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Brief Title: A Clinical Study Evaluating a Combination of Oregovomab and Niraparib in Adult Women With Platinum Sensitive Recurrent Ovarian Cancer.
Official Title: Phase 2, Single Arm Clinical Trial to Evaluate the Safety and Activity of Oregovomab and Niraparib as a Combinatorial Immune Priming Strategy in Subjects With Platinum Sensitive Recurrent Ovarian Cancer
Study ID: NCT05335993
Brief Summary: Study to evaluate the safety and activity of oregovomab and niraparib as a combinatorial immune priming strategy in subjects with platinum sensitive recurrent ovarian cancer.
Detailed Description: Phase 2 single arm open label study to evaluate the combination of oregovomab and niraparib as a combinatorial immune priming strategy in subjects with platinum sensitive recurrent ovarian cancer. Approximately 15 subjects will be screened to enroll approximately 10 evaluable subjects. The study will include: * Screening period up to 28 days prior to start of study treatment. * Treatment period up to 24 weeks. * Post-treatment follow-up period: * Safety Follow-up: all subjects will be followed at least 30 days after end of treatment for safety. * Long Term Follow-up: all subjects will be followed for survival approximately every 3 months for 1 year, until death, withdrawal of consent, lost to follow-up, or sponsor decision to close the study; or whichever comes first.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Duke Cancer Center, Durham, North Carolina, United States
Stephenson Cancer Center- University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
University of Virginia Health System, Charlottesville, Virginia, United States
Name: Sunil Gupta, MD, FRCPC
Affiliation: CanariaBio Inc.
Role: STUDY_DIRECTOR