A Trial to Find Out if REGN5678 (Nezastomig) 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
Start Date
8/12/2019
Completion Date
11/15/2027
Summary
The main purpose of this study is to determine the safety, tolerability (how the body reacts to the drug\[s\]) and effectiveness (ability to treat the cancer) of REGN5678 (Nezastomig) 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
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
REGN5678
Cemiplimab
Conditions
Locations
Banner MD Anderson Cancer Center
Gilbert, Arizona 85234
United States
Mayo Clinic
Phoenix, Arizona 85054
United States
University of Arizona
Tucson, Arizona 85724
United States
John Wayne Cancer Institute (JWCI)
Santa Monica, California 90404
United States
Sarah Cannon Research Institute (SCRI)
Denver, Colorado 80218
United States
Yale University Hospital
New Haven, Connecticut 06510
United States
Mayo Clinic Jacksonville
Jacksonville, Florida 32224
United States
Moffitt Cancer Center - McKinley Drive
Tampa, Florida 33612
United States
Massachusetts General Hospital
Boston, Massachusetts 02114
United States
Henry Ford Health
Detroit, Michigan 48202
United States
Mayo Clinic
Rochester, Minnesota 55905
United States
NYU Langone Health Perlmutter Cancer Center
New York, New York 10016
United States
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United States
Columbia University - The Trustees of Columbia University in the City of New York
New York, New York 10032
United States
Montefiore Medical Center
New York, New York 10461
United States
University of Rochester Medical Center (URMC) - Wilmot Cancer Institute (WCI) (James P. Wilmot Cancer Center) - Rochester
Rochester, New York 14642
United States
James Cancer Hospital and Solove Research Institute
Columbus, Ohio 43210
United States
Providence Portland Medical Center
Portland, Oregon 97213
United States
Oregon Health & Science University (3485 S. Bond)
Portland, Oregon 97239
United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107
United States
Lifespan Cancer Institute
Providence, Rhode Island 02903
United States
MD Anderson Cancer Center
Houston, Texas 77030
United States
Emily Couric Clinical Cancer Center
Charlottesville, Virginia 22908
United States
West Virginia University
Morgantown, West Virginia 26506
United States