Nivolumab + Axitinib for Advanced Melanoma

Recruiting in Palo Alto (17 mi)

Investigators - UPMC Hillman Cancer Center

Overseen byYana Najjar, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Yana Najjar

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This is Phase II trial of nivolumab plus axitinib for patients with unresectable stage III or IV melanoma who have progressed on prior anti-PD1 therapy with or without concomitant anti-CTLA4 therapy. Patients will receive treatment with nivolumab 480 mg intravenously every 4 weeks and axitinib 5 mg twice daily by mouth. Patients may continue both agents for up to two years if they do not experience disease progression or dose-limiting toxicities.

Eligibility Criteria

This trial is for adults with stage III or IV melanoma that worsened after anti-PD1 therapy, possibly with anti-CTLA4. They must have measurable disease, be able to perform daily activities (ECOG 0 or 1), and use birth control. Excluded are those with active TB, recent major surgery or radiation, certain heart conditions, uncontrolled hypertension, known allergies to the drugs tested, some prior severe side effects from similar treatments, and pregnant or breastfeeding individuals.

Inclusion Criteria

I am not pregnant, using birth control, sterile, or abstaining from sex for the study duration and 5 months after.

My melanoma cannot be removed by surgery and is not uveal melanoma.

My cancer worsened after treatment with anti-PD1, possibly with anti-CTLA4, confirmed by scans.

+6 more

Exclusion Criteria

You are allergic to nivolumab or axitinib, or any of the ingredients in these medications.

I have severe heart failure.

I have HIV with specific CD4 count and viral load levels.

+28 more

Participant Groups

The study tests a combination of nivolumab (an immunotherapy drug) given intravenously every four weeks and axitinib (a cancer growth blocker) taken orally twice daily. Participants can receive these medications for up to two years unless they experience significant disease progression or intolerable side effects.

1Treatment groups

Experimental Treatment

Group I: Nivolumab plus AxitinibExperimental Treatment2 Interventions

Nivolumab 480mg, IV, every 4 weeks, for up to two years. Axitinib 5mg, PO, BID, for up to two years.

Axitinib is already approved in European Union, United States, United Kingdom for the following indications:

🇪🇺 Approved in European Union as Inlyta for: