A Study to Find Out How Safe REGN5668 is and How Well it Works In Adult Women When Given With Either Cemiplimab, or Cemiplimab + Fianlimab, or Ubamatamab
Start Date
12/8/2020
Completion Date
11/30/2027
Summary
This study is researching an investigational drug called REGN5668 : * alone or, * combined with cemiplimab (also known as REGN2810) or, * combined with both cemiplimab and fianlimab (also known as REGN3767), or * combined with ubamatamab (also known as REGN4018), with or without sarilumab. The main purposes of this study are to: * Learn about the safety and profile of any side effects from the study drugs and to determine the highest, safe dose that can be given to participants with ovarian cancer or cancer of the uterus * Look for signs that the study drugs can treat ovarian cancer or cancer of the uterus This study has 2 parts. The purpose of Part 1 (Escalation) is to find the highest, safe dose of the study drug(s). The purpose of Part 2 (Expansion) is to use the doses chosen in Part 1. Participants with cancer of the uterus will only participate in Part 2. The study is looking at several other research questions, including: * Side effects that may be experienced by participants taking REGN5668 alone and/or in combination with cemiplimab, cemiplimab and fianlimab, or ubamatamab * How REGN5668 works in the body either alone and/or in combination with cemiplimab, cemiplimab and fianlimab, or ubamatamab * How much of the study drugs (REGN5668, cemiplimab, fianlimab, ubamatamab) are in the blood * To see if REGN5668 in combination with cemiplimab, cemiplimab and fianlimab, or ubamatamab works to treat cancer
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
REGN5668
Cemiplimab
Ubamatamab
Sarilumab
Cemiplimab + Fianlimab [Fixed Dose Combination (FDC)]
Conditions
Locations
City of Hope Comprehensive Cancer Center
Duarte, California 91010
United States
The City of Hope Orange County Lennar Foundation Cancer Center
Irvine, California 92618
United States
Chao Family Comprehensive Cancer Center
Orange, California 92868
United States
H. Lee Moffitt Cancer Center
Tampa, Florida 33612
United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago, Illinois 60611
United States
University of Chicago Medical Center
Chicago, Illinois 60637
United States
Massachusetts General Hospital
Boston, Massachusetts 02114
United States
Dana Farber Cancer Institute Brookline Avenue
Boston, Massachusetts 02215
United States
Karmanos Cancer Institute
Detroit, Michigan 48201
United States
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
The Ohio State University Wexner Medical Center
Columbus, Ohio 43210
United States
Perelman School of Medicine at the University of Pennsylvania
Philadelphia, Pennsylvania 19104
United States
Seattle Cancer Care Alliance at South Lake Union - G3630
Seattle, Washington 98109
United States
Universitair Ziekenhuis Leuven
Leuven, Vlaams-Brabant 3000
Belgium
Hopital Lyon Sud
Pierre-Bénite, Auvergne-Rhône 69310
France
Centre Georges Francois Leclerc
Dijon, Bourgogne-Franche-Comté 21000
France
Institut Bergonie
Bordeaux, New Aquitaine 33076
France
Centre Francois Baclesse (CFB)
Caen, Normandy 14076
France
Institut Gustave Roussy
Villejuif, 94805
France
Hospital Clinico Universitario Santiago de Compostela
Santiago de Compostela, A Coruna 15706
Spain
Institut Catala dOncologia Girona
Girona, 17007
Spain
Ciudad Universitaria
Madrid, 28040
Spain
Hospital Universitario Fundacion Jimenez
Madrid, 28040
Spain
Hospital Universitario 12 de Octubre Universidad Complutense de Madrid UCM
Madrid, 28041
Spain