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Brief Title: Study of REGN3767 (Anti-LAG-3) With or Without REGN2810 (Anti-PD1) in Advanced Cancers
Official Title: A Phase 1, Open-Label, Dose-Escalation and Cohort Expansion First-in-Human Study of the Safety, Tolerability, Activity and Pharmacokinetics of REGN3767 (Anti-LAG-3 mAb) Administered Alone or in Combination With REGN2810 (Anti-PD-1 mAb) in Patients With Advanced Malignancies
Study ID: NCT03005782
Brief Summary: The primary objectives in the dose escalation phase are to evaluate safety and pharmacokinetics (PK) in order to determine the selected dose level(s) for expansion of REGN3767 as monotherapy and in combination with cemiplimab in patients with advanced malignancies, including lymphoma. The primary objectives in the dose expansion phase are to assess preliminary anti-tumor activity of REGN3767 alone and in combination with cemiplimab (separately by cohort) as measured by objective response rate (ORR).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
California Cancer Associates for Research and Excellence, Encinitas, California, United States
California Cancer Associates For Research And Excellence, Fresno, California, United States
University of California San Diego (UCSD), La Jolla, California, United States
The Angeles Clinic, Los Angeles, California, United States
University of California Davis Health Systems, Sacramento, California, United States
California Pacific Medical Center (CPMC), San Francisco, California, United States
University of Colorado Cancer Center, Aurora, Colorado, United States
Lombardi Comprehensive Cancer Center - MedStar Georgetown University Hospital, Washington, District of Columbia, United States
Miami Cancer Institute, Miami, Florida, United States
Orlando Health, Inc, Orlando, Florida, United States
Winship Cancer Institute at Emory University, Atlanta, Georgia, United States
University of Kansas Clinical Research Center, Fairway, Kansas, United States
Dana Farber Cancer Institute, Jamaica Plain, Massachusetts, United States
Henry Ford Health Hospital, Detroit, Michigan, United States
Cancer and Hematology Centers of Western Michigan, Grand Rapids, Michigan, United States
Washington University in Saint Louis, Saint Louis, Missouri, United States
John Theurer Cancer Center, Hackensack University Medical Center, Hackensack, New Jersey, United States
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
New Mexico Cancer Care Alliance-UNM Cancer Center, Albuquerque, New Mexico, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Northwell Health-Monter Cancer Center, Lake Success, New York, United States
Laura & Isaac Perlmutter Cancer Center, New York, New York, United States
Columbia University, New York, New York, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Levine Cancer Institute, Charlotte, North Carolina, United States
University Hospitals Seidman Cancer Center and Case Western Reserve University, Cleveland, Ohio, United States
Stephenson Cancer Center, Oklahoma City, Oklahoma, United States
Rhode Island Hospital, Providence, Rhode Island, United States
Hollings Cancer Center - Medical University of South Carolina, Charleston, South Carolina, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
South Texas Oncology and Hematology, San Antonio, Texas, United States
Virginia Cancer Care Specialist, PC, Fairfax, Virginia, United States
The University of Western Australia - The Queen Elizabeth II Medical Centre (QEIIMC) - Sir Charles Gairdner Hospital (SCGH), Perth, Western Australia, Australia
Royal Brisbane and Women's Hospital, Brisbane, , Australia
Peter Maccallum Cancer Centre (PMCC), Melbourne, , Australia
St. Vincents University Hospital, Dublin, , Ireland
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Guy's Hospital, London, Europe, United Kingdom
University Of Oxford - Churchill Hospital, Headington, Oxford, United Kingdom
Name: Clinical Trial Management
Affiliation: Regeneron Pharmaceuticals
Role: STUDY_DIRECTOR