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Purpose

Researchers want to learn if calderasib 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 calderasib alone or with cetuximab and how these responses compare - About the safety of calderasib alone or with cetuximab and if people tolerate the treatments.

Condition

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
Calderasib 		Participants will receive calderasib orally. Per protocol treatment of calderasib has no maximum number of cycles. Participants will be treated until any of the criteria for discontinuation of study intervention are met.
  • Drug: Calderasib
    Oral administration
    Other names:
    • MK-1084
  • Biological: Cetuximab
    Intravenous administration
Experimental
Calderasib + Cetuximab 		Participants will receive calderasib orally. Participants will receive Cetuximab 500 mg/m^2 via intravenous (IV) infusion once every 2 weeks (Q2W). Per protocol treatment of calderasib 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: Calderasib
    Oral administration
    Other names:
    • MK-1084
  • Biological: Cetuximab
    Intravenous administration

Recruiting Locations

Greater Baltimore Medical Center ( Site 1104)
Baltimore, Maryland 21204
Contact:
Study Coordinator
443-849-3285

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

Comprehensive Cancer Centers of Nevada ( Site 1109)
Las Vegas, Nevada 89169
Contact:
Study Coordinator
702-952-3400

Rutgers Cancer Institute of New Jersey ( Site 1100)
New Brunswick, New Jersey 08903
Contact:
Study Coordinator
732-235-3443

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

Virginia Cancer Specialists ( Site 1102)
Fairfax, Virginia 22031
Contact:
Study Coordinator
703-208-9268

More Details

Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.