome sequencing) Patients with only a previous fine-needle aspirate are ineligible for enrollment.

• Patients must be willing to donate a small amount of whole blood prior to treatment and during treatment for laboratory analysis.

• Patients must give informed consent prior to initiation of therapy.

• Patients must be ambulatory with good performance status (ECOG 0 or 1)

Exclusion Criteria:

• Patients who do not have available tissue for immunohistochemistry and nucleic acids analyses.

• Patients who have received prior immunotherapy for unresectable or metastatic disease.

• Patients with untreated brain metastases, leptomeningeal disease, or seizure disorders are ineligible. Patients with a history of brain metastases must have completed treatment (i.e. surgery or radiation) 1 month prior to enrollment and have no evidence of disease or edema on brain CT or head MRI.

• Patients with inadequate tissue for analysis.