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RECRUITING

NCT06997497

PHASE3

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

Sponsor: Merck Sharp & Dohme LLC

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

477

Start Date

2025-07-16

Completion Date

2030-10-27

Last Updated

2026-10-07

Healthy Volunteers

Conditions

Colon Adenocarcinoma Rectal Adenocarcinoma

Interventions

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

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

Locations (244)

Mayo Clinic - Arizona ( Site 0090)

Phoenix, Arizona, United States

Orange Coast Memorial Medical Center ( Site 2007)

Fountain Valley, California, United States

Los Angeles Hematology Oncology Medical Group ( Site 0084)

Los Angeles, California, United States

University of California Davis (UC Davis) Comprehensive Cancer Center ( Site 2021)

Sacramento, California, United States

UCLA Hematology/Oncology - Santa Monica ( Site 0088)

Santa Monica, California, United States

University of Colorado Health - Harmony-Cancer Care and Hematology - Ft. Collins ( Site 0087)

Fort Collins, Colorado, United States

Rocky Mountain Cancer Centers (RMCC) ( Site 8000)

Lone Tree, Colorado, United States

Florida Cancer Specialists - South ( Site 7002)

Fort Myers, Florida, United States

Mayo Clinic in Florida ( Site 0092)

Jacksonville, Florida, United States

Orlando Health Cancer Institute ( Site 0065)

Orlando, Florida, United States

Florida Cancer Specialists - North ( Site 7001)

St. Petersburg, Florida, United States

Florida Cancer Specialists - East ( Site 7000)

West Palm Beach, Florida, United States

Piedmont Atlanta Hospital ( Site 2002)

Atlanta, Georgia, United States

Saint Alphonsus Regional Medical Center ( Site 0085)

Boise, Idaho, United States

Endeavor Health ( Site 2027)

Evanston, Illinois, United States

Accellacare of Duly ( Site 2015)

Lisle, Illinois, United States

University of Iowa ( Site 0074)

Iowa City, Iowa, United States

University of Kentucky ( Site 0055)

Lexington, Kentucky, United States

Norton Cancer Institute, Audubon Hospital Campus ( Site 0054)

Louisville, Kentucky, United States

University of Maryland ( Site 2016)

Baltimore, Maryland, United States

Greater Baltimore Medical Center ( Site 0068)

Baltimore, Maryland, United States

Mayo Clinic in Rochester, Minnesota ( Site 0091)

Rochester, Minnesota, United States

Hattiesburg Clinic ( Site 0064)

Hattiesburg, Mississippi, United States

Saint Luke's Cancer Institute ( Site 0082)

Kansas City, Missouri, United States

Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana ( Site 2000)

Billings, Montana, United States

University Of Nebraska Medical Center ( Site 0078)

Omaha, Nebraska, United States

Comprehensive Cancer Centers of Nevada ( Site 2026)

Las Vegas, Nevada, United States

Renown Regional Medical Center ( Site 0056)

Reno, Nevada, United States

John Theurer Cancer Center at Hackensack University Medical Center ( Site 0060)

Hackensack, New Jersey, United States

Atlantic Health System ( Site 0093)

Summit, New Jersey, United States

San Juan Oncology Associates, P.C ( Site 2011)

Farmington, New Mexico, United States

Memorial Sloan Kettering Cancer Center ( Site 0095)

New York, New York, United States

Ellis Hospital ( Site 0098)

Schenectady, New York, United States

WakeMed Raleigh Campus ( Site 0094)

Raleigh, North Carolina, United States

Miami Valley Hospital South ( Site 0075)

Centerville, Ohio, United States

University of Cincinnati Medical Center ( Site 2005)

Cincinnati, Ohio, United States

St. Luke's University Health Network ( Site 2014)

Easton, Pennsylvania, United States

UPMC Hillman Cancer Center ( Site 2024)

Pittsburgh, Pennsylvania, United States

Texas Oncology - DFW ( Site 8002)

Dallas, Texas, United States

UT Southwestern Medical Center ( Site 0059)

Dallas, Texas, United States

Texas Oncology - Northeast Texas ( Site 8001)

Denison, Texas, United States

Texas Oncology - San Antonio ( Site 8004)

San Antonio, Texas, United States

Community Cancer Trials of Utah ( Site 0086)

Ogden, Utah, United States

University of Virginia ( Site 0080)

Charlottesville, Virginia, United States

Virginia Cancer Specialists, PC ( Site 0069)

Fairfax, Virginia, United States

Fred Hutchinson Cancer Center ( Site 0076)

Seattle, Washington, United States

West Virginia University ( Site 2017)

Morgantown, West Virginia, United States

Medical College of Wisconsin ( Site 2003)

Milwaukee, Wisconsin, United States

Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 0110)

Berazategui, Buenos Aires, Argentina

Hospital Italiano de Buenos Aires ( Site 0102)

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Instituto Alexander Fleming ( Site 0101)

Mar del Plata, Buenos Aires, Argentina

Fundacion Estudios Clinicos ( Site 0105)

Rosario, Santa Fe Province, Argentina

Sanatorio Parque ( Site 0103)

Rosario, Santa Fe Province, Argentina

Hospital Privado Universitario de Córdoba ( Site 0108)

Córdoba, Argentina

Wollongong Hospital ( Site 0453)

Wollongong, New South Wales, Australia

Sunshine Coast University Hospital ( Site 0451)

Birtinya, Queensland, Australia

Monash Health ( Site 0454)

Clayton, Victoria, Australia

Western Health-Sunshine & Footscray Hospitals ( Site 0450)

St Albans, Victoria, Australia

Hospital de Câncer de Recife ( Site 0158)

Recife, Pernambuco, Brazil

Hospital de Caridade de Ijuí ( Site 0150)

Ijuí, Rio Grande do Sul, Brazil

Associação Hospitalar Beneficente São Vicente de Paulo ( Site 0153)

Passo Fundo, Rio Grande do Sul, Brazil

Hospital Nossa Senhora da Conceição ( Site 0156)

Porto Alegre, Rio Grande do Sul, Brazil

CEPEN - Centro de Pesquisa e Ensino em Oncologia de Santa Catarina ( Site 0157)

Florianópolis, Santa Catarina, Brazil

Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0155)

Barretos, São Paulo, Brazil

Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0159)

São José do Rio Preto, São Paulo, Brazil

COE Ensino e Pesquisa ( Site 0151)

São José dos Campos, São Paulo, Brazil

Instituto do Cancer Arnaldo Vieira de Carvalho ( Site 0160)

São Paulo, Brazil

IBCC - Núcleo de Pesquisa e Ensino ( Site 0154)

São Paulo, Brazil

Cancercare Manitoba ( Site 0009)

Winnipeg, Manitoba, Canada

Moncton Hospital - Horizon Health Network ( Site 0011)

Moncton, New Brunswick, Canada

London Health Sciences Centre ( Site 0012)

London, Ontario, Canada

Princess Margaret Cancer Centre ( Site 0001)

Toronto, Ontario, Canada

CIUSSS- saguenay-Lac-Saint-Jean ( Site 0007)

Chicoutimi, Quebec, Canada

Jewish General Hospital ( Site 0006)

Montreal, Quebec, Canada

CIDO SpA ( Site 0212)

Temuco, Araucania, Chile

Clínica Puerto Montt ( Site 0206)

Port Montt, Los Lagos Region, Chile

Oncocentro Valdivia ( Site 0204)

Valdivia, Los Ríos Region, Chile

Fundacion Arturo Lopez Perez ( Site 0201)