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RecruitingLast updated: 17 October 2023

COLUMBUS-AD: This phase III study is evaluating how safe and effective combination targeted therapy (Encorafenib and Binimetinib), compared to a targeted therapy combined with a placebo (Binimetinib and placebo), is in people with melanoma who have had prior surgeryAdjuvant Encorafenib & Binimetinib vs. Placebo in Fully Resected Stage IIB/C BRAF V600E/K Mutated Melanoma: a Randomized Triple-blind Phase III Study in Collaboration With the EORTC Melanoma Group

Clinical summary


Eligible participants will be randomly allocated to either the Experimental Arm or the Placebo Comparator Arm. In the Experimental Arm, participants will receive encorafenib (450mg, once daily) and binimetinib (45mg, twice daily) orally for a maximum of 12 months. In the Placebo Comparator Arm, participants will receive a placebo to match encorafenib (once daily) and binimetinib (45mg, twice daily) orally for a maximum of 12 months.


This trial is treating patients with melanoma with BRAF V600/K mutation.


Skin Cancers Skin





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Scientific Title

Adjuvant Encorafenib & Binimetinib vs. Placebo in Fully Resected Stage IIB/C BRAF V600E/K Mutated Melanoma: a Randomized Triple-blind Phase III Study in Collaboration With the EORTC Melanoma Group




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


  • Melanoma confirmed centrally to be BRAF V600E/K mutation-positive;
  • 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);
  • No more than 12 weeks elapsed between full surgical resection (including SLNB) and randomization;
  • Recovered from definitive surgery (e.g., complete wound healing, no uncontrolled wound infections or indwelling drains);
  • 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;

  • Adequate renal function as defined as Serum creatinine ≤ 1.5 × ULN; or calculated creatinine clearance ≥ 50 mL/min;
  • Adequate electrolytes, defined as serum potassium and magnesium levels within institutional normal limits;
  • 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;
  • 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;
  • 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;
  • Negative serum β-HCG test (female patient of childbearing potential only) performed within 3 days prior to Day 1;
  • 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.



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


  • Breast feeding women;
  • Pregnant women;
  • History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO;
  • History of thromboembolic or cerebrovascular events ≤ 12 weeks prior to randomization;
  • History of previous or concurrent malignancy within preceding 3 years or any condition with a life expectancy of less than 5 years;
  • Participants with a prior cancer associated with RAS mutation;
  • Prior systemic anticancer therapy for melanoma or radiotherapy for melanoma;
  • Hypersensitivity to the study drugs or to any of the excipients;
  • Participants with severe lactose intolerance (e.g., Rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption);
  • Impaired cardiovascular function or clinically significant cardiovascular diseases;
  • Neuromuscular disorders that are associated with CK > ULN (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy);
  • Non-infectious pneumonitis and Interstitial Lung Disease;
  • 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;
  • 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.


  • You are able to swallow medication by mouth.
  • You have had a certain type of treatment or surgical procedure.


  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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