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 now · Phase 3

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT05281471

Run by

Genelux Corporation

People needed

186

Starts

2022-08-31

Expected to finish

2027-12-01

Last updated by the study team

2026-07-10

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 it is running

• The University of South Alabama, Mitchell Cancer Institute — Mobile, Alabama, United States (enrolling)
• University of Arizona Cancer Center — Tucson, Arizona, United States (enrolling)
• City of Hope — Duarte, California, United States (enrolling)
• UC San Diego Health - Moores Cancer Center — La Jolla, California, United States (enrolling)
• Hoag Gynecologic Oncology — Newport Beach, California, United States (enrolling)
• UCI Health Chao Family Comprehensive Cancer Center — Orange, California, United States (enrolling)
• AdventHealth Cancer Institute — Orlando, Florida, United States (enrolling)
• Sarasota Memorial Healthcare System — Sarasota, Florida, United States (enrolling)
• Women's Cancer Associates with Women's Care Florida — St. Petersburg, Florida, United States (enrolling)
• Emory University — Atlanta, Georgia, United States (enrolling)
• Indiana University Simon Comprehensive Cancer Center — Indianapolis, Indiana, United States (enrolling)
• Holy Cross Hospital — Silver Spring, Maryland, United States (enrolling)
• University of Michigan — Ann Arbor, Michigan, United States (enrolling)
• Karmanos Cancer Institute — Detroit, Michigan, United States (enrolling)
• Washington University School of Medicine — St Louis, Missouri, United States (enrolling)
• Mercy Hospital St. Louis — St Louis, Missouri, United States (enrolling)
• Women's Cancer Center of Nevada — Las Vegas, Nevada, United States (enrolling)
• Center of Hope — Reno, Nevada, United States (enrolling)
• Stony Brook Cancer Center — Stony Brook, New York, United States (enrolling)
• Levine Cancer Institute — Charlotte, North Carolina, United States (enrolling)
• East Carolina University — Greenville, North Carolina, United States (enrolling)
• Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
• OhioHealth Research Institute — Columbus, Ohio, United States (enrolling)
• Kettering Health — Kettering, Ohio, United States (enrolling)
• ProMedica Flower Hospital — Sylvania, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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