Safety Study of Anti-LAG-3 in Relapsed or Refractory Hematologic Malignancies

Titre officiel

A Phase 1/2a Dose Escalation and Cohort Expansion Study of the Safety, Tolerability, and Efficacy of Anti-LAG-3 (BMS-986016) in Monoclonal Antibody (BMS-986016) Administered Alone and in Combination With Anti-PD-1 Monoclonal Antibody (Nivolumab, BMS-936558) in Relapsed or Refractory B-Cell Malignancies

Sommaire:

Le principal objectif de cette étude est de caractériser l’innocuité, la tolérabilité et la dose tolérée maximale du BMS-986016 administré seul ou en association avec du nivolumab à des sujets présentant une affection maligne hématologique récidivante. L’objectif coprimaire est d’étudier l’efficacité primaire du BMS-986016 en association avec le nivolumab chez des sujets atteints d’un lymphome de Hodgkin et d’un lymphome diffus à grandes cellules B, tous deux réfractaires ou récidivants.

Description de l'essai

Primary Outcome:

  • Proportion of subjects with Adverse Events (AEs)
  • Proportion of subjects with Serious Adverse Events (SAEs)
  • Proportion of Deaths
  • Proportion of subjects with clinical laboratory test abnormalities
  • Objective response rate (ORR)
  • Duration of Response (DOR)
Secondary Outcome:
  • Maximum observed serum concentration (Cmax) of BMS-986016 administered alone and in combination with Nivolumab
  • Time of maximum observed serum concentration (Tmax) of BMS-986016 administered both alone and in combination with Nivolumab
  • Trough observed serum concentration (Ctrough) of BMS-986016 administered both alone and in combination with Nivolumab
  • Concentration at the end of a dosing interval (Ctau) of BMS-986016 administered both alone and in combination with Nivolumab
  • Average concentration over a dosing interval [AUC(TAU)/tau] (Css,avg) of BMS-986016 administered both alone and in combination with Nivolumab
  • Area under the concentration-time curve in one dosing interval (AUC(TAU)) of BMS-986016 administered both alone and in combination with Nivolumab
  • Total body clearance (CLT) of BMS-986016 administered both alone alone and in combination with Nivolumab
  • Volume of distribution at steady state (Vss) of BMS-986016 administered both alone and in combination with Nivolumab
  • Effective elimination half-life that explains the degree of AUC administered alone accumulation observed (T-HALFeff AUC) of BMS-986016 administered both alone and in combination with Nivolumab
  • Effective elimination half-life that explains the degree of Cmax administered alone accumulation observed (T-HALFeff Cmax) of BMS-986016 administered both alone and in combination with Nivolumab
  • Accumulation index; ration 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
  • 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
  • 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
  • Degree of fluctuation or fluctuation index ([Cmax - Ctau]/Css,avg) (DF) of BMS-986016 administered both alone and in combination with Nivolumab
  • Incidence of ADA to nivolumab and BMS-986016
  • Summary of AEs of special interest by

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