Clinical Trials /

Safety Study of BMS-986016 With or Without Nivolumab in Patients With Advanced Solid Tumors

NCT02966548

Description:

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.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Safety Study of BMS-986016 With or Without Nivolumab in Patients With Advanced Solid Tumors
  • 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

Clinical Trial IDs

  • ORG STUDY ID: CA224-034
  • NCT ID: NCT02966548

Conditions

  • Cancer

Interventions

DrugSynonymsArms
RelatlimabBMS-986016Combination Therapy
NivolumabBMS-936558, OpdivoCombination Therapy

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
MonotherapyExperimentalRelatlimab (BMS-986016) administered every 2 weeks as a single agent intravenous formulation
  • Relatlimab
Combination TherapyExperimentalRelatlimab (BMS-986016) will be administered in combination with Nivolumab every 2 weeks or every 4 weeks as an intravenous formulation
  • Relatlimab
  • Nivolumab

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:20 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of adverse events (AE)
Time Frame:Approximately 2.2 years
Safety Issue:
Description:

Secondary Outcome Measures

Measure: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
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Bristol-Myers Squibb

Last Updated

August 4, 2020