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Evaluating Olvi-Vec with chemotherapy for advanced ovarian cancer

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)

Phase 3 Interventional Genelux Corporation · NCT05281471

This study is testing if a new virus-based treatment called Olvi-Vec, combined with chemotherapy, can help women with tough-to-treat advanced ovarian cancer live longer and feel better.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment186 (estimated)
Ages18 Years and up
SexFemale
SponsorGenelux Corporation Industry-sponsored
Drugs / interventionsbevacizumab, chemotherapy, immunotherapy
Locations31 sites (Mobile, Alabama and 30 other locations)
Trial IDNCT05281471 on ClinicalTrials.gov

What this trial studies

This phase 3 clinical trial investigates the efficacy and safety of Olvi-Vec, an oncolytic virus-based immunotherapy, combined with platinum-doublet chemotherapy and bevacizumab in women with platinum-resistant or refractory ovarian cancer. Participants will receive Olvi-Vec through an intraperitoneal catheter followed by systemic chemotherapy, while a control group will receive physician's choice of chemotherapy and bevacizumab. The study aims to assess progression-free survival, safety, and overall survival, building on promising results from a previous phase 2 trial. Biological samples will also be collected for further analysis of treatment response.

Who should consider this trial

Good fit: Ideal candidates include women with histologically confirmed non-resectable platinum-resistant or refractory ovarian, fallopian tube, or primary peritoneal cancer.

Not a fit: Patients who have not received prior platinum-based therapy or those with resectable tumors may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with difficult-to-treat platinum-resistant ovarian cancer.

How similar studies have performed: Previous studies have shown promising results with similar oncolytic virus therapies, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Mobile, Alabama and 30 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Platinum-resistant Ovarian CancerPlatinum-refractory Ovarian CancerFallopian Tube CancerPrimary Peritoneal CancerHigh-grade Serous Ovarian CancerEndometrioid Ovarian CancerOvarian Clear Cell Carcinomaolvimulogene nanivacirepvec
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.