Nivolumab + Ipilimumab + Cabozantinib for Melanoma

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen byGeoffrey T Gibney, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Georgetown University

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

Adults over 18 with advanced melanoma that can't be surgically removed may join this trial. They should have recovered from previous treatments, have good organ and bone marrow function, not be pregnant, and agree to use contraception. Participants need measurable disease by certain criteria and a sample of their tumor available.

Inclusion Criteria

Capable of understanding and complying with the protocol requirements and must have signed the informed consent document.

My organs and bone marrow are working well.

I agree to use effective birth control during and for 4 months after the study.

+6 more

Participant Groups

The study tests Nivolumab/Ipilimumab combined with Cabozantinib in patients during a 12-week induction phase followed by maintenance therapy for up to two years unless there's disease progression or unacceptable side effects. The main goal is to see how many are free from disease progression after one year.

1Treatment groups

Experimental Treatment

Group I: Single ArmExperimental Treatment3 Interventions

Nivolumab 3mg/kg IV plus Ipilimumab 1mg/kg IV every 3 weeks x 4 cycles with Cabozantinib 40mg PO daily for 12 weeks (Induction); Followed by Maintenance therapy: Nivolumab 480mg IV every 4 weeks for up to 92 weeks; Cabozantinib 40mg PO daily for up to 92 weeks; Maintenance therapy will continue for up to 92 weeks to complete 2 years total of treatment if tolerating therapy well and disease is controlled.

Cabozantinib is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Cabometyx for: