Study on MK-5684 for Treating Certain Solid Tumors
Sponsor: Merck Sharp & Dohme LLC
ClinicalTrials ID:NCT06979596
This clinical trial is exploring whether the new drug MK-5684 can effectively treat breast, ovarian, and endometrial cancers by blocking steroid hormone production. Researchers will compare MK-5684 to standard treatments to see if it helps patients live longer without the cancer growing or spreading.
Patient Parameters
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Program Overview
The study aims to find out if MK-5684, a new medication, can help treat breast, ovarian, and endometrial cancers by stopping the body from making certain hormones. Researchers will compare the effects of MK-5684 with standard cancer treatments to see if it helps patients live longer without their cancer getting worse.
Eligibility Criteria
Inclusion Criteria
- For Breast Cancer Patients:
- Have hormone receptor positive/HER2 negative breast cancer that cannot be surgically removed or has spread.
- Have had the cancer worsen after at least one hormone-based treatment for metastatic cancer.
- For Ovarian Cancer Patients:
- Have high-grade ovarian, fallopian tube, or primary peritoneal cancer.
- Have received 4 to 8 cycles of platinum-based chemotherapy in the third-line setting.
- For Endometrial Cancer Patients:
- Have advanced or recurrent low-grade endometrioid cancer.
- Have not been treated or have had up to one prior platinum-based treatment.
- For All Participants:
- Must have recovered from side effects of previous cancer treatments.
- HIV-positive participants must have well-controlled HIV.
- Hepatitis B positive participants must have undetectable viral load after antiviral therapy.
- Hepatitis C positive participants must have undetectable viral load.
Exclusion Criteria
- For Breast Cancer Patients:
- Cancer that can be treated with surgery or other curative treatments.
- Cancer that has spread to vital organs and is causing severe symptoms.
- For Ovarian Cancer Patients:
- Have certain types of ovarian cancer that are not eligible.
- Have ovarian cancer that is resistant or unresponsive to platinum-based treatments.
- Are candidates for surgery or radiotherapy aimed at curing the cancer.
- For Endometrial Cancer Patients:
- Have high-grade endometrioid cancer or other specific types of cancer.
- Are candidates for surgery or radiotherapy aimed at curing the cancer.
- For All Participants:
- Have adrenal gland metastases.
- Have difficulty swallowing or absorbing oral medications.
- Have a history of adrenal insufficiency.
- HIV-positive participants with certain conditions like Kaposi's sarcoma.
- Have received a live vaccine within 30 days before starting the study.
- Have another active cancer needing treatment in the past 3 years.
- Have active brain metastases or cancer in the brain lining.
- Have had a stem cell or organ transplant.
- Have not fully recovered from major surgery.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Alaska Womens Cancer Care ( Site 0037) | 99508 | Anchorage | Alaska |
| Mount Sinai Cancer Center ( Site 0009) | 33140 | Miami Beach | Florida |
| TRIALS 365 ( Site 0022) | 71103 | Shreveport | Louisiana |
| Mary Lanning Healthcare ( Site 0019) | 68901 | Hastings | Nebraska |
| Mays Cancer Center ( Site 0039) | 78229 | San Antonio | Texas |
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