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Spots Global Cancer Trial Database for A Trial to Find Out How Safe REGN5668 is and How Well it Works When Given With Either Cemiplimab or REGN4018

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Trial Identification

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

Study Description

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:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

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

Contact Details

Name: Clinical Trial Management

Affiliation: Regeneron Pharmaceuticals

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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