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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)
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)

NCT05281471

RecruitingPhase 3

Sponsor: Genelux Corporation

Conditions: Platinum-resistant Ovarian Cancer, Platinum-refractory Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, 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)

Countries: United States

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 overview

Sex: FEMALE

Age: 18 Years to

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Histologically confirmed (from prior treatment) non-resectable ovarian, fallopian tube or primary peritoneal cancer.
* High-grade serous \[including malignant mixed Mullerian tumor (MMMT) with metastasis that contains high-grade epithelial carcinoma, FIGO grades 2 \& 3 allowed\], 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).
* Have disease progression after last prior line of therapy based on radiological assessment prior to randomization.
* At least 1 measurable target lesion per RECIST 1.1 based on abdominal/pelvis imaging scan at screening.
* Evidence by CT and/or PET scans or physical exam of abdominal/pelvis region likely having disease in the peritoneal cavity (i.e., peritoneal carcinomatosis).
* Adequate renal, hepatic, bone marrow function, adequate coagulation tests, adequate immune function by lymphocyte count.

Exclusion Criteria:

* 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.
* History of thromboembolic event within the prior 3 months.
* Contraindications 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.
* Clinically significant cardiac disease at screening (New York Heart Association Class III/IV).
* Acute cerebrovascular event(s) such as cerebrovascular accident (CVA) or transient ischemic attack (TIA) in previous 6 months.
* Oxygen saturation \<90%.
* Received prior virus-based gene therapy or therapy with cytolytic virus of any type.
* Receiving concurrent antiviral agent.
* Prior 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.
* Received chemotherapy, radiotherapy, other anti-cancer biologic therapies within 4 weeks prior to planned treatment.
* Underwent surgery within 4 weeks, or have insufficient recovery from surgical-related trauma or wound healing, prior to first study treatment in either Arm.
* Receiving immunosuppressive therapy or steroids (except acute concurrent corticosteroid of no more than 20 mg per day for medical management with prednisolone equivalent.
* Symptomatic 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.
* Known hypersensitivity to gentamicin.
Locations (32)
  • Mobile, Alabama, United States
  • Tucson, Arizona, United States
  • Duarte, California, United States
  • La Jolla, California, United States
  • Newport Beach, California, United States
  • Orange, California, United States
  • Orlando, Florida, United States
  • Sarasota, Florida, United States
  • St. Petersburg, Florida, United States
  • Atlanta, Georgia, United States
  • Indianapolis, Indiana, United States
  • Silver Spring, Maryland, United States
  • Ann Arbor, Michigan, United States
  • Detroit, Michigan, United States
  • St Louis, Missouri, United States
  • St Louis, Missouri, United States
  • Las Vegas, Nevada, United States
  • Reno, Nevada, United States
  • Stony Brook, New York, United States
  • Charlotte, North Carolina, United States
  • Greenville, North Carolina, United States
  • Cleveland, Ohio, United States
  • Columbus, Ohio, United States
  • Kettering, Ohio, United States
  • Sylvania, Ohio, United States
  • Oklahoma City, Oklahoma, United States
  • Pittsburgh, Pennsylvania, United States
  • Charleston, South Carolina, United States
  • Chattanooga, Tennessee, United States
  • Houston, Texas, United States
  • + 2 more on CT.gov