A Clinical Trial to Evaluate the Safety and Efficacy of COM701 in Relapsed Platinum Sensitive Ovarian Cancer
MAIA-ovarian
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)
1 other identifier
interventional
60
3 countries
28
Brief 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,
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 ovarian-cancer
Started Jul 2025
Shorter than P25 for phase_1 ovarian-cancer
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 12, 2025
CompletedFirst Posted
Study publicly available on registry
March 21, 2025
CompletedStudy Start
First participant enrolled
July 21, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
April 1, 2026
September 1, 2025
1.6 years
March 12, 2025
March 31, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
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
Secondary Outcomes (2)
To evaluate the safety and tolerability of the COM701 as a single agent when administered as a maintenance regimen in participants with relapsed PSOC
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
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.
Study Arms (2)
COM701
EXPERIMENTALNormal Saline
PLACEBO COMPARATORInterventions
Saline will be administered via intravenous (IV) infusion once every 3 weeks
Eligibility Criteria
You may qualify if:
- 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 being randomized into the study, must have had a minimum of 4 cycles of a platinum containing 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 a ≤grade 2).
You may not qualify if:
- 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 check point 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 the 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, respectively.
- 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 (mAb) 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 associated with study participation or may interfere with the interpretation of study results and, in the opinion of the investigator, would make the subject inappropriate for entry into the study.
- Is currently participating in or have participated in a clinical study and received an investigational agent or used an investigational device within 4 weeks prior to the first dose of study treatment.
- Is pregnant or breastfeeding or planning to become pregnant during the period of the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Compugen Ltdlead
Study Sites (28)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 12, 2025
First Posted
March 21, 2025
Study Start
July 21, 2025
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
March 1, 2027
Last Updated
April 1, 2026
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, CSR
- Time Frame
- Within 12 months of final database lock
- Access Criteria
- To be decided