A Clinical Study of MK-1084 With Targeted Therapy and Chemotherapy in People With Colorectal Cancer (MK-1084-012/KANDLELIT-012)
Purpose
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 MK-1084 (the study medicine) and cetuximab to mFOLFOX6 can treat locally advanced or mCRC with the KRAS G12C mutation. MK-1084 and cetuximab are targeted therapies. The goals of this study are to learn: - About the safety of MK-1084 with cetuximab and mFOLFOX6 and if people tolerate the treatments - If people who receive MK-1084 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
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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 - 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 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 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
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental MK-1084 + Cetuximab + mFOLFOX6 |
Participants will receive MK-1084 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 Q2W at the investigator's discretion. Treatment will continue until criteria for discontinuation is met. |
|
Recruiting Locations
Orlando 4167147, Florida 4155751 32806
Study Coordinator
321-841-6780
Louisville 4299276, Kentucky 6254925 40217
Study Coordinator
502-636-7845
Reno 5511077, Nevada 5509151 89502
Study Coordinator
775-982-4000
Hackensack 5098706, New Jersey 5101760 07601
Study Coordinator
551-996-5855
Centerville 4508204, Ohio 5165418 45459
Study Coordinator
937-438-2400
More Details
- Status
- Recruiting
- Sponsor
- Merck Sharp & Dohme LLC
Detailed Description
This study will have 2 parts.