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

Recruiting now · Phase 3

Conditions studied: Colon Adenocarcinoma, Rectal Adenocarcinoma

In brief

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.

Key facts

Study ID

NCT06997497

Run by

Merck Sharp & Dohme LLC

People needed

477

Starts

2025-07-16

Expected to finish

2030-10-27

Last updated by the study team

2026-08-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UCLA Hematology/Oncology - Santa Monica ( Site 0088) — Santa Monica, California, United States (enrolling)
• University of Colorado Health - Harmony-Cancer Care and Hematology - Ft. Collins ( Site 0087) — Fort Collins, Colorado, United States (enrolling)
• Rocky Mountain Cancer Centers (RMCC) ( Site 8000) — Lone Tree, Colorado, United States (enrolling)
• Florida Cancer Specialists - South ( Site 7002) — Fort Myers, Florida, United States (enrolling)
• Orlando Health Cancer Institute ( Site 0065) — Orlando, Florida, United States (enrolling)
• Florida Cancer Specialists - North ( Site 7001) — St. Petersburg, Florida, United States (enrolling)
• Florida Cancer Specialists - East ( Site 7000) — West Palm Beach, Florida, United States (enrolling)
• Saint Alphonsus Regional Medical Center ( Site 0085) — Boise, Idaho, United States (enrolling)
• Accellacare of Duly ( Site 2015) — Lisle, Illinois, United States (enrolling)
• University of Iowa ( Site 0074) — Iowa City, Iowa, United States (enrolling)
• University of Kentucky ( Site 0055) — Lexington, Kentucky, United States (enrolling)
• Norton Cancer Institute, Audubon Hospital Campus ( Site 0054) — Louisville, Kentucky, United States (enrolling)
• Greater Baltimore Medical Center ( Site 0068) — Baltimore, Maryland, United States (enrolling)
• Hattiesburg Clinic ( Site 0064) — Hattiesburg, Mississippi, United States (enrolling)
• Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana ( Site 2000) — Billings, Montana, United States (enrolling)
• University Of Nebraska Medical Center ( Site 0078) — Omaha, Nebraska, United States (enrolling)
• Renown Regional Medical Center ( Site 0056) — Reno, Nevada, United States (enrolling)
• John Theurer Cancer Center at Hackensack University Medical Center ( Site 0060) — Hackensack, New Jersey, United States (enrolling)
• Atlantic Health System ( Site 0093) — Summit, New Jersey, United States (enrolling)
• San Juan Oncology Associates, P.C ( Site 2011) — Farmington, New Mexico, United States (enrolling)
• Ellis Hospital ( Site 0098) — Schenectady, New York, United States (enrolling)
• Miami Valley Hospital South ( Site 0075) — Centerville, Ohio, United States (enrolling)
• Texas Oncology - DFW ( Site 8002) — Dallas, Texas, United States (enrolling)
• UT Southwestern Medical Center ( Site 0059) — Dallas, Texas, United States (enrolling)
• Los Angeles Hematology Oncology Medical Group ( Site 0084) — Los Angeles, California, United States (enrolling)

Full record on ClinicalTrials.gov

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