NRG-GY038

A Randomized Phase II Trial of Sacituzumab Govitecan-HZIY (SG) and Bevacizumab Versus Standard of Care Carboplatin, Pegylated Liposomal Doxorubicin (PLD) and Bevacizumab in Patients with Platinum-Sensitive Ovarian Cancer That Has Progressed on Prior Maintenance PARP Inhibitor Therapy

Principal Investigator

Rebecca Porter, MD, PhD

Status

Disease Site

Gynecologic [GY] Ovarian

Phase

II

Developmental Therapeutics

No

Primary Objective

To assess the clinical activity of Sacituzumab govitecan-hziy (SG) and bevacizumab (or an anti-VEGF antibody biosimilar) compared to standard of care carboplatin, pegylated liposomal doxorubicin (PLD) and bevacizumab (or an anti-VEGF antibody biosimilar), as measured by progression-free survival, in patients with platinum-sensitive ovarian cancer that has progressed while receiving first-line PARP inhibitor maintenance therapy.

Patient Population

Patients with histologic diagnosis of high grade serious or endometrioid epithelial ovarian, fallopian tube or primary peritoneal cancer. Disease must be platinum sensitive, as defined by progression documented ≥ 6 months (182 days) from the last receipt of platinum. Disease must have progressed during first line maintenance PARPi for advanced ovarian cancer. NO intervening therapies between progression on PARPi and study registration are permitted. Disease must be germline or somatic BRCA1 or BRCA2 mutated or homologous recombination deficiency test positive.

Target Accrual

87