A Multicenter, Open-label, Phase 2 Basket Study of MK-5684 in Participants With Selected Solid Tumors (OMAHA-015)
Summary
Researchers want to learn if MK-5684 (the study medicine) can treat breast cancer, ovarian cancer, and endometrial cancer. MK-5684, the study medicine, is designed to treat cancer by blocking the body from making steroid hormones. Researchers will compare MK-5684 to the standard treatments for each cancer type in this study. The goal of this study is to learn if people who receive MK-5684 live longer without the cancer growing or spreading compared to people who receive a standard treatment.
Arms & interventions
- DrugOpevesostat
Tablet for oral administration.
- DrugFludrocortisone/ Fludrocortisone acetate
Tablet for oral administration.
- DrugDexamethasone/Dexamethasone acetate
Tablet for oral administration.
- DrugRescue Medications
Hydrocortisone or hydrocortisone/hydrocortisone acetate administered via intramuscular injection as rescue medication.
- DrugFulvestrant
Administered via intramuscular injection.
- DrugExemestane
Tablet for oral administration.
- DrugMegestrol acetate/Medroxyprogesterone acetate
Tablet for oral administration.
- DrugTamoxifen
Tablet for oral administration.
- DrugLetrozole
Tablet for oral administration.
Outcome measures
Primary
Progression-Free Survival (PFS) - All Cohorts
For all cohorts, PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1). PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review (BICR) will be presented.
Time frame: Up to approximately 2 years
Secondary
Overall Survival (OS) - All Cohorts
Time frame: Up to approximately 2 years
Clinical Benefit Rate (CBR) - Cohort A
Time frame: Up to approximately 2 years
Objective Response Rate (ORR) - All Cohorts
Time frame: Up to approximately 2 years
Duration of Response (DOR) - All Cohorts
Time frame: Up to approximately 2 years
Number of Participants who Discontinue Study Intervention Due to an Adverse Event (AE) - All Cohorts
Time frame: Up to approximately 8 months
Number of Participants who Experience One or More Adverse Events (AEs) - All Cohorts
Time frame: Up to approximately 11 months
Eligibility criteria
Study locations (9)
Alaska Womens Cancer Care ( Site 0037)
Anchorage, Alaska, 99508
Mount Sinai Cancer Center ( Site 0009)
Miami Beach, Florida, 33140
TRIALS 365 ( Site 0022)
Shreveport, Louisiana, 71103
Mary Lanning Healthcare ( Site 0019)
Hastings, Nebraska, 68901
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0021)
Hackensack, New Jersey, 07601
Memorial Sloan Kettering Cancer Center ( Site 0002)
New York, New York, 10065
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 0008)
Columbus, Ohio, 43210
Baylor College of Medicine Medical Center ( Site 0004)
Houston, Texas, 77030
Mays Cancer Center ( Site 0039)
San Antonio, Texas, 78229