An Investigational Immuno-therapy Study to Assess the Safety, Tolerability and Effectiveness of Anti-LAG-3 With and Without Anti-PD-1 in the Treatment of Solid Tumors



Status:Recruiting
Healthy:No
Age Range:12 - Any
Updated:11/8/2018
Start Date:October 14, 2013
End Date:December 18, 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 I/2a Dose Escalation and Cohort Expansion Study of the Safety, Tolerability, and Efficacy of Anti-LAG-3 Monoclonal Antibody (BMS-986016) Administered Alone and in Combination With Anti-PD-1 Monoclonal Antibody (Nivolumab, BMS-936558) in Advanced Solid Tumors

The purpose of the study is to assess the safety, tolerability and effectiveness of
experimental medication BMS-986016 administered alone and in combination with nivolumab in
patients with solid tumors that have spread and/or cannot be removed by surgery.

The following tumor types are included in this study:

Non-Small Cell Lung Cancer (NSCLC), gastric cancer, hepatocellular carcinoma, renal cell
carcinoma, bladder cancer, squamous cell carcinoma of the head and neck, and melanoma, that
have NOT previously been treated with immunotherapy. NSCLC and melanoma that HAVE previously
been treated with immunotherapy.


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

Inclusion Criteria:

- For Dose escalation: subjects with cervical, ovarian, bladder and colorectal cancer
(CRC), head and neck, gastric and hepatocellular cancer naive to immuno-oncology
agents; 1st line melanoma and 1st line/2nd line NSCLC; Renal Cell Carcinoma naive to
IO; NSCLC progressing while on or after therapy with anti-PD1/anti-PDL-1 and melanoma
subjects progressed while-on or after treatment with anti-PD1 or anti-PDL1 with or
without anti-CTLA-4.

- For Dose Expansion: all of the above in escalation except for cervical, ovarian, and
CRC

- Progressed, or been intolerant to, at least one standard treatment regimen, except for
subjects in 1st line cohorts.

- ECOG performance status between 0 and 2

- At least 1 lesion with measurable disease at baseline

- Availability of an existing tumor biopsy sample (and consent to allow pre-treatment
tumor biopsy)

Exclusion Criteria:

- Primary central nervous system (CNS) tumors or solid tumors with CNS metastases as the
only site of active disease

- Autoimmune disease

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

- Uncontrolled CNS metastases
We found this trial at
18
sites
Allentown, Pennsylvania 18103
Phone: 610-402-1642
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Baltimore, Maryland 21231
410-955-6190
Phone: 410-502-9380
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins The name Johns Hopkins has become synonymous...
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4805 Northeast Glisan Street
Portland, Oregon 97213
(503) 215-1111
Phone: 503-215-5763
Providence Portland Medical Center We strive to give those we serve exceptional, compassionate health care...
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Portland, OR
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12902 USF Magnolia Dr
Tampa, Florida 33612
(888) 663-3488
Phone: 813-745-4398
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
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Aurora, Colorado 80045
Phone: 720-848-7135
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Phone: 617-582-7603
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
Phone: 773-702-2085
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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Dallas, Texas 75246
Phone: 214-370-1000
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Detroit, Michigan 48201
Phone: 313-576-8599
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Houston, Texas 77030
Phone: 713-563-9451
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La Jolla, California 92093
Phone: 858-822-0201
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1275 York Ave
New York, New York 10021
(212) 639-2000
Phone: 646-888-3359
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Niles, Illinois 60714
Phone: 847-410-0658
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116 Pacific Highway
North Sydney, New South Wales 2060
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Pittsburgh, Pennsylvania 15213
Phone: 412-623-0327
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200 1st Street Southwest
Rochester, Minnesota 55905
Phone: 507-284-4567
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Phone: 314-747-7992
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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825 Eastlake Avenue East
Seattle, Washington 98109
Phone: 206-606-6765
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