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A Study of MK-5684 in People With Certain Solid Tumors (MK-5684-015/OMAHA-015)
250 patients around the world
Available in Argentina, United States
Merck Sharp & Dohme LLC
3Research sites
250Patients around the world
This study is for people with
Solid tumors
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.Cohort A: 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.Cohort B: 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).Cohort C: 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.All Cohorts: Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy.All Cohorts: 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.All Cohorts: Participants with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable.
- Cohort A: Breast cancer amenable to treatment with curative intent.Cohort A: 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.Cohort B: 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).Cohort B: 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.Cohort C: Is a candidate for curative-intent surgery or curative-intent radiotherapy.All Cohorts: Has confirmed or suspected adrenal metastases.All Cohorts: Has known difficulty in tolerating oral medications, unable to swallow orally administered medication, or conditions which would impair absorption of oral medications.All Cohorts: Has any prior history or current condition of adrenal insufficiency.All Cohorts: HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.All Cohorts: Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.All Cohorts: Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.All Cohorts: Has known active central nervous system metastases and/or carcinomatous meningitis.All Cohorts: Has a history of stem cell/solid organ transplant.All Cohorts: Has not adequately recovered from major surgery or has ongoing surgical complications.
Sites
Instituto Médico Especializado Alexander Fleming - CABA, Buenos Aires
Recruiting
Hospital Alemán
Recruiting
Fundación Respirar
Recruiting
SponsorMerck Sharp & Dohme LLC
Study typeInterventional
Conditions
Solid tumors
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06979596
