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OncoMatch/Clinical Trials/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)

Is NCT05281471 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including olvimulogene nanivacirepvec and Platinum chemotherapy: carboplatin (preferred) or cisplatin for platinum-resistant ovarian cancer.

Phase 3RecruitingGenelux CorporationNCT05281471Data as of May 2026

Treatment: 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 doxorubicin · Bevacizumab (or biosimilar)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.

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Extracted eligibility criteria

Cancer type

Ovarian Cancer

Disease stage

Grade: 23 (figo)

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 3 prior lines

Must have received: platinum-based chemotherapy (carboplatin, cisplatin)

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.

Must have received: anti-VEGF therapy (bevacizumab)

Received prior bevacizumab (or biosimilar) treatment.

Cannot have received: virus-based gene therapy or cytolytic virus

Received prior virus-based gene therapy or therapy with cytolytic virus of any type.

Cannot have received: chemotherapy

Exception: within 4 weeks prior to planned treatment

Received chemotherapy, radiotherapy, other anti-cancer biologic therapies within 4 weeks prior to planned treatment.

Cannot have received: radiotherapy

Exception: within 4 weeks prior to planned treatment

Received chemotherapy, radiotherapy, other anti-cancer biologic therapies within 4 weeks prior to planned treatment.

Cannot have received: anti-cancer biologic therapy

Exception: within 4 weeks prior to planned treatment

Received chemotherapy, radiotherapy, other anti-cancer biologic therapies within 4 weeks prior to planned treatment.

Lab requirements

Blood counts

adequate bone marrow function

Kidney function

adequate renal function

Liver function

adequate hepatic function

Adequate renal, hepatic, bone marrow function, adequate coagulation tests, adequate immune function by lymphocyte count.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • The University of South Alabama, Mitchell Cancer Institute · Mobile, Alabama
  • University of Arizona Cancer Center · Tucson, Arizona
  • City of Hope · Duarte, California
  • UC San Diego Health - Moores Cancer Center · La Jolla, California
  • Hoag Gynecologic Oncology · Newport Beach, California

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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