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Brief Title: A Trial to Find Out How Safe REGN5668 is and How Well it Works When Given With Either Cemiplimab or REGN4018
Official Title: Phase 1/2 Study of REGN5668 (MUC16xCD28, a Costimulatory Bispecific) Administered in Combination With Cemiplimab or REGN4018 (MUC16xCD3)
Study ID: NCT04590326
Brief Summary: This study is researching an investigational drug called REGN5668. Participants will receive additional investigational drugs in combination with REGN5668. These additional drugs include cemiplimab or 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) 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 or REGN4018 * How REGN5668 works in the body either alone and/or in combination with cemiplimab or REGN4018 * How much of the study drugs (REGN5668, cemiplimab, REGN4018) are in the blood * To see if REGN5668 in combination with cemiplimab or REGN4018 works to treat cancer * To find out how safe, tolerable, and effective in mitigating Cytokine Release Syndrome (CRS) sarilumab pretreatment is when given before REGN4018
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
City of Hope, Duarte, California, United States
H. Lee Moffitt Cancer Center, Tampa, Florida, United States
Northwestern Memorial Hospital, Chicago, Illinois, United States
University of Chicago, Chicago, Illinois, United States
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Karmanos Cancer Institute, Detroit, Michigan, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
The Ohio State University Wexner Medical Center, Columbus, Ohio, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
Universitair Ziekenhuis Leuven, Leuven, Vlaams-Brabant, Belgium
Name: Clinical Trial Management
Affiliation: Regeneron Pharmaceuticals
Role: STUDY_DIRECTOR