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A Randomized Phase 3 Study Assessing the Efficacy and Safety of Olvi-Vec Followed by Platinum-doublet Chemotherapy and Bevacizumab Compared With Physician's Choice of Chemotherapy and Bevacizumab in Women With 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 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
Inclusion Criteria
- 1Histologically confirmed (from prior treatment) non-resectable ovarian, fallopian tube or primary peritoneal cancer.
- 2High-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.
- 3Performance status ECOG of 0 or 1.
- 4Life expectancy of at least 6 months.
- 5Received a minimum of 3 prior lines (including the 1st line) of systemic therapy with no maximal limit.
- 6Platinum-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.
- 7Received prior bevacizumab (or biosimilar) treatment.
- 8No contraindication to receive carboplatin, cisplatin or bevacizumab (or biosimilar).
- 9Have disease progression after last prior line of therapy based on radiological assessment prior to randomization.
- 10At least 1 measurable target lesion per RECIST 1.1 based on abdominal/pelvis imaging scan at screening.
- 11Evidence by CT and/or PET scans or physical exam of abdominal/pelvis region likely having disease in the peritoneal cavity (i.e., peritoneal carcinomatosis).
- 12Adequate renal, hepatic, bone marrow function, adequate coagulation tests, adequate immune function by lymphocyte count.
Exclusion Criteria
- 1Tumors 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).
- 2Bowel obstruction within last 3 months prior to screening.
- 3Active urinary tract infection, pneumonia, other systemic infections.
- 4Active gastrointestinal bleeding.
- 5Known current central nervous system (CNS) metastasis.
- 6Inflammatory diseases of the bowel.
- 7History of HIV infection.
- 8Active hepatitis B virus or hepatitis C virus within 4 weeks prior to study.
- 9History of thromboembolic event within the prior 3 months.
- 10Contraindications for intraperitoneal (IP) catheter placement: Bowel obstruction with distended abdomen, rigid abdomen with bulky anterior wall carcinomatosis, abdominal wall hernia mesh that precludes laparoscopic entry to abdomen.
- 11Clinically significant cardiac disease at screening (New York Heart Association Class III/IV).
- 12Acute cerebrovascular event(s) such as cerebrovascular accident (CVA) or transient ischemic attack (TIA) in previous 6 months.
- 13Oxygen saturation \<90%.
- 14Received prior virus-based gene therapy or therapy with cytolytic virus of any type.
- 15Receiving concurrent antiviral agent.
- 16Prior malignancy of other histology active within previous 3 years except for locally curable cancers apparently cured such as basal/squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of cervix or breast, any other stage I/II local malignancies.
- 17Received chemotherapy, radiotherapy, other anti-cancer biologic therapies within 4 weeks prior to planned treatment.
- 18Underwent surgery within 4 weeks, or have insufficient recovery from surgical-related trauma or wound healing, prior to first study treatment in either Arm.
- 19Receiving immunosuppressive therapy or steroids (except acute concurrent corticosteroid of no more than 20 mg per day for medical management with prednisolone equivalent.
- 20Symptomatic malignant ascites or pleural effusions defined as rapidly progressive ascites with abdominal distension and gastrointestinal dysfunction, pleural effusions with respiratory difficulties requiring frequent paracentesis \> once every 14 days.
- 21Known hypersensitivity to gentamicin.
Locations
31 sites participating in this study
Emory University
Atlanta, Georgia 30322
Jennifer Scalici, MD
The University of South Alabama, Mitchell Cancer Institute
Mobile, Alabama 36604
Jennifer Pierce, MD
University of Arizona Cancer Center
Tucson, Arizona 85719
Setsuko K. Chambers, MD