RECRUITING

A Clinical Trial to Evaluate the Safety and Efficacy of COM701 in Relapsed Platinum Sensitive Ovarian Cancer

Conditions

Ovarian Cancer Ovarian Cancer Recurrent maintenance therapy relapsed platinum sensitive ovarian cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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,

Official Title

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)

Quick Facts

Study Start:2025-04

Study Completion:2027-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06888921

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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).	* 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.

Inclusion Criteria

Exclusion Criteria

* 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).

* 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.

Contacts and Locations

Study Locations (Sites)

West Cancer Center

Germantown, Tennessee, 38138

United States

Collaborators and Investigators

Sponsor: Compugen Ltd

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04

Study Completion Date2027-03

Study Record Updates

Study Start Date2025-04

Study Completion Date2027-03

Terms related to this study

Keywords Provided by Researchers

maintenance therapy
relapsed platinum sensitive ovarian cancer

Additional Relevant MeSH Terms

Ovarian Cancer
Ovarian Cancer Recurrent