RECRUITING

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)

Description

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.

Study Overview

Study Details

Study overview

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.

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)

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)

Condition
Platinum-resistant Ovarian Cancer
Intervention / Treatment

-

Contacts and Locations

Mobile

The University of South Alabama, Mitchell Cancer Institute, Mobile, Alabama, United States, 36604

Tucson

University of Arizona Cancer Center, Tucson, Arizona, United States, 85719

Duarte

City of Hope, Duarte, California, United States, 91010

La Jolla

UC San Diego Health - Moores Cancer Center, La Jolla, California, United States, 92093

Newport Beach

Hoag Gynecologic Oncology, Newport Beach, California, United States, 92663

Orange

UCI Health Chao Family Comprehensive Cancer Center, Orange, California, United States, 92868

Orlando

AdventHealth Cancer Institute, Orlando, Florida, United States, 32804

Sarasota

Sarasota Memorial Research Institute, Sarasota, Florida, United States, 34239

Tampa

Tampa General Hospital/University of South Florida, Tampa, Florida, United States, 33606

Tampa

Women's Cancer Associates with Women's Care Florida, Tampa, Florida, United States, 33713

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * Time from Last Platinum of less than or equal to 24 months since the last dose of platinum in the most recent platinum-based line of therapy (excluding using platinum as a radiosensitizer) until consent into this trial.
  • * 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Genelux Corporation,

Study Record Dates

2026-10