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)
Public ClinicalTrials.gov record NCT05281471. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized Phase 3 Study Assessing the Efficacy and Safety of Olvi-Vec Followed by Platinum-doublet Chemotherapy and Bevacizumab Compared With Physician's Choice of Chemotherapy and Bevacizumab in Women With Platinum-Resistant/Refractory Ovarian Cancer (PRROC) (OnPrime, GOG-3076)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05281471
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 186 participants
Conditions and interventions
Conditions
Interventions
- 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
Biological · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 30, 2022
- Primary completion
- Nov 30, 2026
- Completion
- Nov 30, 2027
- Last update posted
- Aug 25, 2026
2022 – 2027
United States locations
- U.S. sites
- 33
- U.S. states
- 19
- U.S. cities
- 31
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The University of South Alabama, Mitchell Cancer Institute | Mobile | Alabama | 36604 | Recruiting |
| University of Arizona Cancer Center | Tucson | Arizona | 85719 | Recruiting |
| City of Hope | Duarte | California | 91010 | Recruiting |
| UC San Diego Health - Moores Cancer Center | La Jolla | California | 92093 | Recruiting |
| Hoag Gynecologic Oncology | Newport Beach | California | 92663 | Recruiting |
| UCI Health Chao Family Comprehensive Cancer Center | Orange | California | 92868 | Recruiting |
| AdventHealth Cancer Institute | Orlando | Florida | 32804 | Recruiting |
| Sarasota Memorial Healthcare System | Sarasota | Florida | 34239 | Recruiting |
| Women's Cancer Associates with Women's Care Florida | St. Petersburg | Florida | 33713 | Recruiting |
| Emory University | Atlanta | Georgia | 30322 | Recruiting |
| Indiana University Simon Comprehensive Cancer Center | Indianapolis | Indiana | 46202 | Recruiting |
| Holy Cross Hospital | Silver Spring | Maryland | 20910 | Recruiting |
| University of Michigan | Ann Arbor | Michigan | 48109 | Recruiting |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | Recruiting |
| Washington University School of Medicine | St Louis | Missouri | 63110 | Recruiting |
| Mercy Hospital St. Louis | St Louis | Missouri | 63141 | Recruiting |
| Women's Cancer Center of Nevada | Las Vegas | Nevada | 89106 | Recruiting |
| Center of Hope | Reno | Nevada | 89511 | Recruiting |
| Stony Brook Cancer Center | Stony Brook | New York | 11794 | Recruiting |
| Levine Cancer Institute | Charlotte | North Carolina | 28204 | Recruiting |
| East Carolina University | Greenville | North Carolina | 27834 | Recruiting |
| Atrium Health Wake Forest Baptist, Comprehensive Cancer Center | Winston-Salem | North Carolina | 27157-0001 | Recruiting |
| Cleveland Clinic | Cleveland | Ohio | 44195 | Recruiting |
| OhioHealth Research Institute | Columbus | Ohio | 43214 | Recruiting |
| Kettering Health | Kettering | Ohio | 45429 | Recruiting |
| ProMedica Flower Hospital | Sylvania | Ohio | 43560 | Recruiting |
| Oklahoma University Health Stephenson Cancer Center | Oklahoma City | Oklahoma | 73104 | Recruiting |
| AHN West Penn Hospital | Pittsburgh | Pennsylvania | 15224 | Recruiting |
| Hollings Cancer Center | Charleston | South Carolina | 29425 | Recruiting |
| Erlanger Health, Inc. | Chattanooga | Tennessee | 37403 | Recruiting |
| Baylor College of Medicine | Houston | Texas | 77030 | Recruiting |
| University of Texas Science Center at Houston, McGovern Medical School | Houston | Texas | 77030 | Recruiting |
| Providence Sacred Heart Medical Center & Children's Hospital | Spokane | Washington | 99204 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05281471, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 25, 2026 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05281471 live on ClinicalTrials.gov.