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RecruitingPHASE2INTERVENTIONAL

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

Researchers are investigating a new medicine called MK-5684 for people with certain types of breast, ovarian, and endometrial cancers. The study medicine, MK-5684, works by preventing the body from making steroid hormones, which can sometimes help cancer grow. The main goal is to find out if patients treated with MK-5684 live longer without their cancer growing or spreading when compared to those receiving standard cancer treatments. This is a Phase 2 study, meaning the treatment has already shown some promise in earlier testing and is now being more thoroughly evaluated in a larger group of people. Participants will be carefully monitored throughout the study.

At a glance

Status
Recruiting
Phase
PHASE2
Sponsor
Merck Sharp & Dohme LLC
Enrolment target
250
Start
11 Aug 2025
Estimated completion
04 Nov 2027

What is this study about?

This study, called OMAHA-015, is looking into a new treatment called MK-5684 for people diagnosed with specific types of breast, ovarian, and endometrial cancers. These cancers are sometimes influenced by hormones in the body, particularly steroid hormones. The new medicine, MK-5684, is designed to block the production of these hormones, with the hope that this will stop the cancer from growing or spreading.

In this study, researchers want to see how effective MK-5684 is compared to the usual treatments currently given for these cancers. They will be looking to see if people who take MK-5684 can live for a longer time without their cancer getting worse or spreading to other parts of the body. This is an important step in finding new and potentially better ways to manage these conditions.

The study involves different groups of patients depending on their specific cancer type and previous treatments. For example, some breast cancer patients must have hormone-sensitive cancer that has progressed after other hormone-blocking treatments. Similarly, there are specific requirements for ovarian and endometrial cancer patients regarding their previous treatments. By carefully comparing MK-5684 to standard care, the study aims to understand its benefits and how it might fit into future cancer treatment plans.

Key takeaways

  • This study is testing a new medicine, MK-5684, for certain breast, ovarian, and endometrial cancers.
  • MK-5684 works by blocking certain steroid hormones in the body.
  • The main goal is to see if MK-5684 can prevent cancer from growing or spreading for longer than current standard treatments.
  • You might be eligible if you have specific types of advanced or recurrent cancer that fit the study criteria.
  • Taking part involves regular check-ups and close monitoring by medical staff.
  • You can withdraw from the study at any time without affecting your usual medical care.

Who may be eligible?

This study is looking for adults aged 18 and over, of any sex. Generally, you might be able to take part if you have certain types of advanced or recurrent breast, ovarian, or endometrial cancer, and your cancer has either spread or come back after previous treatments.

For breast cancer, you would usually need to have hormone-sensitive breast cancer that has already advanced or spread, and has worsened despite at least one previous hormone-blocking treatment. For ovarian cancer, you would typically have a specific high-grade type and have received a certain number of chemotherapy cycles. For endometrial cancer, you would need to have an advanced or recurrent low-grade type, and either not had treatment yet or only one previous chemotherapy.

Everyone joining the study needs to be generally well, meaning any side effects from your past cancer treatments should have mostly cleared up. You would also need to have well-controlled HIV, if applicable, or well-managed Hepatitis B.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Do you have advanced or recurrent breast, ovarian, or endometrial cancer?
  3. Have you been treated for side effects from previous cancer treatments, and have they mostly improved?
  4. For breast cancer, has your hormone-sensitive cancer progressed after previous hormone therapy?
  5. For ovarian or endometrial cancer, does your diagnosis and past treatment history match the specific requirements?
Answer every question to see your result.

What does participation involve?

Taking part in this study would involve regular visits to the clinic for check-ups, assessments, and to receive your study medication (MK-5684 or a standard treatment). These assessments might include blood tests, scans, and physical exams to monitor your health and how the treatment is working. You will be closely followed by the study doctors and nurses. The duration of your participation would depend on how your treatment progresses and could continue as long as the treatment is beneficial for you and you tolerate it well. You'd also receive clear guidance on taking any other necessary medications.

Potential risks and benefits

There is a possibility that participating in this study could offer a benefit, such as the new medicine being more effective than standard treatments in controlling your cancer. However, it's also possible that the new medicine may not work for you, or it might cause side effects, some of which could be serious. All participants will be very closely monitored by the medical team. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (55)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Alaska Womens Cancer Care ( Site 0037)
    Verified postcode
    Anchorage, United States· Recruiting
  • Mount Sinai Cancer Center ( Site 0009)
    Verified postcode
    Miami Beach, United States· Recruiting
  • TRIALS 365 ( Site 0022)
    Verified postcode
    Shreveport, United States· Recruiting
  • Mary Lanning Healthcare ( Site 0019)
    Verified postcode
    Hastings, United States· Recruiting
  • John Theurer Cancer Center at Hackensack University Medical Center ( Site 0021)
    Verified postcode
    Hackensack, United States· Recruiting
  • Memorial Sloan Kettering Cancer Center ( Site 0002)
    Verified postcode
    New York, United States· Recruiting
  • The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 0008)
    Verified postcode
    Columbus, United States· Recruiting
  • Baylor College of Medicine Medical Center ( Site 0004)
    Verified postcode
    Houston, United States· Recruiting
  • Mays Cancer Center ( Site 0039)
    Verified postcode
    San Antonio, United States· Recruiting
  • Hospital Aleman ( Site 0301)
    Unverified
    Ciudad Autonoma de Buenos Aires, Argentina· Recruiting
  • Centro Medico Dr. Doreski - Fundación Respirar ( Site 0302)
    Verified postcode
    Buenos Aires, Argentina· Recruiting
  • Instituto Alexander Fleming ( Site 0303)
    Verified postcode
    Buenos Aires, Argentina· Recruiting

Common questions

What is MK-5684?

MK-5684 is the new study medicine being tested. It's designed to treat cancer by reducing the amount of certain hormones in your body that can help cancer grow.

What does 'Phase 2' mean?

Phase 2 means that this medicine has already been safely tested in a smaller group of people. Now, it's being given to a larger group to understand how well it works and to check for side effects.

Will I definitely get the new medicine?

This study compares the new medicine (MK-5684) with standard treatments. Depending on which group you are assigned to, you might receive MK-5684 or one of the widely used treatments for your cancer type.

How long will I be in the study?

The length of time you participate will vary. You will continue to receive treatment and be monitored as long as it is helping you and you are tolerating it well.

What if I feel unwell during the study?

The study team will monitor you very closely. You should always tell them immediately if you experience any new symptoms or feel unwell, so they can provide appropriate care.

How to find out more

Toll Free Number

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "A Study of MK-5684 in People With Certain Solid Tumors (MK-5…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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