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)

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 heavil

Trial Details

NCT ID
NCT05281471
Phase
PHASE3
Sponsor
Genelux Corporation
Status
RECRUITING
Cancer Type
High-Grade Serous Ovarian Cancer
Interventions
  • 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)
Locations (sample)
  • Mobile, Alabama, United States|30.69436,-88.04305
  • Tucson, Arizona, United States|32.22174,-110.92648
  • Duarte, California, United States|34.13945,-117.97729
  • La Jolla, California, United States|32.84727,-117.2742
  • Newport Beach, California, United States|33.61891,-117.92895

Key Eligibility 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 \…
  • Performance status ECOG of 0 or 1.
  • Life expectancy of at least 6 months.

For full eligibility, visit ClinicalTrials.gov.

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