We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety Study of BMS-986016 With or Without Nivolumab in Patients With Advanced 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: NCT02966548
Recruitment Status : Active, not recruiting
First Posted : November 17, 2016
Last Update Posted : January 11, 2023
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This study will be used to determine the safety and tolerability of BMS-986016 administered alone and in combination with Nivolumab in subjects with advanced solid tumors.

Condition or disease Intervention/treatment Phase
Cancer Drug: Relatlimab Drug: Nivolumab Phase 1

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 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 : January 4, 2017
Estimated Primary Completion Date : September 8, 2023
Estimated Study Completion Date : September 8, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Monotherapy
Relatlimab (BMS-986016) administered every 2 weeks as a single agent intravenous formulation
 Drug: Relatlimab
Specified dose on specified days
Other Name: BMS-986016
Experimental: Combination Therapy
Relatlimab (BMS-986016) will be administered in combination with Nivolumab every 2 weeks or every 4 weeks as an intravenous formulation
 Drug: Relatlimab
Specified dose on specified days
Other Name: BMS-986016

Drug: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Number of adverse events (AE) [ Time Frame: Approximately 2.2 years ]
  2. Number of serious adverse events (SAE) [ Time Frame: Approximately 2.2 years ]
  3. Number of deaths [ Time Frame: Approximately 2.2 years ]
  4. Number of laboratory abnormalities [ Time Frame: Approximately 2.2 years ]

Secondary Outcome Measures :
  1. Maximum observed serum concentration (Cmax) of BMS-986016 [ Time Frame: Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up ]
  2. Time of maximum observed serum concentration (Tmax) of BMS-986016 [ Time Frame: Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up ]
  3. Trough observed serum concentration (Ctrough) of BMS-986016 [ Time Frame: Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up ]
  4. Concentration at the end of a dosing interval (Ctau) of BMS-986016 [ Time Frame: Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up ]
  5. Average concentration over a dosing interval [AUC(TAU)/tau] (Css,avg) of BMS-986016 [ Time Frame: Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up ]
  6. Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] of BMS-986016 [ Time Frame: Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up ]
  7. Total body clearance (CLT) of BMS-986016 [ Time Frame: Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up ]
  8. Volume of distribution at steady state (Vss) of BMS-986016 [ Time Frame: Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up ]
  9. Effective elimination half-life (T-HALFeff) that explains the degree of AUC accumulation observed (T-HALFeff AUC) of BMS-986016 [ Time Frame: Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up ]
  10. Effective elimination half-life that explains the degree of Cmax accumulation observed (T-HALFeff Cmax) of BMS-986016 [ Time Frame: Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up ]
  11. Accumulation index; ration of AUC(TAU) at steady state to AUC(TAU) after the first dose (AI_AUC) of BMS-986016 [ Time Frame: Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up ]
  12. Cmax accumulation index; ratio of Cmax at steady state to Cmax after the first dose (AI_Cmax) of BMS-986016 [ Time Frame: Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up ]
  13. Ctau accumulation index; ratio of Ctau at steady state to Ctau after the first dose (AI_Ctau) of BMS-986016 [ Time Frame: Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up ]
  14. Degree of fluctuation or fluctuation index ([Cmax - Ctau]/Css,avg) (DF) of BMS-986016 [ Time Frame: Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up ]
  15. Best overall response (BOR) [ Time Frame: Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up ]
  16. Duration of response (DOR) [ Time Frame: Cycle 1, 2, 3, 4, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up ]
  17. Frequency of positive anti-drug antibody (ADA) to BMS-986016 [ Time Frame: Cycle 1, 2, 3, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up ]
  18. Frequency of positive anti-drug antibody (ADA) to Nivolumab [ Time Frame: Cycle 1, 2, 3, 5, 9, 13, 17, 21 (28 days/cycle), 60-day follow-up, 135-day follow-up ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Must have histologic or cytologic confirmation of an incurable solid malignancy that is advanced (metastatic and/or unresectable)
  • Must have received, and then progressed or been intolerant to, standard treatment regimen in the advanced or metastatic setting, if such a therapy exists
  • Presence of at least one lesion with measurable disease as defined by RECIST v1.1 criteria for response assessment
  • Males and Females, ages 20 years or older, inclusive

Exclusion Criteria:

  • Known or suspected CNS (central nervous system) metastases or with the CNS as the only site of active disease
  • Other concomitant malignancies (with some exceptions per protocol)
  • Any active autoimmune disease or history of known or suspected autoimmune disease
  • History of uncontrolled or significant cardiovascular disease

Other protocol defined inclusion/exclusion criteria could apply

Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT02966548


Locations
Layout table for location information
Japan
Local Institution - 0001
Kashiwa-shi, Chiba, Japan, 2778577
Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
Investigators
Layout table for investigator information
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02966548    
Other Study ID Numbers: CA224-034
First Posted: November 17, 2016    Key Record Dates
Last Update Posted: January 11, 2023
Last Verified: January 2023
Additional relevant MeSH terms:
Layout table for MeSH terms
Nivolumab
Relatlimab
Antineoplastic Agents, Immunological
 Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action