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Encorafenib + Binimetinib for Melanoma (COLUMBUS-AD Trial)

Phase 3
Waitlist Available
Research Sponsored by Pierre Fabre Medicament
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Melanoma confirmed centrally to be BRAF V600E/K mutation-positive
Surgically resected, with tumour free margins, and histologically/pathologically confirmed new diagnosis of stage II (pT3b-pT4bN0) cutaneous melanoma
Must not have
History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO
History of previous or concurrent malignancy within preceding 3 years or any condition with a life expectancy of less than 5 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 6.0 years from first patient in
Awards & highlights
Pivotal Trial

Summary

This trial will compare the effectiveness of a new combination therapy versus surveillance for people with stage IIB/C melanoma.

Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
Possible side effects of Encorafenib and Binimetinib include fatigue, skin rash, vision changes, abnormal liver tests, high blood pressure, muscle pain or weakness. Serious but less common side effects may involve heart problems or severe bleeding.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My melanoma has a BRAF V600 mutation.
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My melanoma was surgically removed with clear margins and is stage II.
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My blood counts for neutrophils, platelets, and hemoglobin are within the required range.
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My cancer has not spread to my lymph nodes.
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I am fully active or can carry out light work.
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My kidney function is within the normal range.
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My heart functions well, with a good ejection fraction and no QT syndrome.
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I have fully recovered from my surgery with no ongoing wound issues.
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My liver is functioning within the required limits.
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My tumor sample can be tested for the BRAF V600 mutation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have or am at risk for blocked veins in my eye.
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I have not had another cancer or a condition shortening my life to under 5 years in the last 3 years.
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My cancer has spread to lymph nodes or other parts of my body.
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I had cancer before that was linked to a RAS mutation.
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I have heart problems or significant heart disease.
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I do not have any active infections, including HBV, HCV, HIV/AIDS, or any needing treatment in the last 2 weeks.
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I do not have lung inflammation caused by infections or lung disease with scarring.
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My cancer has spread to nearby skin or lymph nodes.
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My melanoma is in the eye (uveal) or in mucous membranes.
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I have a muscle disorder with higher than normal CK levels.
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I have tested positive for COVID-19 or am suspected to have it, with confirmation pending.
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I have received treatment for melanoma before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 6.0 years from first patient in
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 6.0 years from first patient in for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Recurrence-free survival (RFS)
Secondary study objectives
Distant metastasis-free survival (DMFS)
Overall survival (OS)
Patient-reported health-related (HRQoL)-European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) .
+18 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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

Find a Location

Who is running the clinical trial?

Pierre Fabre MedicamentLead Sponsor
79 Previous Clinical Trials
19,186 Total Patients Enrolled
9 Trials studying Melanoma
957 Patients Enrolled for Melanoma
European Organisation for Research and Treatment of Cancer - EORTCNETWORK
414 Previous Clinical Trials
164,866 Total Patients Enrolled
19 Trials studying Melanoma
5,994 Patients Enrolled for Melanoma
Alexander C.J. van AKKOOI, MD, PhDStudy ChairEuropean Organisation for Research and Treatment of Cancer - EORTC

Media Library

Encorafenib and Binimetinib Clinical Trial Eligibility Overview. Trial Name: NCT05270044 — Phase 3
Melanoma Research Study Groups: Arm A, Arm B
Melanoma Clinical Trial 2023: Encorafenib and Binimetinib Highlights & Side Effects. Trial Name: NCT05270044 — Phase 3
Encorafenib and Binimetinib 2023 Treatment Timeline for Medical Study. Trial Name: NCT05270044 — Phase 3
~393 spots leftby Mar 2027
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