RecruitingPhase 3NCT05281471

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)

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)

Sponsor

Genelux Corporation

Enrollment

186 participants

Start Date

Aug 31, 2022

Study Type

INTERVENTIONAL

Conditions

Endometrioid Ovarian Cancer Primary Peritoneal Cancer Fallopian Tube Cancer High Grade Serous Ovarian Cancer Platinum Resistant Ovarian Cancer Ovarian Clear Cell Carcinoma Platinum-refractory Ovarian Cancer

Summary

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new treatment combination for platinum-resistant or platinum-refractory ovarian cancer — meaning the cancer stopped responding to platinum-based chemotherapy. The new approach adds an oncolytic virus called Olvi-Vec (delivered into the belly) to standard chemotherapy and bevacizumab. **You may be eligible if...** - You are a woman with ovarian, fallopian tube, or peritoneal cancer (high-grade serous, endometrioid, or clear cell subtypes) - Your cancer stopped responding to platinum-based chemotherapy within 6 months (platinum-resistant) or while still on it (platinum-refractory) - You have received at least 3 prior lines of treatment, including bevacizumab - Your cancer has spread into the abdominal cavity (peritoneal disease) **You may NOT be eligible if...** - You have certain rare subtypes of ovarian cancer (mucinous, low-grade serous, etc.) - You have had a bowel obstruction in the last 3 months - You have active infection, gastrointestinal bleeding, or active brain metastases - You have HIV, active hepatitis, or a blood clot in the last 3 months - You have had prior virus-based gene therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALolvimulogene nanivacirepvec

Olvi-Vec is an engineered oncolytic vaccinia virus

DRUGPlatinum chemotherapy: carboplatin (preferred) or cisplatin

Administered according to local practice

DRUGNon-platinum chemotherapy: Physician's Choice of gemcitabine, taxane (paclitaxel, docetaxel or nab-paclitaxel) or pegylated liposomal doxorubicin

Administered according to local practice

DRUGBevacizumab (or biosimilar)

Administered according to local practice

Locations(31)

The University of South Alabama, Mitchell Cancer Institute

Mobile, Alabama, United States

University of Arizona Cancer Center

Tucson, Arizona, United States

City of Hope

Duarte, California, United States

UC San Diego Health - Moores Cancer Center

La Jolla, California, United States

Hoag Gynecologic Oncology

Newport Beach, California, United States

UCI Health Chao Family Comprehensive Cancer Center

Orange, California, United States

AdventHealth Cancer Institute

Orlando, Florida, United States

Sarasota Memorial Research Institute

Sarasota, Florida, United States

Emory University

Atlanta, Georgia, United States

Indiana University Simon Comprehensive Cancer Center

Indianapolis, Indiana, United States

Holy Cross Hospital

Silver Spring, Maryland, United States

University of Michigan

Ann Arbor, Michigan, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Washington University School of Medicine

St Louis, Missouri, United States

Mercy Hospital St. Louis

St Louis, Missouri, United States

Women's Cancer Center of Nevada

Las Vegas, Nevada, United States

Center of Hope

Reno, Nevada, United States

Stony Brook Cancer Center

Stony Brook, New York, United States

Levine Cancer Institute

Charlotte, North Carolina, United States

East Carolina University

Greenville, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

OhioHealth Research Institute

Columbus, Ohio, United States

Kettering Health

Kettering, Ohio, United States

ProMedica Flower Hospital

Sylvania, Ohio, United States

Oklahoma University Health Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

AHN West Penn Hospital

Pittsburgh, Pennsylvania, United States

Hollings Cancer Center

Charleston, South Carolina, United States

Erlanger Health, Inc.

Chattanooga, Tennessee, United States

Baylor College of Medicine

Houston, Texas, United States

University of Texas Science Center at Houston, McGovern Medical School

Houston, Texas, United States

Providence Sacred Heart Medical Center & Children's Hospital

Spokane, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT05281471

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