Trials / Recruiting
RecruitingNCT06997497
A Clinical Study of Calderasib (MK-1084) With Targeted Therapy and Chemotherapy in People With Colorectal Cancer (MK-1084-012/KANDLELIT-012)
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)
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 477 (estimated)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
This study will have 2 parts.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Calderasib | Oral tablet |
| DRUG | Oxaliplatin | Per label |
| DRUG | Leucovorin/levofolinate calcium | Per label |
| DRUG | 5-Fluorouracil | Per label |
| BIOLOGICAL | Cetuximab | Per label |
| DRUG | Bevacizumab | Per label |
| DRUG | Bevacizumab biosimilar | Per label |
Timeline
- Start date
- 2025-07-16
- Primary completion
- 2029-03-28
- Completion
- 2030-10-27
- First posted
- 2025-05-30
- Last updated
- 2026-04-13
Locations
148 sites across 25 countries: United States, Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Finland, France, Germany, Hong Kong, Hungary, Israel, Italy, Japan, Netherlands, Poland, Romania, Singapore, South Korea, Spain, Taiwan, Ukraine, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06997497. Inclusion in this directory is not an endorsement.