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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
Sponsor: Regeneron Pharmaceuticals
Summary
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)
Official title: A Phase 1/2 Study of REGN4018 (Ubamatamab), a MUC16×CD3 Bispecific Antibody, Administered Alone or in Combination With Cemiplimab in Patients With Recurrent Ovarian Cancer or Other Recurrent MUC16+ Cancers
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
890
Start Date
2018-05-21
Completion Date
2027-01-31
Last Updated
2025-12-03
Healthy Volunteers
No
Conditions
Interventions
Ubamatamab
Administered per the protocol
Cemiplimab
Administered per the protocol
Sarilumab
Administered per the protocol
Tocilizumab
Administered per the protocol
Locations (51)
University of Alabama_6th Ave
Birmingham, Alabama, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana Farber / Harvard Cancer Center
Boston, Massachusetts, United States
Mayo Clinic - Rochester
Rochester, Minnesota, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Columbia University Medical Center
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
The Ohio State University Wexner Medical Center James Comprehensive Cancer Center
Hilliard, Ohio, United States
Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Prince of Wales Hospital
Randwick, New South Wales, Australia
Peter MacCallum Cancer Center
Melbourne, Australia
Universitair Ziekenhuis Antwerpen
Edegem, Antwerp, Belgium
Grand Hopital de Charleroi
Charleroi, Hainaut, Belgium
UZLeuven
Leuven, Vlaams-Brabant, Belgium
Hopital Lyon Sud
Pierre-Bénite, Auvergne-Rhône, France
Centre Georges Francois Leclerc
Dijon, Bourgogne-Franche-Comté, France
Centre Francois Baclesse (CFB)
Caen, Normandy, France
Institut Bergonie
Bordeaux, Nouvelle-Aquitaine, France
Centre Antoine Lacassagne
Nice, Provence Alpes Cote dAzur, France
Institut Gustave Roussy
Villejuif, Île-de-France Region, France
Rambam Health Care Campus
Haifa, Israel
Sharet Institute of Oncology
Jerusalem, Israel
Sheba Medical Center
Tel Litwinsky, Israel
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Lazio, Italy
Istituto Europeo di Oncologia
Milan, Italy
Instituto Nazionale Tumori- Fondazione Pascale
Naples, Italy
Radboudumc
Nijmegen, Gelderland, Netherlands
Erasmus MC
Rotterdam, South Holland, Netherlands
University Medical Center Groningen
Groningen, Netherlands
Yonsei University Health System
Seoul, South Korea
Asan Medical Center, Univ. of Ulsan
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Korea University Guro Hospital
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Clinica Universidad de Navarra
Pamplona, Navarre, Spain
Institut Catala dOncologia Badalona
Badalona, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Institut Catala d'Oncologia
Barcelona, Spain
Clinica Universidad Navarra (CUN) Madrid
Madrid, Spain
Fundacion Jimenez Diaz
Madrid, Spain
Hospital Universitario San Carlos
Madrid, Spain
Hospital Clinico Universitatio Santiago de Compostela
Santiago de Compostela, Spain
University of Oxford
Oxford, Oxfordshire, United Kingdom
Royal Marsden Hospital - Sutton
Sutton, Surrey, United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton, Surrey, United Kingdom
University College London Hospitals
London, United Kingdom
Guys Hospital
London, United Kingdom
Imperial College Healthcare NHS Trust
London, United Kingdom
The Christie NHS Foundation Trust
Manchester, United Kingdom