Study of REGN3767 (Anti-LAG-3) With or Without REGN2810 (Anti-PD1) in Advanced Cancers



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:6/20/2018
Start Date:November 7, 2016
End Date:March 29, 2022
Contact:Clinical Trials Administrator
Email:clinicaltrials@regeneron.com
Phone:844-734-6643

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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

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 REGN2810 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 REGN2810
(separately by cohort) as measured by objective response rate (ORR).


Key Inclusion Criteria:

- Dose escalation cohorts: Patients with histologically or cytologically confirmed
diagnosis of malignancy (including lymphoma) with demonstrated progression of a tumor
for whom there is no available therapy likely to convey clinical benefit AND who have
not been previously treated with a PD-1/PD-L1 inhibitor. These patients do not require
measurable disease

- 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

Key Exclusion Criteria:

- Prior treatment with any LAG-3 targeting biologic or small molecule

- 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

- Documented allergic or acute hypersensitivity reaction attributed to antibody
treatments

Note: Other protocol defined Inclusion / Exclusion criteria may apply
We found this trial at
24
sites
San Antonio, Texas 78229
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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Buffalo, NY
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86 Jonathan Lucas Street
Charleston, South Carolina 29425
(843) 792-0700
Hollings Cancer Center at Medical University of South Carolina Located at the Medical University of...
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Charleston, SC
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593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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Providence, RI
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801 University Boulevard Southeast
Albuquerque, New Mexico 87131
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Albuquerque, NM
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Aurora, Colorado 80045
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Cleveland, OH
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1 Ford Place
Detroit, Michigan 48202
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Detroit, MI
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8503 Arlington Boulevard
Fairfax, Virginia 22031
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Fairfax, VA
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Fairway, KS
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Grand Rapids, MI
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92 2nd St
Hackensack, New Jersey 07601
(201) 996-5900
John Theurer Cancer Center at the Hackensack University Medical Center The mission of the John...
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Hackensack, NJ
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Houston, TX
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Lake Success, New York
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Lake Success, NY
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Los Angeles, California 90025
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Los Angeles, CA
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3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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Nashville, TN
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New Brunswick, New Jersey 08903
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New Brunswick, NJ
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New York, New York 10016
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New York, NY
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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Oklahoma City, Oklahoma 73104
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Oklahoma City, OK
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Sacramento, CA
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Saint Louis, Missouri 63110
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Seoul,
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