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

Locations

31
Alabama
The University of South Alabama, Mitchell Cancer Institute36604, Mobile United States
Arizona
University of Arizona Cancer Center85719, Tucson United States
California
City of Hope91010, Duarte United States
UC San Diego Health - Moores Cancer Center92093, La Jolla United States

Sponsors and collaborators

Genelux Corporation

Lead sponsor

GOG Foundation

Collaborator