A Clinical Trial to Evaluate the Safety and Efficacy of COM701 in Relapsed Platinum Sensitive Ovarian Cancer
Start Date
7/21/2025
Completion Date
3/1/2027
Summary
The goal of this clinical trial is to learn if the experimental antibody COM701 delays the progression of ovarian cancer in participants with Relapsed Platinum Sensitive Ovarian Cancer. It will also learn about the safety of COM701. The main questions the trial aims to answer are: * Does COM701, when used as a maintenance treatment, stop or slow the progression of ovarian cancer? * Does COM701 delay the time to needing a new anti-cancer treatment? * What side effects do participants have when taking COM701? Participants will: * Visit the clinic once every 3 weeks during which the study treatment will be administered intravenously * Undergo various tests and procedures to monitor general health throughout the trial including physical examinations, vital sign measurements (heart rate, blood pressure, breathing, and body temperature), weight measurements, electrocardiography (ECG), blood and urine tests and pregnancy tests if relevant. * Undergo various tests and procedures to assess disease response throughout the trial including tumor imaging by CT scans or MRI to assess the tumor, its location, and size, and the testing of a sample of tumor tissue (from a prior biopsy or a fresh biopsy if feasible, to evaluate tumor response to treatment and to measure levels of tumor markers,
Detailed Description
Trial CPG-01-201 is an adaptive-platform trial comprised of multiple sub-studies. Sub-study 1 will be a parallel group, double-blind, randomized placebo-controlled trial in which participants will be randomized in a 1:2 ratio to either placebo (a look-alike substance that contains no drug) or COM701 treatment arms. This means that there is a 33% chance of being placed in the group getting placebo and a 67% chance of being placed in the group that will get the experimental COM701 antibody. Subsequent sub-studies will evaluate COM701 in combination with other anti-cancer drugs.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
COM701
Normal Saline
Conditions
Locations
Georgia Cancer Center at Augusta University
Augusta, Georgia 30912
United States
The University of Chicago Medical Center
Chicago, Illinois 60637
United States
Northwestern Memorial Hospital
Warrenville, Illinois 60555
United States
Massachusetts General Hospital
Boston, Massachusetts 02114
United States
Corewell Health
Grand Rapids, Michigan 49503
United States
Memorial Sloan Kettering Cancer Center- Main Campus
New York, New York 10065
United States
University of Rochester Medical Center
Rochester, New York 14642
United States
Levine Cancer Institute
Charlotte, North Carolina 28204
United States
Ohio State University Wexner Medical Center Gynecologic Oncology at Mill Run
Hilliard, Ohio 43026
United States
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma 73104
United States
UPMC Magee- Womens Hospital
Pittsburgh, Pennsylvania 15213
United States
Avera Cancer Institute
Sioux Falls, South Dakota 57105
United States
West Cancer Center
Germantown, Tennessee 38138
United States
UVA Comprehensive Cancer Center
Charlottesville, Virginia 22903
United States
Centre Hospitalier Regional et Universitaire de Besancon - Hopital Jean-Minjoz
Besançon, France 25000
France
Oncopole Claudius Regaud
Toulouse, France 31059
France
Centre Oscar Lambret
Lille, 59000
France
Institut Paoli-Calmettes
Marseille, 13009
France
Hospices Civils de Lyon- Centre Hospitalier Lyon Sud
Pierre-Bénite, 69310
France
Centre Eugene Marquis
Rennes, 35042
France
Institut de Cancerologie de l'Ouest- Site Rene Gauducheau
Saint-Herblain, 44805
France
Gustave Roussy
Villejuif, 94800
France
Assuta Medical Center
Ashdod, 7747629
Israel
Rambam Health Care Campus
Haifa, 3109601
Israel
The Edith Wolfson Medical Center
Holon, 5822012
Israel
Shaare Zedek Medical Center
Jerusalem, 9103102
Israel
Hadassah, University Hospital Ein Kerem
Jerusalem, 9112001
Israel
The Chaim Sheba Medical Center
Ramat Gan, 5265601
Israel