Actively Recruiting
An Adaptive Clinical Platform Trial to Evaluate the Safety and Efficacy of COM701 as Monotherapy or Combination Therapy as Maintenance Therapy in Participants With Relapsed Platinum Sensitive Ovarian Cancer (PSOC)
Led by Compugen Ltd · Updated on 2026-04-01
60
Participants Needed
28
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the experimental antibody COM701 to see if it can delay the progression of relapsed platinum sensitive ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. The trial aims to find out if COM701, given as maintenance treatment, can slow disease progression, delay the need for new anti-cancer treatments, and to understand its safety profile in participants who have had prior platinum-containing therapies. This trial is a randomized, double-blind, placebo-controlled study where participants have a 67% chance to receive COM701 and a 33% chance to receive a placebo. The treatment is given through intravenous infusion once every three weeks. The study includes multiple sub-studies, with initial focus on COM701 alone and later evaluation of COM701 combined with other anti-cancer drugs as maintenance therapy. Participants will visit the clinic every three weeks for treatment infusion and undergo various health checks including physical exams, vital signs, ECG, blood and urine tests, and pregnancy tests if applicable. Disease response is monitored through tumor imaging by CT or MRI scans and analysis of tumor tissue samples. The main outcome is progression-free survival over up to two years, with safety monitored during and up to 90 days after treatment. The study duration and follow-up depend on individual participant progress.
CONDITIONS
Brief 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 of platinum-containing therapy
- Has had a minimum of 4 cycles of platinum-containing chemotherapy in last course with 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 these therapies
- Has recovered from toxicities of prior chemotherapy or other therapy to grade 1 or less except alopecia and neuropathy recovered to grade 2 or less
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 other checkpoint inhibitors
- Has radiographic or biopsy proven liver metastases at the start or end of current platinum chemotherapy
- Has had drainage of ascites during last 2 cycles of chemotherapy or after completion
- Has had bowel obstruction in the 6 weeks prior to randomization
- Has active central nervous system metastases or carcinomatous meningitis/leptomeningeal carcinomatosis
- Has active hepatitis B, hepatitis C, or HIV infection
- Has active uncontrolled bacterial, fungal, or viral infection requiring systemic treatment
- Has received a live viral vaccine within 30 days before study start or requires live vaccine during study
- Has history of severe allergic or hypersensitivity reactions to human or humanized monoclonal antibodies or excipients
- Has serious or unstable systemic disorders
- Has any condition increasing risk or interfering with study results as judged by investigator
- Has participated in another clinical study with investigational agent or device within 4 weeks prior to first study dose
- Is pregnant, breastfeeding, or planning pregnancy during the study
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
Participants receive COM701 or placebo via intravenous infusion once every 3 weeks as maintenance therapy.
Infusions every 3 weeks
Duration - Up to 90 days post-treatment
Participants are monitored for safety and treatment effects up to 90 days after the last study treatment cycle.
Visits as needed for safety monitoring
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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