drugset / Trial / NCT02795429

Phase Ib/II Study of INC280 + PDR001 or PDR001 Single Agent in Advanced HCC

NCT02795429

Phase 1/2 Completed 89 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study of capmatinib (INC280) and spartalizumab (PDR001) was to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of spartalizumab administered intravenously (i.v.) as a single agent or in combination with capmatinib administered orally in adult patients with advanced hepatocellular carcinoma (HCC).

Timeline

Start
2016-06-15
Primary completion
2021-06-01
Completion
2021-06-24

Drugs

EvaluationDrugModalityDoseRoute
Subject Capmatinib Small molecule 200 mg Oral
Subject Capmatinib Small molecule 300 mg Oral
Subject Capmatinib Small molecule 400 mg Oral
Subject Spartalizumab Monoclonal antibody 300 mg Intravenous