⭐️⭐️⭐️⭐️⭐️ "A total no brainer"

⭐️⭐️⭐️⭐️⭐️ "Love this, so easy."

Spots is the easy way to track your skin, mole and cancer changes.

Spots Global Cancer Trial Database for 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)

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: 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)

Official Title: 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)

Study ID: NCT05281471

Study Description

Brief 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.

Detailed Description: Olvi-Vec (olvimulogene nanivacirepvec, aka GL-ONC1, laboratory name: GLV-1h68) is an oncolytic vaccinia virus-based immunotherapy. This study is to test the hypothesis that the combination of Olvi-Vec followed by further chemotherapy is particularly effective against established tumors by virus-mediated immune activation and re-sensitization of tumor cells to chemotherapy. Participant population includes histologically confirmed non-resectable platinum-resistant/refractory ovarian cancer (PRROC). Determination of progression-free survival, safety and overall survival are key objectives. Participants randomized into the Experimental Arm will receive a single-cycle (2 infusions on two consecutive days) of Olvi-Vec through an intraperitoneal catheter. The catheter is then removed, and patients receive systemically administered platinum-doublet chemotherapy and bevacizumab. The control arm receives the Physician's Choice of chemotherapy and bevacizumab at the same dose and schedule. Biological samples will be obtained from some Experimental Arm participants for virus-shedding testing. Assessment of response to treatment in both arms will be by RECIST 1.1 and iRECIST as assessed by Blinded Independent Central Review. Maintenance/continued treatment with non-platinum chemotherapy and bevacizumab is dependent on a participant being clinically stable until confirmed progressive disease by iRECIST or can no longer tolerate therapy. Dr. Robert W. Holloway (AdventHealth Cancer Institute, Orlando, FL) will serve as the National Principal Investigator for this Phase 3 study in PRROC.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

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

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

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

Indiana University Simon Comprehensive Cancer Center, Indianapolis, Indiana, United States

Holy Cross Hospital, Silver Spring, Maryland, United States

Karmanos Cancer Institute, Detroit, Michigan, United States

Washington University School of Medicine, Saint Louis, Missouri, United States

Mercy Hospital St. Louis, Saint Louis, Missouri, United States

Center of Hope, Reno, Nevada, United States

Levine Cancer Institute, Charlotte, North Carolina, United States

Cleveland Clinic, Cleveland, Ohio, United States

Kettering Health, Kettering, 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

Chattanooga's Program in Women's Oncology, Chattanooga, Tennessee, United States

Providence Sacred Heart Medical Center & Children's Hospital, Spokane, Washington, United States

Contact Details

Name: Robert W Holloway, MD

Affiliation: OnPrime Study

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

Logo

Take Control of Your Skin and Body Changes Today.

Try out Spots for free, set up only takes 2 mins.

spots app storespots app store

Join others from around the world: