Pronounced clinical response following the oncolytic vaccinia virus GL-ONC1 and chemotherapy in a heavily pretreated ovarian cancer patient.
Kristina M Mori, Peter D Giuliano, Katrina L Lopez...
https://pubmed.ncbi.nlm.nih.gov/31567308Actively Recruiting
Phase 3
Age: 18Years +
FEMALE
ID05281471
Efficacy and Safety of Olvi-Vec Followed by Platinum-doublet Chemotherapy and Bevacizumab Compared to Physician's Choice of Chemotherapy and Bevacizumab in Women with Platinum-Resistant/Refractory Ovarian Cancer
Led by Genelux Corporation · Updated on 2026-03-18
186
Participants Needed
31
Research Sites
17 weeks
Total Duration
On this page
Sponsors
G
Genelux Corporation
Lead Sponsor
G
GOG Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of Olvi-Vec followed by platinum-doublet chemotherapy and bevacizumab compared to the Physician's Choice of chemotherapy and bevacizumab in women with platinum-resistant or refractory ovarian cancer, including fallopian tube and primary peritoneal cancers. This phase 3 study builds on earlier phase 2 results that showed promise with Olvi-Vec delivered inside the peritoneal cavity, which helped activate the immune system and potentially reversed resistance to platinum chemotherapy in difficult-to-treat patients. Participants in the experimental group receive Olvi-Vec through an intraperitoneal catheter with two infusions on consecutive days, followed by systemic platinum-doublet chemotherapy and bevacizumab starting at week 4 or 5. The control group receives a Physician's Choice of chemotherapy, which may be single-agent non-platinum or platinum-doublet chemotherapy, combined with bevacizumab, beginning at week 0. Biological samples may be collected from some in the experimental group to test for virus shedding. During the study, participants undergo regular assessments including imaging scans to measure tumor response using RECIST 1.1 and iRECIST criteria. Researchers track progression-free survival, overall survival, response duration, and treatment-emergent side effects from treatment start up to 36 months. The study includes follow-up evaluations for safety and treatment effects, with participation lasting up to three years from the start of treatment.
CONDITIONS
Brief 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
Age: 18Years +
FEMALE
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 lines of systemic therapy including platinum-based treatment
- Platinum-resistant or refractory disease based on platinum-free interval and disease progression
- Prior treatment with bevacizumab or its biosimilar
- No contraindications for carboplatin, cisplatin, or bevacizumab
- Evidence of disease progression after last therapy by radiological assessment
- At least one measurable target lesion per RECIST 1.1 on abdominal/pelvic imaging
- Evidence of peritoneal carcinomatosis by CT, PET, or physical exam
- Adequate kidney, liver, bone marrow, coagulation, and immune function
You will not qualify if you...
- Tumors of mucinous, low-grade serous, squamous cell, small cell neuroendocrine subtypes, or non-epithelial ovarian cancers
- Bowel obstruction within 3 months prior to screening
- Active urinary tract infection, pneumonia, or other systemic infections
- Active gastrointestinal bleeding
- Known central nervous system metastasis
- Inflammatory bowel diseases
- History of HIV infection
- Active hepatitis B or C within 4 weeks prior to study
- Recent thromboembolic event within 3 months
- Contraindications for intraperitoneal catheter placement
- Significant cardiac disease (NYHA Class III/IV)
- Recent acute cerebrovascular events within 6 months
- Low oxygen saturation (<90%)
- Prior virus-based gene therapy or cytolytic virus therapy
- Current use of antiviral agents
- Recent other active malignancies within 3 years except certain localized cancers
- Recent chemotherapy, radiotherapy, or other anti-cancer biologics within 4 weeks
- Recent surgery within 4 weeks or incomplete recovery
- Use of immunosuppressive therapy or steroids above specified doses
- 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
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 12 months
Participants receive either Olvi-Vec via intraperitoneal catheter infusions on two consecutive days followed by platinum-doublet chemotherapy and bevacizumab starting around Week 4, or Physician's Choice of chemotherapy and bevacizumab starting in Week 0. Treatment continues until disease progression or intolerance.
1 to 2 visits for Olvi-Vec infusions plus regular chemotherapy and bevacizumab visits depending on treatment schedule
Follow-up
Duration - Up to 36 months
Participants are monitored for treatment-emergent adverse events, response to treatment, progression-free survival, and overall survival for up to 36 months from the start of treatment.
Periodic visits for safety and survival assessments
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
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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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Published Research Related To This Trial
A phase 1b study of intraperitoneal oncolytic viral immunotherapy in platinum-resistant or refractory ovarian cancer.
Madhavi Manyam, Amanda J Stephens, Jessica A Kennard...
https://pubmed.ncbi.nlm.nih.gov/34686353Clinical Activity of Olvimulogene Nanivacirepvec-Primed Immunochemotherapy in Heavily Pretreated Patients With Platinum-Resistant or Platinum-Refractory Ovarian Cancer: The Nonrandomized Phase 2 VIRO-15 Clinical Trial.
Robert W Holloway, Alberto A Mendivil, James E Kendrick...
https://pubmed.ncbi.nlm.nih.gov/37227734A phase III, multicenter, randomized study of olvimulogene nanivacirepvec followed by platinum-doublet chemotherapy and bevacizumab compared with platinum-doublet chemotherapy and bevacizumab in women with platinum-resistant/refractory ovarian cancer.
Robert W Holloway, Premal Thaker, Alberto A Mendivil...
https://pubmed.ncbi.nlm.nih.gov/37666539