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

Titre officiel

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

Sommaire:

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).

Description de l'essai

Primary Outcome:

  • Recurrence-free survival (RFS)
Secondary Outcome:
  • Distant metastasis-free survival (DMFS)
  • Overall survival (OS)
  • Safety - Incidence, nature, severity and seriousness of treatment emergent adverse events (TEAEs)
  • Safety -Incidence, nature and severity of cutaneous malignancies by dermatological examination
  • Safety -Incidence of Serious adverse events (SAEs)
  • Safety and tolerability - Incidence of treatment-emergent adverse events (TEAEs) related to notable or abnormal changes in physical examination
  • Safety and tolerability - Incidence of treatment-emergent adverse events (TEAEs) related to notable or abnormal changes in vital signs
  • Safety and tolerability : Incidence of TEAEs related to notable changes in clinical safety laboratory parameters from baseline.
  • Safety and tolerability -Incidence of treatment-emergent adverse events (TEAEs) related to notable or abnormal changes from baseline of 12-lead electrocardiograms (ECGs)
  • Safety and tolerability - Incidence of treatment-emergent adverse events (TEAEs) related to notable or abnormal changes from baseline of echocardiogram or multigated acquisition (ECHO/MUGA) scans.
  • Safety and tolerability - Incidence of treatment-emergent adverse events (TEAEs) related to notable or abnormal changes in ophtalmic examination
  • Safety and tolerability-Treatment emergent adverse events (TEAEs) leading to dose interruption, reduction and discontinuation.
  • Performance status using the Eastern Co-operative Oncology Group (ECOG) performance status scale.
  • Patient-reported health-related (HRQoL)-European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) .
  • Patient-reported health-related (HRQoL)_European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer Patients (EORTC QLQ-C30)
  • Pharmacokinetic (PK) parameter of encorafenib and its metabolite (LHY746)_Cmin
  • Pharmacokinetic (PK) parameter of encorafenib and its metabolite (LHY746)-Cmax
  • Pharmacokinetic (PK) parameter of encorafenib and its metabolite (LHY746)_AUC
  • Pharmacokinetic (PK) parameter of binimetinib and its metabolite (AR00426032)-Cmin
  • Pharmacokinetic (PK) parameter of binimetinib and its metabolite (AR00426032)-Cmax
  • Pharmacokinetic (PK) parameter of binimetinib and its metabolite (AR00426032)-AUC

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/K status by central assay will be randomized 1 to 1 to receive either treatment with encorafenib and binimetinib or their two placebos for 12 months. Patients will be stratified according to the stage of the disease according to AJCC version 8 between:

  • stage IIB (i.e., pT3b or pT4a)
  • stage IIC (i.e., pT4b).

The long-term evaluation of all endpoints (including information about the occurrence of new treatment-related adverse events, if any) will take place 10 years from the randomization of the last patient.

Voir cet essai sur ClinicalTrials.gov

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