🔎 Trials Near Me

Home › Colon Cancer › NCT06997497

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

RecruitingPhase 3

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)

Who can join

Ages 18 and older · All sexes

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

About the study

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.

What is being tested

Sponsor: Merck Sharp & Dohme LLC · Participants: 477 · Started: Jul 16, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06997497

Locations in the U.S.

ArizonaMayo Clinic - Arizona ( Site 0090), Phoenix
CaliforniaOrange Coast Memorial Medical Center ( Site 2007), Fountain Valley
Los Angeles Hematology Oncology Medical Group ( Site 0084), Los Angeles
UCLA Hematology/Oncology - Santa Monica ( Site 0088), Santa Monica
ColoradoUniversity of Colorado Health - Harmony-Cancer Care and Hematology - Ft. Collins ( Site 0087), Fort Collins
Rocky Mountain Cancer Centers (RMCC) ( Site 8000), Lone Tree
FloridaFlorida Cancer Specialists - South ( Site 7002), Fort Myers
Mayo Clinic in Florida ( Site 0092), Jacksonville
Orlando Health Cancer Institute ( Site 0065), Orlando
Florida Cancer Specialists - North ( Site 7001), St. Petersburg
Florida Cancer Specialists - East ( Site 7000), West Palm Beach
GeorgiaPiedmont Atlanta Hospital ( Site 2002), Atlanta
IdahoSaint Alphonsus Regional Medical Center ( Site 0085), Boise
IllinoisEndeavor Health ( Site 2027), Evanston
Accellacare of Duly ( Site 2015), Lisle
IowaUniversity of Iowa ( Site 0074), Iowa City
KentuckyUniversity of Kentucky ( Site 0055), Lexington
Norton Cancer Institute, Audubon Hospital Campus ( Site 0054), Louisville
MarylandGreater Baltimore Medical Center ( Site 0068), Baltimore
MinnesotaMayo Clinic in Rochester, Minnesota ( Site 0091), Rochester
MississippiHattiesburg Clinic ( Site 0064), Hattiesburg
MissouriSaint Luke's Cancer Institute ( Site 0082), Kansas City
MontanaIntermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana ( Site 2000), Billings
NebraskaUniversity Of Nebraska Medical Center ( Site 0078), Omaha
NevadaComprehensive Cancer Centers of Nevada ( Site 2026), Las Vegas
Renown Regional Medical Center ( Site 0056), Reno
New JerseyJohn Theurer Cancer Center at Hackensack University Medical Center ( Site 0060), Hackensack
Atlantic Health System ( Site 0093), Summit
New MexicoSan Juan Oncology Associates, P.C ( Site 2011), Farmington
New YorkMemorial Sloan Kettering Cancer Center ( Site 0095), New York
Ellis Hospital ( Site 0098), Schenectady
North CarolinaWakeMed Raleigh Campus ( Site 0094), Raleigh
OhioMiami Valley Hospital South ( Site 0075), Centerville
PennsylvaniaSt. Luke's University Health Network ( Site 2014), Easton
UPMC Hillman Cancer Center ( Site 2024), Pittsburgh
TexasTexas Oncology - DFW ( Site 8002), Dallas
UT Southwestern Medical Center ( Site 0059), Dallas
Texas Oncology - Northeast Texas ( Site 8001), Denison
Texas Oncology - San Antonio ( Site 8004), San Antonio
UtahCommunity Cancer Trials of Utah ( Site 0086), Ogden
VirginiaUniversity of Virginia ( Site 0080), Charlottesville
Virginia Cancer Specialists, PC ( Site 0069), Fairfax
WashingtonFred Hutchinson Cancer Center ( Site 0076), Seattle
West VirginiaWest Virginia University ( Site 2017), Morgantown

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.