Belvarafenib + Cobimetinib/Nivolumab for Melanoma

Recruiting in Palo Alto (17 mi)

+27 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Genentech, Inc.

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This trial tests belvarafenib alone and in combination with other drugs for advanced melanoma patients who haven't responded to previous treatments. The drugs aim to stop cancer growth or help the immune system fight the cancer.

Eligibility Criteria

This trial is for adults with advanced melanoma that has an NRAS mutation and worsened after anti-PD-1/PD-L1 therapy. They can have had up to two cancer treatments before, but not certain drugs like pan-RAF inhibitors or MEK inhibitors (for cobimetinib arm). No serious liver disease, untreated brain metastases, significant heart issues, autoimmune diseases, or immune deficiencies are allowed.

Inclusion Criteria

You have a disease that can be measured using a specific set of guidelines.

My cancer has a documented NRAS mutation within the last 5 years.

I can provide a sample of my tumor for testing.

+3 more

Exclusion Criteria

You have had a disease that affects your immune system, or your immune system does not work properly.

I haven't had immunotherapy or similar treatments in the last 28 days.

I have a history of serious heart problems.

+6 more

Participant Groups

The study tests the safety and effectiveness of belvarafenib alone and combined with cobimetinib or both cobimetinib and nivolumab in treating advanced melanoma with NRAS mutations. Participants will be assessed for how their bodies handle the drugs (pharmacokinetics) and how well their tumors respond.

3Treatment groups

Experimental Treatment

Group I: Belvarafenib Plus Cobimetinib Plus NivolumabExperimental Treatment1 Intervention

Recommended dose (RD) and schedule of belvarafenib and cobimetinib plus nivolumab IV infusion every 4 weeks (Q4W) in a run-in phase followed by an expansion phase

Group II: Belvarafenib Plus CobimetinibExperimental Treatment1 Intervention

Recommended dose (RD) and schedule of belvarafenib and cobimetinib selected based on the safety data, tolerability, pharmacokinetics, and anti-tumor activity tested in dose-finding phase followed by an expansion phase.

Group III: Belvarafenib MonotherapyExperimental Treatment1 Intervention

Twice daily (BID), continuous dosing.