OnPrime Study: Olvi-Vec and Chemotherapy for Platinum-Resistant Ovarian Cancer
This study, called OnPrime, is testing a new treatment approach for women with platinum-resistant/refractory ovarian cancer (including fallopian tube and primary peritoneal cancer). It compares a treatment plan that includes Olvi-Vec (an engineered virus that fights cancer, also known as an oncolytic vaccinia virus), platinum-based chemotherapy, and bevacizumab, against a standard treatment chosen by your doctor, which includes chemotherapy and bevacizumab. The study aims to see how well these treatments work and if they are safe. You may be able to join if you have non-resectable (cannot be surgically removed) high-grade serous, endometrioid, or clear-cell ovarian cancer, and a good performance status (ECOG of 0 or 1). The main goal is to see how long people live without their cancer getting worse (progression-free survival). The current status of this study is unclear.
- Study design
- This is a multi-center, randomized, open-label Phase 3 study comparing two treatment approaches. It plans to enroll 186 participants.
- What's involved
- If you are in the experimental group, you will receive two infusions of Olvi-Vec through an intraperitoneal catheter over two consecutive days. After the catheter is removed, you will receive platinum-doublet chemotherapy and bevacizumab. The control group receives chemotherapy and bevacizumab chosen by their doctor.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will measure how long you live without your cancer progressing for up to 12 months from the date of randomization.
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NCT05281471
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)
Recruiting
PHASE3Ages 18+InterventionalTreatmentGenelux Corporation
~186 participants
Updated 2026-08-26 on ClinicalTrials.gov
What's tested:olvimulogene nanivacirepvecPlatinum chemotherapy: carboplatin (preferred) or cisplatinNon-platinum chemotherapy: Physician's Choice of gemcitabine, taxane (paclitaxel, docetaxel or nab-paclitaxel) or pegylated liposomal doxorubicinBevacizumab (or biosimilar)
At a glance
Recruiting sites
33 of 33 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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)
Measured over From date of randomization up to 12 months
Conditions
Where it's being run
33 sites across 19 statesCalifornia4
Ohio4
Florida3
North Carolina3
Michigan2
Missouri2
Nevada2
Texas2
Study leadership
- Robert W. Holloway, MD · PRINCIPAL_INVESTIGATOR · AdventHealth Cancer Institute
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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.
What this trial measures
- 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.