An Study to Evaluate the Safety and Efficacy of Copanlisib in Combination With Nivolumab in Patients With Advanced Solid Tumours

Titre officiel

An Open-label, Multi-centre, Phase 1b/2 Study to Evaluate the Safety and Efficacy of Copanlisib in Combination With Nivolumab in Patients With Advanced Solid Tumours.

Sommaire:

The purpose of the dose escalation part of this study is to determine the feasibility of using the combination of copanlisib and nivolumab in subjects with advanced solid tumours, and to determine the maximum tolerated dose of copanlisib in combination with nivolumab. The maximum tolerated dose will then be used in Phase 2 (dose expansion) of the study.

Description de l'essai

Primary Outcome:

  • Phase 1b: Frequency of dose limiting toxicities (DLT) at each dose level associated with administration of copanlisib and nivolumab
  • Phase 2: Overall response rate (ORR) as per RECIST v 1.1 (Response evaluation criteria in solid tumours, v 1.1) (by local investigator
Secondary Outcome:
  • Phase 1b: Overall response rate (ORR) as per RECIST v 1.1 (by local investigator assessment)
  • Phase 1b and 2:Maximum drug concentration in plasma (Cmax) of copanlisib
  • Phase 1b and 2:Area under the curve (AUC) of copanlisib
  • Phase 1b and 2: Cmax for nivolumab
  • Phase 1b and 2: Minimum plasma drug concentration (Cmin) for nivolumab
  • Phase 1b and 2: Overall survival (OS)
  • Phase 1b and 2: Progression-free survival (PFS)
  • Phase 1b and 2: Disease control rate (DCR)
  • Phase 1b and 2: Duration of stable disease (DSD)
  • Phase 1b and 2: Time to response (TTR)
  • Phase 1b and 2: Time to progression (TTP)
  • Phase 1b and 2: Duration of response (DOR)
  • Phase 1b and 2:Number of participants with Adverse events (AE) and Serious AEs (SAE)
  • Phase 1b and 2:Number of participants with clinically significantly abnormal changes in electrocardiograms (ECG) including heart rate and measures PR, QRS, QT, and QTc intervals
  • Phase 1b and 2:Number of participants with changes in dose including interruptions, reductions and dose intensity

Voir cet essai sur ClinicalTrials.gov

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