Study of REGN3767 (Anti-LAG-3) With or Without REGN2810 (Anti-PD1) in Advanced Cancers
NCT ID: NCT03005782
Last Updated: 2024-05-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
333 participants
INTERVENTIONAL
2016-11-07
2024-04-02
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Monotherapy (REGN3767)
Group A will consist of up to 4 sequential dose cohorts. Each cohort will receive 1 of 3 ascending dose levels of study drug during dose escalation. In addition 1 tumor-specific cohort will be treated at the recommended phase 2 dose (RP2D) during dose expansion.
REGN3767
Combination Therapy (REGN3767+cemiplimab)
Group B will consist of up to 4 sequential dose cohorts. Each cohort will receive 1 of 3 ascending dose levels of study drug during dose escalation. In addition, 9 tumor-specific cohorts will be treated at the RP2D during dose expansion
REGN3767
cemiplimab
Interventions
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REGN3767
cemiplimab
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Dose expansion cohorts: Patients with histologically or cytologically confirmed diagnosis of 1 of specified tumors with measurable disease per RECIST 1.1 or Lugano criteria. Some patients may have been previously treated with a PD-1 or PD-L1 inhibitor
* Eastern Cooperative Oncology Group performance status of 0 or 1
* Adequate organ and bone marrow function
Exclusion Criteria
* Radiation therapy within 2 weeks prior to randomization and not recovered to baseline from any AE due to radiation
* Untreated or active central nervous system metastases - Ongoing or recent (within 5 years) evidence of significant autoimmune disease
* Corticosteroid therapy (\>10 mg prednisone/day or equivalent) within 1 week prior to the first dose of study drug
* Myocardial infarction within 6 months
18 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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Guy's Hospital
London, Europe, United Kingdom
University Of Oxford - Churchill Hospital
Headington, Oxford, United Kingdom
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 D.C., 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
St 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, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Countries
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References
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Hamid O, Lewis KD, Weise A, McKean M, Papadopoulos KP, Crown J, Kim TM, Lee DH, Thomas SS, Mehnert J, Kaczmar J, Lakhani NJ, Kim KB, Middleton MR, Rabinowits G, Spira AI, Yushak M, Mehmi I, Fang F, Chen S, Mani J, Jankovic V, Wang F, Fiaschi N, Brennan L, Paccaly A, Masinde S, Salvati M, Fury MG, Kroog G, Lowy I, Gullo G. Phase I Study of Fianlimab, a Human Lymphocyte Activation Gene-3 (LAG-3) Monoclonal Antibody, in Combination With Cemiplimab in Advanced Melanoma. J Clin Oncol. 2024 Aug 20;42(24):2928-2938. doi: 10.1200/JCO.23.02172. Epub 2024 Jun 20.
Other Identifiers
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2016-002789-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
R3767-ONC-1613
Identifier Type: -
Identifier Source: org_study_id
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