A Multicenter, Open-label, Phase 2 Basket Study of MK-5684 in Participants With Selected Solid Tumors (OMAHA-015)

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

∙ The main inclusion criteria include but are not limited to the following:

• Cohort A:

‣ 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.

• Cohort B:

‣ 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.

• Cohort C:

‣ 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.

Locations
United States
Florida
Mount Sinai Cancer Center ( Site 0009)
RECRUITING
Miami Beach
Louisiana
TRIALS 365 ( Site 0022)
RECRUITING
Shreveport
Nebraska
Mary Lanning Healthcare ( Site 0019)
RECRUITING
Hastings
Other Locations
Spain
CHUAC-Complejo Hospitalario Universitario A Coruña ( Site 2003)
RECRUITING
A Coruña
Clinica Universitaria Navarra - Madrid ( Site 2004)
RECRUITING
Madrid
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 2001)
RECRUITING
Madrid
Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 2002)
RECRUITING
Madrid
Taiwan
National Cheng Kung University Hospital ( Site 1003)
RECRUITING
Tainan City
Mackay Memorial Hospital ( Site 1002)
RECRUITING
Taipei
United Kingdom
The Christie NHS Foundation Trust ( Site 2300)
RECRUITING
Manchester
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date: 2025-08-11
Estimated Completion Date: 2027-11-04
Participants
Target number of participants: 250
Treatments
Experimental: MK-5684 and Supportive Adrenal Therapy (SAT)
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.
Experimental: Fulvestrant or Exemestane
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.
No_intervention: Observation (No Treatment)
Participants with ovarian cancer will be observed but will receive no treatment for the duration of the study.
Experimental: Treatment of Physician's Choice
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.
Sponsors
Leads: Merck Sharp & Dohme LLC

This content was sourced from clinicaltrials.gov

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