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)

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorGenelux Corporation

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • 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)

Treatment groups

186 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Genelux Corporation

Lead sponsor

GOG Foundation

Collaborator