Status:
ACTIVE_NOT_RECRUITING
Adjuvant Encorafenib and Binimetinib in High-risk Stage II Melanoma With a BRAF Mutation.
Lead Sponsor:
Pierre Fabre Medicament
Collaborating Sponsors:
European Organisation for Research and Treatment of Cancer - EORTC
Conditions:
Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ...
Detailed Description
This is a randomized triple-blind placebo-controlled international multicenter phase III superiority clinical trial. Participants with completely resected cutaneous melanoma and documented BRAF V600E...
Eligibility Criteria
Inclusion
- Pre-Screening
- 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.
- Screening
- 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.
Exclusion
- Pre-screening
- Unknown ulceration status;
- Uveal and mucosal melanoma;
- Clinically apparent metastases (N+/M1);
- Microsatellites, satellites and/or in-transit metastases,
- Local (scar) recurrences.
- Screening
- 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.
Key Trial Info
Start Date :
May 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 2 2035
Estimated Enrollment :
815 Patients enrolled
Trial Details
Trial ID
NCT05270044
Start Date
May 2 2022
End Date
May 2 2035
Last Update
November 22 2023
Active Locations (155)
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1
Centro Oncologico Korben
CABA, Buenos Aires, Argentina, C1426
2
Centro de Investigaciones Medicas Mar del Plata
Mar del Plata, Buenos Aires, Argentina, B7600FYK
3
Fundacion CIDEA
Ciudad Autonoma Bs As, Ciudad Autonoma Buenos Aires, Argentina, C1121ABE
4
Sanatorio Britanico S.A.
Rosario, Santa Fe Province, Argentina, 2000