Status:
RECRUITING
A Clinical Study of MK-1084 With Targeted Therapy and Chemotherapy in People With Colorectal Cancer (MK-1084-012/KANDLELIT-012)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Colon Adenocarcinoma
Rectal Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 f...
Detailed Description
This study will have 2 parts.
Eligibility Criteria
Inclusion
- 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
- Tumor tissue 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
- 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 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
- 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
Key Trial Info
Start Date :
July 16 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 27 2030
Estimated Enrollment :
477 Patients enrolled
Trial Details
Trial ID
NCT06997497
Start Date
July 16 2025
End Date
October 27 2030
Last Update
January 9 2026
Active Locations (69)
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1
Orlando Health Cancer Institute ( Site 0065)
Orlando, Florida, United States, 32806
2
Norton Cancer Institute, Audubon Hospital Campus ( Site 0054)
Louisville, Kentucky, United States, 40217
3
Renown Regional Medical Center ( Site 0056)
Reno, Nevada, United States, 89502
4
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0060)
Hackensack, New Jersey, United States, 07601