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)
Start Date
8/31/2022
Completion Date
12/1/2027
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.
Detailed Description
Olvi-Vec (olvimulogene nanivacirepvec, aka GL-ONC1, laboratory name: GLV-1h68) is an oncolytic vaccinia virus-based immunotherapy. This study is to test the hypothesis that the combination of Olvi-Vec followed by further chemotherapy is particularly effective against established tumors by virus-mediated immune activation and re-sensitization of tumor cells to chemotherapy. Participant population includes histologically confirmed non-resectable platinum-resistant/refractory ovarian cancer (PRROC). Determination of progression-free survival, safety and overall survival are key objectives. Participants randomized into the Experimental Arm will receive a single-cycle (2 infusions on two consecutive days) of Olvi-Vec through an intraperitoneal catheter. The catheter is then removed, and patients receive systemically administered platinum-doublet chemotherapy and bevacizumab. The control arm receives the Physician's Choice of chemotherapy and bevacizumab at the same dose and schedule. Biological samples will be obtained from some Experimental Arm participants for virus-shedding testing. Assessment of response to treatment in both arms will be by RECIST 1.1 and iRECIST as assessed by Blinded Independent Central Review. Maintenance/continued treatment with non-platinum chemotherapy and bevacizumab is dependent on a participant being clinically stable until confirmed progressive disease by iRECIST or can no longer tolerate therapy. Dr. Robert W. Holloway (AdventHealth Cancer Institute, Orlando, FL) will serve as the National Principal Investigator for this Phase 3 study in PRROC.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
olvimulogene nanivacirepvec
Platinum chemotherapy: carboplatin (preferred) or cisplatin
Non-platinum chemotherapy: Physician's Choice of gemcitabine, taxane (paclitaxel, docetaxel or nab-paclitaxel) or pegylated liposomal doxorubicin
Bevacizumab (or biosimilar)
Conditions
Locations
The University of South Alabama, Mitchell Cancer Institute
Mobile, Alabama 36604
United States
University of Arizona Cancer Center
Tucson, Arizona 85719
United States
City of Hope
Duarte, California 91010
United States
UC San Diego Health - Moores Cancer Center
La Jolla, California 92093
United States
Hoag Gynecologic Oncology
Newport Beach, California 92663
United States
UCI Health Chao Family Comprehensive Cancer Center
Orange, California 92868
United States
AdventHealth Cancer Institute
Orlando, Florida 32804
United States
Sarasota Memorial Healthcare System
Sarasota, Florida 34239
United States
Women's Cancer Associates with Women's Care Florida
St. Petersburg, Florida 33713
United States
Emory University
Atlanta, Georgia 30322
United States
Indiana University Simon Comprehensive Cancer Center
Indianapolis, Indiana 46202
United States
Holy Cross Hospital
Silver Spring, Maryland 20910
United States
University of Michigan
Ann Arbor, Michigan 48109
United States
Karmanos Cancer Institute
Detroit, Michigan 48201
United States
Washington University School of Medicine
St Louis, Missouri 63110
United States
Mercy Hospital St. Louis
St Louis, Missouri 63141
United States
Women's Cancer Center of Nevada
Las Vegas, Nevada 89106
United States
Center of Hope
Reno, Nevada 89511
United States
Stony Brook Cancer Center
Stony Brook, New York 11794
United States
Levine Cancer Institute
Charlotte, North Carolina 28204
United States
East Carolina University
Greenville, North Carolina 27834
United States
Cleveland Clinic
Cleveland, Ohio 44195
United States
OhioHealth Research Institute
Columbus, Ohio 43214
United States
Kettering Health
Kettering, Ohio 45429
United States
ProMedica Flower Hospital
Sylvania, Ohio 43560
United States
Oklahoma University Health Stephenson Cancer Center
Oklahoma City, Oklahoma 73104
United States
AHN West Penn Hospital
Pittsburgh, Pennsylvania 15224
United States
Hollings Cancer Center
Charleston, South Carolina 29425
United States
Erlanger Health, Inc.
Chattanooga, Tennessee 37403
United States
Baylor College of Medicine
Houston, Texas 77030
United States
University of Texas Science Center at Houston, McGovern Medical School
Houston, Texas 77030
United States
Providence Sacred Heart Medical Center & Children's Hospital
Spokane, Washington 99204
United States