MK-5684 for Breast Cancer

Recruiting at 18 trial locations

Overseen By Toll Free Number

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Merck Sharp & Dohme LLC

Must not be taking: Live vaccines

Disqualifiers: Adrenal metastases, CNS metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to approximately 8 months

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether the new treatment, MK-5684 (a hormone-blocking drug), can stop breast, ovarian, and endometrial cancers from growing or spreading. MK-5684 blocks the production of certain hormones that fuel these cancers. The study compares this treatment to standard therapies to determine if it helps patients live longer without cancer progression. Suitable candidates for this trial include those with advanced or metastatic forms of these cancers who have already tried other unsuccessful treatments. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that MK-5684 is being tested for its safety and effectiveness in treating certain cancers. Previous studies found that most patients tolerated MK-5684 well. Some side effects, common in cancer treatments, were reported. These side effects are usually mild and manageable, such as nausea, tiredness, or changes in blood pressure.

The treatment works by stopping the body from making certain hormones that some cancers need to grow. This method has been used in other cancer treatments before, providing some confidence about its safety.

Since MK-5684 is currently in Phase 2 trials, researchers are still learning about its safety. Treatments in this phase have usually been tested in humans before, so some existing information on its safety is available. This phase is crucial for understanding how well people can handle the drug, and any new findings will help make the treatment safer. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about MK-5684 for breast cancer because it targets the condition differently than traditional treatments. While standard therapies often focus on hormone receptor modulation or chemotherapy, MK-5684 works by enhancing adrenal function, which may offer a new way to fight cancer cells. Additionally, this treatment is unique because it is taken orally as a pill, twice a day, which could be more convenient than other more invasive treatments. This novel approach has the potential to provide new hope for patients who might not respond well to existing therapies.

What evidence suggests that MK-5684 might be an effective treatment for breast cancer, ovarian cancer, and endometrial cancer?

Research has shown that MK-5684, which participants in this trial may receive, might help treat certain cancers by inhibiting the production of steroid hormones that can promote cancer growth. This method has shown promise in other cancers, such as prostate cancer, where it significantly lowered levels of male hormones. In some studies, MK-5684 reduced cancer markers in more than half of the patients. These early results suggest it might help prevent cancer from growing or spreading. Although more research is needed, the initial findings offer hope for those with breast, ovarian, and endometrial cancers. ^{1 3 4 5 6}

Who Is on the Research Team?

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Are You a Good Fit for This Trial?

This trial is for adults with certain advanced or metastatic cancers: hormone receptor positive breast cancer that's worsened after endocrine therapy, high-grade ovarian cancer treated with platinum chemotherapy, or low-grade endometrial carcinoma. Participants must have controlled HIV if present, and undetectable hepatitis B or C viral loads if previously infected.

Inclusion Criteria

My cancer is a specific type of advanced ovarian, fallopian tube, or peritoneal.

I've had 4-8 rounds of specific chemo for ovarian cancer as my third treatment.

My cancer is a low-grade endometrioid carcinoma.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive MK-5684 or standard treatment for their cancer type until discontinuation criteria are met

Up to approximately 8 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to approximately 5 years

What Are the Treatments Tested in This Trial?

Interventions

• MK-5684

Trial Overview The study tests MK-5684 against standard treatments to see if it helps patients live longer without their cancer growing. MK-5684 aims to block the body from making steroid hormones which can fuel some cancers. It's a comparison of new medicine versus established therapies across different types of solid tumors.

How Is the Trial Designed?

Group I: Treatment of Physician's Choice Experimental Treatment 3 Interventions

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.

Group II: MK-5684 and Supportive Adrenal Therapy (SAT) Experimental Treatment 4 Interventions

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.

Group III: Fulvestrant or Exemestane Experimental Treatment 2 Interventions

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.

Group IV: Observation (No Treatment) Active Control 1 Intervention

Participants with ovarian cancer will be observed but will receive no treatment for the duration of the study.

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06979596

A Study of MK-5684 in People With Certain Solid Tumors ... 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 ...

2. clinicaltrials.eu clinicaltrials.eu/trial/study-of-mk-5684-compared-to-standard-therapy-in-patients-with-breast-cancer-ovarian-cancer-or-endometrial-cancer/

Study of MK-5684 compared to standard therapy in ... This clinical trial studies the effectiveness of MK-5684 (opevesostat) in treating specific types of solid tumors. The study focuses on ...

3. trial.medpath.com trial.medpath.com/news/12ff521504a5e886/msd-expands-opevesostat-clinical-program-to-include-breast-endometrial-and-ovarian-cancers

MSD Expands Opevesostat Clinical Program to Include Breast ... MSD has initiated a new Phase 2 clinical trial to evaluate opevesostat (MK-5684) in women's cancers, expanding beyond its current prostate cancer program.

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.4_suppl.159

MK-5684 (ODM-208), a CYP11A1 inhibitor, in patients with ... MK-5684 profoundly suppressed androgen synthesis resulting in PSA50 responses in 55.6% and 16.7% of patients and PSA30 responses in 69.8% and ...

5. withpower.com withpower.com/trial/phase-2-neoplasms-6-2025-4d173

MK-5684 for Breast Cancer This Phase 2 medical study run by Merck Sharp & Dohme LLC is evaluating whether MK-5684 will have tolerable side effects & efficacy for patients with Cancer ...

6. merckclinicaltrials.com merckclinicaltrials.com/trial/nct06979596/

A Study of MK-5684 in People With Certain Solid Tumors 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 ...