Fludrocortisone/ Fludrocortisone acetate: Tablet for oral administration.
Dexamethasone/Dexamethasone acetate: Tablet for oral administration.
Rescue Medications: Hydrocortisone or hydrocortisone/hydrocortisone acetate administered via intramuscular injection as rescue medication.
Fulvestrant: Administered via intramuscular injection.
Exemestane: Tablet for oral administration.
Megestrol acetate/Medroxyprogesterone acetate: Tablet for oral administration.
Tamoxifen: Tablet for oral administration.
Letrozole: Tablet for oral administration.
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
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 and received either, 1 line of an approved protocol-specified combination endocrine-based therapy, or 2 or more lines of protocol-specified 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.
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
* Cohort A:
* Breast cancer amenable to treatment with curative intent.
* Has advanced/metastatic, symptomatic visceral spread at risk of rapidly evolving into life-threatening complications, such as lymphangitic lung metastases, radiographic evidence of intratumoral cavitation or invasion/infiltration of a major blood vessel, bone marrow replacement, carcinomatous meningitis, significant symptomatic liver metastases, symptomatic pericardial effusion, symptomatic peritoneal carcinomatosis, or the need to achieve rapid symptom control.
* Cohort B:
* Has nonepithelial cancers (germ cell tumors and sex cord-stromal tumors), borderline tumors (low malignant potential), mucinous, seromucinous that is predominantly mucinous, malignant Brenner's tumor, low-grade serous, low-grade endometrioid, and undifferentiated carcinoma.
* Has platinum-resistant ovarian cancer (defined as disease that has progressed per radiographic imaging within 180 days after the last dose of first-line \[1L\] platinum-based therapy) or platinum-refractory ovarian cancer (defined as disease that has progressed per radiographic imaging while receiving or within 28 days of the last dose of 1L platinum based therapy).
* Is a candidate for curative-intent surgery or curative-intent radiotherapy for ovarian cancer.
* Cohort C:
* Has high-grade (FIGO Grade 3 or poorly differentiated) endometrioid carcinoma and nonendometrioid histologies of any type (including serous, clear cell, mixed, carcinosarcoma), and neuroendocrine tumors are not eligible. Uterine mesenchymal tumors such as an endometrial stromal sarcoma, leiomyosarcoma, or other types of pure sarcomas, and adenosarcomas are not eligible.
* Is a candidate for curative-intent surgery or curative-intent radiotherapy.
* All Cohorts:
* Has confirmed or suspected adrenal metastases.
* Has known difficulty in tolerating oral medications, unable to swallow orally administered medication, or conditions which would impair absorption of oral medications.
* Has any prior history or current condition of adrenal insufficiency.
* HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
* Has known active central nervous system metastases and/or carcinomatous meningitis.
* Has a history of stem cell/solid organ transplant.
* Has not adequately recovered from major surgery or has ongoing surgical complications.
Primary outcome measure(s)
Progression-Free Survival (PFS) - All Cohorts — Up to approximately 2 years For all cohorts, PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1). PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review (BICR) will be presented.
Trial sites (60)
Facility
City
Region
Status
Alaska Womens Cancer Care ( Site 0037)
Anchorage
Alaska
Recruiting
Mount Sinai Cancer Center ( Site 0009)
Miami Beach
Florida
Recruiting
TRIALS 365 ( Site 0022)
Shreveport
Louisiana
Recruiting
Mary Lanning Healthcare ( Site 0019)
Hastings
Nebraska
Recruiting
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0021)
Hackensack
New Jersey
Recruiting
Rockefeller Outpatient Pavilion ( Site 0002)
New York
New York
Recruiting
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 0008)
Columbus
Ohio
Recruiting
Baylor College of Medicine Medical Center ( Site 0004)
Houston
Texas
Recruiting
Harris Health System ( Site 0040)
Houston
Texas
Recruiting
Mays Cancer Center ( Site 0039)
San Antonio
Texas
Recruiting
Hospital Aleman ( Site 0301)
Ciudad Autonoma de Buenos Aires
Buenos Aires
Recruiting
Centro Medico Dr. Doreski - Fundación Respirar ( Site 0302)
Buenos Aires
Buenos Aires F.D.
Recruiting
Instituto Alexander Fleming ( Site 0303)
Buenos Aires
Buenos Aires F.D.
Recruiting
Hospital Santa Rita de Cassia ( Site 3104)
Vitória
Espírito Santo
Recruiting
Obras Sociais Irma Dulce ( Site 3112)
Salvador
Estado de Bahia
Recruiting
Hospital Felicio Rocho ( Site 3105)
Belo Horizonte
Minas Gerais
Recruiting
Hospital de Cancer de Pernambuco ( Site 3103)
Recife
Pernambuco
Recruiting
Liga Norte Riograndense Contra o Cancer ( Site 3108)
Natal
Rio Grande do Norte
Recruiting
Instituto Nacional de Câncer - INCA ( Site 3107)
Rio de Janeiro
Brazil
Recruiting
Sunnybrook Research Institute ( Site 0203)
Toronto
Ontario
Recruiting
Princess Margaret Cancer Centre ( Site 0202)
Toronto
Ontario
Recruiting
Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0200)
Montreal
Quebec
Recruiting
Jewish General Hospital ( Site 0201)
Montreal
Quebec
Recruiting
Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer ( Site 0205)
Sherbrooke
Quebec
Recruiting
FALP ( Site 3300)
Santiago
Region M. de Santiago
Recruiting
Pontificia Universidad Catolica de Chile ( Site 3307)
Santiago
Region M. de Santiago
Recruiting
Bradfordhill ( Site 3301)
Santiago
Region M. de Santiago
Recruiting
ONCOCENTRO APYS ( Site 3302)
Viña del Mar
Valparaiso
Recruiting
Sarawak General Hospital ( Site 0602)
Kuching
Sarawak
Recruiting
Pantai Hospital Kuala Lumpur ( Site 0603)
Kuala Lumpur
Malaysia
Recruiting
University Malaya Medical Centre ( Site 0601)
Kuala Lumpur
Malaysia
Recruiting
Instituto Regional de Enfermedades Neoplasicas del Centro (IREN CENTRO) ( Site 3405)
Concepción
Departamento de Junín
Recruiting
Clínica San Antonio ( Site 3404)
Trujillo
La Libertad
Recruiting
IPOR Instituto Peruano de Oncología & Radioterapia ( Site 3400)
Lima
Peru
Recruiting
Instituto Nacional de Enfermedades Neoplásicas ( Site 3401)
Lima
Peru
Recruiting
National Cancer Centre Singapore ( Site 0800)
Singapore
Central Singapore
Recruiting
Institut Català d'Oncologia - L'Hospitalet-Medical Oncology ( Site 2000)
L'Hospitalet de Llobregat
Barcelona
Recruiting
CHUAC-Complejo Hospitalario Universitario A Coruña ( Site 2003)
A Coruña
La Coruna
Recruiting
Clinica Universitaria Navarra - Madrid ( Site 2004)
Madrid
Madrid, Comunidad de
Recruiting
Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 2002)
Madrid
Madrid, Comunidad de
Recruiting
+ 20 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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