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)

Last updated: May 9, 2025
Sponsor: Genelux Corporation
Overall Status: Active - Recruiting

Phase

3

Condition

Fallopian Tube Cancer

Ovarian Cysts

Pelvic Cancer

Treatment

Platinum chemotherapy: carboplatin (preferred) or cisplatin

Bevacizumab (or biosimilar)

olvimulogene nanivacirepvec

Clinical Study ID

NCT05281471
Olvi-Vec-022
GOG-3076
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically confirmed (from prior treatment) non-resectable ovarian, fallopiantube or primary peritoneal cancer.

  • High-grade serous [including malignant mixed Mullerian tumor (MMMT) with metastasisthat 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 therapywith no maximal limit.

  • Platinum-resistant or -refractory disease based on platinum-free interval (PFI) fromthe last dose of the most recent. platinum-based line of therapy (must have receiveda minimum of 2 doses of platinum in that line) to subsequent disease progressionbased on radiological assessment. Platinum-refractory: PFI of < 1 month (includingdisease progression while on platinum-based therapy). Platinum-resistant: PFI of 1-6months.

  • Received prior bevacizumab (or biosimilar) treatment.

  • No contraindication to receive carboplatin, cisplatin or bevacizumab (orbiosimilar).

  • Have disease progression after last prior line of therapy based on radiologicalassessment prior to randomization.

  • At least 1 measurable target lesion per RECIST 1.1 based on abdominal/pelvis imagingscan at screening.

  • Evidence by CT and/or PET scans or physical exam of abdominal/pelvis region likelyhaving disease in the peritoneal cavity (i.e., peritoneal carcinomatosis).

  • Adequate renal, hepatic, bone marrow function, adequate coagulation tests, adequateimmune function by lymphocyte count.

Exclusion

Exclusion Criteria:

  • Tumors of mucinous, low-grade serous, squamous cell, small cell neuroendocrinesubtypes, MMMT tumors absent an epithelial component on recent biopsy, ornon-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 obstructionwith 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 AssociationClass III/IV).

  • Acute cerebrovascular event(s) such as cerebrovascular accident (CVA) or transientischemic 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 forlocally curable cancers apparently cured such as basal/squamous cell skin cancer,superficial bladder cancer, carcinoma in situ of cervix or breast, any other stageI/II local malignancies.

  • Received chemotherapy, radiotherapy, other anti-cancer biologic therapies within 4weeks prior to planned treatment.

  • Underwent surgery within 4 weeks, or have insufficient recovery fromsurgical-related trauma or wound healing, prior to first study treatment in eitherArm.

  • Receiving immunosuppressive therapy or steroids (except acute concurrentcorticosteroid of no more than 20 mg per day for medical management withprednisolone equivalent.

  • Symptomatic malignant ascites or pleural effusions defined as rapidly progressiveascites with abdominal distension and gastrointestinal dysfunction, pleuraleffusions with respiratory difficulties requiring frequent paracentesis > once every 14 days.

  • Known hypersensitivity to gentamicin.

Study Design

Total Participants: 186
Treatment Group(s): 4
Primary Treatment: Platinum chemotherapy: carboplatin (preferred) or cisplatin
Phase: 3
Study Start date:
August 31, 2022
Estimated Completion Date:
October 31, 2026

Study 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.

Connect with a study center

  • The University of South Alabama, Mitchell Cancer Institute

    Mobile, Alabama 36604
    United States

    Active - Recruiting

  • University of Arizona Cancer Center

    Tucson, Arizona 85719
    United States

    Active - Recruiting

  • City of Hope

    Duarte, California 91010
    United States

    Active - Recruiting

  • UC San Diego Health - Moores Cancer Center

    La Jolla, California 92093
    United States

    Active - Recruiting

  • Hoag Gynecologic Oncology

    Newport Beach, California 92663
    United States

    Active - Recruiting

  • UCI Health Chao Family Comprehensive Cancer Center

    Orange, California 92868
    United States

    Active - Recruiting

  • AdventHealth Cancer Institute

    Orlando, Florida 32804
    United States

    Active - Recruiting

  • Women's Cancer Associates with Women's Care Florida

    Saint Petersburg, Florida 33713
    United States

    Active - Recruiting

  • Sarasota Memorial Research Institute

    Sarasota, Florida 34239
    United States

    Active - Recruiting

  • Tampa General Hospital/University of South Florida

    Tampa, Florida 33606
    United States

    Active - Recruiting

  • Women's Cancer Associates with Women's Care Florida

    Tampa, Florida 33713
    United States

    Active - Recruiting

  • Indiana University Simon Comprehensive Cancer Center

    Indianapolis, Indiana 46202
    United States

    Active - Recruiting

  • Holy Cross Hospital

    Silver Spring, Maryland 20910
    United States

    Active - Recruiting

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • Karmanos Cancer Institute

    Detroit, Michigan 48201
    United States

    Active - Recruiting

  • Mercy Hospital St. Louis

    Saint Louis, Missouri 63141
    United States

    Active - Recruiting

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • Mercy Hospital St. Louis

    St. Louis, Missouri 63141
    United States

    Site Not Available

  • Washington University School of Medicine

    St. Louis, Missouri 63110
    United States

    Active - Recruiting

  • Women's Cancer Center of Nevada

    Las Vegas, Nevada 89106
    United States

    Active - Recruiting

  • Center of Hope

    Reno, Nevada 89511
    United States

    Active - Recruiting

  • Southwest Women's Oncology Inc./Optimum Clinical Research Group

    Albuquerque, New Mexico 87109
    United States

    Site Not Available

  • Stony Brook Cancer Center

    Stony Brook, New York 11794
    United States

    Active - Recruiting

  • Levine Cancer Institute

    Charlotte, North Carolina 28204
    United States

    Active - Recruiting

  • East Carolina University

    Greenville, North Carolina 27834
    United States

    Active - Recruiting

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • OhioHealth Research Institute

    Columbus, Ohio 43214
    United States

    Active - Recruiting

  • Kettering Health

    Kettering, Ohio 45429
    United States

    Active - Recruiting

  • Oklahoma University Health Stephenson Cancer Center

    Oklahoma City, Oklahoma 73104
    United States

    Active - Recruiting

  • AHN West Penn Hospital

    Pittsburgh, Pennsylvania 15224
    United States

    Active - Recruiting

  • Hollings Cancer Center

    Charleston, South Carolina 29425
    United States

    Active - Recruiting

  • Chattanooga's Program in Women's Oncology

    Chattanooga, Tennessee 37403
    United States

    Site Not Available

  • Baylor College of Medicine

    Houston, Texas 77030
    United States

    Active - Recruiting

  • University of Texas Science Center at Houston, McGovern Medical School

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Providence Sacred Heart Medical Center & Children's Hospital

    Spokane, Washington 99204
    United States

    Active - Recruiting

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