Study of REGN4018 (Ubamatamab) Administered Alone or in Combination With Cemiplimab in Adult Patients With Recurrent Ovarian Cancer or Other Recurrent Mucin-16 Expressing (MUC16+) Cancers
Recruiting now · Phase 1/Phase 2
Conditions studied: Recurrent Ovarian Cancer, Recurrent Fallopian Tube Cancer, Recurrent Primary Peritoneal Cancer, Recurrent Endometrial Cancer, Endometrial Cancer, Low-grade Serous Ovarian Cancer
In brief
The main purpose of this study is to: * Learn about the safety of ubamatamab and to find out what dose of ubamatamab can be given alone or with cemiplimab to patients with ovarian cancer or cancer of the uterus * The study will also look at the levels of ubamatamab and/or cemiplimab in the body and measure how well the body can remove the study drug(s). This is called pharmacokinetics * The study will also look at any signs that ubamatamab alone or with cemiplimab can treat recurrent advanced ovarian cancer or cancer of the uterus * To find out how safe and tolerable pretreatment is in combination with ubamatamab and to see how well it works to prevent or minimize Cytokine Release Syndrome (CRS)
Key facts
- Study ID
- NCT03564340
- Run by
- Regeneron Pharmaceuticals
- People needed
- 890
- Starts
- 2018-05-21
- Expected to finish
- 2027-05-10
- Last updated by the study team
- 2026-07-22
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
Where it is running
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Rome, Lazio, Italy (enrolling)
- Istituto Europeo di Oncologia — Milan, Italy (enrolling)
- Mayo Clinic - Rochester — Rochester, Minnesota, United States (enrolling)
- University of Alabama_6th Ave — Birmingham, Alabama, United States (enrolling)
- Humanitas S. Pio X — Milan, Italy (enrolling)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
- The Ohio State University Wexner Medical Center — Columbus, Ohio, United States (enrolling)
- Stephenson Cancer Center — Oklahoma City, Oklahoma, United States (enrolling)
- Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
- Virginia Commonwealth University — Richmond, Virginia, United States (enrolling)
- Columbia University Medical Center — New York, New York, United States (enrolling)
- Dana Farber / Harvard Cancer Center — Boston, Massachusetts, United States (enrolling)
- Universitair Ziekenhuis Antwerpen — Edegem, Antwerp, Belgium (enrolling)
- Grand Hopital de Charleroi — Charleroi, Hainaut, Belgium (enrolling)
- UZLeuven — Leuven, Vlaams-Brabant, Belgium (enrolling)
- Hopital Lyon Sud — Pierre-Bénite, Auvergne-Rhône, France (enrolling)
- Centre Georges Francois Leclerc — Dijon, Bourgogne-Franche-Comté, France (enrolling)
- Institut Bergonie — Bordeaux, New Aquitaine, France (enrolling)
- Centre Francois Baclesse (CFB) — Caen, Normandy, France (enrolling)
- Centre Antoine Lacassagne — Nice, Provence Alpes Cote dAzur, France (enrolling)
- Institut Gustave Roussy — Villejuif, Île-de-France Region, France (enrolling)
- Rambam Health Care Campus — Haifa, Israel (enrolling)
- Sharet Institute of Oncology — Jerusalem, Israel (enrolling)
- Sheba Medical Center — Tel Litwinsky, Israel (enrolling)
- Instituto Nazionale Tumori- Fondazione Pascale — Naples, Italy (enrolling)
Full record on ClinicalTrials.gov
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