Study on MK-5684 for Treating Certain Solid Tumors

Sponsor: Merck Sharp & Dohme LLC

Sponsor score: 40

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

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

FACILITYZIPCITYSTATE
Alaska Womens Cancer Care ( Site 0037)99508AnchorageAlaska
Mount Sinai Cancer Center ( Site 0009)33140Miami BeachFlorida
TRIALS 365 ( Site 0022)71103ShreveportLouisiana
Mary Lanning Healthcare ( Site 0019)68901HastingsNebraska
Mays Cancer Center ( Site 0039)78229San AntonioTexas

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