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)
- Colon Adenocarcinoma
- Rectal Adenocarcinoma
At a glance
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- Merck Sharp & Dohme LLC
- Enrolment target
- 477
- Started
- 16 July 2025
- Main results due
- 28 March 2029
- Study sites
- 239
- Registry updated
- 28 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
Inclusion Criteria: 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 Criteria: The main exclusion criteria include but are not limited to the following: * 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 uncontrolled, significant cardiovascular disease or cerebrovascular disease * Has known partial or complete dihydropyrimidine dehydrogenase (DPD) deficiency * HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease * 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 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 not adequately recovered from major surgery or have ongoing surgical complications * Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(239)
Mayo Clinic - Arizona ( Site 0090)
Phoenix, Arizona, United States
Recruiting
Orange Coast Memorial Medical Center ( Site 2007)
Fountain Valley, California, United States
Recruiting
Los Angeles Hematology Oncology Medical Group ( Site 0084)
Los Angeles, California, United States
Recruiting
UCLA Hematology/Oncology - Santa Monica ( Site 0088)
Santa Monica, California, United States
Recruiting
University of Colorado Health - Harmony-Cancer Care and Hematology - Ft. Collins ( Site 0087)
Fort Collins, Colorado, United States
Recruiting
Rocky Mountain Cancer Centers (RMCC) ( Site 8000)
Lone Tree, Colorado, United States
Recruiting
Florida Cancer Specialists - South ( Site 7002)
Fort Myers, Florida, United States
Recruiting
Mayo Clinic in Florida ( Site 0092)
Jacksonville, Florida, United States
Recruiting
Orlando Health Cancer Institute ( Site 0065)
Orlando, Florida, United States
Recruiting
Florida Cancer Specialists - North ( Site 7001)
St. Petersburg, Florida, United States
Recruiting
Florida Cancer Specialists - East ( Site 7000)
West Palm Beach, Florida, United States
Recruiting
Piedmont Atlanta Hospital ( Site 2002)
Atlanta, Georgia, United States
Recruiting
Saint Alphonsus Regional Medical Center ( Site 0085)
Boise, Idaho, United States
Recruiting
Endeavor Health ( Site 2027)
Evanston, Illinois, United States
Recruiting
Accellacare of Duly ( Site 2015)
Lisle, Illinois, United States
Recruiting
University of Iowa ( Site 0074)
Iowa City, Iowa, United States
Recruiting
University of Kentucky ( Site 0055)
Lexington, Kentucky, United States
Recruiting
Norton Cancer Institute, Audubon Hospital Campus ( Site 0054)
Louisville, Kentucky, United States
Recruiting
Greater Baltimore Medical Center ( Site 0068)
Baltimore, Maryland, United States
Recruiting
Mayo Clinic in Rochester, Minnesota ( Site 0091)
Rochester, Minnesota, United States
Recruiting
Hattiesburg Clinic ( Site 0064)
Hattiesburg, Mississippi, United States
Recruiting
Saint Luke's Cancer Institute ( Site 0082)
Kansas City, Missouri, United States
Recruiting
Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana ( Site 2000)
Billings, Montana, United States
Recruiting
University Of Nebraska Medical Center ( Site 0078)
Omaha, Nebraska, United States
Recruiting
Comprehensive Cancer Centers of Nevada ( Site 2026)
Las Vegas, Nevada, United States
Recruiting
Renown Regional Medical Center ( Site 0056)
Reno, Nevada, United States
Recruiting
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0060)
Hackensack, New Jersey, United States
Recruiting
Atlantic Health System ( Site 0093)
Summit, New Jersey, United States
Recruiting
San Juan Oncology Associates, P.C ( Site 2011)
Farmington, New Mexico, United States
Recruiting
Memorial Sloan Kettering Cancer Center ( Site 0095)
New York, New York, United States
Recruiting
Ellis Hospital ( Site 0098)
Schenectady, New York, United States
Recruiting
WakeMed Raleigh Campus ( Site 0094)
Raleigh, North Carolina, United States
Recruiting
Miami Valley Hospital South ( Site 0075)
Centerville, Ohio, United States
Recruiting
St. Luke's University Health Network ( Site 2014)
Easton, Pennsylvania, United States
Recruiting
UPMC Hillman Cancer Center ( Site 2024)
Pittsburgh, Pennsylvania, United States
Recruiting
Texas Oncology - DFW ( Site 8002)
Dallas, Texas, United States
Recruiting
UT Southwestern Medical Center ( Site 0059)
Dallas, Texas, United States
Recruiting
Texas Oncology - Northeast Texas ( Site 8001)
Denison, Texas, United States
Recruiting
Texas Oncology - San Antonio ( Site 8004)
San Antonio, Texas, United States
Recruiting
Community Cancer Trials of Utah ( Site 0086)
Ogden, Utah, United States
Recruiting
University of Virginia ( Site 0080)
Charlottesville, Virginia, United States
Recruiting
Virginia Cancer Specialists, PC ( Site 0069)
Fairfax, Virginia, United States
Recruiting
Fred Hutchinson Cancer Center ( Site 0076)
Seattle, Washington, United States
Recruiting
West Virginia University ( Site 2017)
Morgantown, West Virginia, United States
Recruiting
Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 0110)
Berazategui, Buenos Aires, Argentina
Recruiting
Hospital Italiano de Buenos Aires ( Site 0102)
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Recruiting
Instituto Alexander Fleming ( Site 0101)
Mar del Plata, Buenos Aires, Argentina
Recruiting
Fundacion Estudios Clinicos ( Site 0105)
Rosario, Santa Fe Province, Argentina
Recruiting
Sanatorio Parque ( Site 0103)
Rosario, Santa Fe Province, Argentina
Recruiting
Hospital Privado Universitario de Córdoba ( Site 0108)
Córdoba, Argentina
Recruiting
Wollongong Hospital ( Site 0453)
Wollongong, New South Wales, Australia
Recruiting
Sunshine Coast University Hospital ( Site 0451)
Birtinya, Queensland, Australia
Recruiting
Monash Health ( Site 0454)
Clayton, Victoria, Australia
Recruiting
Western Health-Sunshine & Footscray Hospitals ( Site 0450)
St Albans, Victoria, Australia
Recruiting
Hospital de Câncer de Recife ( Site 0158)
Recife, Pernambuco, Brazil
Recruiting
Hospital de Caridade de Ijuí ( Site 0150)
Ijuí, Rio Grande do Sul, Brazil
Recruiting
Associação Hospitalar Beneficente São Vicente de Paulo ( Site 0153)
Passo Fundo, Rio Grande do Sul, Brazil
Recruiting
Hospital Nossa Senhora da Conceição ( Site 0156)
Porto Alegre, Rio Grande do Sul, Brazil
Recruiting
CEPEN - Centro de Pesquisa e Ensino em Oncologia de Santa Catarina ( Site 0157)
Florianópolis, Santa Catarina, Brazil
Recruiting
Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0155)
Barretos, São Paulo, Brazil
Recruiting
Showing 60 of 239 sites — filter to narrow it down. 239 of the 239 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT06997497. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
Not the right study?
Answer three questions and see the studies recruiting near you, in plain language.
Find a study for me