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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
250
Tablet for oral administration.
Tablet for oral administration.
Tablet for oral administration.
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
Overall Survival (OS) - All Cohorts
For all cohorts, OS is defined the time from randomization to death due to any cause.
Time frame: Up to approximately 2 years
Clinical Benefit Rate (CBR) - Cohort A
For cohort A (participants with breast cancer), CBR is defined as the percentage of participants who have complete response (CR): disappearance of all target lesions; partial response (PR): At least a 30% decrease in the sum of diameters of target lesions; or stable disease (SD): Neither sufficient decrease to qualify for PR nor sufficient increase to qualify for progressive disease (PD), with reference to the smallest sum diameters while on study) for ≥24 weeks per RECIST 1.1 as assessed by BICR.
Time frame: Up to approximately 2 years
Objective Response Rate (ORR) - All Cohorts
For all cohorts, ORR is defined as the percentage of participants who have achieved confirmed Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by BICR.
Time frame: Up to approximately 2 years
Duration of Response (DOR) - All Cohorts
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Hydrocortisone or hydrocortisone/hydrocortisone acetate administered via intramuscular injection as rescue medication.
Administered via intramuscular injection.
Tablet for oral administration.
Tablet for oral administration.
Tablet for oral administration.
Tablet for oral administration.
Alaska Womens Cancer Care ( Site 0037)
Anchorage, Alaska, United States
RECRUITINGMount Sinai Cancer Center ( Site 0009)
Miami Beach, Florida, United States
RECRUITINGTRIALS 365 ( Site 0022)
Shreveport, Louisiana, United States
RECRUITINGMary Lanning Healthcare ( Site 0019)
Hastings, Nebraska, United States
RECRUITINGJohn Theurer Cancer Center at Hackensack University Medical Center ( Site 0021)
Hackensack, New Jersey, United States
RECRUITINGRockefeller Outpatient Pavilion ( Site 0002)
New York, New York, United States
RECRUITINGThe James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 0008)
Columbus, Ohio, United States
RECRUITINGBaylor College of Medicine Medical Center ( Site 0004)
Houston, Texas, United States
RECRUITINGHarris Health System ( Site 0040)
Houston, Texas, United States
RECRUITINGMays Cancer Center ( Site 0039)
San Antonio, Texas, United States
RECRUITING...and 49 more locations
For all cohorts, for participants who demonstrate CR or PR, DOR is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.
Time frame: Up to approximately 2 years
Number of Participants who Discontinue Study Intervention Due to an Adverse Event (AE) - All Cohorts
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Time frame: Up to approximately 8 months
Number of Participants who Experience One or More Adverse Events (AEs) - All Cohorts
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Time frame: Up to approximately 11 months