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Trial record 1 of 2 for:    Anti-LAG-3 Monoclonal Antibody (BMS-986016) Anti-PD-1 Monoclonal Antibody (Nivolumab, BMS-936558) | Advanced Solid Tumors
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Safety Study of BMS-986016 With or Without Nivolumab in Patients With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT02966548
Recruitment Status : Recruiting
First Posted : November 17, 2016
Last Update Posted : August 14, 2018
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 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 : November 28, 2016
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

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




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 ]


Information from the National Library of Medicine

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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


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


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 #.

Locations
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Japan
Local Institution Recruiting
Kashiwa-shi, Chiba, Japan, 2778577
Contact: Site 0001         
Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
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: NCT02966548     History of Changes
Other Study ID Numbers: CA224-034
First Posted: November 17, 2016    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018

Additional relevant MeSH terms:
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Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents