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Brief Title: ONC-392 and Pembrolizumab in Platinum Resistant Ovarian Cancer
Official Title: Phase 2 Randomized Open-label Multicenter Study of Combination of ONC-392 and Pembrolizumab for the Treatment of Patients With Platinum Resistant Ovarian Cancer (PROC)
Study ID: NCT05446298
Brief Summary: This is a study to test the safety and efficacy with the combination of a next generation anti-CTLA-4 antibody, ONC-392, and anti-PD-1 antibody, pembrolizumab, in platinum resistant ovarian cancer patients.
Detailed Description: The purpose of this Phase 2 study is to compare two doses of ONC-392 in combination with a fixed dose of pembrolizumab in participants with ovarian cancer who are resistant to platinum-based chemotherapy and have disease progression on line of therapy containing bevacizumab. Results from this study will be used to inform the study design, patient population, and dose selection for future studies in advanced ovarian cancer.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Cancer Treatment Centers of America, Phoenix. 403, Goodyear, Arizona, United States
Honor Health, USOR, 406, Phoenix, Arizona, United States
Nuvance Health System, 401, Danbury, Connecticut, United States
Baptist MD Anderson Cancer Center, 404, Jacksonville, Florida, United States
Sudarshan Sharma, MD. LTD. 414, Hinsdale, Illinois, United States
Cancer Treatment Centers of America, Chicago. 410, Zion, Illinois, United States
Northwest Cancer Centers - Dyer, IN - USOR, 422, Dyer, Indiana, United States
Baptist Health Lexington, 407, Lexington, Kentucky, United States
Norton Cancer Institute - St. Matthews, 416, Louisville, Kentucky, United States
Willis-Knighton Physician Network / Gynecologic Oncology Associates, 409, Shreveport, Louisiana, United States
Minnesota Oncology Hematology, P. A. - USOR, 421, Maplewood, Minnesota, United States
Center of Hope, 413, Reno, Nevada, United States
The Valley Hosptial, Inc. 411, Ridgewood, New Jersey, United States
Women's Cancer Care Associates, LLC. 405, Albany, New York, United States
The Ohio State University James Cancer Center, 412, Columbus, Ohio, United States
Oncology Associates of Oregon, P. C. - USOR. 419, Eugene, Oregon, United States
Texas Oncology, P. A. - Austin, USOR. 417, Austin, Texas, United States
Texas Oncology, P.A., Fort Worth - USOR. 420, Fort Worth, Texas, United States
Texas Oncology, P. A. Woodlands - USOR, 418, The Woodlands, Texas, United States
Texas Oncology - Northeast Texas - USOR, 423, Tyler, Texas, United States
Medical College of Wisconsin, 408, Milwaukee, Wisconsin, United States
Name: Bradley Monk, MD
Affiliation: GOG Partners
Role: PRINCIPAL_INVESTIGATOR
Name: Joyce Barlin, MD
Affiliation: GOG Partners
Role: PRINCIPAL_INVESTIGATOR