A Study of MK-5684 in People With Certain Solid Tumors (MK-5684-015/OMAHA-015)

Part of paid clinical trials in Anchorage, Alaska.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT06979596
Phase
PHASE2
Status
Recruiting
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Conditions

  • Malignant Neoplasm

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Opevesostat — DRUG
    Tablet for oral administration.
  • Fludrocortisone/ Fludrocortisone acetate — DRUG
    Tablet for oral administration.
  • Dexamethasone/Dexamethasone acetate — DRUG
    Tablet for oral administration.
  • Rescue Medications — DRUG
    Hydrocortisone or hydrocortisone/hydrocortisone acetate administered via intramuscular injection as rescue medication.
  • Fulvestrant — DRUG
    Administered via intramuscular injection.
  • Exemestane — DRUG
    Tablet for oral administration.
  • Megestrol acetate/Medroxyprogesterone acetate — DRUG
    Tablet for oral administration.
  • Tamoxifen — DRUG
    Tablet for oral administration.
  • Letrozole — DRUG
    Tablet for oral administration.

Study Details

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.

Key Dates

Start date
Aug 11, 2025
Status verified
May 2026
Primary completion
Nov 4, 2027
Completion
Nov 4, 2027

Study Design

Enrollment
250 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: MK-5684 and Daily Corticosteroids
    Participants with breast cancer, ovarian cancer, or endometrial cancer will receive 5 mg of MK-5684 orally twice daily. Participants will also receive fludrocortisone/fludrocortisone acetate starting at 0.1 mg orally, and dexamethasone/dexamethasone acetate starting at 1 mg orally; both will be adjusted individually during the study. Participants will receive treatment until one of the conditions for discontinuation of study intervention is met.
  • Experimental: Fulvestrant or Exemestane
    Participants with breast cancer receive endocrine therapy of the physician's choice: either 500 mg of fulvestrant on Day 1 and Day 15 of Cycle 1 and Day 1 of every cycle thereafter (cycles are 28 days in length) or 25 mg of exemestane once daily (QD). Participants will receive treatment until one of the conditions for discontinuation of study intervention is met.
  • No Intervention: Observation (No Treatment)
    Participants with ovarian cancer will be observed but will receive no treatment for the duration of the study.
  • Experimental: Treatment of Physician's Choice
    Participants with endometrial cancer will receive the physician's choice of either 80 mg megestrol acetate/medroxyprogesterone acetate twice daily, or alternating between 80 mg megestrol acetate twice daily for three weeks and 20 mg tamoxifen twice daily for three weeks, or 2.5 mg letrozole once daily. Participants will receive treatment until one of the conditions for discontinuation of study intervention is met.

Primary Outcome Measure

Progression-Free Survival (PFS) - All Cohorts [ Time Frame: Up to approximately 2 years ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
Alaska Womens Cancer Care ( Site 0037)AnchorageAlaska99508
Study Coordinator
907-562-2211
Mount Sinai Cancer Center ( Site 0009)Miami BeachFlorida33140
Study Coordinator
305-674-2625
TRIALS 365 ( Site 0022)ShreveportLouisiana71103
Study Coordinator
318-408-1198
Mary Lanning Healthcare ( Site 0019)HastingsNebraska68901
Study Coordinator
402-463-4521
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0021)HackensackNew Jersey07601
Study Coordinator
551-996-5855
Memorial Sloan Kettering Cancer Center ( Site 0002)New YorkNew York10065
Study Coordinator
212-639-2000
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 0008)ColumbusOhio43210
Study Coordinator
(614) 293-8000
Baylor College of Medicine Medical Center ( Site 0004)HoustonTexas77030
Study Coordinator
713-798-2000
Mays Cancer Center ( Site 0039)San AntonioTexas78229
Study Coordinator
210-450-1000

Find similar trials in Anchorage, AK

By research site
Alaska Womens Cancer Care· Anchorage, AKMount Sinai Cancer Center· Miami Beach, FLTRIALS 365· Shreveport, LAMary Lanning Healthcare· Hastings, NEJohn Theurer Cancer Center at Hackensack University Medical Center· Hackensack, NJMemorial Sloan Kettering Cancer Center· New York, NY

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