RECRUITING Phase 3 ClinicalTrials.gov

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)

Sponsor: Genelux Corporation • ClinicalTrials.gov ID: NCT05281471

Registry updated: 2026-08-26

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Description

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.

Interventions

olvimulogene nanivacirepvec (Biological)
Olvi-Vec is an engineered oncolytic vaccinia virus
Platinum chemotherapy: carboplatin (preferred) or cisplatin (Drug)
Administered according to local practice
Non-platinum chemotherapy: Physician's Choice of gemcitabine, taxane (paclitaxel, docetaxel or nab-paclitaxel) or pegylated liposomal doxorubicin (Drug)
Administered according to local practice
Bevacizumab (or biosimilar) (Drug)
Administered according to local practice

Eligibility criteria

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.

Conditions

Platinum-resistant Ovarian Cancer Platinum-refractory Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Cancer High-grade Serous Ovarian Cancer Endometrioid Ovarian Cancer Ovarian Clear Cell Carcinoma

Locations

The University of South Alabama, Mitchell Cancer Institute — Mobile, Alabama, United States
University of Arizona Cancer Center — Tucson, Arizona, United States
City of Hope — Duarte, California, United States
UC San Diego Health - Moores Cancer Center — La Jolla, California, United States
Hoag Gynecologic Oncology — Newport Beach, California, United States
UCI Health Chao Family Comprehensive Cancer Center — Orange, California, United States
AdventHealth Cancer Institute — Orlando, Florida, United States
Sarasota Memorial Healthcare System — Sarasota, Florida, United States
Women's Cancer Associates with Women's Care Florida — St. Petersburg, Florida, United States
Emory University — Atlanta, Georgia, United States
Indiana University Simon Comprehensive Cancer Center — Indianapolis, Indiana, United States
Holy Cross Hospital — Silver Spring, Maryland, United States
University of Michigan — Ann Arbor, Michigan, United States
Karmanos Cancer Institute — Detroit, Michigan, United States
Washington University School of Medicine — St Louis, Missouri, United States
Mercy Hospital St. Louis — St Louis, Missouri, United States
Women's Cancer Center of Nevada — Las Vegas, Nevada, United States
Center of Hope — Reno, Nevada, United States
Stony Brook Cancer Center — Stony Brook, New York, United States
Levine Cancer Institute — Charlotte, North Carolina, United States
East Carolina University — Greenville, North Carolina, United States
Atrium Health Wake Forest Baptist, Comprehensive Cancer Center — Winston-Salem, North Carolina, United States
Cleveland Clinic — Cleveland, Ohio, United States
OhioHealth Research Institute — Columbus, Ohio, United States
Kettering Health — Kettering, Ohio, United States
ProMedica Flower Hospital — Sylvania, Ohio, United States
Oklahoma University Health Stephenson Cancer Center — Oklahoma City, Oklahoma, United States
AHN West Penn Hospital — Pittsburgh, Pennsylvania, United States
Hollings Cancer Center — Charleston, South Carolina, United States
Erlanger Health, Inc. — Chattanooga, Tennessee, United States
Baylor College of Medicine — Houston, Texas, United States
University of Texas Science Center at Houston, McGovern Medical School — Houston, Texas, United States
Providence Sacred Heart Medical Center & Children's Hospital — Spokane, Washington, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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