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Colon AdenocarcinomaGeneticsCancerDrugBiologicalPhase 3

What this study is

Researchers are looking for other ways to treat locally advanced or metastatic colorectal cancer (mCRC) that is unresectable and has a gene mutation called KRAS G12C.

Standard (or usual) treatments for this type of colorectal cancer may include mFOLFOX6 with or without bevacizumab. Researchers want to learn if adding calderasib (the study medicine) and cetuximab to mFOLFOX6 can treat locally advanced or mCRC with the KRAS G12C mutation. Calderasib and cetuximab are targeted therapies.

The goals of this study are to learn:

  • About the safety of calderasib with cetuximab and mFOLFOX6 and if people tolerate the treatments
  • If people who receive calderasib with cetuximab and mFOLFOX6 live longer without mCRC growing or spreading compared to people who receive mFOLFOX6 with or without bevacizumab.

What's being tested

  • Calderasib

    Intervention · DRUG

    Oral tablet

  • Oxaliplatin

    Intervention · DRUG

  • Leucovorin/levofolinate calcium

    Intervention · DRUG

  • 5-Fluorouracil

    Intervention · DRUG

  • Cetuximab

    Intervention · BIOLOGICAL

  • Bevacizumab

    Intervention · DRUG

  • Bevacizumab biosimilar

    Intervention · DRUG

All of Oxaliplatin, Leucovorin/levofolinate calcium, 5-Fluorouracil, Cetuximab, Bevacizumab, Bevacizumab biosimilar

Per label

Study details

Official title
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)
Sponsor
Merck Sharp & Dohme LLC
Conditions
Colon Adenocarcinoma · Rectal Adenocarcinoma
Enrolling
477 people
Starts
2025-07-16
Est. completion
2030-10-27
Design
Single-blind, randomized, parallel groups, Phase 3
Record
View on ClinicalTrials.gov ↗