RecruitingPlatinum-resistant Ovarian CancerPlatinum-refractory Ovarian CancerFallopian Tube Cancer

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)

Eligible age

18+ yrs

Accepts

Women

Locations

19 states

Healthy volunteers

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About this study

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.

Sponsor: Genelux Corporation

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).

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.