Encorafenib + Binimetinib for Melanoma
(COLUMBUS-AD Trial)

Recruiting in Palo Alto (17 mi)

+179 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Pierre Fabre Medicament

Stay on Your Current Meds

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The purpose of the Columbus-AD study is to evaluate the efficacy and safety of 12 months of encorafenib in combination with binimetinib in adjuvant setting of BRAF V600E/K mutant stage IIB/C melanoma versus the current standard of care (surveillance).

Research Team

Alexander C.J. van AKKOOI, MD, PhD

Principal Investigator

European Organisation for Research and Treatment of Cancer - EORTC

Eligibility Criteria

Adults over 18 with high-risk Stage II melanoma that has a BRAF mutation, who've had surgery recently and are disease-free. They must have good organ function, agree to contraception if applicable, and not be pregnant or breastfeeding. Excluded are those with other cancers in the last 3 years, certain heart conditions, severe infections or lactose intolerance.

Inclusion Criteria

My melanoma has a BRAF V600 mutation.

My melanoma was surgically removed with clear margins and is stage II.

My blood counts for neutrophils, platelets, and hemoglobin are within the required range.

See 15 more

Exclusion Criteria

I have or am at risk for blocked veins in my eye.

I have not had another cancer or a condition shortening my life to under 5 years in the last 3 years.

My cancer has spread to lymph nodes or other parts of my body.

See 15 more

Treatment Details

Interventions

Binimetinib (Kinase Inhibitor)
Encorafenib (Kinase Inhibitor)

Trial OverviewThe trial is testing whether taking Encorafenib and Binimetinib for one year after surgery can prevent melanoma from coming back better than just watching and waiting (surveillance). Participants will either receive the drugs or placebo versions without knowing which they're getting.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm AExperimental Treatment1 Intervention

Encorafenib and Binimetinib

Group II: Arm BPlacebo Group1 Intervention

Placebo to match Encorafenib Placebo to match Binimetinib