An Investigational Immuno-therapy Study to Evaluate the Safety and Effectiveness of Experimental Medication BMS-986207 by Itself and in Combination With Nivolumab in Solid Cancers That Are Advanced or Have Spread

Titre officiel

Phase 1/2a First-In-Human Study of BMS-986207 Monoclonal Antibody Alone and in Combination With Nivolumab in Advanced Solid Tumours

Sommaire:

Une étude visant à évaluer l’innocuité et la tolérabilité de l’anticorps monoclonal BMS-986207 en monothérapie ou en association avec le nivolumab dans le traitement de cancers avancés (tumeur solide).

Description de l'essai

Primary Outcome:

  • Incidence of adverse events of BMS-986207
  • Incidence of adverse events of nivolumab (BMS-936558) and BMS-986207 when given in combination
  • Incidence of clinically significant abnormalities in general laboratory tests of BMS-986207
  • Incidence of clinically significant abnormalities in general laboratory tests of nivolumab(BMS-936558) and BMS-986207 when given in combination
Secondary Outcome:
  • Best Overall Response (BOR)
  • Objective Response Rate (ORR)
  • median Duration of Response (mDOR)
  • Progression Free Survival Rate (PFSR)
  • Maximum observed plasma concentration (Cmax) of BMS-986207
  • Time of maximum observed plasma concentration (Tmax) of BMS-986207
  • Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-t)] of BMS-986207
  • Trough observed plasma concentration (Ctrough) of BMS-986207
  • Area under the concentration-time curve in one dosing interval [AUC(tau)] of BMS-986207
  • Total body clearance (CLT) of BMS-986207
  • Observed concentration at the end of a dosing interval (Ctau) of BMS-986207
  • Effective elimination half-life (T-HALFeff) of BMS-986207
  • Accumulation Index (AI) of BMS-986207
  • Average concentration of BMS-986207 over a dosing interval
  • Immunogenicity measured by the occurrence of anti-drug antibody after the administration of BMS-986207
  • Immunogenicity measured by the occurrence of anti-drug antibody after the administration of BMS-986207 in combination with nivolumab (BMS-936558)
  • Tumour infiltrating lymphocyte (TIL) evaluations for BMS-986207
  • Serum cytokines profiling for BMS-986207
  • Serum proteome analysis for BMS-986207
  • Flow-cytometry evaluation of circulating immune cell subsets for BMS-986207
  • Tumour-specific immune cells for BMS-986207
  • Tumour infiltrating lymphocyte (TIL) evaluations for BMS-986207 in combination with nivolumab (BMS-936558)
  • Serum cytokines profiling for BMS-986207 in combination with nivolumab (BMS-936558)
  • Serum proteome analysis for BMS-986207 in combination with nivolumab(BMS-936558)
  • Flow-cytometry evaluation of circulating immune cell subsets for BMS-986207 in combination with nivolumab (BMS-936558)
  • Tumour-specific immune cells for BMS-986207 in combination with nivolumab(BMS-936558)

Voir cet essai sur ClinicalTrials.gov

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