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OncoMatch/Clinical Trials/NCT06997497

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

Is NCT06997497 recruiting? Yes, currently enrolling (Sep 2026). This Phase 3 trial studies multiple treatments for colon adenocarcinoma.

Phase 3RecruitingMerck Sharp & Dohme LLCNCT06997497Data as of Sep 2026Location: International · 28 countries

Treatment: Calderasib · Oxaliplatin · Leucovorin/levofolinate calcium · 5-Fluorouracil · Cetuximab · Bevacizumab · Bevacizumab biosimilarResearchers 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.

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Extracted eligibility criteria

Treatments studied

Targeted therapy

CetuximabBevacizumabBevacizumab biosimilar

Chemotherapy

Oxaliplatin5-Fluorouracil

Other

CalderasibLeucovorin/levofolinate calcium

Cancer type

Colorectal Cancer

Biomarker criteria

Required: KRAS g12c

Disease stage

Required: Stage UNRESECTABLE STAGE III, STAGE IV

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Los Angeles Hematology Oncology Medical Group ( Site 0084) · Los Angeles, California
  • University of Colorado Health - Harmony-Cancer Care and Hematology - Ft. Collins ( Site 0087) · Fort Collins, Colorado
  • Rocky Mountain Cancer Centers (RMCC) ( Site 8000) · Lone Tree, Colorado
  • Florida Cancer Specialists - South ( Site 7002) · Fort Myers, Florida
  • Orlando Health Cancer Institute ( Site 0065) · Orlando, Florida

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See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT06997497 currently recruiting?

Yes, this trial is currently recruiting patients.

Does this trial require KRAS?

Yes, KRAS g12c is a required biomarker for enrollment.

What disease stage is eligible?

Stage UNRESECTABLE STAGE III or STAGE IV is required.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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