Actively Recruiting
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)
Led by Genelux Corporation · Updated on 2026-03-18
186
Participants Needed
31
Research Sites
213 weeks
Total Duration
On this page
Sponsors
G
Genelux Corporation
Lead Sponsor
G
GOG Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed non-resectable ovarian, fallopian tube, or primary peritoneal cancer.
- High-grade serous (including malignant mixed Mullerian tumor with high-grade epithelial carcinoma), endometrioid, or clear-cell ovarian cancer.
- ECOG performance status of 0 or 1.
- Life expectancy of at least 6 months.
- Received at least 3 prior systemic therapy lines including first-line treatment.
- Platinum-resistant or platinum-refractory disease with progression based on radiological assessment; platinum-refractory defined as progression within less than 1 month, platinum-resistant defined as progression within 1 to 6 months after last platinum dose.
- Prior treatment with bevacizumab or biosimilar.
- No contraindication to carboplatin, cisplatin, or bevacizumab.
- Disease progression after last therapy confirmed by imaging prior to randomization.
- At least one measurable target lesion by RECIST 1.1 on abdominal/pelvis imaging.
- Evidence of disease likely in the peritoneal cavity by CT, PET, or physical exam.
- Adequate kidney, liver, bone marrow function, coagulation, and immune function as shown by lab tests.
You will not qualify if you...
- Tumors of mucinous, low-grade serous, squamous cell, small cell neuroendocrine subtypes, or malignant mixed Mullerian tumors without epithelial component.
- Non-epithelial ovarian cancers such as germ cell or sex-cord tumors.
- Bowel obstruction within 3 months before screening.
- Active urinary tract infection, pneumonia, or other systemic infections.
- Active gastrointestinal bleeding.
- Known current central nervous system metastases.
- Inflammatory bowel diseases.
- History of HIV infection.
- Active hepatitis B or C within 4 weeks before study.
- Thromboembolic event within past 3 months.
- Contraindications to intraperitoneal catheter placement such as distended abdomen or abdominal wall hernia mesh.
- Significant heart disease (NYHA Class III/IV).
- Recent stroke or transient ischemic attack within 6 months.
- Oxygen saturation below 90%.
- Prior virus-based gene therapy or cytolytic virus therapy.
- Concurrent antiviral treatment.
- Active malignancy within past 3 years except certain early-stage cured cancers.
- Chemotherapy, radiotherapy, or biologic anti-cancer therapy within 4 weeks before planned treatment.
- Surgery within 4 weeks or incomplete recovery from surgery.
- Immunosuppressive therapy or steroids exceeding 20 mg prednisolone equivalent daily.
- Symptomatic malignant ascites or pleural effusions requiring frequent drainage.
- Known allergy to gentamicin.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 31 locations
1
The University of South Alabama, Mitchell Cancer Institute
Mobile, Alabama, United States, 36604
Actively Recruiting
2
University of Arizona Cancer Center
Tucson, Arizona, United States, 85719
Actively Recruiting
3
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
4
UC San Diego Health - Moores Cancer Center
La Jolla, California, United States, 92093
Actively Recruiting
5
Hoag Gynecologic Oncology
Newport Beach, California, United States, 92663
Actively Recruiting
6
UCI Health Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
Actively Recruiting
7
AdventHealth Cancer Institute
Orlando, Florida, United States, 32804
Actively Recruiting
8
Sarasota Memorial Research Institute
Sarasota, Florida, United States, 34239
Actively Recruiting
9
Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
10
Indiana University Simon Comprehensive Cancer Center
Indianapolis, Indiana, United States, 46202
Actively Recruiting
11
Holy Cross Hospital
Silver Spring, Maryland, United States, 20910
Actively Recruiting
12
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
13
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Actively Recruiting
14
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
15
Mercy Hospital St. Louis
St Louis, Missouri, United States, 63141
Actively Recruiting
16
Women's Cancer Center of Nevada
Las Vegas, Nevada, United States, 89106
Actively Recruiting
17
Center of Hope
Reno, Nevada, United States, 89511
Actively Recruiting
18
Stony Brook Cancer Center
Stony Brook, New York, United States, 11794
Actively Recruiting
19
Levine Cancer Institute
Charlotte, North Carolina, United States, 28204
Actively Recruiting
20
East Carolina University
Greenville, North Carolina, United States, 27834
Actively Recruiting
21
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
22
OhioHealth Research Institute
Columbus, Ohio, United States, 43214
Actively Recruiting
23
Kettering Health
Kettering, Ohio, United States, 45429
Actively Recruiting
24
ProMedica Flower Hospital
Sylvania, Ohio, United States, 43560
Actively Recruiting
25
Oklahoma University Health Stephenson Cancer Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
26
AHN West Penn Hospital
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
27
Hollings Cancer Center
Charleston, South Carolina, United States, 29425
Actively Recruiting
28
Erlanger Health, Inc.
Chattanooga, Tennessee, United States, 37403
Actively Recruiting
29
Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
30
University of Texas Science Center at Houston, McGovern Medical School
Houston, Texas, United States, 77030
Actively Recruiting
31
Providence Sacred Heart Medical Center & Children's Hospital
Spokane, Washington, United States, 99204
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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