Nivolumab/Ipilimumab Plus Cabozantinib in Patients With Unresectable Advanced Melanoma
Status:
Recruiting
Trial end date:
2023-03-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 2
Details
Lead Sponsor:
Georgetown University
Collaborators:
Exelixis Hackensack Meridian Health MedStar Franklin Square Medical Center