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

NCT05270044 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 815

Last updated 2023-11-22

No results posted yet for this study

Summary

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).

Conditions

Interventions

DRUG

Encorafenib and Binimetinib

Encorafenib 450 mg (6 × 75 mg capsules) once daily (QD) and binimetinib 45 mg (3 x 15 mg tablets) twice daily (BID) orally for a maximum of 12 months.

DRUG

Placebo to match Encorafenib ; Placebo to match Binimetinib

Encorafenib (6 × 75 mg placebo capsules) QD and binimetinib (3 × 15 mg placebo tablets) BID placebos orally for a maximum of 12 months.

Sponsors & Collaborators

  • European Organisation for Research and Treatment of Cancer - EORTC

    collaborator NETWORK

  • Pierre Fabre Medicament

    lead INDUSTRY

Principal Investigators

  • Alexander C.J. van AKKOOI, MD, PhD · European Organisation for Research and Treatment of Cancer - EORTC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-02
Primary Completion
2027-03-31
Completion
2035-05-02

Countries

  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Canada
  • Czechia
  • France
  • Germany
  • Greece
  • Hungary
  • Italy
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Serbia
  • South Africa
  • Spain
  • Sweden
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05270044 on ClinicalTrials.gov