Nivolumab/Ipilimumab Plus Cabozantinib in Patients With Unresectable Advanced Melanoma

In this phase II advanced melanoma study, all patients will receive treatment with nivolumab/ipilimumab plus cabozantinib for a 12 week induction period followed by nivolumab plus cabozantinib maintanence to complete up to 2 years of therapy unless disease progression, dose limiting toxicity, provider/patient decision or patient withdrawal of consent occurs. The primary endpoint is the one year PFS rate. Patients will have staging scans at baseline and every 12 weeks during the first 2 years on study. Safety evaluations including labs, EKG and history and physical will occur at each visit. Baseline tumor sample is required and on treatment biopsy will be optional of superficial tumor in the skin, subcutaneous tissue or lymph node that is palpable.

NCT Number	NCT04091750
Lead Sponsor	Georgetown University Collaborators: MedStar Franklin Square Medical Center, Hackensack Meridian Health, Exelixis
Conditions	Melanoma
Enrollment	14 participants
Start Date	2020-03-02
Primary Completion	2023-08-08 (estimated)
Study Completion	2026-12 (estimated)
Updated on ClinicalTrials.gov	2026-03-03