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)

March 16, 2026 updated by: Genelux Corporation

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

186

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States, 36604
        • Recruiting
        • The University of South Alabama, Mitchell Cancer Institute
        • Contact:
        • Principal Investigator:
          • Jennifer Pierce, MD
    • Arizona
      • Tucson, Arizona, United States, 85719
        • Recruiting
        • University of Arizona Cancer Center
        • Principal Investigator:
          • Setsuko K. Chambers, MD
        • Contact:
        • Contact:
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope
        • Contact:
          • Edward Wang, MD, PhD
          • Phone Number: 877-467-3411
          • Email: edwang@coh.org
        • Principal Investigator:
          • Edward Wang, MD, PhD
      • La Jolla, California, United States, 92093
        • Recruiting
        • UC San Diego Health - Moores Cancer Center
        • Principal Investigator:
          • Michael McHale, MD
        • Sub-Investigator:
          • Ramez Eskander, MD
        • Contact:
      • Newport Beach, California, United States, 92663
        • Recruiting
        • Hoag Gynecologic Oncology
        • Contact:
        • Principal Investigator:
          • Alberto Mendivil, MD
      • Orange, California, United States, 92868
        • Recruiting
        • UCI Health Chao Family Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Krishnansu S. Tewari, MD
    • Florida
      • Orlando, Florida, United States, 32804
        • Recruiting
        • AdventHealth Cancer Institute
        • Principal Investigator:
          • Robert W Holloway, MD
        • Contact:
      • Sarasota, Florida, United States, 34239
        • Recruiting
        • Sarasota Memorial Research Institute
        • Principal Investigator:
          • Beverly Long, MD
        • Contact:
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30322
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University Simon Comprehensive Cancer Center
        • Principal Investigator:
          • Jessica E. Parker, MD
        • Contact:
    • Maryland
      • Silver Spring, Maryland, United States, 20910
        • Recruiting
        • Holy Cross Hospital
        • Contact:
        • Principal Investigator:
          • Frederick D Min, MD
        • Sub-Investigator:
          • Jasmine Ebott, MD
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan
        • Contact:
        • Principal Investigator:
          • Jean Siedel, MD
        • Contact:
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • Karmanos Cancer Institute
        • Principal Investigator:
          • Robert Morris, MD
        • Contact:
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Principal Investigator:
          • Premal Thaker, MD
        • Contact:
      • St Louis, Missouri, United States, 63141
        • Recruiting
        • Mercy Hospital St. Louis
        • Principal Investigator:
          • Madhavi Manyam, MD
        • Contact:
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Recruiting
        • Women's Cancer Center of Nevada
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nicola M. Spirtos, MD
      • Reno, Nevada, United States, 89511
        • Recruiting
        • Center of Hope
        • Principal Investigator:
          • Peter Lim, MD
        • Contact:
    • New York
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Recruiting
        • Levine Cancer Institute
        • Contact:
        • Principal Investigator:
          • Erin K Crane, MD
      • Greenville, North Carolina, United States, 27834
        • Recruiting
        • East Carolina University
        • Principal Investigator:
          • Grainger Lanneau, MD
        • Contact:
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Principal Investigator:
          • Peter Rose, MD
        • Contact:
      • Columbus, Ohio, United States, 43214
        • Recruiting
        • OhioHealth Research Institute
        • Principal Investigator:
          • Aine Clements, MD
        • Contact:
      • Kettering, Ohio, United States, 45429
        • Recruiting
        • Kettering Health
        • Principal Investigator:
          • Thomas J. Reid, MD
        • Contact:
      • Sylvania, Ohio, United States, 43560
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • Oklahoma University Health Stephenson Cancer Center
        • Principal Investigator:
          • Debra Richardson, MD
        • Contact:
        • Contact:
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15224
        • Recruiting
        • AHN West Penn Hospital
        • Contact:
        • Principal Investigator:
          • Sarah Crafton, MD
        • Contact:
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Hollings Cancer Center
        • Principal Investigator:
          • Brian Orr, MD
        • Contact:
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • Recruiting
        • Erlanger Health, Inc.
        • Principal Investigator:
          • Stephen DePasquale, MD
        • Contact:
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Baylor College of Medicine
        • Contact:
        • Principal Investigator:
          • Jan Sunde, MD
      • Houston, Texas, United States, 77030
        • Recruiting
        • University of Texas Science Center at Houston, McGovern Medical School
        • Principal Investigator:
          • Joseph Lucci, III, MD
        • Contact:
    • Washington
      • Spokane, Washington, United States, 99204
        • Recruiting
        • Providence Sacred Heart Medical Center & Children's Hospital
        • Principal Investigator:
          • Melanie Bergman, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histologically confirmed (from prior treatment) non-resectable ovarian, fallopian tube or primary peritoneal cancer.
  • High-grade serous [including malignant mixed Mullerian tumor (MMMT) with metastasis that contains high-grade epithelial carcinoma, FIGO grades 2 & 3 allowed], endometrioid, or clear-cell ovarian cancer.
  • Performance status ECOG of 0 or 1.
  • Life expectancy of at least 6 months.
  • Received a minimum of 3 prior lines (including the 1st line) of systemic therapy with no maximal limit.
  • Platinum-resistant or -refractory disease based on platinum-free interval (PFI) from the last dose of the most recent. platinum-based line of therapy (must have received a minimum of 2 doses of platinum in that line) to subsequent disease progression based on radiological assessment. Platinum-refractory: PFI of < 1 month (including disease progression while on platinum-based therapy). Platinum-resistant: PFI of 1-6 months.
  • Received prior bevacizumab (or biosimilar) treatment.
  • No contraindication to receive carboplatin, cisplatin or bevacizumab (or biosimilar).
  • Have disease progression after last prior line of therapy based on radiological assessment prior to randomization.
  • At least 1 measurable target lesion per RECIST 1.1 based on abdominal/pelvis imaging scan at screening.
  • Evidence by CT and/or PET scans or physical exam of abdominal/pelvis region likely having disease in the peritoneal cavity (i.e., peritoneal carcinomatosis).
  • Adequate renal, hepatic, bone marrow function, adequate coagulation tests, adequate immune function by lymphocyte count.

Exclusion Criteria:

  • Tumors of mucinous, low-grade serous, squamous cell, small cell neuroendocrine subtypes, MMMT tumors absent an epithelial component on recent biopsy, or non-epithelial ovarian cancers (e.g., germ cell tumors, Sex-cord tumors).
  • Bowel obstruction within last 3 months prior to screening.
  • Active urinary tract infection, pneumonia, other systemic infections.
  • Active gastrointestinal bleeding.
  • Known current central nervous system (CNS) metastasis.
  • Inflammatory diseases of the bowel.
  • History of HIV infection.
  • Active hepatitis B virus or hepatitis C virus within 4 weeks prior to study.
  • History of thromboembolic event within the prior 3 months.
  • Contraindications for intraperitoneal (IP) catheter placement: Bowel obstruction with distended abdomen, rigid abdomen with bulky anterior wall carcinomatosis, abdominal wall hernia mesh that precludes laparoscopic entry to abdomen.
  • Clinically significant cardiac disease at screening (New York Heart Association Class III/IV).
  • Acute cerebrovascular event(s) such as cerebrovascular accident (CVA) or transient ischemic attack (TIA) in previous 6 months.
  • Oxygen saturation <90%.
  • Received prior virus-based gene therapy or therapy with cytolytic virus of any type.
  • Receiving concurrent antiviral agent.
  • Prior malignancy of other histology active within previous 3 years except for locally curable cancers apparently cured such as basal/squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of cervix or breast, any other stage I/II local malignancies.
  • Received chemotherapy, radiotherapy, other anti-cancer biologic therapies within 4 weeks prior to planned treatment.
  • Underwent surgery within 4 weeks, or have insufficient recovery from surgical-related trauma or wound healing, prior to first study treatment in either Arm.
  • Receiving immunosuppressive therapy or steroids (except acute concurrent corticosteroid of no more than 20 mg per day for medical management with prednisolone equivalent.
  • Symptomatic malignant ascites or pleural effusions defined as rapidly progressive ascites with abdominal distension and gastrointestinal dysfunction, pleural effusions with respiratory difficulties requiring frequent paracentesis > once every 14 days.
  • Known hypersensitivity to gentamicin.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Olvi-Vec + Platinum-doublet & bevacizumab

Olvi-Vec: A total of 2 consecutive days of intraperitoneal catheter infusions in Week 0

Platinum-doublet & bevacizumab (or biosimilar) administered beginning in Week 4 (preferred), but no later than Week 5
Biological: olvimulogene nanivacirepvec
Olvi-Vec is an engineered oncolytic vaccinia virus
Other Names:
  • GL-ONC1 and GLV-1h68
Drug: Platinum chemotherapy: carboplatin (preferred) or cisplatin
Administered according to local practice
Drug: Non-platinum chemotherapy: Physician's Choice of gemcitabine, taxane (paclitaxel, docetaxel or nab-paclitaxel) or pegylated liposomal doxorubicin
Administered according to local practice
Drug: Bevacizumab (or biosimilar)
Administered according to local practice
Active Comparator: Physician's Choice of Chemotherapy & bevacizumab
Physician's Choice of chemotherapy & bevacizumab (or biosimilar) administered beginning in Week 0. Physician's Choice of chemotherapy includes either a single agent non-platinum chemotherapy, or as platinum chemotherapy is allowed as an option, a platinum-doublet (i.e., platinum agent combined with a non-platinum agent).
Drug: Platinum chemotherapy: carboplatin (preferred) or cisplatin
Administered according to local practice
Drug: Non-platinum chemotherapy: Physician's Choice of gemcitabine, taxane (paclitaxel, docetaxel or nab-paclitaxel) or pegylated liposomal doxorubicin
Administered according to local practice
Drug: Bevacizumab (or biosimilar)
Administered according to local practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Time Frame: 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.
From date of randomization up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-emergent Adverse Events in the ITT population
Time Frame: From date of first study treatment until death or study completion; assessed up to 36 months
Determine safety and tolerability of administering multiple doses of Olvi-Vec via intraperitoneal catheter in combination with platinum-doublet and bevacizumab (or biosimilar) as assessed by CTCAE v. 5.0 following initiation of study treatment until end of study participation.
From date of first study treatment until death or study completion; assessed up to 36 months
Duration of Response (DOR) by RECIST 1.1 in the ITT population
Time Frame: From date of randomization up to 12 months
Time from date of first response until the first date of progressive disease based on radiological assessment.
From date of randomization up to 12 months
PFS by RECIST 1.1 in the modified ITT (mITT) population (participants who received at least 1 dose of treatment in either Arm)
Time Frame: From date of randomization up to 12 months
Time from randomization to first documented disease progression based on radiological assessment or death from any cause.
From date of randomization up to 12 months
PFS by iRECIST in the ITT population
Time Frame: From date of randomization up to 12 months
Time from randomization to first documented disease progression with confirmatory imaging scan performed 4-8 weeks after unconfirmed disease progression or death from any cause.
From date of randomization up to 12 months
Overall Response Rate (ORR) by RECIST 1.1 in the ITT population
Time Frame: From date of randomization up to 12 months
Ratio of the sum of CR & PR divided by the number of ITT participants from start of treatment to confirmation of response.
From date of randomization up to 12 months
Overall Survival in the ITT population
Time Frame: From date of randomization until death or study completion; assessed up to 36 months
Time from randomization until date of death from any cause.
From date of randomization until death or study completion; assessed up to 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genelux Corporation

Collaborators

GOG Foundation

Investigators

  • Principal Investigator: Robert W. Holloway, MD, AdventHealth Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 31, 2022

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

March 7, 2022

First Submitted That Met QC Criteria

March 7, 2022

First Posted (Actual)

March 16, 2022

Study Record Updates

Last Update Posted (Actual)

March 18, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Olvi-Vec-022
  • GOG-3076 (Other Identifier: GOG Foundation)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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