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Brief Title: Study of REGN4018 Administered Alone or in Combination With Cemiplimab in Adult Patients With Recurrent Ovarian Cancer or Other Recurrent Mucin-16 Expressing (MUC16+) Cancers
Official Title: A Phase 1/2 Study of REGN4018 (A MUC16xCD3 Bispecific Antibody) Administered Alone or in Combination With Cemiplimab in Patients With Recurrent Ovarian Cancer or Other Recurrent MUC16+ Cancers
Study ID: NCT03564340
Brief Summary: The main purpose of this study is to: * Learn about the safety of REGN4018 and to find out what dose of REGN4018 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 REGN4018 and/or cemiplimab in your body and measure how well your body can remove the study drug(s). This is called pharmacokinetics * The study will also look at any signs that REGN4018 alone or with cemiplimab can treat recurrent advanced ovarian cancer or cancer of the uterus * To find out how safe and tolerable the sarilumab pretreatment is, in combination with REGN4018 and cemiplimab
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
University of Alabama at Birmingham, Birmingham, Alabama, United States
The General Hospital Corporation d/b/a Massachusetts General Hospital, Boston, Massachusetts, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Mayo Clinic Hospital Rochester, Rochester, Minnesota, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Columbia University Irving Medical Center, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
James Care Gynecologic Oncology at Mill Run, Hilliard, Ohio, United States
Stephenson Cancer Center, Oklahoma City, Oklahoma, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
Prince of Wales Hospital, Randwick, New South Wales, Australia
Peter MacCallum Cancer Center, Melbourne, Victoria, Australia
Universitair Ziekenhuis Antwerpen, Edegem, Antwerp, Belgium
Grand Hôpital de Charleroi, Charleroi, Hainaut, Belgium
UZLeuven, Leuven, Vlaams Brabant, Belgium
Centre Georges-Francois Leclerc, Dijon cedex, Bourgogne, France
Centre Antoine Lacassagne, Nice, Cedex 2, France
Centre Hospitalier Lyon Sud, Hospices Civils de Lyon, Pierre-Benite, Lyon, France
Centre Regional de Lutte Contre le Cancer de Bordeaux et du Sud-Ouest - Institut Bergonie, Bordeaux, , France
UNICANCER - Centre Francois Baclesse (CFB), Caen cedex 5, , France
Institut Gustave Roussy, Villejuif Cedex, , France
Rambam Health Care Campus RHCC - Rambam Medical Center, Haifa, , Israel
The Chaim Sheba Medical Center, Tel Hashomer, , Israel
Fondazione Policlinico Agostino Gemelli IRCCS di Roma, Roma, Lazio, Italy
Istituto Europeo di Oncologia, Milano, , Italy
Instituto Nazionale Tumori- Fondazione Pascale, Naples, , Italy
Yonsei University Health System, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Seoul National University College of Medicine, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Radboudumc, dept Medical Oncology hp 452, Nijmegen, Gelderland, Netherlands
Erasmus MC, Rotterdam, Zuid Holland, Netherlands
University Medical Center Groningen, Groningen, , Netherlands
Clínica Universidad de Navarra, Pamplona, Navarra, Spain
Clinica Universidad de Navarra, Madrid, Navarre, Spain
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
Institut Catala d'Oncologia, Barcelona, , Spain
Institut Catala d'Oncologia, Barcelona, , Spain
Hospital Universitario Fundacion Jimenez Diaz, Madrid, , Spain
Hospital Universitario San Carlos, Madrid, , Spain
Hospital Clinico Universitatio Santiago de Compostela, Santiago de Compostela, , Spain
University College London Hospitals, London, England, United Kingdom
Guy's Hospital, London, England, United Kingdom
The Christie NHS Foundation Trust, Manchester, Greater Manchester, United Kingdom
The Royal Marsden NHS Foundation Trust, Sutton, London, United Kingdom
University of Oxford, Oxford, Oxfordshire, United Kingdom
Royal Marsden Hospital - Sutton, Sutton, Surrey, United Kingdom
Name: Clinical Trial Management
Affiliation: Regeneron Pharmaceuticals
Role: STUDY_DIRECTOR