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,
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
COM701 will be administered via intravenous (IV) infusion once every 3 weeks.
Saline will be administered via intravenous (IV) infusion once every 3 weeks
Georgia Cancer Center at Augusta University
Augusta, Georgia, United States
RECRUITINGThe University of Chicago Medical Center
Chicago, Illinois, United States
RECRUITINGNorthwestern Memorial Hospital
Warrenville, Illinois, United States
RECRUITINGMassachusetts General Hospital
Boston, Massachusetts, United States
To evaluate the effect of COM701 as a single agent on progression free survival when administered as a maintenance regimen in participants with relapsed PSOC
Progression free survival in COM701-treated participants compared to placebo-treated participants
Time frame: From the date of randomization until the date of disease progression, or date of death from any cause whichever occurs first, assessed up to 2 years
To evaluate the safety and tolerability of the COM701 as a single agent when administered as a maintenance regimen in participants with relapsed PSOC
Number of participants with adverse events in the COM701 treatment arm compared to the placebo treatment arm
Time frame: From randomization up to 90 days post last cycle of study treatment (each cycle is 3 weeks; study treatment may continue up to 2 years).
To evaluate the effect of COM701 as a single agent on other efficacy endpoints when administered as a maintenance regimen in participants with relapsed PSOC
Time to the initiation of a new anti-cancer treatment in COM701-treated participants compared to placebo-treated participants
Time frame: From date of randomization until the date of the initiation of a new anti-cancer treatment, or date of death from any cause whichever occurs first, assessed up to 2 years.
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Corewell Health
Grand Rapids, Michigan, United States
RECRUITINGMemorial Sloan Kettering Cancer Center- Main Campus
New York, New York, United States
RECRUITINGUniversity of Rochester Medical Center
Rochester, New York, United States
RECRUITINGOhio State University Wexner Medical Center Gynecologic Oncology at Mill Run
Hilliard, Ohio, United States
RECRUITINGOU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
RECRUITINGAvera Cancer Institute
Sioux Falls, South Dakota, United States
RECRUITING...and 16 more locations