815 Participants Needed

Encorafenib + Binimetinib for Melanoma

(COLUMBUS-AD Trial)

Recruiting at 179 trial locations
IK
Overseen ByIsabelle Klauck, MD
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Pierre Fabre Medicament
Stay on Your Current MedsYou can continue your current medications while participating
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on anticoagulant therapy, you may continue as long as your blood tests are within the therapeutic range.

What data supports the effectiveness of the drug combination of Encorafenib and Binimetinib for melanoma?

The combination of Encorafenib and Binimetinib has shown to improve overall survival in patients with advanced BRAF mutation-positive melanoma, achieving a median overall survival of 33.6 months, which is longer than other similar drug combinations. Additionally, this combination may have fewer side effects like fever and sensitivity to sunlight, making it a potentially better option for patients.12345

Is the combination of Encorafenib and Binimetinib safe for humans?

The combination of Encorafenib and Binimetinib has shown an acceptable safety profile in patients with certain types of melanoma and non-small-cell lung cancer, although some patients may experience side effects like visual symptoms.26789

How is the drug combination of encorafenib and binimetinib unique for treating melanoma?

The drug combination of encorafenib and binimetinib is unique for treating melanoma because it targets specific mutations in the BRAF gene, offering improved overall survival and progression-free survival compared to other treatments. It also has fewer side effects like fever and skin sensitivity, making it more tolerable for patients.12345

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

AC

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 14 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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive encorafenib and binimetinib or placebo for 12 months

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 years

Treatment Details

Interventions

  • Binimetinib
  • Encorafenib
Trial Overview 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.
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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Pierre Fabre Medicament

Lead Sponsor

Trials
83
Recruited
90,400+

Marie-Andrée Gamache

Pierre Fabre Medicament

Chief Executive Officer

MBA from HEC Montréal

Dr. Núria Perez-Cullell

Pierre Fabre Medicament

Chief Medical Officer since 2022

PhD in Pharmacy from the University of Barcelona

European Organisation for Research and Treatment of Cancer - EORTC

Collaborator

Trials
417
Recruited
166,000+

Findings from Research

In a 5-year study of patients with advanced BRAF V600-mutant melanoma, those treated with the combination of encorafenib and binimetinib (COMBO group) had a longer duration of survival without disease progression compared to those receiving either encorafenib alone or vemurafenib.
The combination treatment also resulted in fewer patients needing additional anticancer therapies after treatment, and while side effects were similar across all groups, they decreased over time for the COMBO group.
COLUMBUS 5-year update: a randomized, open-label, phase III trial of encorafenib plus binimetinib versus vemurafenib or encorafenib in patients with BRAF.Dummer, R., Flaherty, KT., Robert, C., et al.[2023]
Encorafenib and binimetinib, a combination of a BRAF inhibitor and a MEK inhibitor, received FDA approval in June 2018 for treating patients with unresectable or metastatic melanoma that has specific BRAF mutations (V600E or V600K).
The combination therapy is also being explored in ongoing phase III clinical trials for metastatic colorectal cancer, indicating its potential broader application beyond melanoma.
Encorafenib and Binimetinib: First Global Approvals.Shirley, M.[2019]
The combination of encorafenib and binimetinib has shown a median overall survival of 33.6 months in patients with advanced BRAFV600 mutation-positive melanoma, outperforming other BRAF/MEK inhibitor combinations that achieved 22 months.
Encorafenib's unique pharmacokinetics allow for prolonged binding and greater BRAF inhibition, which may lead to improved efficacy and better tolerability, with fewer side effects like pyrexia and photosensitivity.
Encorafenib in combination with binimetinib for unresectable or metastatic melanoma with BRAF mutations.Trojaniello, C., Festino, L., Vanella, V., et al.[2019]

References

COLUMBUS 5-year update: a randomized, open-label, phase III trial of encorafenib plus binimetinib versus vemurafenib or encorafenib in patients with BRAF. [2023]
Encorafenib and Binimetinib: First Global Approvals. [2019]
Encorafenib in combination with binimetinib for unresectable or metastatic melanoma with BRAF mutations. [2019]
Overall survival in patients with BRAF-mutant melanoma receiving encorafenib plus binimetinib versus vemurafenib or encorafenib (COLUMBUS): a multicentre, open-label, randomised, phase 3 trial. [2019]
[Long-term efficacy of encorafenib plus binimetinib combined treatment: case report.] [2021]
Phase II, Open-Label Study of Encorafenib Plus Binimetinib in Patients With BRAFV600-Mutant Metastatic Non-Small-Cell Lung Cancer. [2023]
Quality of life in patients with BRAF-mutant melanoma receiving the combination encorafenib plus binimetinib: Results from a multicentre, open-label, randomised, phase III study (COLUMBUS). [2021]
Encorafenib and binimetinib for the treatment of BRAF V600E/K-mutated melanoma. [2019]
Visual symptoms in a patient treated with MEK inhibitors. [2022]
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