Phase 3 Study Comparing Olvi-Vec Followed by Platinum-Doublet Chemotherapy and Bevacizumab Versus Physicians Choice Chemotherapy with Bevacizumab in Women with Platinum-Resistant or Refractory Ovarian Cancer

What this Trial Is About

Researchers are evaluating the safety and effectiveness of Olvi-Vec followed by platinum-doublet chemotherapy and bevacizumab compared to the physicians choice of chemotherapy and bevacizumab in women diagnosed with platinum-resistant or refractory ovarian cancer, including fallopian tube and primary peritoneal cancers. This Phase 3 study builds on prior Phase 2 results showing promising tumor response and progression-free survival, with intraperitoneal delivery of Olvi-Vec activating the immune system and potentially reversing platinum resistance in this difficult-to-treat group. Participants randomized to the experimental group receive two consecutive daily infusions of Olvi-Vec through an intraperitoneal catheter in Week 0, which is then removed. Afterward, starting in Week 4 or 5, they receive platinum-doublet chemotherapy and bevacizumab administered systemically. The comparison group receives the physicians choice of chemotherapyeither non-platinum single agent or platinum-doublet chemotherapyalong with bevacizumab beginning in Week 0. Biological samples may be collected from some experimental participants to test for virus shedding. During the study, participants undergo assessments to measure tumor response using RECIST 1.1 and iRECIST criteria. Safety is monitored by tracking treatment-related adverse events. Key outcomes include progression-free survival, overall response rate, duration of response, and overall survival. Participants are followed for up to 36 months for safety and survival data. The study aims to determine if Olvi-Vec combined with chemotherapy can improve outcomes in this patient population.

Efficacy & Safety of Olvi-Vec and Platinum-doublet + Bevacizumab Compared to Physician's Choice of Chemotherapy and Bevacizumab in Platinum-Resistant/Refractory Ovarian Cancer (PRROC) (OnPrime, GOG-3076)