A Clinical Study of Calderasib (MK-1084) With Targeted Therapy and Chemotherapy in People With Colorectal Cancer (MK-1084-012/KANDLELIT-012) (NCT06997497)
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)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Los Angeles Hematology Oncology Medical Group ( Site 0084) — Los Angeles, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (232 Sites)
Showing the first 25 of 232 sites.
- Los Angeles Hematology Oncology Medical Group ( Site 0084) — Los Angeles, California
- UCLA Hematology/Oncology - Santa Monica ( Site 0088) — Santa Monica, 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
- Mayo Clinic in Florida ( Site 0092) — Jacksonville, Florida
- Orlando Health Cancer Institute ( Site 0065) — Orlando, Florida
- Florida Cancer Specialists - North ( Site 7001) — St. Petersburg, Florida
- Florida Cancer Specialists - East ( Site 7000) — West Palm Beach, Florida
- Piedmont Atlanta Hospital ( Site 2002) — Atlanta, Georgia
- Saint Alphonsus Regional Medical Center ( Site 0085) — Boise, Idaho
- Accellacare of Duly ( Site 2015) — Lisle, Illinois
- University of Iowa ( Site 0074) — Iowa City, Iowa
- University of Kentucky ( Site 0055) — Lexington, Kentucky
- Norton Cancer Institute, Audubon Hospital Campus ( Site 0054) — Louisville, Kentucky
- Greater Baltimore Medical Center ( Site 0068) — Baltimore, Maryland
- Mayo Clinic in Rochester, Minnesota ( Site 0091) — Rochester, Minnesota
- Hattiesburg Clinic ( Site 0064) — Hattiesburg, Mississippi
- Saint Luke's Cancer Institute ( Site 0082) — Kansas City, Missouri
- Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana ( Site 2000) — Billings, Montana
- University Of Nebraska Medical Center ( Site 0078) — Omaha, Nebraska
- Comprehensive Cancer Centers of Nevada ( Site 2026) — Las Vegas, Nevada
- Renown Regional Medical Center ( Site 0056) — Reno, Nevada
- John Theurer Cancer Center at Hackensack University Medical Center ( Site 0060) — Hackensack, New Jersey
- Atlantic Health System ( Site 0093) — Summit, New Jersey
📞 Contact the Study Coordinator
Phone: (888) 577-8839
Email: Trialsites@msd.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.