Atezolizumab + Cobimetinib + Vemurafenib for Melanoma

Recruiting at 132 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Hoffmann-La Roche

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This is a Phase III, double-blinded, placebo-controlled, randomized, multicenter study designed to evaluate the efficacy, safety, and pharmacokinetics of atezolizumab + cobimetinib + vemurafenib compared with placebo + cobimetinib + vemurafenib in patients with previously untreated BRAFv600 mutation-positive metastatic or unresectable locally advanced melanoma.

Research Team

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Eligibility Criteria

This trial is for adults with untreated BRAFv600 mutation-positive advanced melanoma. They must be able to use effective contraception, have no other cancers or severe diseases, and not be pregnant or breastfeeding. Participants should have a life expectancy of at least 18 weeks and an ECOG status of 0 or 1, indicating they are fully active or restricted in physically strenuous activity but ambulatory.

Inclusion Criteria

You are expected to live for at least 18 weeks.

My blood thinner medication and INR levels have been stable for the last 28 days.

I will avoid exposing pregnant partners to sperm and not donate sperm for 6 months after treatment.

See 8 more

Exclusion Criteria

My heart's pumping ability is below normal or less than 50%.

You are allergic to certain biopharmaceutical drugs.

I have not had cancer, other than BRAFv600 positive melanoma, in the last 3 years.

See 18 more

Treatment Details

Interventions

Atezolizumab (Monoclonal Antibodies)
Cobimetinib (Protein Kinase Inhibitor)
Vemurafenib (Protein Kinase Inhibitor)

Trial OverviewThe study tests the effectiveness and safety of combining Atezolizumab (an immunotherapy drug) with Cobimetinib and Vemurafenib (targeted cancer therapies) versus placebo versions in patients who haven't had systemic anti-cancer treatment for their melanoma. It's a Phase III trial where participants are randomly assigned to either the drug combination or placebo group.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Atezolizumab Placebo + Cobimetinib + VemurafenibExperimental Treatment3 Interventions

Run-In Period (Cycle1=28 days): Participants will receive vemurafenib 960 milligrams (mg) (four, 240 mg tablets) orally (PO) twice a day (BID) along with cobimetinib 60 mg (three, 20 mg tablets) PO once a day (QD) on Days 1 to 21 followed by vemurafenib 960 mg (four, 240 mg tablets) PO BID on Days 22 to 28. Triple Combination Period (Cycle 1 onwards): Participants will receive ATZ placebo by intravenous (IV) infusion on Day 1 and 15, cobimetinib 60 mg (three, 20 mg tablets) PO QD on Days 1 to 21, and vemurafenib 960 mg (four, 240 mg tablets) PO BID on Days 1 to 28 of each 28-day cycle. Study treatment will continue until investigator-determined disease progression, death, unacceptable toxicity, withdrawal of consent, or pregnancy, whichever occurs first.

Group II: Atezolizumab + Cobimetinib + Vemurafenib + Vemurafenib PlaceboExperimental Treatment4 Interventions

Run-In Period (Cycle 1=28 days): Participants will receive vemurafenib 960 mg (four, 240 mg tablets) PO BID along with cobimetinib 60 mg (three, 20 mg tablets) PO QD on Days 1 to 21 followed by vemurafenib 720 mg (three, 240 mg tablets) PO BID on Days 22 to 28 and vemurafenib placebo (1 tablet) PO BID on Days 22 to 28. Triple Combination Period (Cycle 1 onwards): Participants will receive atezolizumab 840 mg IV infusion on Day 1 and 15, cobimetinib 60 mg (three, 20 mg tablets) PO QD on Days 1 to 21, vemurafenib 720 mg (three, 240 mg tablets) PO BID on Days 1 to 28, and vemurafenib placebo (1 tablet) PO BID on Days 1 to 28 of each 28-day cycle. Study treatment will continue until investigator-determined disease progression, death, unacceptable toxicity, withdrawal of consent, or pregnancy, whichever occurs first.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Hoffmann-La Roche

Lead Sponsor

Trials

2,482

Recruited

1,107,000+

Headquarters

Basel, Switzerland

Known For

Precision medicine