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Spots Global Cancer Trial Database for 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

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Trial Identification

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

Study Description

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:

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

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

Contact Details

Name: Clinical Trial Management

Affiliation: Regeneron Pharmaceuticals

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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