For Healthcare Professionals

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


About the study

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).

Who can take part

You may be eligible to participate in the study if you meet the following criteria:


Inclusion Criteria:


  1. Male or female ≥ 18 years of age;
  2. Surgically resected, with tumour free margins, and histologically/pathologically confirmed new diagnosis of stage II (pT3b-pT4bN0) cutaneous melanomaa;
  3. Sentinel node (SN) biopsy within 14 weeks from initial diagnosis of melanoma.
  4. Sentinel node (SN) staged node negative (pN0);
  5. Available tumour sample for central determination of the BRAF V600E/K mutation.


  1. Melanoma confirmed centrally to be BRAF V600E/K mutation-positive;
  2. Participant still free of disease as evidenced by the required baseline imaging and physical/dermatological assessments performed respectively within 6 weeks and 2 weeks before randomization (Day 1);
  3. No more than 12 weeks elapsed between full surgical resection (including SLNB) and randomization;
  4. Recovered from definitive surgery (e.g., complete wound healing, no uncontrolled wound infections or indwelling drains);
  5. ECOG performance status of 0 or 1;

Adequate haematological function as defined as Absolute neutrophil count (ANC) ≥ 1.5 x 109/L, Platelets ≥ 100 x 109/L and Hemoglobin

≥ 9.0 g/dL;

  1. Adequate renal function as defined as Serum creatinine ≤ 1.5 × ULN; or calculated creatinine clearance ≥ 50 mL/min;
  2. Adequate electrolytes, defined as serum potassium and magnesium levels within institutional normal limits;
  3. Adequate hepatic function as defined as Serum total bilirubin ≤ 1.5 x ULN and < 2 mg/dL, Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≤ 2.5 x ULN;
  4. Adequate cardiac function as defined as LVEF ≥ 50% as determined by MUGA scan or echocardiogram and Mean triplicate QTcF value ≤ 480 msec and no history of QT syndrome;
  5. Adequate coagulation function, defined as INR ≤1.5× ULN unless the patient is receiving anticoagulant therapy as long as PT or aPTT is within the therapeutic range;
  6. Negative serum β-HCG test (female patient of childbearing potential only) performed within 3 days prior to Day 1;
  7. Female patients of child-bearing potential and male patients must agree to follow the protocol's contraception guidance during the treatment period and for ≥30 days after last administration.


Exclusion Criteria:


  1. Unknown ulceration status;
  2. Uveal and mucosal melanoma;
  3. Clinically apparent metastases (N+/M1);
  4. Microsatellites, satellites and/or in-transit metastases,
  5. Local (scar) recurrences.


  1. Breast feeding women;
  2. Pregnant women;
  3. History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO;
  4. History of thromboembolic or cerebrovascular events ≤ 12 weeks prior to randomization;
  5. History of previous or concurrent malignancy within preceding 3 years or any condition with a life expectancy of less than 5 years;
  6. Participants with a prior cancer associated with RAS mutation;
  7. Prior systemic anticancer therapy for melanoma or radiotherapy for melanoma;
  8. Hypersensitivity to the study drugs or to any of the excipients;
  9. Participants with severe lactose intolerance (e.g., Rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption);
  10. Impaired cardiovascular function or clinically significant cardiovascular diseases;
  11. Neuromuscular disorders that are associated with CK > ULN (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy);
  12. Non-infectious pneumonitis and Interstitial Lung Disease;
  13. Positive SARs-CoV-2 or variants of SARs-CoV2 RT-PCR test at screening or suspected to be infected with SARs-CoV2 or variants of SARsCoV2 with confirmation pending;
  14. Active bacterial, fungal, or viral infection, including, but not limited to HBV, HCV, and known HIV or AIDS-related illness, or an infection requiring systemic therapeutic treatment within 2 weeks prior to randomization.

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Study Locations

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How to Apply

Contact the study center to learn if this study is a good match for you.

Study’s details



Age (in years)



Phase 3

Participants needed


Est. Completion Date

May 2, 2035

Treatment type



Pierre Fabre Medicament identifier


Study number


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