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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)
Sponsor: Genelux Corporation
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.
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)
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
186
Start Date
2022-08-31
Completion Date
2026-10
Last Updated
2026-03-18
Healthy Volunteers
No
Conditions
Interventions
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
Locations (31)
The University of South Alabama, Mitchell Cancer Institute
Mobile, Alabama, United States
University of Arizona Cancer Center
Tucson, Arizona, United States
City of Hope
Duarte, California, United States
UC San Diego Health - Moores Cancer Center
La Jolla, California, United States
Hoag Gynecologic Oncology
Newport Beach, California, United States
UCI Health Chao Family Comprehensive Cancer Center
Orange, California, United States
AdventHealth Cancer Institute
Orlando, Florida, United States
Sarasota Memorial Research Institute
Sarasota, Florida, United States
Emory University
Atlanta, Georgia, United States
Indiana University Simon Comprehensive Cancer Center
Indianapolis, Indiana, United States
Holy Cross Hospital
Silver Spring, Maryland, United States
University of Michigan
Ann Arbor, Michigan, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Washington University School of Medicine
St Louis, Missouri, United States
Mercy Hospital St. Louis
St Louis, Missouri, United States
Women's Cancer Center of Nevada
Las Vegas, Nevada, United States
Center of Hope
Reno, Nevada, United States
Stony Brook Cancer Center
Stony Brook, New York, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
East Carolina University
Greenville, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
OhioHealth Research Institute
Columbus, Ohio, United States
Kettering Health
Kettering, Ohio, United States
ProMedica Flower Hospital
Sylvania, Ohio, United States
Oklahoma University Health Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
AHN West Penn Hospital
Pittsburgh, Pennsylvania, United States
Hollings Cancer Center
Charleston, South Carolina, United States
Erlanger Health, Inc.
Chattanooga, Tennessee, United States
Baylor College of Medicine
Houston, Texas, United States
University of Texas Science Center at Houston, McGovern Medical School
Houston, Texas, United States
Providence Sacred Heart Medical Center & Children's Hospital
Spokane, Washington, United States