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

ArmDescriptionAssigned 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.
  • Drug: MK-1084
    Oral administration
  • Biological: Cetuximab
    Intravenous administration
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.
  • Drug: MK-1084
    Oral administration
  • Biological: Cetuximab
    Intravenous administration

Recruiting Locations

START Midwest ( Site 1103)
Grand Rapids 4994358, Michigan 5001836 49546
Contact:
Study Coordinator
616-389-1808

START Mountain Region ( Site 1106)
West Valley City 5784607, Utah 5549030 84119
Contact:
Study Coordinator
210-593-5250

More Details

Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

Toll Free Number
1-888-577-8839
Trialsites@msd.com