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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 6.0 years from first patient in

Awards & highlights

COLUMBUS-AD 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.Check my eligibility

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.See study design

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.

COLUMBUS-AD Trial 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.

COLUMBUS-AD Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 6.0 years from first patient in

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Recurrence-free survival (RFS)

Secondary outcome measures

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

COLUMBUS-AD 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

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

Pierre Fabre MedicamentLead Sponsor

74 Previous Clinical Trials

18,097 Total Patients Enrolled

8 Trials studying Melanoma

697 Patients Enrolled for Melanoma

European Organisation for Research and Treatment of Cancer - EORTCNETWORK

412 Previous Clinical Trials

164,269 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA cleared Encorafenib and Binimetinib for use?

"Encorafenib and Binimetinib have both gone through multiple rounds of testing, meaning that there is significant safety data for these drugs. As such, our team has rated their safety a 3."

Answered by AI

Are we still admitting patients to this trial?

"The study is still recruiting patients, if the information found on clinicaltrials.gov is accurate. That website indicates that the trial was originally posted on May 2nd, 2020 and last edited November 8th, 2020."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Adjuvant Encorafenib and Binimetinib in High-risk Stage II Melanoma With a BRAF Mutation.

2022. "Adjuvant Encorafenib and Binimetinib in High-risk Stage II Melanoma With a BRAF Mutation.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05270044.