A Clinical Study of MK-1084 With Targeted Therapy and Chemotherapy in People With Colorectal Cancer (MK-1084-012/KANDLELIT-012)
Sponsor: Merck Sharp & Dohme LLC
ClinicalTrials ID:NCT06997497
This study evaluates the safety and efficacy of MK-1084 with cetuximab and mFOLFOX6 in treating KRAS G12C-mutated, unresectable colorectal cancer. Eligible participants include those with advanced colorectal adenocarcinoma, controlled HIV, and undetectable HBV/HCV. Interventions include MK-1084, oxaliplatin, leucovorin, 5-fluorouracil, cetuximab, and bevacizumab.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
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.
Description
This study will have 2 parts.
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
- 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
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Orlando Health Cancer Institute ( Site 0065) | 32806 | Orlando | Florida |
| Norton Cancer Institute, Audubon Hospital Campus ( Site 0054) | 40217 | Louisville | Kentucky |
| Renown Regional Medical Center ( Site 0056) | 89502 | Reno | Nevada |
| John Theurer Cancer Center at Hackensack University Medical Center ( Site 0060) | 07601 | Hackensack | New Jersey |
| Miami Valley Hospital South ( Site 0075) | 45459 | Centerville | Ohio |
Get This Program In Your Inbox
You can sign up and apply your patients for this program.