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)
Condition(s) studied
Investigational drug(s) / intervention(s)
olvimulogene nanivacirepvec: Olvi-Vec is an engineered oncolytic vaccinia virus
Platinum chemotherapy: carboplatin (preferred) or cisplatin: Administered according to local practice
Non-platinum chemotherapy: Physician's Choice of gemcitabine, taxane (paclitaxel, docetaxel or nab-paclitaxel) or pegylated liposomal doxorubicin: Administered according to local practice
Bevacizumab (or biosimilar): Administered according to local practice
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.
Eligibility
Primary outcome measure(s)
- Progression-free survival (PFS) by RECIST 1.1 in the Intention-to-Treat (ITT) population (all randomized participants regardless of whether they received any dose of treatment) — From date of randomization up to 12 months
To assess progression-free survival from time of randomization until first documented disease progression based on radiological assessment or death from any cause.
Trial sites (33)
| Facility | City | Region | Status |
|---|---|---|---|
| The University of South Alabama, Mitchell Cancer Institute | Mobile | Alabama | Recruiting |
| University of Arizona Cancer Center | Tucson | Arizona | Recruiting |
| City of Hope | Duarte | California | Recruiting |
| UC San Diego Health - Moores Cancer Center | La Jolla | California | Recruiting |
| Hoag Gynecologic Oncology | Newport Beach | California | Recruiting |
| UCI Health Chao Family Comprehensive Cancer Center | Orange | California | Recruiting |
| AdventHealth Cancer Institute | Orlando | Florida | Recruiting |
| Sarasota Memorial Healthcare System | Sarasota | Florida | Recruiting |
| Women's Cancer Associates with Women's Care Florida | St. Petersburg | Florida | Recruiting |
| Emory University | Atlanta | Georgia | Recruiting |
| Indiana University Simon Comprehensive Cancer Center | Indianapolis | Indiana | Recruiting |
| Holy Cross Hospital | Silver Spring | Maryland | Recruiting |
| University of Michigan | Ann Arbor | Michigan | Recruiting |
| Karmanos Cancer Institute | Detroit | Michigan | Recruiting |
| Washington University School of Medicine | St Louis | Missouri | Recruiting |
| Mercy Hospital St. Louis | St Louis | Missouri | Recruiting |
| Women's Cancer Center of Nevada | Las Vegas | Nevada | Recruiting |
| Center of Hope | Reno | Nevada | Recruiting |
| Stony Brook Cancer Center | Stony Brook | New York | Recruiting |
| Levine Cancer Institute | Charlotte | North Carolina | Recruiting |
| East Carolina University | Greenville | North Carolina | Recruiting |
| Atrium Health Wake Forest Baptist, Comprehensive Cancer Center | Winston-Salem | North Carolina | Recruiting |
| Cleveland Clinic | Cleveland | Ohio | Recruiting |
| OhioHealth Research Institute | Columbus | Ohio | Recruiting |
| Kettering Health | Kettering | Ohio | Recruiting |
| ProMedica Flower Hospital | Sylvania | Ohio | Recruiting |
| Oklahoma University Health Stephenson Cancer Center | Oklahoma City | Oklahoma | Recruiting |
| AHN West Penn Hospital | Pittsburgh | Pennsylvania | Recruiting |
| Hollings Cancer Center | Charleston | South Carolina | Recruiting |
| Erlanger Health, Inc. | Chattanooga | Tennessee | Recruiting |
| Baylor College of Medicine | Houston | Texas | Recruiting |
| University of Texas Science Center at Houston, McGovern Medical School | Houston | Texas | Recruiting |
| Providence Sacred Heart Medical Center & Children's Hospital | Spokane | Washington | Recruiting |
More Genelux Corporation trials in the USA
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05281471 on ClinicalTrials.gov ↗ ← All trials in the USA