Safety Study of Anti-LAG-3 in Relapsed or Refractory Hematologic Malignancies



Status:Recruiting
Conditions:Blood Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:11/17/2018
Start Date:February 25, 2014
End Date:January 15, 2020
Contact:Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email:
Email:Clinical.Trials@bms.com

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A Phase 1/2a Dose Escalation and Cohort Expansion Study of the Safety, Tolerability, and Efficacy of Anti-LAG-3 (BMS-986016) in Monoclonal Antibody (BMS-986016) Administered Alone and in Combination With Anti-PD-1 Monoclonal Antibody (Nivolumab, BMS-936558) in Relapsed or Refractory B-Cell Malignancies

The primary objective of this study is to characterize the safety, tolerability and maximum
tolerated dose of BMS-986016 administered alone or in combination with Nivolumab to subjects
with relapsed hematologic malignancies. Co-primary objective is to investigate the
preliminary efficacy of BMS-986016 in combination with nivolumab in subjects with relapsed or
refractory Hodgkin lymphoma (HL), and relapsed or refractory Diffuse Large B Cell lymphoma
(DLBCL)


For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com

Inclusion Criteria:

- For dose escalation monotherapy: CLL, HL, NHL, MM

- For dose expansion monotherapy: CLL, HL, NHL

- For dose escalation and dose expansion in combination with BMS-936558: HL and DLBCL

- Progressed, or been intolerant to, at least one standard treatment regimen

- Not eligible for or declined transplantation or any standard therapy known to be life
prolonging or life saving

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

- At least 1 lesion with measurable disease at baseline

- Availability of an existing tumor biopsy sample (or consent to allow pre-treatment
tumor biopsy if sample not available)

Exclusion Criteria:

- Known or suspected central nervous system (CNS) metastases or with the CNS as the only
site of active disease (controlled CNS metastases are allowed)

- Autoimmune disease

- Encephalitis, meningitis, or uncontrolled seizures in the year prior to informed
consent

- Uncontrolled or significant cardiovascular disease

Other protocol defined inclusion/exclusion criteria could apply
We found this trial at
9
sites
3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Phone: 503-418-2086
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Portland, OR
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4100 John R
Detroit, Michigan 48201
800-527-6266
Phone: 313-576-9376
Barbara Ann Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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Detroit, MI
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Seattle, Washington 98104
(206) 543-2100
Phone: 206-288-2037
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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Seattle, WA
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Baltimore, Maryland 21231
Phone: 410-614-8040
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Baltimore, MD
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Phone: 617-582-8437
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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Houston, Texas 77030
Phone: 713-792-4887
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Houston, TX
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New York, New York 10021
Phone: 212-746-1362
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New York, NY
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Phone: 314-747-7402
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Saint Louis, MO
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Vancouver, British Columbia
Phone: 60487760002738
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Vancouver,
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