Clinical Trial

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

Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
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.
Protocol Amendment History 14 changes
notable Trial sites expanded: 220 -> 223 locations 2026-08-08
notable Trial sites expanded: 217 -> 220 locations 2026-08-04
notable Trial sites expanded: 211 -> 215 locations 2026-07-21
notable Trial sites expanded: 200 -> 211 locations 2026-07-11
notable Trial sites expanded: 196 -> 200 locations 2026-06-16
notable Trial sites expanded: 192 -> 196 locations 2026-06-09
notable Trial sites expanded: 187 -> 192 locations 2026-05-30
notable Trial sites expanded: 180 -> 187 locations 2026-05-27
notable Trial sites expanded: 161 -> 180 locations 2026-05-15
notable Trial sites expanded: 152 -> 161 locations 2026-04-29
notable Trial sites expanded: 148 -> 152 locations 2026-04-21
notable Trial sites expanded: 143 -> 148 locations 2026-04-14
notable Trial sites expanded: 137 -> 143 locations 2026-04-04
notable Trial sites expanded: 133 -> 137 locations 2026-03-31
Trial Details
NCT Number NCT06997497
Lead Sponsor Merck Sharp & Dohme LLC
Conditions Colon Adenocarcinoma, Rectal Adenocarcinoma
Enrollment 477 participants
Start Date 2025-07-16
Primary Completion 2029-03-28 (estimated)
Study Completion 2030-10-27 (estimated)
Updated on ClinicalTrials.gov 2026-08-07