Recruiting

Phase 3

MK-1084 with CetuximabA 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

Code:

NCT06997497

Conditions

Colon Adenocarcinoma

Rectal Adenocarcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Calderasib

Oxaliplatin

Leucovorin/levofolinate calcium

5-Fluorouracil

Cetuximab

Study Details

Brief 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.

Conditions

Colon Adenocarcinoma

Rectal Adenocarcinoma

Study ID

NCT06997497

Start date

Jul 16, 2025

Status verified date

Aug, 2026

Completion date

Oct 27, 2030

Anticipated

Primary completion date

Mar 28, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

477 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Calderasib + Cetuximab + mFOLFOX6

Participants will receive calderasib orally, cetuximab per label every 2 weeks (Q2W), and mFOLFOX6 chemotherapy: oxaliplatin per label every 2 weeks (Q2W), leucovorin or levofolinate calcium per label Q2W, and 5-fluorouracil (5-FU) per label Q2W. Treatment will continue until criteria for discontinuation is met.

active comparator: mFOLFOX6

Participants will receive mFOLFOX6 chemotherapy: oxaliplatin per label Q2W, leucovorin or levofolinate calcium per label Q2W, and 5-fluorouracil (5-FU) per label Q2W. Participants may also receive bevacizumab or bevacizumab biosimilar Q2W at the investigator's discretion. Treatment will continue until criteria for discontinuation is met.

Interventions

Calderasib

Oral tablet

Oxaliplatin

Per label

Leucovorin/levofolinate calcium

Per label

5-Fluorouracil

Per label

Cetuximab

Per label

Bevacizumab

Per label

Bevacizumab biosimilar

Per label

Primary outcome measure

Number of Participants Experiencing Dose-Limiting Toxicity (DLT) [ Time Frame: Up to approximately 28 days ]
Part 1: Number of Participants Who Experience an Adverse Event (AE) [ Time Frame: Up to approximately 44 months ]
Part 1: Number of Participants Who Discontinue Study Treatment Due to an AE [ Time Frame: Up to approximately 44 months ]
Progression Free Survival (PFS) [ Time Frame: Up to approximately 44 months ]

Central Contacts and Locations

Central contacts

Toll Free Number

1-888-577-8839 Trialsites@msd.com

Locations

Los Angeles Hematology Oncology Medical Group ( Site 0084)

Recruiting

Los Angeles, California, United States, 90017

Contacts

Study Coordinator

213-533-9655

UCLA Hematology/Oncology - Santa Monica ( Site 0088)

Recruiting

Santa Monica, California, United States, 90404

Contacts

Study Coordinator

310-794-6500

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

Recruiting

Fort Collins, Colorado, United States, 80528

Contacts

Study Coordinator

970-493-6337

Rocky Mountain Cancer Centers (RMCC) ( Site 8000)

Recruiting

Lone Tree, Colorado, United States, 80124

Contacts

Study Coordinator

303-925-0700

Florida Cancer Specialists - South ( Site 7002)

Recruiting

Fort Myers, Florida, United States, 33901

Contacts

Study Coordinator

239-274-9930

Mayo Clinic in Florida ( Site 0092)

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Study Coordinator

904-953-5380

Orlando Health Cancer Institute ( Site 0065)

Recruiting

Orlando, Florida, United States, 32806

Contacts

Study Coordinator

321-841-6780

Florida Cancer Specialists - North ( Site 7001)

Recruiting

St. Petersburg, Florida, United States, 33705

Contacts

Study Coordinator

727-216-1143

Florida Cancer Specialists - East ( Site 7000)

Recruiting

West Palm Beach, Florida, United States, 33401

Contacts

Study Coordinator

561-366-4100

Piedmont Atlanta Hospital ( Site 2002)

Recruiting

Atlanta, Georgia, United States, 30318

Contacts

Study Coordinator

404-605-3068

Saint Alphonsus Regional Medical Center ( Site 0085)

Recruiting

Boise, Idaho, United States, 83706

Contacts

Study Coordinator

208-367-2121

Accellacare of Duly ( Site 2015)

Recruiting

Lisle, Illinois, United States, 60532

Contacts

Study Coordinator

630-545-7760

University of Iowa ( Site 0074)

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Study Coordinator

319-356-4200

University of Kentucky ( Site 0055)

Recruiting

Lexington, Kentucky, United States, 40536

Contacts

Study Coordinator

859-218-1758

Norton Cancer Institute, Audubon Hospital Campus ( Site 0054)

Recruiting

Louisville, Kentucky, United States, 40217

Contacts

Study Coordinator

502-636-7845

Greater Baltimore Medical Center ( Site 0068)

Recruiting

Baltimore, Maryland, United States, 21204

Contacts

Study Coordinator

443-849-3051

Mayo Clinic in Rochester, Minnesota ( Site 0091)

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Study Coordinator

507-284-2511

Hattiesburg Clinic ( Site 0064)

Recruiting

Hattiesburg, Mississippi, United States, 39401

Contacts

Study Coordinator

601-288-2495

Saint Luke's Cancer Institute ( Site 0082)

Recruiting

Kansas City, Missouri, United States, 64111

Contacts

Study Coordinator

816-932-2677

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

Recruiting

Billings, Montana, United States, 59102

Contacts

Study Coordinator

406-238-6685

University Of Nebraska Medical Center ( Site 0078)

Recruiting

Omaha, Nebraska, United States, 68198

Contacts

Study Coordinator

402-559-4000

Comprehensive Cancer Centers of Nevada ( Site 2026)

Recruiting

Las Vegas, Nevada, United States, 89169

Contacts

Study Coordinator

702-952-3400

Renown Regional Medical Center ( Site 0056)

Recruiting

Reno, Nevada, United States, 89502

Contacts

Study Coordinator

775-982-4000

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

Recruiting

Hackensack, New Jersey, United States, 07601

Contacts

Study Coordinator

551-996-5855

Atlantic Health System ( Site 0093)

Recruiting

Summit, New Jersey, United States, 07901

Contacts

Study Coordinator

908-522-2000

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

Recruiting

Farmington, New Mexico, United States, 87401

Contacts

Study Coordinator

505-564-6850

Memorial Sloan Kettering Cancer Center ( Site 0095)

Recruiting

New York, New York, United States, 10065

Contacts

Study Coordinator

347-798-9213

Ellis Hospital ( Site 0098)

Recruiting

Schenectady, New York, United States, 12308

Contacts

Study Coordinator

518-243-4762

WakeMed Raleigh Campus ( Site 0094)

Recruiting

Raleigh, North Carolina, United States, 27610

Contacts

Study Coordinator

919-350-2873

Miami Valley Hospital South ( Site 0075)

Recruiting

Centerville, Ohio, United States, 45459

Contacts

Study Coordinator

937-438-2400

Texas Oncology - DFW ( Site 8002)

Recruiting

Dallas, Texas, United States, 75246

Contacts

Study Coordinator

214-370-1000

UT Southwestern Medical Center ( Site 0059)

Recruiting

Dallas, Texas, United States, 75390

Contacts

Study Coordinator

214-645-9685

Texas Oncology - Northeast Texas ( Site 8001)

Recruiting

Denison, Texas, United States, 75020

Contacts

Study Coordinator

903-868-4700

Texas Oncology - San Antonio ( Site 8004)

Recruiting

San Antonio, Texas, United States, 78240

Contacts

Study Coordinator

210-595-5300

Community Cancer Trials of Utah ( Site 0086)

Recruiting

Ogden, Utah, United States, 84405

Contacts

Study Coordinator

801-689-3909

University of Virginia ( Site 0080)

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Study Coordinator

434-243-8237

Virginia Cancer Specialists, PC ( Site 0069)

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Study Coordinator

703-280-5390

Fred Hutchinson Cancer Center ( Site 0076)

Recruiting

Seattle, Washington, United States, 98109

Contacts

Study Coordinator

206-616-9025

West Virginia University ( Site 2017)

Recruiting

Morgantown, West Virginia, United States, 26506

Contacts

Study Coordinator

304-598-4000

Cancercare Manitoba ( Site 0009)

Recruiting

Winnipeg, Manitoba, Canada, R3E 0V9

Contacts

Study Coordinator

204-787-4156

Moncton Hospital - Horizon Health Network ( Site 0011)

Recruiting

Moncton, New Brunswick, Canada, E1C 6Z8

Contacts

Study Coordinator

5068575756

London Health Sciences Centre ( Site 0012)

Recruiting

London, Ontario, Canada, N6A 5W9

Contacts

Study Coordinator

5196858500

Princess Margaret Cancer Centre ( Site 0001)

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Study Coordinator

416-946-4559

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

Recruiting

Chicoutimi, Quebec, Canada, G7H 5H6

Contacts

Study Coordinator

41854112342707

Jewish General Hospital ( Site 0006)

Recruiting

Montreal, Quebec, Canada, H3T 1E2

Contacts

Study Coordinator

514-340-8222

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-08-28.