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BRIEF TITLE: 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

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

Condition:

  • Neoplasms by Site

Eligibility

Criteria:
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
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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:

Phone:

Email: Clinical.Trials@bms.com

Link: FDA Safety Alerts and Recalls

Locations

Facility Status Contact
University Of Colorado
Aurora, Colorado 80045
United States
Recruiting Karl Lewis, Site 0053
720-848-7135
University Of Chicago Medical Center
Chicago, Illinois 60637
United States
Recruiting Thomas Gajewski, Site 0003
773-702-2085
Advocate Health and Hospitals Corporation
Niles, Illinois 60714
United States
Recruiting Sigrun Hallmeyer, Site 0048
847-410-0658
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
Baltimore, Maryland 21205
United States
Recruiting Evan Lipson, Site 0004
410-502-9380
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United States
Recruiting F. Stephen Hodi, Site 0001
617-582-7603
Karmanos Cancer Institute
Detroit, Michigan 48201
United States
Recruiting Amy Weise, Site 0011
313-576-8599
Washington University School Of Medicine
Saint Louis, Missouri 63110
United States
Recruiting Leonel Hernandez Aya, Site 0044
314-747-7992
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
Recruiting Karen Autio, Site 0005
646-888-3359
Providence Portland Med Ctr
Portland, Oregon 97213
United States
Recruiting Rachel Sanborn, Site 0002
503-215-5763
Lehigh Valley Hospital and Health Network
Allentown, Pennsylvania 18103
United States
Recruiting Suresh Nair, Site 0047
610-402-1642
UPMC Eye and Ear Institute
Pittsburgh, Pennsylvania 15213
United States
Recruiting Robert Ferris, Site 0010
412-623-0327
Local Institution
Dallas, Texas 75246
United States
Not yet recruiting Site 0057

Md Anderson Can Cnt
Houston, Texas 77030
United States
Recruiting Wen-Jen Hwu, Site 0045
713-563-9451
University Of Washington Cancer Care Alliance
Seattle, Washington 98109
United States
Recruiting Shailender Bhatia, Site 0008
206-606-6765
Local Institution
North Sydney, New South Wales 2060
Australia
Recruiting Site 0029

Local Institution
Greenslopes, Queensland 4120
Australia
Recruiting Site 0031

Local Institution
Southport, Queensland 4215
Australia
Recruiting Site 0039

Local Institution
Melbourne, Victoria 3000
Australia
Recruiting Site 0033

Local Institution
Nedlands, Western Australia 6009
Australia
Recruiting Site 0032

Local Institution
Wien, 1090
Austria
Recruiting Site 0024

Local Institution
Wien, 1090
Austria
Recruiting Site 0023

Local Institution
Toronto, Ontario M5G 2M9
Canada
Recruiting Site 0049

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

Local Institution
Herlev, 2730
Denmark
Recruiting Site 0020

Local Institution
Helsinki, 00029
Finland
Recruiting Site 0021

Local Institution
Marseille Cedex 5, 13385
France
Recruiting Site 0038

Local Institution
Nantes Cedex 01, 44093
France
Recruiting Site 0037

Local Institution
Pierre Benite Cedex, 69495
France
Recruiting Site 0036

Local Institution
Toulouse Cedex 9, 31059
France
Recruiting Site 0026

Local Institution
Vlllejuif, 94800
France
Recruiting Site 0018

Local Institution
Essen, 45122
Germany
Recruiting Site 0007

Westdeutsches Tumorzentrum
Essen, 45122
Germany
Recruiting Sebastian Bauer, Site 0007

Local Institution
Heilbronn, 74078
Germany
Recruiting Site 0040

Local Institution
Wuerzburg, 97080
Germany
Recruiting Site 0041

Istituto Europeo Di Oncologia
Milano, 20141
Italy
Recruiting Giuseppe Curigliano, Site 0014

Local Institution
Napoli, 80131
Italy
Recruiting Site 0013

Istituto Oncologico Veneto - I.R.C.C.S.
Padova, 35128
Italy
Recruiting Vanna Chiarion Sileni, Site 0035

Local Institution
Nagoya-shi, Aichi 4668560
Japan
Recruiting Site 0055

Local Institution
Sunto-gun, Shizuoka 4118777
Japan
Recruiting Site 0054

Local Institution
Chuo-ku, Tokyo 1040045
Japan
Recruiting Site 0052

Antoni Van Leeuwenhoek Ziekenhuis
Amsterdam, 1066 CX
Netherlands
Recruiting J.H.M Schellens, Site 0025

Local Institution
Oslo, 0379
Norway
Recruiting Site 0019

Local Institution
Barcelona, 08035
Spain
Recruiting Site 0015

Local Institution
Malaga, 29010
Spain
Recruiting Site 0046

Local Institution
Pamplona, 31008
Spain
Recruiting Site 0006

Local Institution
Lausanne, 1011
Switzerland
Recruiting Site 0017

Local Institution
Zurich, 8091
Switzerland
Recruiting Site 0016

University College Hospital
London, Greater London NW1 2PG
United Kingdom
Recruiting Martin Forster, Site 0027

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