Actively Recruiting
A Clinical Trial to Evaluate the Safety and Efficacy of COM701 in Relapsed Platinum Sensitive Ovarian Cancer
Led by Compugen Ltd · Updated on 2026-04-01
60
Participants Needed
28
Research Sites
84 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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,
CONDITIONS
Official Title
A Clinical Trial to Evaluate the Safety and Efficacy of COM701 in Relapsed Platinum Sensitive Ovarian Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Has relapsed platinum sensitive epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer
- Has completed at least 2 previous courses (i.e. lines) of platinum-containing therapy
- For the last chemotherapy course prior to study randomization, must have had a minimum of 4 cycles of a platinum regimen and achieved a partial or complete tumor response
- Has received prior maintenance therapy with bevacizumab or a PARP inhibitor if eligible and is not a candidate for, or has declined in writing, bevacizumab or PARP inhibitor therapy
- Have recovered from toxicities of prior chemotherapy or other therapy (to grade 1 or less, except for alopecia and neuropathy recovered to 64grade 2)
You will not qualify if you...
- Has had 4 or more lines of cytotoxic chemotherapy in total
- Is being treated with immunosuppressive doses of systemic medications, such as steroids within 2 weeks before study drug administration
- Has had prior treatment with PD-1, PD-L1, anti-PVRIG, TIGIT or any other checkpoint inhibitors
- Presence of radiographic or biopsy proven liver metastases at the beginning or completion of current line of platinum-based chemotherapy
- Drainage of ascites during last 2 cycles of last chemotherapy or any time after completion of last chemotherapy regimen
- Bowel obstruction in the 6 weeks prior to randomization
- Have known active central nervous system metastases and/or carcinomatous meningitis / leptomeningeal carcinomatosis
- Has active hepatitis B virus (HBV) or hepatitis C virus (HCV), or subjects with human immunodeficiency virus (HIV)
- Has active and clinically relevant bacterial, fungal, or viral infection that is not controlled or requires systemic antibiotics, antifungals, or antivirals
- Has received a live viral vaccine within 30 days of planned start of study treatment or requiring a live vaccine during the study
- Has a history of severe allergic, anaphylactic, or other hypersensitivity reactions to a human or humanized monoclonal antibody or allergy to any excipients in the investigational products
- Has any serious or unstable concomitant systemic disorder
- Has any other condition that may increase the risk or interfere with study participation or results interpretation, per investigator opinion
- Is currently participating in or have participated in a clinical study and received an investigational agent or device within 4 weeks prior to first dose
- Is pregnant or breastfeeding or planning to become pregnant during the study
AI-Screening
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Trial Site Locations
Total: 28 locations
1
Georgia Cancer Center at Augusta University
Augusta, Georgia, United States, 30912
Actively Recruiting
2
The University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Actively Recruiting
3
Northwestern Memorial Hospital
Warrenville, Illinois, United States, 60555
Actively Recruiting
4
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
5
Corewell Health
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center- Main Campus
New York, New York, United States, 10065
Actively Recruiting
7
University of Rochester Medical Center
Rochester, New York, United States, 14642
Actively Recruiting
8
Levine Cancer Institute
Charlotte, North Carolina, United States, 28204
Actively Recruiting
9
Ohio State University Wexner Medical Center Gynecologic Oncology at Mill Run
Hilliard, Ohio, United States, 43026
Actively Recruiting
10
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
11
UPMC Magee- Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
12
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
Actively Recruiting
13
West Cancer Center
Germantown, Tennessee, United States, 38138
Withdrawn
14
UVA Comprehensive Cancer Center
Charlottesville, Virginia, United States, 22903
Actively Recruiting
15
Centre Hospitalier Regional et Universitaire de Besancon - Hopital Jean-Minjoz
Besançon, France, France, 25000
Actively Recruiting
16
Oncopole Claudius Regaud
Toulouse, France, France, 31059
Actively Recruiting
17
Centre Oscar Lambret
Lille, France, 59000
Actively Recruiting
18
Institut Paoli-Calmettes
Marseille, France, 13009
Actively Recruiting
19
Hospices Civils de Lyon- Centre Hospitalier Lyon Sud
Pierre-Bénite, France, 69310
Actively Recruiting
20
Centre Eugene Marquis
Rennes, France, 35042
Actively Recruiting
21
Institut de Cancerologie de l'Ouest- Site Rene Gauducheau
Saint-Herblain, France, 44805
Actively Recruiting
22
Gustave Roussy
Villejuif, France, 94800
Actively Recruiting
23
Assuta Medical Center
Ashdod, Israel, 7747629
Actively Recruiting
24
Rambam Health Care Campus
Haifa, Israel, 3109601
Actively Recruiting
25
The Edith Wolfson Medical Center
Holon, Israel, 5822012
Actively Recruiting
26
Shaare Zedek Medical Center
Jerusalem, Israel, 9103102
Actively Recruiting
27
Hadassah, University Hospital Ein Kerem
Jerusalem, Israel, 9112001
Actively Recruiting
28
The Chaim Sheba Medical Center
Ramat Gan, Israel, 5265601
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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