A Clinical Study of MK-1084 in People With Advanced Solid Tumors (MK-1084-014)
Purpose
Researchers want to learn if MK-1084 given alone or with cetuximab can treat certain advanced solid tumors in people with the KRAS G12C mutation. The goals of this study are to learn: - How many people have the cancer respond (get smaller or go away) to MK-1084 alone or with cetuximab and how these responses compare - About the safety of MK-1084 alone or with cetuximab and if people tolerate the treatments.
Condition
- Neoplasm Malignant
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 locally advanced unresectable or metastatic solid tumor malignancy other than colorectal cancer and has progressed on, or following, standard of care systemic treatment - Has a tumor that demonstrates the presence of Kirsten rat sarcoma (KRAS) G12C mutation
Exclusion Criteria
The main exclusion criteria include but are not limited to the following: - Has uncontrolled, significant cardiovascular disease or cerebrovascular disease - Has known additional malignancy that is progressing or has required active treatment within the past 3 years - Has known active central nervous system metastases and/or carcinomatous meningitis and/or primary brain tumors - Has active infection, other than those permitted per protocol, requiring systemic therapy - Has not adequately recovered from major surgery or has ongoing surgical complications
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental MK-1084 |
Participants will receive MK-1084 orally. Per protocol treatment of MK-1084 has no maximum number of cycles. Participants will be treated until any of the criteria for discontinuation of study intervention are met. |
|
|
Experimental MK-1084 + Cetuximab |
Participants will receive MK-1084 orally. Participants will receive Cetuximab 500 mg/m^2 via intravenous (IV) infusion once every 2 weeks (Q2W). Per protocol treatment of MK-1084 and Cetuximab has no maximum number of cycles. Participants will be treated until any of the criteria for discontinuation of study intervention are met. |
|
Recruiting Locations
Baltimore 4347778, Maryland 4361885 21204
Study Coordinator
443-849-3285
Grand Rapids 4994358, Michigan 5001836 49546
Study Coordinator
616-389-1808
West Valley City 5784607, Utah 5549030 84119
Study Coordinator
210-593-5250
Fairfax 4758023, Virginia 6254928 22031
Study Coordinator
703-208-9268
More Details
- NCT ID
- NCT07209111
- Status
- Recruiting
- Sponsor
- Merck Sharp & Dohme LLC