Triple Drug Therapy for Advanced Melanoma

Recruiting in Palo Alto (17 mi)

+250 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Pfizer

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial is testing a combination of three drugs to treat advanced skin cancer in patients with a specific genetic mutation. One drug helps the immune system fight cancer, while the other two stop cancer cells from growing. The study aims to see if this combination is safe and effective.

Eligibility Criteria

Adults with advanced or metastatic melanoma that has a specific BRAF gene mutation and no prior treatment for their condition. They must be able to follow the study plan, have at least one measurable lesion, proper organ function, and an ECOG status of 0 or 1. Exclusions include significant heart disease history, recent serious blood clots or strokes, active infections requiring treatment, brain metastases involvement, certain medication use within specified timeframes before the trial starts.

Inclusion Criteria

You have at least one detectable abnormality that can be seen on a scan or in a photo according to certain guidelines.

My melanoma has a BRAF V600 mutation confirmed by a certified test.

I haven't had systemic therapy for advanced melanoma.

Exclusion Criteria

You have signs of hepatitis B or C virus infection.

Pregnant, confirmed by a positive β-hCG laboratory test result, or is breastfeeding (lactating)

I haven't had any cancer except for certain skin, prostate, or cervical pre-cancers in the last 2 years.

Treatment Details

Interventions

• Binimetinib (Kinase Inhibitor)
• Encorafenib (Kinase Inhibitor)
• Pembrolizumab (PD-1 Inhibitor)

Trial Overview The trial is testing a combination of three drugs: Encorafenib and Binimetinib taken orally daily at home along with Pembrolizumab given via IV every three weeks in the clinic. The goal is to assess their effectiveness when used together against melanoma that hasn't been treated before.

Participant Groups

Group I: Triplet Arm Experimental Treatment 3 Interventions

Encorafenib and Binimetinib in combination with Pembrolizumab

Group II: Control Arm Active Control 1 Intervention

Pembrolizumab

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

🇺🇸 Approved in United States as Mektovi for:

• Unresectable or metastatic melanoma with a BRAF V600E or V600K mutation

🇪🇺 Approved in European Union as Mektovi for:

• Unresectable or metastatic melanoma with a BRAF V600 mutation

🇨🇦 Approved in Canada as Mektovi for:

• Unresectable or metastatic melanoma with a BRAF V600E or V600K mutation

🇯🇵 Approved in Japan as Mektovi for:

• Unresectable or metastatic melanoma with a BRAF V600 mutation

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

The University of Arizona Cancer Center - North Campus Tucson, AZ

AdventHealth Hematology and Oncology Orlando, FL

Baylor Scott and White Medical Center-Temple Temple, TX

GenesisCare USA Aventura, FL

More Trial Locations

Who Is Running the Clinical Trial?

Pfizer Lead Sponsor

Merck Sharp & Dohme LLC Industry Sponsor

References