A Clinical Study of Calderasib (MK-1084) With Targeted Therapy and Chemotherapy in People With Colorectal Cancer (MK-1084-012/KANDLELIT-012)

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 p

Trial Details

NCT ID
NCT06997497
Phase
PHASE3
Sponsor
Merck Sharp & Dohme LLC
Status
RECRUITING
Cancer Type
Colorectal Cancer
Interventions
  • Calderasib
  • Oxaliplatin
  • Leucovorin/levofolinate calcium
  • 5-Fluorouracil
  • Cetuximab
  • Bevacizumab
Locations (sample)
  • Los Angeles, California, United States|34.05223,-118.24368
  • Fort Myers, Florida, United States|26.62168,-81.84059
  • Orlando, Florida, United States|28.53834,-81.37924
  • St. Petersburg, Florida, United States|27.77086,-82.67927
  • West Palm Beach, Florida, United States|26.71534,-80.05337

Key Eligibility Criteria

  • The main inclusion criteria include but are not limited to the following:
  • Has a histologically confirmed diagnosis of locally advanced unresectable or metastatic (unresectable Stage III or Stage IV as defined by American …
  • Part 2 only: Has not received systemic anticancer therapy for locally advanced unresectable or metastatic colorectal cancer
  • Tumor tissue demonstrates presence of a Kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation

For full eligibility, visit ClinicalTrials.gov.

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