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Trial record 2 of 2 for:    Anti-LAG-3 Monoclonal Antibody (BMS-986016) Anti-PD-1 Monoclonal Antibody (Nivolumab, BMS-936558) | Advanced Solid Tumors

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01968109
Recruitment Status : Active, not recruiting
First Posted : October 23, 2013
Last Update Posted : December 3, 2021
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Neoplasms by Site Biological: Relatlimab Biological: Nivolumab Biological: BMS-986213 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1499 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : November 5, 2013
Estimated Primary Completion Date : November 30, 2021
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arm Intervention/treatment
Experimental: Relatlimab
Relatlimab (BMS-986016) specified dose on specified days
Biological: Relatlimab
Other Names:
  • BMS-986016
  • Anti-LAG-3 (Anti-Lymphocyte Activation Gene-3)

Experimental: Relatlimab + Nivolumab
Relatlimab (BMS-986016) + Nivolumab (BMS-936558) specified dose on specified days
Biological: Relatlimab
Other Names:
  • BMS-986016
  • Anti-LAG-3 (Anti-Lymphocyte Activation Gene-3)

Biological: Nivolumab
Other Names:
  • Anti-PD-1 (Anti-Programmed-Death-1)
  • BMS-936558

Experimental: BMS-986213
Relatlimab (BMS-986016) + Nivolumab (BMS-936558)
Biological: BMS-986213
Relatlimab + Nivolumab




Primary Outcome Measures :
  1. Proportion of participants with Adverse Events (AEs) [ Time Frame: Approximately Up to 3 years ]
    Grade 3 or higher per CTCAE v4 (Common Terminology Criteria for Adverse Events)

  2. Proportion of participants with Serious Adverse Events (SAEs) [ Time Frame: Approximately Up to 3 years ]
    Grade 3 or higher per CTCAE v4 ( Common Terminology Criteria for Adverse Events)

  3. Proportion of Deaths [ Time Frame: Approximately Up to 3 years ]
  4. Proportion of participants with laboratory abnormalities in blood [ Time Frame: Approximately Up to 3 years ]
  5. Proportion of participants with laboratory abnormalities in blood serum [ Time Frame: Approximately Up to 3 years ]
  6. Proportion of participants with laboratory abnormalities in urine [ Time Frame: Approximately Up to 3 years ]
  7. Objective response rate (ORR) [ Time Frame: Approximately 3 years ]
  8. Disease control rate (DCR) [ Time Frame: Approximately 3 years ]
  9. Duration of response (DOR) [ Time Frame: Approximately 3 years ]
  10. Number of AEs in the Broad Scope MedDRA Anaphylactic Reaction SMQ [ Time Frame: Approximately 3 years ]
  11. Proportion of participants with AEs leading to discontinuation of treatment [ Time Frame: Approximately up to 3 years ]

Secondary Outcome Measures :
  1. Maximum observed serum concentration (Cmax) of BMS-986016 administered both alone and in combination with nivolumab [ Time Frame: Approximately 2.3 years ]
  2. Time of maximum observed serum concentration (Tmax) of BMS-986016 administered both alone and in combination with nivolumab [ Time Frame: Approximately 2.3 years ]
  3. Trough observed serum concentration (Ctrough) of BMS-986016 administered both alone and in combination with nivolumab [ Time Frame: Approximately 2.3 years ]
  4. Concentration at the end of a dosing interval (Ctau) [Eg: concentration at 336 hours] of BMS-986016 administered both alone and in combination with nivolumab [ Time Frame: Approximately 2.3 years ]
  5. Area under the concentration-time curve in one dosing interval [AUC(TAU)] of BMS-986016 administered both alone and in combination with nivolumab [ Time Frame: Approximately 2.3 years ]
  6. Total body clearance (CLT) of BMS-986016 administered both alone and in combination with nivolumab [ Time Frame: Approximately 2.3 years ]
  7. Volume of distribution at steady state (Vss) of BMS-986016 administered both alone and in combination with nivolumab [ Time Frame: Approximately 2.3 years ]
  8. Effective elimination half-life that explains the degree of area under the concentration-time curve (AUC) accumulation observed (T-HALFeff AUC) of BMS-986016 administered both alone and in combination with nivolumab [ Time Frame: Approximately 2.3 years ]
  9. Effective elimination half-life that explains the degree of Cmax accumulation observed (T-HALFeff Cmax) of BMS-986016 administered both alone and in combination with nivolumab [ Time Frame: Approximately 2.3 years ]
  10. Accumulation index; ratio of AUC(TAU) at steady state to AUC(TAU) after the first dose (AI_AUC) of BMS-986016 administered both alone and in combination with nivolumab [ Time Frame: Approximately 2.3 years ]
  11. Cmax accumulation index; ratio of Cmax at steady state to Cmax after the first dose (AI_Cmax) of BMS-986016 administered both alone and in combination with nivolumab [ Time Frame: Approximately 2.3 years ]
  12. Ctau accumulation index; ratio of Ctau at steady state to Ctau after the first dose (AI_Ctau) of BMS-986016 administered both alone and in combination with nivolumab [ Time Frame: Approximately 2.3 years ]
  13. Degree of fluctuation (DF) or fluctuation index ([Cmax - Ctau]/Css,avg]) of BMS-986016 administered both alone and in combination with nivolumab [ Time Frame: Approximately 2.3 years ]
  14. Immunogenicity measured by anti-drug antibody (ADA) for BMS-986016 (all participants) and nivolumab [ Time Frame: Approximately 2.3 years ]
  15. QTc interval from centrally read electrocardiograms (ECGs) [ Time Frame: Approximately 2.3 years ]
  16. Best overall response (BOR) [ Time Frame: Approximately 3 years ]
  17. ORR [ Time Frame: Approximately 3 years ]
  18. DCR [ Time Frame: Approximately 3 years ]
  19. Duration of response (DOR) [ Time Frame: Approximately 3 years ]
  20. Progression-free survival (PFS) rates [ Time Frame: Up to approximately 3 years ]
  21. Overall survival (OS) [ Time Frame: Approximately 2 years ]
  22. Number of AEs in the Narrow Scope MedDRA Anaphylactic Reaction SMQ [ Time Frame: Approximately 3 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 participants 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

Other protocol defined inclusion/exclusion criteria could apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01968109


Locations
Hide Hide 53 study locations
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United States, California
UCSD Moores Cancer Center
La Jolla, California, United States, 92093-0698
United States, Colorado
University Of Colorado
Aurora, Colorado, United States, 80045
United States, Florida
H Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
United States, Illinois
University Of Chicago Medical Center
Chicago, Illinois, United States, 60637
Advocate Health and Hospitals Corporation
Park Ridge, Illinois, United States, 60068
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Michigan
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, Minnesota
Mayo Clinic - PPDS
Rochester, Minnesota, United States, 55905-0001
United States, Missouri
Washington University School Of Medicine
Saint Louis, Missouri, United States, 63110
United States, New York
Memorial Sloan Kettering Nassau
New York, New York, United States, 10065
United States, Oregon
Providence Portland Med Ctr
Portland, Oregon, United States, 97213
United States, Pennsylvania
Lehigh Valley Hospital and Health Network
Allentown, Pennsylvania, United States, 18103
UPMC Eye and Ear Institute
Pittsburgh, Pennsylvania, United States, 15232-1305
United States, Texas
Baylor Sammons Cancer Center
Dallas, Texas, United States, 75246
Md Anderson Can Cnt
Houston, Texas, United States, 77030-4009
United States, Washington
University Of Washington Cancer Care Alliance
Seattle, Washington, United States, 98109
Australia, New South Wales
Melanoma Institute Australia
North Sydney, New South Wales, Australia, 2060
Australia, Queensland
Gallipoli Medical Research Foundation
Greenslopes, Queensland, Australia, 4120
Tasman Oncology Research Pty Ltd
Southport, Queensland, Australia, 4215
Australia, Victoria
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 3000
Australia, Western Australia
Linear Clinical Research Ltd
Nedlands, Western Australia, Australia, 6009
Austria
Local Institution
Wien, Austria, 1090
Canada, Ontario
Local Institution
Toronto, Ontario, Canada, M5G 2M9
Canada
CHU de Quebec - Universite Laval
Quebec, Canada, G1R 2J6
Denmark
Local Institution
Copenhagen, Denmark, 2100
Local Institution
Herlev, Denmark, 2730
Finland
Local Institution
Helsinki, Finland, 00290
France
Local Institution
Marseille Cedex 5, France, 13385
Local Institution
Nantes Cedex 01, France, 44093
Local Institution
Pierre Benite Cedex, France, 69495
Local Institution
Toulouse Cedex 9, France, 31059
Local Institution
Villejuif, France, 94805
Germany
Local Institution
Essen, Germany, 45122
Local Institution
Heilbronn, Germany, 74078
Local Institution
Wuerzburg, Germany, 97080
Italy
Istituto Europeo Di Oncologia
Milano, Italy, 20141
Istituto Nazionale Tumori Fondazione Pascale
Napoli, Italy, 80131
Istituto Oncologico Veneto - I.R.C.C.S.
Padova, Italy, 35128
Japan
Local Institution
Nagoya-shi, Aichi, Japan, 4668560
Local Institution
Sapporo-shi, Hokkaido, Japan, 0608543
Local Institution
Sunto-gun, Shizuoka, Japan, 4118777
Local Institution
Chuo-ku, Tokyo, Japan, 1040045
Netherlands
Antoni Van Leeuwenhoek Ziekenhuis
Amsterdam, Netherlands, 1066 CX
Norway
Local Institution
Oslo, Norway, 0379
Spain
H. Univ. Vall dHebron
Barcelona, Spain, 08035
Hospital Universitario Virgen De La Victoria
Malaga, Spain, 29010
Clinica Universidad de Navarra
Pamplona, Spain, 31008
Switzerland
Local Institution
Lausanne, Switzerland, 1011
Local Institution
Zuerich, Switzerland, 8091
United Kingdom
University College Hospital
London, Greater London, United Kingdom, NW1 2PG
Royal Marsden Nhs Foundation Trust
London, Greater London, United Kingdom, SW3 6JJ
Christie Hospital Nhs Trust
Manchester, United Kingdom, M20 4BX
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01968109    
Other Study ID Numbers: CA224-020
2014-002605-38 ( EudraCT Number )
First Posted: October 23, 2013    Key Record Dates
Last Update Posted: December 3, 2021
Last Verified: December 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms by Site
Neoplasms
Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action