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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01968109
Recruitment Status : Recruiting
First Posted : October 23, 2013
Last Update Posted : November 6, 2018
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)
Estimated Enrollment : 1000 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 : October 14, 2013
Estimated Primary Completion Date : August 28, 2020
Estimated Study Completion Date : December 18, 2020

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 subjects 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 subjects 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 subjects with laboratory abnormalities [ Time Frame: Approximately Up to 3 years ]
  5. Objective response rate (ORR) [ Time Frame: Approximately 3 years ]
  6. Disease control rate (DCR) [ Time Frame: Approximately 3 years ]
  7. Duration of response (DOR) [ Time Frame: Approximately 3 years ]
  8. Proportion of participants with AEs meeting acute safety criteria [ Time Frame: Approximately 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 subjects) 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) [ Time Frame: Approximately 3 years ]
  21. Overall survival (OS) [ Time Frame: Approximately 2 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 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

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


Contacts
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Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.

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Locations
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United States, California
UCSD Moores Cancer Center Recruiting
La Jolla, California, United States, 92093-0698
Contact: Mina Nikanjam, Site 0043    858-822-0201      
United States, Colorado
University Of Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Karl Lewis, Site 0053    720-848-7135      
United States, Florida
H Lee Moffitt Cancer Center and Research Institute Recruiting
Tampa, Florida, United States, 33612
Contact: Nikhil Khushalani, Site 0058    813-745-4398      
United States, Illinois
University Of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
Contact: Thomas Gajewski, Site 0003    773-702-2085      
Advocate Health and Hospitals Corporation Recruiting
Niles, Illinois, United States, 60714
Contact: Sigrun Hallmeyer, Site 0048    847-410-0658      
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21205
Contact: Evan Lipson, Site 0004    410-502-9380      
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: F. Stephen Hodi, Site 0001    617-582-7603      
United States, Michigan
Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Contact: Amy Weise, Site 0011    313-576-8599      
United States, Minnesota
Mayo Clinic - PPDS Recruiting
Rochester, Minnesota, United States, 55905-0001
Contact: Matthew Block, Site 0051    507-284-4567      
United States, Missouri
Washington University School Of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Leonel Hernandez Aya, Site 0044    314-747-7992      
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Margaret Callahan, Site 0005    646-888-3359      
United States, Oregon
Providence Portland Med Ctr Recruiting
Portland, Oregon, United States, 97213
Contact: Rachel Sanborn, Site 0002    503-215-5763      
United States, Pennsylvania
Lehigh Valley Hospital and Health Network Recruiting
Allentown, Pennsylvania, United States, 18103
Contact: Suresh Nair, Site 0047    610-402-1642      
UPMC Eye and Ear Institute Completed
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
Baylor Sammons Cancer Center Recruiting
Dallas, Texas, United States, 75246
Contact: Charles Cowey, Site 0057    214-370-1000      
Md Anderson Can Cnt Recruiting
Houston, Texas, United States, 77030
Contact: Hussein Tawbi, Site 0045    713-563-9451      
United States, Washington
University Of Washington Cancer Care Alliance Recruiting
Seattle, Washington, United States, 98109
Contact: Shailender Bhatia, Site 0008    206-606-6765      
Australia, New South Wales
Local Institution Recruiting
North Sydney, New South Wales, Australia, 2060
Contact: Site 0029         
Australia, Queensland
Local Institution Recruiting
Greenslopes, Queensland, Australia, 4120
Contact: Site 0031         
Local Institution Recruiting
Southport, Queensland, Australia, 4215
Contact: Site 0039         
Australia, Victoria
Local Institution Recruiting
Melbourne, Victoria, Australia, 3000
Contact: Site 0033         
Australia, Western Australia
Local Institution Recruiting
Nedlands, Western Australia, Australia, 6009
Contact: Site 0032         
Austria
Local Institution Recruiting
Wien, Austria, 1090
Contact: Site 0024         
Local Institution Recruiting
Wien, Austria, 1090
Contact: Site 0023         
Canada, Ontario
Local Institution Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Site 0049         
Canada
CHU de Quebec - Universite Laval Recruiting
Quebec, Canada, G1R 2J6
Contact: Joel Claveau, Site 0050    4186912950      
Denmark
Local Institution Recruiting
Copenhagen, Denmark, 2100
Contact: Site 0028         
Local Institution Recruiting
Herlev, Denmark, 2730
Contact: Site 0020         
Finland
Local Institution Recruiting
Helsinki, Finland, 00029
Contact: Site 0021         
France
Local Institution Recruiting
Marseille Cedex 5, France, 13385
Contact: Site 0038         
Local Institution Recruiting
Nantes Cedex 01, France, 44093
Contact: Site 0037         
Local Institution Recruiting
Pierre Benite Cedex, France, 69495
Contact: Site 0036         
Local Institution Recruiting
Toulouse Cedex 9, France, 31059
Contact: Site 0026         
Local Institution Recruiting
Vlllejuif, France, 94800
Contact: Site 0018         
Germany
Local Institution Recruiting
Essen, Germany, 45122
Contact: Site 0007         
Local Institution Recruiting
Heilbronn, Germany, 74078
Contact: Site 0040         
Local Institution Recruiting
Wuerzburg, Germany, 97080
Contact: Site 0041         
Italy
Istituto Europeo Di Oncologia Recruiting
Milano, Italy, 20141
Contact: Giuseppe Curigliano, Site 0014         
Istituto Nazionale Tumori Fondazione Pascale Recruiting
Napoli, Italy, 80131
Contact: Paolo Ascierto, Site 0013         
Istituto Oncologico Veneto - I.R.C.C.S. Recruiting
Padova, Italy, 35128
Contact: Vanna Chiarion Sileni, Site 0035         
Japan
Local Institution Recruiting
Nagoya-shi, Aichi, Japan, 4668560
Contact: Site 0055         
Local Institution Recruiting
Sapporo-shi, Hokkaido, Japan, 0608543
Contact: Site 0059         
Local Institution Recruiting
Sunto-gun, Shizuoka, Japan, 4118777
Contact: Site 0054         
Local Institution Recruiting
Chuo-ku, Tokyo, Japan, 1040045
Contact: Site 0052         
Netherlands
Antoni Van Leeuwenhoek Ziekenhuis Recruiting
Amsterdam, Netherlands, 1066 CX
Contact: Sofie Wilgenhof, Site 0025         
Norway
Local Institution Recruiting
Oslo, Norway, 0379
Contact: Site 0019         
Spain
H. Univ. Vall dHebron Recruiting
Barcelona, Spain, 08035
Contact: Juan Jesus Martin Liberal, Site 0015    +34934893000      
Hospital Universitario Virgen De La Victoria Recruiting
Malaga, Spain, 29010
Contact: Jose Manuel Trigo Perez, Site 0046    +34951032338      
Clinica Universitaria De Navarra Recruiting
Pamplona, Spain, 31008
Contact: Ignacio Melero, Site 0006    +34948286397      
Switzerland
Local Institution Recruiting
Lausanne, Switzerland, 1011
Contact: Site 0017         
Local Institution Recruiting
Zurich, Switzerland, 8091
Contact: Site 0016         
United Kingdom
University College Hospital Recruiting
London, Greater London, United Kingdom, NW1 2PG
Contact: Martin Forster, Site 0027         
The Royal Marsden Hospital Recruiting
London, United Kingdom, SW3 6JJ
Contact: James Larkin, Site 0022         
Christie Hospital Recruiting
Manchester, United Kingdom, M20 4BX
Contact: Paul Lorigan, Site 0034         
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     History of Changes
Other Study ID Numbers: CA224-020
2014-002605-38 ( EudraCT Number )
First Posted: October 23, 2013    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018

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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