A Phase 3, Randomized, Open-label, Multicenter Clinical Study to Evaluate the Safety and Efficacy of MK-1084, Cetuximab, and mFOLFOX6 versus mFOLFOX6 With or Without Bevacizumab as First-line Treatment of Participants With KRAS G12C-mutant, Locally Advanced Unresectable or Metastatic Colorectal Cancer (KANDLELIT-012).

Condition studied

KRAS G12C-mutant, Locally Advanced Unresectable or Metastatic Colorectal Cancer

Investigational medicinal product(s)

Eligibility

Primary endpoint

Number of Participants Experiencing Dose-Limiting Toxicity (DLT), Part 1: Number of Participants Who Experience an Adverse Event (AE), Part 1: Number of Participants Who Discontinue Study Treatment Due to an AE, Progression-free Survival (PFS)

Endpoint detail

Objective Response Rate (ORR), Overall Survival (OS), Duration of Response (DOR), Part 2: Number of Participants Who Experience an AE, Part 2: Number of Participants Who Discontinue Study Treatment Due to an AE, Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score, Change from Baseline in the EORTC-QLQ-C30 Physical Functioning (Items 1-5) Score, Change from Baseline in the EORTC-QLQ-C30 Role Functioning (Items 6 and 7) Score, Change from Baseline in the EORTC-QLQ-C30 Appetite Loss (Item 13) Score, Change from Baseline in the EORTC-Quality of Life Questionnaire-Colorectal Cancer-Specific 29 Items (QLQ-CR29) Bloating (Item 37) Score, Time to First Deterioration (TTD) in EORTC QLQ-C30 Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score, TTD in EORTC QLQ-C30 Physical Functioning (Items 1-5) Score, TTD in EORTC QLQ-C30 Role Functioning (Items 6 and 7) Score, TTD in EORTC QLQ-C30 Appetite Loss (Item 13) Score, TTD in EORTC QLQ-CR29 Bloating (Item 37) Score