A Study of MK-5684 in People With Certain Solid Tumors (MK-5684-015/OMAHA-015)
ConditionMalignant Neoplasm
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMerck Sharp & Dohme LLC
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 and received either, 1 line of an approved protocol-specified combination endocrine-based therapy, or 2 or more lines of protocol-specified endocrine-based therapy in the metastatic setting
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.
Disqualifiers
Breast cancer amenable to treatment with curative intent.
Has advanced/metastatic, symptomatic visceral spread at risk of rapidly evolving into life-threatening complications, such as lymphangitic lung metastases, radiographic evidence of intratumoral cavitation or invasion/infiltration of a major blood vessel, bone marrow replacement, carcinomatous meningitis, significant symptomatic liver metastases, symptomatic pericardial effusion, symptomatic peritoneal carcinomatosis, or the need to achieve rapid symptom control.
Has nonepithelial cancers (germ cell tumors and sex cord-stromal tumors), borderline tumors (low malignant potential), mucinous, seromucinous that is predominantly mucinous, malignant Brenner's tumor, low-grade serous, low-grade endometrioid, and undifferentiated carcinoma.
Has platinum-resistant ovarian cancer (defined as disease that has progressed per radiographic imaging within 180 days after the last dose of first-line [1L] platinum-based therapy) or platinum-refractory ovarian cancer (defined as disease that has progressed per radiographic imaging while receiving or within 28 days of the last dose of 1L platinum based therapy).
Trial design
Design model
Parallel
Treatments tested in this trial
Opevesostat
DrugTablet for oral administration.
Fludrocortisone/ Fludrocortisone acetate
DrugTablet for oral administration.
Dexamethasone/Dexamethasone acetate
DrugTablet for oral administration.
Rescue Medications
DrugHydrocortisone or hydrocortisone/hydrocortisone acetate administered via intramuscular injection as rescue medication.
Fulvestrant
DrugAdministered via intramuscular injection.
Exemestane
DrugTablet for oral administration.
Megestrol acetate/Medroxyprogesterone acetate
DrugTablet for oral administration.
Tamoxifen
DrugTablet for oral administration.
Letrozole
DrugTablet for oral administration.
Treatment groups
250 Participants
are divided into 4 treatment groupsGroup A: MK-5684 and Daily CorticosteroidsExperimental treatment 4 interventions
Group B: Fulvestrant or ExemestaneExperimental treatment 2 interventions
Group C: Observation (No Treatment)No intervention 0 interventions
Group D: Treatment of Physician's ChoiceExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
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 yearsSecondary outcomes
1
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 years2
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 years3
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 years4
Duration of Response (DOR) - All Cohorts
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 yearsSponsors and contacts
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Source ClinicalTrials.gov