Spots Global Cancer Trial Database for A Trial to Find Out if REGN5678 is Safe and How Well it Works Alone or in Combination With Cemiplimab for Adult Participants With Metastatic Castration-Resistant Prostate Cancer and Other Tumors
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Trial Identification
Brief Title: A Trial to Find Out if REGN5678 is Safe and How Well it Works Alone or in Combination With Cemiplimab for Adult Participants With Metastatic Castration-Resistant Prostate Cancer and Other Tumors
Official Title: A Phase 1/2 Study of REGN5678 (Anti-PSMAxCD28) With or Without Cemiplimab (Anti-PD-1) in Patients With Metastatic Castration-Resistant Prostate Cancer and Other Tumors Associated With PSMA Expression
Study ID: NCT03972657
Study Description
Brief Summary: The main purpose of this study is to determine the safety, tolerability (how your body reacts to the drug) and effectiveness (ability to treat your cancer) of REGN5678 alone, or in combination with cemiplimab. The study has 2 parts. The goal of Part 1 (dose escalation) is to determine a safe dose(s) of REGN5678 when it is given alone or in combination with cemiplimab. The goal of Part 2 (dose expansion) is to use the REGN5678 drug dose(s) found in Part 1 to see how well REGN5678 alone or in combination with cemiplimab works to shrink tumors. This study is looking at several other research questions, including: 1. Side effects that may be experienced by taking REGN5678 alone or in combination with cemiplimab 2. How REGN5678 alone or in combination with cemiplimab works in the body 3. How much REGN5678 and/or cemiplimab are present in the blood 4. To see if REGN5678 alone or in combination with cemiplimab works to reduce the size of the tumor by helping the immune system destroy the tumor
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
The University of Arizona Cancer Center, Tucson, Arizona, United States
John Wayne Cancer Institute, Santa Monica, California, United States
Sarah Cannon Research Institute at HealthONE, Denver, Colorado, United States
Yale University School of Medicine, New Haven, Connecticut, United States
Moffitt Cancer Center, Tampa, Florida, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health, New York, New York, United States
Icahn School of Medicine at Mount Sinai, New York, New York, United States
Columbia University Medical Center, New York, New York, United States
Montefiore Medical Center, New York, New York, United States
Providence Cancer Institute Franz Clinic, Portland, Oregon, United States
Thomas Jefferson University, Sidney Kimmel Cancer Center, Clinical Research Organization, Philadelphia, Pennsylvania, United States
Rhode Island Hospital, Providence, Rhode Island, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Contact Details
Name: Clinical Trials Management
Affiliation: Regeneron Pharmaceuticals
Role: STUDY_DIRECTOR
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