Evaluating COM701 for relapsed platinum-sensitive ovarian cancer
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)
This study is testing a new treatment called COM701 to see if it can help people with relapsed platinum-sensitive ovarian cancer by delaying the progression of their disease.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Compugen Ltd Industry-sponsored |
| Drugs / interventions | bevacizumab, chemotherapy |
| Locations | 28 sites (Augusta, Georgia and 27 other locations) |
| Trial ID | NCT06888921 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the safety and efficacy of the experimental antibody COM701 in patients with relapsed platinum-sensitive ovarian cancer. Participants will receive either COM701 or a placebo as maintenance therapy, with the primary focus on determining if COM701 can delay cancer progression and the need for new treatments. The trial involves regular clinic visits every three weeks for treatment administration and health monitoring through various tests and procedures. It is designed as a double-blind, randomized study to ensure unbiased results.
Who should consider this trial
Good fit: Ideal candidates are individuals with relapsed platinum-sensitive epithelial ovarian cancer who have completed at least two courses of platinum-containing therapy and achieved a partial or complete tumor response.
Not a fit: Patients who have undergone four or more lines of cytotoxic chemotherapy or are currently on immunosuppressive medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly delay cancer progression and improve quality of life for patients with relapsed platinum-sensitive ovarian cancer.
How similar studies have performed: Other studies have shown promise with similar maintenance therapies in ovarian cancer, suggesting potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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). Exclusion Criteria: * 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.
Where this trial is running
Augusta, Georgia and 27 other locations
- Georgia Cancer Center at Augusta University — Augusta, Georgia, United States (Recruiting)
- The University of Chicago Medical Center — Chicago, Illinois, United States (Recruiting)
- Northwestern Memorial Hospital — Warrenville, Illinois, United States (Recruiting)
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- Corewell Health — Grand Rapids, Michigan, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center- Main Campus — New York, New York, United States (Recruiting)
- University of Rochester Medical Center — Rochester, New York, United States (Recruiting)
- Levine Cancer Institute — Charlotte, North Carolina, United States (Recruiting)
- Ohio State University Wexner Medical Center Gynecologic Oncology at Mill Run — Hilliard, Ohio, United States (Recruiting)
- OU Health Stephenson Cancer Center — Oklahoma City, Oklahoma, United States (Recruiting)
- UPMC Magee- Womens Hospital — Pittsburgh, Pennsylvania, United States (Recruiting)
- Avera Cancer Institute — Sioux Falls, South Dakota, United States (Recruiting)
- West Cancer Center — Germantown, Tennessee, United States (Withdrawn)
- UVA Comprehensive Cancer Center — Charlottesville, Virginia, United States (Recruiting)
- Centre Hospitalier Regional et Universitaire de Besancon - Hopital Jean-Minjoz — Besançon, France, France (Recruiting)
- Oncopole Claudius Regaud — Toulouse, France, France (Recruiting)
- Centre Oscar Lambret — Lille, France (Recruiting)
- Institut Paoli-Calmettes — Marseille, France (Recruiting)
- Hospices Civils de Lyon- Centre Hospitalier Lyon Sud — Pierre-Bénite, France (Recruiting)
- Centre Eugene Marquis — Rennes, France (Recruiting)
- Institut de Cancerologie de l'Ouest- Site Rene Gauducheau — Saint-Herblain, France (Recruiting)
- Gustave Roussy — Villejuif, France (Recruiting)
- Assuta Medical Center — Ashdod, Israel (Recruiting)
- Rambam Health Care Campus — Haifa, Israel (Recruiting)
- The Edith Wolfson Medical Center — Holon, Israel (Recruiting)
- Shaare Zedek Medical Center — Jerusalem, Israel (Recruiting)
- Hadassah, University Hospital Ein Kerem — Jerusalem, Israel (Recruiting)
- The Chaim Sheba Medical Center — Ramat Gan, Israel (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.