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NCT05281471 · ClinicalTrials.gov registry record · Phase 3
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)
A Phase 3 study of Fallopian Tube Cancer and Primary Peritoneal Cancer, sponsored by Genelux Corporation.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 186
- Enrollment target
- 20
- Study locations
NCT05281471 is a Phase 3 study of Fallopian Tube Cancer and Primary Peritoneal Cancer that is actively recruiting participants, run by Genelux Corporation. The registered enrollment target is 186 participants, below the 254-participant average among 85 other Fallopian Tube Cancer trials with a reported enrollment target (27% lower). The trial reports 20 study locations across 12 states.
The verdict
NCT05281471, a Phase 3 study of Fallopian Tube Cancer and Primary Peritoneal Cancer, is actively recruiting participants, sponsored by Genelux Corporation.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 186 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- BIOLOGICAL olvimulogene nanivacirepvec
- DRUG Platinum chemotherapy: carboplatin (preferred) or cisplatin
- DRUG Non-platinum chemotherapy: Physician's Choice of gemcitabine, taxane (paclitaxel, docetaxel or nab-paclitaxel) or pegylated liposomal doxorubicin
- DRUG Bevacizumab (or biosimilar)
Study Locations (20)
California
- City of Hope - Duarte
- UC San Diego Health - Moores Cancer Center - La Jolla
- Hoag Gynecologic Oncology - Newport Beach
- UCI Health Chao Family Comprehensive Cancer Center - Orange
Florida
- AdventHealth Cancer Institute - Orlando
- Sarasota Memorial Research Institute - Sarasota
Michigan
- University of Michigan - Ann Arbor
- Karmanos Cancer Institute - Detroit
Missouri
- Washington University School of Medicine - St Louis
- Mercy Hospital St. Louis - St Louis
Nevada
- Women's Cancer Center of Nevada - Las Vegas
- Center of Hope - Reno
North Carolina
- Levine Cancer Institute - Charlotte
- East Carolina University - Greenville
Alabama
- The University of South Alabama, Mitchell Cancer Institute - Mobile
Arizona
- University of Arizona Cancer Center - Tucson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 186 participants |
| Start Date | 2022-08-31 |
| Est. Completion | 2026-10 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05281471
The ClinicalTrials.gov registry entry for NCT05281471 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 186 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 254-participant average among 85 other Fallopian Tube Cancer trials with a reported enrollment target (27% lower). The listed sponsor is Genelux Corporation, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 7 conditions, with Fallopian Tube Cancer appearing as the primary indexed condition, and to 4 interventions - of which olvimulogene nanivacirepvec is the first listed.
NCT05281471 reports 20 study locations spanning 12 distinct geographic areas - top geographies include California, Florida, Michigan.
Frequently Asked Questions
What is clinical trial NCT05281471 about?
NCT05281471 is a clinical study titled "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)". 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 plat...
What is the current status of trial NCT05281471?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 186 participants. The study started on 2022-08-31. Estimated completion is 2026-10.
What conditions does trial NCT05281471 study?
This clinical trial studies the following conditions: Fallopian Tube Cancer, Primary Peritoneal Cancer, Platinum-resistant Ovarian Cancer, Ovarian Clear Cell Carcinoma, High-grade Serous Ovarian Cancer.
What interventions are being tested in trial NCT05281471?
The interventions under investigation include: olvimulogene nanivacirepvec (BIOLOGICAL), Platinum chemotherapy: carboplatin (preferred) or cisplatin (DRUG), Non-platinum chemotherapy: Physician's Choice of gemcitabine, taxane (paclitaxel, docetaxel or nab-paclitaxel) or pegylated liposomal doxorubicin (DRUG), Bevacizumab (or biosimilar) (DRUG).
Who is sponsoring clinical trial NCT05281471?
This trial is sponsored by Genelux Corporation, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05281471 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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