Malignant Neoplasm
Conditions
Brief 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.
Interventions
DRUGOpevesostat
Tablet for oral administration.
DRUGFludrocortisone/ Fludrocortisone acetate
Tablet for oral administration.
DRUGDexamethasone/Dexamethasone acetate
Tablet for oral administration.
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.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The main inclusion criteria include but are not limited to the following: * Cohort A: * Has a diagnosis of hormone receptor positive/Human Epidermal Growth Factor Receptor 2 negative (HR+/HER2-) invasive breast carcinoma that is either locally advanced disease not amenable to resection with curative intent (herein called unresectable) or metastatic disease not treatable with curative intent. * Has experienced disease progression on or after at least 1 prior endocrine-based therapy in the metastatic setting. * Cohort B: * Has histologically confirmed high-grade epithelial (including high-grade serous or predominantly serous, high-grade endometrioid, malignant mixed Müllerian tumors \[carcinosarcoma\], or clear cell) ovarian, fallopian tube, or primary peritoneal carcinoma. * Has received between 4 to 8 cycles of platinum-based doublet chemotherapy in third-line (3L) setting for ovarian cancer. * Cohort C: * Histologically confirmed diagnosis of primary advanced or recurrent low-grade endometrioid carcinoma (eg, Federation of Gynecology and Obstetrics \[FIGO\] Grade 1/2, or well/moderately differentiated). * Treatment naïve or has received up to 1 prior line of platinum-based therapy in either the advanced/metastatic OR adjuvant/neoadjuvant setting. * All Cohorts : * Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. * Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy. * Participants who are Hepatitis B surface antigen positive are eligible if they have received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load. * Participants with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable.
Exclusion criteria
The main
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) - All Cohorts | Up to approximately 5 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) - All Cohorts | Up to approximately 5 years | For all cohorts, OS is defined the time from randomization to death due to any cause. |
| Clinical Benefit Rate (CBR) - Cohort A | Up to approximately 5 years | 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. |
| Objective Response Rate (ORR) - All Cohorts | Up to approximately 5 years | 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. |
| Duration of Response (DOR) - All Cohorts | Up to approximately 5 years | 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. |
| Number of Participants who Discontinue Study Intervention Due to an Adverse Event (AE) - All Cohorts | Up to approximately 8 months | 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. |
| Number of Participants who Experience One or More Adverse Events (AEs) - All Cohorts | Up to approximately 11 months | 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. |
Countries
Argentina, Brazil, Canada, Chile, Malaysia, Peru, Singapore, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, United States
Contacts
CONTACTToll Free Number
STUDY_DIRECTORMedical Director
Merck Sharp & Dohme LLC
Outcome results
None listed