Study of BMS-986315 Alone and in Combination With Nivolumab or Cetuximab in Participants With Advanced Solid Tumours

Official Title

A Phase 1/2 Study of BMS-986315 as Monotherapy and in Combination With Nivolumab or Cetuximab in Participants With Advanced Solid Tumours

Summary:

Study of BMS-986315 alone and in combination with nivolumab or cetuximab in participants with advanced solid tumours

Trial Description

Primary Outcome:

  • Incidence of adverse events (AEs)
  • Incidence of serious adverse events (SAEs)
  • Incidence of adverse events (AEs) meeting protocol-defined DLT (dose-limiting toxicity) criteria
  • Incidence of adverse events (AEs) leading to discontinuation
  • Number of deaths
Secondary Outcome:
  • Objective Response Rate (ORR)
  • Duration of Response (DOR)
  • Progression-Free Survival Rate (PFSR)
  • Maximum observed serum concentration (Cmax) of BMS-986315
  • Maximum observed serum concentration (Cmax) of BMS-986315 with nivolumab
  • Maximum observed serum concentration (Cmax) of BMS-986315 with cetuximab
  • Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of BMS-986315
  • Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of BMS-986315 with nivolumab
  • Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of BMS-986315 with cetuximab
  • Time of maximum observed serum concentration (Tmax) of BMS-986315
  • Time of maximum observed serum concentration (Tmax) of BMS-986315 with nivolumab
  • Time of maximum observed serum concentration (Tmax) of BMS-986315 with cetuximab
  • Incidence of anti-drug antibodies to BMS-986315
  • Incidence of anti-drug antibodies to BMS-986315 with nivolumab
  • Incidence of anti-drug antibodies to BMS-986315 with cetuximab

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