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Brief Title: Study of REGN6569 and Cemiplimab in Adult Patients With Advanced Solid Tumor Malignancies
Official Title: A Phase 1 Study of REGN6569, an Anti-GITR mAb, With Cemiplimab in Patients With Advanced Solid Tumor Malignancies
Study ID: NCT04465487
Brief Summary: There are two main goals of this study: The first is to find the highest safe dose of REGN6569 when given with cemiplimab. The second is to get some initial information about how well the REGN6569 in combination with cemiplimab may help shrink certain types of cancer. The study is also looking at: * Side effects that may be experienced by people taking REGN6569 alone and with cemiplimab * How REGN6569 and cemiplimab work in the body * How much REGN6569 and cemiplimab is in your blood * To see if REGN6569 can lower the number of Treg cells in tumors * To see if REGN6569 and cemiplimab can shrink tumors when given together
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Angeles Clinic and Research Institute - Clinic/Outpatient Facility, Los Angeles, California, United States
H.Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
University of Michigan, Ann Arbor, Michigan, United States
START South Texas Accelerated Research Therapeutics, Grand Rapids, Michigan, United States
Hospital Universitario Vall d'Hebrón, Barcelona, , Spain
ICO l'Hospitalet - Hospital Duran i Reynals, Barcelona, , Spain
MD Anderson Cancer Center, Madrid, , Spain
Hospital Universitario Ramon y Cajal, Madrid, , Spain
Hospital Universitario Fundacion Jimenez, Madrid, , Spain
Hospital Universitario HM Sanchinarro, Madrid, , Spain
Name: Clinical Trial Management
Affiliation: Regeneron Pharmaceuticals
Role: STUDY_DIRECTOR