BMS-986012 in Relapsed/Refractory SCLC

Official Title

A Phase 1/2 Multicentre Study of BMS-986012 in Subjects With Relapsed/Refractory Small Cell Lung Cancer

Summary:

The purpose of this study is to determine the safety, tolerability, pharmacokinetics, immunogenicity, antitumour activity and pharmacodynamics of BMS-986012 alone and in combination with nivolumab in patients with relapsed/refractory SCLC.

Trial Description

Primary Outcome:

  • Safety as measured by frequency of worst grade of adverse events (AEs), worst grade of serious adverse events (SAEs), incidence of adverse events leading to discontinuations, and deaths
Secondary Outcome:
  • Maximum observed serum concentration (Cmax) for BMS-986012 (anti-fucosyl-GM1)
  • Maximum observed serum concentration (Cmax) for BMS-986012 (anti-fucosyl-GM1) in combination with Nivolumab
  • Time of maximum observed serum concentration (Tmax) for BMS-986012 (anti-fucosyl-GM1)
  • Time of maximum observed serum concentration (Tmax) for BMS-986012 (anti-fucosyl-GM1) in combination with Nivolumab
  • Observed serum concentration at the end of a dosing interval (Ctau) for BMS-986012 (anti-fucosyl-GM1)
  • Observed serum concentration at the end of a dosing interval (Ctau) for BMS-986012 (anti-fucosyl-GM1) in combination with Nivolumab
  • Area under the serum concentration-time curve from time zero to time t (AUC(0-t)) for BMS-986012 (anti-fucosyl-GM1) in combination with Nivolumab
  • Area under the serum concentration-time curve from time zero to time t (AUC(0-t)) for BMS-986012 (anti-fucosyl-GM1)
  • Area under the serum concentration-time curve in one dosing interval (AUC(TAU)) for BMS-986012 (anti-fucosyl-GM1)
  • Area under the serum concentration-time curve in one dosing interval (AUC(TAU)) for BMS-986012 (anti-fucosyl-GM1) in combination with Nivolumab
  • Best overall response (BOR) for BMS-986012 (anti-fucosyl-GM1)
  • Objective Response Rate (ORR) for BMS-986012 (anti-fucosyl-GM1)
  • Duration of Response for BMS-986012 (anti-fucosyl-GM1)
  • Progression Free Survival (PFS) for BMS-986012 (anti-fucosyl-GM1)
  • Progression Free Survival Rate (PFSR) at week "t"; for BMS-986012 (anti-fucosyl-GM1)
  • Overall Survival (OS) for BMS-986012 (anti-fucosyl-GM1)
  • Overall Survival Rate (OSR) at month "t" for BMS-986012 (anti-fucosyl-GM1)
  • Occurrence of specific anti-drug antibodies (ADA) to BMS-986012 every 3 weeks for first 3 cycles then every 4 cycles, at end of treatment and during clinical follow-up
  • Occurrence of specific anti-drug antibodies (ADA) to BMS-986012 in combination with Nivolumab every 3 weeks for first 3 cycles then every 4 cycles, at end of treatment and during clinical follow-up
  • Changes in the QTcF following administration of BMS-986012 at multiple timepoints during first cycle, then Day 1 of subsequent cycles and at end of treatment
  • Changes in the QTcF following administration of BMS-986012 in combination with Nivolumab at multiple timepoints during first cycle, then Day 1 of subsequent cycles and at end of treatment

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society