Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05281471 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial
NCT05281471 · ClinicalTrials.gov record · last posted 2026-08-26

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)

StatusRecruiting
PhasePhase 3
Started2022-08-31
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
The OnPrime study is a multi-center, randomized open-label phase 3 study evaluating the safety and efficacy of Olvi-Vec followed by platinum-doublet chemotherapy and bevacizumab compared to the Active Comparator Arm with Physician's Choice of chemotherapy and bevacizumab in women diagnosed with platinum-resistant/refractory ovarian cancer (includes fallopian tube cancer and primary peritoneal cancer). This Phase III trial builds on the efficacy and safety data reported in the previous Phase II VIRO-15 trial with promising objective response rate and progression-free survival observed in heavily pre-treated patients with platinum-resistant/refractory ovarian cancer. The phase II results also showed that the intra-peritoneal route of delivery was efficient in generating tumor cell killing and immune activation, and led to clinical reversal of platinum-resistance or refractoriness in this difficult-to-treat patient population.

Protocol amendment history 2 changes detected by DataLookout

2026-07-11
notable
Primary completion pushed: 2026-06 → 2026-12
2026-07-11
minor
Completion pushed: 2026-10 → 2027-12
Trial Details
NCT Number NCT05281471
Lead Sponsor Genelux Corporation
Collaborators: GOG Foundation
Conditions Platinum-resistant Ovarian Cancer, Platinum-refractory Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, High-grade Serous Ovarian Cancer, Endometrioid Ovarian Cancer, Ovarian Clear Cell Carcinoma
Enrollment 186 participants
Start Date 2022-08-31
Primary Completion 2026-12 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2026-08-26