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NCT06979596 · Merck Sharp & Dohme LLC

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

What this study is about

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.

View original scientific description

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

DRUG

Opevesostat

Tablet for oral administration.

DRUG

Fludrocortisone/ Fludrocortisone acetate

Tablet for oral administration.

DRUG

Dexamethasone/Dexamethasone acetate

Tablet for oral administration.

DRUG

Rescue Medications

Hydrocortisone or hydrocortisone/hydrocortisone acetate administered via intramuscular injection as rescue medication.

DRUG

Fulvestrant

Administered via intramuscular injection.

DRUG

Exemestane

Tablet for oral administration.

DRUG

Megestrol acetate/Medroxyprogesterone acetate

Tablet for oral administration.

DRUG

Tamoxifen

Tablet for oral administration.

DRUG

Letrozole

Tablet for oral administration.

Primary outcome measures

Progression-Free Survival (PFS) - All Cohorts

Time frame: Up to approximately 2 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.

Who can participate

This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.

Inclusion criteria

  • The main inclusion criteria include but are not limited to the following:
  • 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.
  • 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 exclusion criteria include but are not limited to the following:
  • 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).
  • Is a candidate for curative-intent surgery or curative-intent radiotherapy for ovarian cancer.
  • Has high-grade (FIGO Grade 3 or poorly differentiated) endometrioid carcinoma and nonendometrioid histologies of any type (including serous, clear cell, mixed, carcinosarcoma), and neuroendocrine tumors are not eligible. Uterine mesenchymal tumors such as an endometrial stromal sarcoma, leiomyosarcoma, or other types of pure sarcomas, and adenosarcomas are not eligible.
  • Is a candidate for curative-intent surgery or curative-intent radiotherapy.
  • All Cohorts:
  • Has confirmed or suspected adrenal metastases.
  • Has known difficulty in tolerating oral medications, unable to swallow orally administered medication, or conditions which would impair absorption of oral medications.
  • Has any prior history or current condition of adrenal insufficiency.
  • HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
  • Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
  • Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
  • Has known active central nervous system metastases and/or carcinomatous meningitis.
  • Has a history of stem cell/solid organ transplant.
  • Has not adequately recovered from major surgery or has ongoing surgical complications.

Where

  • Anchorage, Alaska
  • Miami Beach, Florida
  • Shreveport, Louisiana
  • Hastings, Nebraska
  • Hackensack, New Jersey
  • New York, New York
  • Columbus, Ohio
  • Houston, Texas
  • San Antonio, Texas

Related conditions & keywords

Malignant Neoplasm

Frequently asked questions

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Data: ClinicalTrials.gov · synced Oct 6, 2026 · Source of record for eligibility and locations

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See if this study fits

A short prescreen based on this study's listed criteria. A coordinator confirms eligibility — this is not a medical assessment.

Preparing your pre-screening questions…

Study locations

Choose your preferred location, or select flexible during enrollment.

RECRUITING

Anchorage

Alaska

Location available
RECRUITING

Miami Beach

Florida

Location available
RECRUITING

Shreveport

Louisiana

Location available
RECRUITING

Hastings

Nebraska

Location available
RECRUITING

Hackensack

New Jersey

Location available
RECRUITING

New York

New York

Location available
RECRUITING

Columbus

Ohio

Location available
RECRUITING

Houston

Texas

Location available
RECRUITING

Houston

Texas

Location available

And 1 more location available.

Express your interest

Share your contact details and a study coordinator can follow up about screening.

Secure & Confidential

Your information is protected and will only be shared with the research team.

What participation can include

  • Study-related care provided by the research team
  • Close monitoring by medical professionals
  • Possible compensation for time and travel*
  • The option to withdraw at any time
  • Contributing to medical research that may help future patients

*Compensation varies by study. Confirm details with coordinator.

Typical next steps

  1. 1.Submit this form
  2. 2.Phone screening
  3. 3.In-person assessment if eligible
  4. 4.Begin participation

Find More Advanced Solid Tumors Trials by City

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Looking for Solid Tumors Treatment in Anchorage?

Join others in Alaska exploring innovative treatment options through clinical research

Solid Tumors Treatment Options in Anchorage, Alaska

If you're searching for Solid Tumors treatment in Anchorage, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Anchorage, Miami Beach, Shreveport and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Solid Tumors. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Alaska
Now Enrolling
Up to 250 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Solid Tumors?

Potential Benefits

  • ✓Access to new treatment approaches before public availability
  • ✓Close monitoring by experienced medical professionals
  • ✓Study-related care provided at no cost
  • ✓Contribute to medical research for Solid Tumors

What to Expect

  • →Initial screening to determine eligibility
  • →Regular check-ups and monitoring visits
  • →Possible compensation for time and travel
  • →You can withdraw at any time

Frequently Asked Questions About This Solid Tumors Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT06979596. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.