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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

INTRODUCTION

  • Org Study ID: CA224-020
  • Secondary ID: 2014-002605-38
  • NTC ID: NCT01968109
  • Sponsor: 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.


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

PRIMARY OUTCOMES

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

Primary Outcome 1 - Timeframe: Approximately Up to 3 years

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

Primary Outcome 2 - Timeframe: Approximately Up to 3 years

Primary Outcome 3 - Measure: Proportion of Deaths

Primary Outcome 3 - Timeframe: Approximately Up to 3 years

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

Primary Outcome 4 - Timeframe: Approximately Up to 3 years

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

Primary Outcome 5 - Timeframe: Approximately 3 years

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

Primary Outcome 6 - Timeframe: Approximately 3 years

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

Primary Outcome 7 - Timeframe: Approximately 3 years

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

Primary Outcome 8 - Timeframe: Approximately 3 years

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

Primary Outcome 9 - Timeframe: Approximately up to 3 years

CONDITION

  • Neoplasms by Site

ELIGIBILITY


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

Gender: All

Minimum Age: N/A

Maximum Age: 12 Years

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Bristol-Myers Squibb

Role: Study Director

Affiliation: Bristol-Myers Squibb

Overall Contact

Name: Bristol-Myers Squibb

Phone: N/A

Email: Clinical.Trials@bms.com

LOCATION

Facility Status Contact
Facility: UCSD Moores Cancer Center
La Jolla, California 92093-0698
United States
Status: Recruiting Contact:
Mina Nikanjam, Site 0043
858-822-0201
Facility: University Of Colorado
Aurora, Colorado 80045
United States
Status: Recruiting Contact:
Karl Lewis, Site 0053
720-848-7135
Facility: H Lee Moffitt Cancer Center and Research Institute
Tampa, Florida 33612
United States
Status: Recruiting Contact:
Nikhil Khushalani, Site 0058
813-745-4398
Facility: University Of Chicago Medical Center
Chicago, Illinois 60637
United States
Status: Recruiting Contact:
Thomas Gajewski, Site 0003
773-702-2085
Facility: Advocate Health and Hospitals Corporation
Niles, Illinois 60714
United States
Status: Recruiting Contact:
Sigrun Hallmeyer, Site 0048
847-410-0658
Facility: Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
Baltimore, Maryland 21205
United States
Status: Recruiting Contact:
Evan Lipson, Site 0004
410-502-9380
Facility: Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United States
Status: Recruiting Contact:
F. Stephen Hodi, Site 0001
617-582-7603
Facility: Karmanos Cancer Institute
Detroit, Michigan 48201
United States
Status: Recruiting Contact:
Amy Weise, Site 0011
313-576-8599
Facility: Mayo Clinic - PPDS
Rochester, Minnesota 55905-0001
United States
Status: Recruiting Contact:
Matthew Block, Site 0051
507-284-4567
Facility: Washington University School Of Medicine
Saint Louis, Missouri 63110
United States
Status: Recruiting Contact:
Leonel Hernandez Aya, Site 0044
314-747-7992
Facility: Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
Status: Recruiting Contact:
Margaret Callahan, Site 0005
646-888-3359
Facility: Providence Portland Med Ctr
Portland, Oregon 97213
United States
Status: Recruiting Contact:
Rachel Sanborn, Site 0002
503-215-5763
Facility: Lehigh Valley Hospital and Health Network
Allentown, Pennsylvania 18103
United States
Status: Recruiting Contact:
Suresh Nair, Site 0047
610-402-1642
Facility: Baylor Sammons Cancer Center
Dallas, Texas 75246
United States
Status: Recruiting Contact:
Charles Cowey, Site 0057
214-370-1000
Facility: Md Anderson Can Cnt
Houston, Texas 77030
United States
Status: Recruiting Contact:
Hussein Tawbi, Site 0045
713-563-9451
Facility: University Of Washington Cancer Care Alliance
Seattle, Washington 98109
United States
Status: Recruiting Contact:
Shailender Bhatia, Site 0008
206-606-6765
Facility: Melanoma Institute Australia
North Sydney, New South Wales 2060
Australia
Status: Recruiting Contact:
Georgina Long, Site 0029
+61299117200
Facility: Gallipoli Medical Research Foundation
Greenslopes, Queensland 4120
Australia
Status: Recruiting Contact:
Victoria Atkinson, Site 0031
+61733947807
Facility: Tasman Oncology Research Pty Ltd
Southport, Queensland 4215
Australia
Status: Recruiting Contact:
Andrew Hill, Site 0039
+61756132484
Facility: Peter MacCallum Cancer Centre
Melbourne, Victoria 3000
Australia
Status: Recruiting Contact:
George Au-Yeung, Site 0033
+61394969802
Facility: Linear Clinical Research Ltd
Nedlands, Western Australia 6009
Australia
Status: Recruiting Contact:
Michael Millward, Site 0032
+61863825122
Facility: Local Institution
Wien, 1090
Austria
Status: Recruiting Contact:
Site 0024

Facility: Local Institution
Wien, 1090
Austria
Status: Recruiting Contact:
Site 0023

Facility: Local Institution
Toronto, Ontario M5G 2M9
Canada
Status: Recruiting Contact:
Site 0049

Facility: CHU de Quebec - Universite Laval
Quebec, G1R 2J6
Canada
Status: Recruiting Contact:
Joel Claveau, Site 0050
4186912950
Facility: Local Institution
Copenhagen, 2100
Denmark
Status: Recruiting Contact:
Site 0028

Facility: Local Institution
Herlev, 2730
Denmark
Status: Recruiting Contact:
Site 0020

Facility: Local Institution
Helsinki, 00029
Finland
Status: Recruiting Contact:
Site 0021

Facility: Local Institution
Marseille Cedex 5, 13385
France
Status: Recruiting Contact:
Site 0038

Facility: Local Institution
Nantes Cedex 01, 44093
France
Status: Recruiting Contact:
Site 0037

Facility: Local Institution
Pierre Benite Cedex, 69495
France
Status: Recruiting Contact:
Site 0036

Facility: Local Institution
Toulouse Cedex 9, 31059
France
Status: Recruiting Contact:
Site 0026

Facility: Local Institution
Villejuif, 94805
France
Status: Recruiting Contact:
Site 0018

Facility: Local Institution
Essen, 45122
Germany
Status: Recruiting Contact:
Site 0007

Facility: Local Institution
Heilbronn, 74078
Germany
Status: Recruiting Contact:
Site 0040

Facility: Local Institution
Wuerzburg, 97080
Germany
Status: Recruiting Contact:
Site 0041

Facility: Istituto Europeo Di Oncologia
Milano, 20141
Italy
Status: Recruiting Contact:
Giuseppe Curigliano, Site 0014
+390257489599
Facility: Istituto Nazionale Tumori Fondazione Pascale
Napoli, 80131
Italy
Status: Recruiting Contact:
Paolo Ascierto, Site 0013
+390815903431
Facility: Istituto Oncologico Veneto - I.R.C.C.S.
Padova, 35128
Italy
Status: Recruiting Contact:
Vanna Chiarion Sileni, Site 0035
+390498215938
Facility: Local Institution
Nagoya-shi, Aichi 4668560
Japan
Status: Recruiting Contact:
Site 0055

Facility: Local Institution
Sapporo-shi, Hokkaido 0608543
Japan
Status: Recruiting Contact:
Site 0059

Facility: Local Institution
Sunto-gun, Shizuoka 4118777
Japan
Status: Recruiting Contact:
Site 0054

Facility: Local Institution
Chuo-ku, Tokyo 1040045
Japan
Status: Recruiting Contact:
Site 0052

Facility: Antoni Van Leeuwenhoek Ziekenhuis
Amsterdam, 1066 CX
Netherlands
Status: Recruiting Contact:
Sofie Wilgenhof, Site 0025
+31020646077
Facility: Local Institution
Oslo, 0379
Norway
Status: Recruiting Contact:
Site 0019

Facility: H. Univ. Vall dHebron
Barcelona, 08035
Spain
Status: Recruiting Contact:
Juan Jesus Martin Liberal, Site 0015
+34934893000
Facility: Hospital Universitario Virgen De La Victoria
Malaga, 29010
Spain
Status: Recruiting Contact:
Jose Manuel Trigo Perez, Site 0046
+34951032338
Facility: Clinica Universidad de Navarra
Pamplona, 31008
Spain
Status: Recruiting Contact:
Ignacio Melero, Site 0006
+34948286397
Facility: Local Institution
Lausanne, 1011
Switzerland
Status: Recruiting Contact:
Site 0017

Facility: Local Institution
Zurich, 8091
Switzerland
Status: Recruiting Contact:
Site 0016

Facility: The Royal Marsden Hospital
London, SW3 6JJ
United Kingdom
Status: Recruiting Contact:
James Larkin, Site 0022
+442073528171
Facility: Christie Hospital
Manchester, M20 4BX
United Kingdom
Status: Recruiting Contact:
Paul Lorigan, Site 0034
+441614446374