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Spots Global Cancer Trial Database for A Clinical Study Evaluating a Combination of Oregovomab and Niraparib in Adult Women With Platinum Sensitive Recurrent Ovarian Cancer.

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Trial Identification

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

Interventions

Oregovomab
Niraparib

Study Description

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

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

Contact Details

Name: Sunil Gupta, MD, FRCPC

Affiliation: CanariaBio Inc.

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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