drugset / Trial / NCT02900664

A Study of PDR001 in Combination With CJM112, EGF816, Ilaris® (Canakinumab) or Mekinist® (Trametinib)

NCT02900664

Phase 1 Completed 283 enrolled Novartis Pharmaceuticals
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study was to combine the PDR001 checkpoint inhibitor with each of four agents with immunomodulatory activity to identify the doses and schedule for combination therapy and to preliminarily assess the safety, tolerability, pharmacological and clinical activity of these combinations.

Timeline

Start
2016-08-23
Primary completion
2021-03-17
Completion
2021-03-17

Drugs

EvaluationDrugModalityDoseRoute
Subject CJM112 Monoclonal antibody 25 mg Intravenous
Subject CJM112 Monoclonal antibody 75 mg Intravenous
Subject CJM112 Monoclonal antibody 225 mg Intravenous
Subject CJM112 Monoclonal antibody 450 mg Intravenous
Subject CJM112 Monoclonal antibody 900 mg Intravenous
Subject CJM112 Monoclonal antibody 1200 mg Intravenous
Subject Canakinumab Monoclonal antibody 100 mg
Subject Canakinumab Monoclonal antibody 300 mg
Subject Nazartinib Small molecule 25 mg
Subject Nazartinib Small molecule 50 mg
Subject Spartalizumab Monoclonal antibody Intravenous
Subject Trametinib Small molecule 0.5 mg
Subject Trametinib Small molecule 1 mg
Subject Trametinib Small molecule 1.5 mg