Tests calderasib with chemotherapy and cetuximab in colorectal cancer
Tests calderasib with chemotherapy in adults with KRAS G12C colorectal cancer.
Plain-language title generated from the registry record
Registry title: A Clinical Study of Calderasib (MK-1084) With Targeted Therapy and Chemotherapy in People With Colorectal Cancer (MK-1084-012/KANDLELIT-012)
Key facts
- Where
- Atlanta, Baltimore, Billings, Boise, Centerville, Charlottesville, Cincinnati, Dallas, Denison, Easton, Evanston, Fairfax, Farmington, Fort Collins, Fort Myers, Fountain Valley, Hackensack, Hattiesburg, Iowa City, Jacksonville, Kansas City, Las Vegas, Lexington, Lisle, Lone Tree, Los Angeles, Louisville, Milwaukee, Morgantown, New York, Ogden, Omaha, Orlando, Phoenix, Pittsburgh, Raleigh, Reno, Rochester, Sacramento, San Antonio, Santa Monica, Schenectady, Seattle, St. Petersburg, Summit, Toledo, and West Palm Beach, United StatesSee the 49 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Has a test of your tumour shown a change (mutation) in the KRAS, NRAS or BRAF genes?
Source: NCT06997497, who can take part
Where in United States
- Piedmont Atlanta Hospital (Site 2002)Atlanta, United StatesTaking people
- Greater Baltimore Medical Center (Site 0068)Baltimore, United StatesTaking people
- University of Maryland (Site 2016)Baltimore, United StatesTaking people
- Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana (Site 2000)Billings, United StatesTaking people
- Saint Alphonsus Regional Medical Center (Site 0085)Boise, United StatesTaking people
- Miami Valley Hospital South (Site 0075)Centerville, United StatesTaking people
- University of Virginia (Site 0080)Charlottesville, United StatesTaking people
- University of Cincinnati Medical Center (Site 2005)Cincinnati, United StatesTaking people
- Texas Oncology - DFW (Site 8002)Dallas, United StatesTaking people
- UT Southwestern Medical Center (Site 0059)Dallas, United StatesTaking people
- Texas Oncology - Northeast Texas (Site 8001)Denison, United StatesTaking people
- St. Luke's University Health Network (Site 2014)Easton, United StatesTaking people
- Endeavor Health (Site 2027)Evanston, United StatesTaking people
- Virginia Cancer Specialists, PC (Site 0069)Fairfax, United StatesTaking people
- San Juan Oncology Associates, P.C (Site 2011)Farmington, United StatesTaking people
- University of Colorado Health - Harmony-Cancer Care and Hematology - Ft. Collins (Site 0087)Fort Collins, United StatesTaking people
- Florida Cancer Specialists - South (Site 7002)Fort Myers, United StatesTaking people
- Orange Coast Memorial Medical Center (Site 2007)Fountain Valley, United StatesTaking people
- John Theurer Cancer Center at Hackensack University Medical Center (Site 0060)Hackensack, United StatesTaking people
- Hattiesburg Clinic (Site 0064)Hattiesburg, United StatesTaking people
- University of Iowa (Site 0074)Iowa City, United StatesTaking people
- Mayo Clinic in Florida (Site 0092)Jacksonville, United StatesTaking people
- Saint Luke's Cancer Institute (Site 0082)Kansas City, United StatesTaking people
- Comprehensive Cancer Centers of Nevada (Site 2026)Las Vegas, United StatesTaking people
- University of Kentucky (Site 0055)Lexington, United StatesTaking people
- Accellacare of Duly (Site 2015)Lisle, United StatesTaking people
- Rocky Mountain Cancer Centers (RMCC) (Site 8000)Lone Tree, United StatesTaking people
- Los Angeles Hematology Oncology Medical Group (Site 0084)Los Angeles, United StatesTaking people
- Norton Cancer Institute, Audubon Hospital Campus (Site 0054)Louisville, United StatesTaking people
- Medical College of Wisconsin (Site 2003)Milwaukee, United StatesTaking people
- West Virginia University (Site 2017)Morgantown, United StatesTaking people
- Memorial Sloan Kettering Cancer Center (Site 0095)New York, United StatesTaking people
- Community Cancer Trials of Utah (Site 0086)Ogden, United StatesTaking people
- University Of Nebraska Medical Center (Site 0078)Omaha, United StatesTaking people
- Orlando Health Cancer Institute (Site 0065)Orlando, United StatesTaking people
- Mayo Clinic - Arizona (Site 0090)Phoenix, United StatesTaking people
- UPMC Hillman Cancer Center (Site 2024)Pittsburgh, United StatesTaking people
- WakeMed Raleigh Campus (Site 0094)Raleigh, United StatesTaking people
- Renown Regional Medical Center (Site 0056)Reno, United StatesTaking people
- Mayo Clinic in Rochester, Minnesota (Site 0091)Rochester, United StatesTaking people
- University of California Davis (UC Davis) Comprehensive Cancer Center (Site 2021)Sacramento, United StatesTaking people
- Texas Oncology - San Antonio (Site 8004)San Antonio, United StatesTaking people
- UCLA Hematology/Oncology - Santa Monica (Site 0088)Santa Monica, United StatesTaking people
- Ellis Hospital (Site 0098)Schenectady, United StatesTaking people
- Fred Hutchinson Cancer Center (Site 0076)Seattle, United StatesTaking people
- Florida Cancer Specialists - North (Site 7001)St. Petersburg, United StatesTaking people
- Atlantic Health System (Site 0093)Summit, United StatesTaking people
- University of Toledo Medical Center (Site 2001)Toledo, United StatesTaking people
- Florida Cancer Specialists - East (Site 7000)West Palm Beach, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Merck Sharp & Dohme LLC
- Trial code
- NCT06997497EU 2024-517232-22-00
- Record updated
- 4 November 2026
- Original description
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.Read full original descriptionShow less
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)
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.
Inclusion: 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 Joint Committee on Cancer [AJCC] eighth edition) colorectal adenocarcinoma; Part 2 only: Has not received systemic anticancer therapy for locally advanced unresectable or metastatic colorectal cancer; an exception is permitted for 1-2 cycles of FOLFOX or 1 cycle of CAPOX as optional chemotherapy before or during the screening period; Demonstrates presence of a Kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation; Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART); Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy and have undetectable HBV viral load; Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable.
Exclusion: Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, chronic diarrhea); Has received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization, with the exception of the optional chemotherapy; Has 1 or more conditions that, in the opinion of the investigator, make the participant ineligible for treatment with bevacizumab; Has not adequately recovered from major surgery or have ongoing surgical complications; Has uncontrolled, significant cardiovascular disease or cerebrovascular disease; HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease; Has known additional malignancy that is progressing or has required active treatment within the past 3 years; Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis or leptomeningeal disease; Has active infection requiring systemic therapy; Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease; The main exclusion criteria include but are not limited to the following:; Has known partial or complete dihydropyrimidine dehydrogenase (DPD) deficiency.