Ireland
--:--IST
Recruiting Phase 3

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)

NCT05281471 · tracked via the Priya Life Science USA tracker
Sponsor
Genelux Corporation
Phase
Phase 3
Started
2022-08-31
Last updated
2026-08-26

Condition(s) studied

Platinum-resistant Ovarian CancerPlatinum-refractory Ovarian CancerFallopian Tube CancerPrimary Peritoneal CancerHigh-grade Serous Ovarian CancerEndometrioid Ovarian CancerOvarian Clear Cell Carcinoma

Investigational drug(s) / intervention(s)

olvimulogene nanivacirepvec →Platinum chemotherapy: carboplatin (preferred) or cisplatin →Non-platinum chemotherapy: Physician's Choice of gemcitabine, taxane (paclitaxel, docetaxel or nab-paclitaxel) or pegylated liposomal doxorubicinAll Nab-paclitaxel trials (234) →All Pegylated liposomal doxorubicin trials (30) →Bevacizumab (or biosimilar) →

olvimulogene nanivacirepvec: Olvi-Vec is an engineered oncolytic vaccinia virus

Platinum chemotherapy: carboplatin (preferred) or cisplatin: Administered according to local practice

Non-platinum chemotherapy: Physician's Choice of gemcitabine, taxane (paclitaxel, docetaxel or nab-paclitaxel) or pegylated liposomal doxorubicin: Administered according to local practice

Bevacizumab (or biosimilar): Administered according to local practice

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

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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) — 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.

Trial sites (33)

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

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05281471 on ClinicalTrials.gov ↗ ← All trials in the USA