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BRIEF TITLE: 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

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

  • Org Study ID: CA224-020
  • Secondary ID: 2014-002605-38
  • NCT ID: NCT01968109
  • NCT Alias:
  • Sponsor: Bristol-Myers Squibb - Industry
  • Source: Bristol-Myers Squibb

Brief Summary

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.

Overal Status Start Date Phase Study Type
Recruiting October 14, 2013 Phase 1/Phase 2 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Proportion of subjects with Adverse Events (AEs)

Primary Outcome 1 - Time Frame: Approximately Up to 3 years

Primary Outcome 2 - Measure: Proportion of subjects with Serious Adverse Events (SAEs)

Primary Outcome 2 - Time Frame: Approximately Up to 3 years

Primary Outcome 3 - Measure: Proportion of Deaths

Primary Outcome 3 - Time Frame: Approximately Up to 3 years

Primary Outcome 4 - Measure: Proportion of subjects with laboratory abnormalities

Primary Outcome 4 - Time Frame: Approximately Up to 3 years

Primary Outcome 5 - Measure: Objective response rate (ORR)

Primary Outcome 5 - Time Frame: Approximately 3 years

Primary Outcome 6 - Measure: Disease control rate (DCR)

Primary Outcome 6 - Time Frame: Approximately 3 years

Primary Outcome 7 - Measure: Duration of response (DOR)

Primary Outcome 7 - Time Frame: Approximately 3 years

Primary Outcome 8 - Measure: Proportion of participants with AEs meeting acute safety criteria

Primary Outcome 8 - Time Frame: Approximately 3 years

Primary Outcome 9 - Measure: Proportion of subjects with AEs leading to discontinuation of treatment

Primary Outcome 9 - Time Frame: Approximately up to 3 years


  • Neoplasms by Site


For more information regarding BMS clinical trial participation, please visit

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

- 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

- Uncontrolled CNS metastases
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Gender: All

Minimum Age: 12 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Bristol-Myers Squibb

Role: Study Director

Affiliation: Bristol-Myers Squibb

Overall Contact

Name: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email:



Link: BMS Clinical Trial Information


Facility Status Contact
UCSD Moores Cancer Center
La Jolla, California 92093-0698
United States
Recruiting Mina Nikanjam, Site 0043
University Of Colorado
Aurora, Colorado 80045
United States
Recruiting Karl Lewis, Site 0053
H Lee Moffitt Cancer Center and Research Institute
Tampa, Florida 33612
United States
Recruiting Nikhil Khushalani, Site 0058
University Of Chicago Medical Center
Chicago, Illinois 60637
United States
Recruiting Thomas Gajewski, Site 0003
Advocate Health and Hospitals Corporation
Niles, Illinois 60714
United States
Recruiting Sigrun Hallmeyer, Site 0048
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
Baltimore, Maryland 21205
United States
Recruiting Evan Lipson, Site 0004
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United States
Recruiting F. Stephen Hodi, Site 0001
Karmanos Cancer Institute
Detroit, Michigan 48201
United States
Recruiting Amy Weise, Site 0011
Mayo Clinic - PPDS
Rochester, Minnesota 55905-0001
United States
Recruiting Matthew Block, Site 0051
Washington University School Of Medicine
Saint Louis, Missouri 63110
United States
Recruiting Leonel Hernandez Aya, Site 0044
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
Recruiting Margaret Callahan, Site 0005
Providence Portland Med Ctr
Portland, Oregon 97213
United States
Recruiting Rachel Sanborn, Site 0002
Lehigh Valley Hospital and Health Network
Allentown, Pennsylvania 18103
United States
Recruiting Suresh Nair, Site 0047
UPMC Eye and Ear Institute
Pittsburgh, Pennsylvania 15213
United States
Baylor Sammons Cancer Center
Dallas, Texas 75246
United States
Recruiting Charles Cowey, Site 0057
Md Anderson Can Cnt
Houston, Texas 77030
United States
Recruiting Hussein Tawbi, Site 0045
University Of Washington Cancer Care Alliance
Seattle, Washington 98109
United States
Recruiting Shailender Bhatia, Site 0008
Melanoma Institute Australia
North Sydney, New South Wales 2060
Recruiting Georgina Long, Site 0029
Gallipoli Medical Research Foundation
Greenslopes, Queensland 4120
Recruiting Victoria Atkinson, Site 0031
Tasman Oncology Research Pty Ltd
Southport, Queensland 4215
Recruiting Andrew Hill, Site 0039
Peter MacCallum Cancer Centre
Melbourne, Victoria 3000
Recruiting George Au-Yeung, Site 0033
Linear Clinical Research Ltd
Nedlands, Western Australia 6009
Recruiting Michael Millward, Site 0032
Local Institution
Wien, 1090
Recruiting Site 0024

Local Institution
Wien, 1090
Recruiting Site 0023

Local Institution
Toronto, Ontario M5G 2M9
Recruiting Site 0049

CHU de Quebec - Universite Laval
Quebec, G1R 2J6
Recruiting Joel Claveau, Site 0050
Local Institution
Copenhagen, 2100
Recruiting Site 0028

Local Institution
Herlev, 2730
Recruiting Site 0020

Local Institution
Helsinki, 00029
Recruiting Site 0021

Local Institution
Marseille Cedex 5, 13385
Recruiting Site 0038

Local Institution
Nantes Cedex 01, 44093
Recruiting Site 0037

Local Institution
Pierre Benite Cedex, 69495
Recruiting Site 0036

Local Institution
Toulouse Cedex 9, 31059
Recruiting Site 0026

Local Institution
Villejuif, 94805
Recruiting Site 0018

Local Institution
Essen, 45122
Recruiting Site 0007

Local Institution
Heilbronn, 74078
Recruiting Site 0040

Local Institution
Wuerzburg, 97080
Recruiting Site 0041

Istituto Europeo Di Oncologia
Milano, 20141
Recruiting Giuseppe Curigliano, Site 0014
Istituto Nazionale Tumori Fondazione Pascale
Napoli, 80131
Recruiting Paolo Ascierto, Site 0013
Istituto Oncologico Veneto - I.R.C.C.S.
Padova, 35128
Recruiting Vanna Chiarion Sileni, Site 0035
Local Institution
Nagoya-shi, Aichi 4668560
Recruiting Site 0055

Local Institution
Sapporo-shi, Hokkaido 0608543
Recruiting Site 0059

Local Institution
Sunto-gun, Shizuoka 4118777
Recruiting Site 0054

Local Institution
Chuo-ku, Tokyo 1040045
Recruiting Site 0052

Antoni Van Leeuwenhoek Ziekenhuis
Amsterdam, 1066 CX
Recruiting Sofie Wilgenhof, Site 0025
Local Institution
Oslo, 0379
Recruiting Site 0019

H. Univ. Vall dHebron
Barcelona, 08035
Recruiting Juan Jesus Martin Liberal, Site 0015
Hospital Universitario Virgen De La Victoria
Malaga, 29010
Recruiting Jose Manuel Trigo Perez, Site 0046
Clinica Universidad de Navarra
Pamplona, 31008
Recruiting Ignacio Melero, Site 0006
Local Institution
Lausanne, 1011
Recruiting Site 0017

Local Institution
Zurich, 8091
Recruiting Site 0016

University College Hospital
London, Greater London NW1 2PG
United Kingdom
Active, not recruiting
The Royal Marsden Hospital
London, SW3 6JJ
United Kingdom
Recruiting James Larkin, Site 0022
Christie Hospital
Manchester, M20 4BX
United Kingdom
Recruiting Paul Lorigan, Site 0034