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NCT06979596 · ClinicalTrials.gov registry record · Phase 2
A Study of MK-5684 in People With Certain Solid Tumors (MK-5684-015/OMAHA-015)
A Phase 2 study of Malignant Neoplasm, sponsored by Merck Sharp & Dohme.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 250
- Enrollment target
- 20
- Study locations
NCT06979596: Recruiting Phase 2 study of Malignant Neoplasm, sponsored by Merck Sharp & Dohme.
NCT06979596 is a Phase 2 study of Malignant Neoplasm that is actively recruiting participants, run by Merck Sharp & Dohme. The registered enrollment target is 250 participants, below the 509-participant average among 59 other Malignant Neoplasm trials with a reported enrollment target (51% lower). The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06979596, a Phase 2 study of Malignant Neoplasm, is actively recruiting participants, sponsored by Merck Sharp & Dohme.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 250 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
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
Conditions Studied
Interventions
- DRUG Fulvestrant
- DRUG Rescue Medications
- DRUG Opevesostat
- DRUG Fludrocortisone/ Fludrocortisone acetate
- DRUG Dexamethasone/Dexamethasone acetate
Study Locations (20)
Texas
- Baylor College of Medicine Medical Center ( Site 0004) - Houston
- Mays Cancer Center ( Site 0039) - San Antonio
Buenos Aires F.D.
- Centro Medico Dr. Doreski - Fundación Respirar ( Site 0302) - Buenos Aires
- Instituto Alexander Fleming ( Site 0303) - Buenos Aires
Region M. de Santiago
- FALP ( Site 3300) - Santiago
- Pontificia Universidad Catolica de Chile ( Site 3307) - Santiago
Alaska
- Alaska Womens Cancer Care ( Site 0037) - Anchorage
Florida
- Mount Sinai Cancer Center ( Site 0009) - Miami Beach
Louisiana
- TRIALS 365 ( Site 0022) - Shreveport
Nebraska
- Mary Lanning Healthcare ( Site 0019) - Hastings
New Jersey
- John Theurer Cancer Center at Hackensack University Medical Center ( Site 0021) - Hackensack
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2025-08-11 |
| Est. Completion | 2027-11-04 |
| Phase | Phase 2 |
What NCT06979596 shows while recruiting
NCT06979596 is an interventional study that assigns participants to a tested intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap, below the 509-participant average among 59 other Malignant Neoplasm trials with a reported enrollment target (51% lower).
The record links to 1 condition, with Malignant Neoplasm appearing as the primary indexed condition, and to 5 interventions - of which Fulvestrant is the first listed.
NCT06979596 names 20 study sites across 17 states, led by Texas, Buenos Aires F.D., Region M. de Santiago.
Frequently Asked Questions
What is clinical trial NCT06979596 about?
NCT06979596 is a clinical study titled "A Study of MK-5684 in People With Certain Solid Tumors (MK-5684-015/OMAHA-015)". 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...
What is the current status of trial NCT06979596?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 250 participants. The study started on 2025-08-11. Estimated completion is 2027-11-04.
What conditions does trial NCT06979596 study?
This clinical trial studies the following conditions: Malignant Neoplasm.
What interventions are being tested in trial NCT06979596?
The interventions under investigation include: Fulvestrant (DRUG), Rescue Medications (DRUG), Opevesostat (DRUG), Fludrocortisone/ Fludrocortisone acetate (DRUG), Dexamethasone/Dexamethasone acetate (DRUG).
Who is sponsoring clinical trial NCT06979596?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06979596 being conducted?
This trial has 20 study locations across Alaska, Florida, Louisiana, Nebraska, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06979596's enrollment target sits among peer trials
250 18th of 59 higher than 41 of 59 other Malignant Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Malignant Neoplasm trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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