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

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

Outcome

Missed primary endpoint

paper The primary endpoint in the phase II study was not met. PMID 38617599 ↗

Publications

Santoro A, Assenat E, Yau T, Delord JP, Maur M, Knox J, Cattan S, Lee KH, Del Conte G, Springfeld C, Leo E, Xyrafas A, Fairchild L, Mardjuadi F, Chan SL. A phase Ib/II trial of capmatinib plus spartalizumab vs. spartalizumab alone in patients with pretreated hepatocellular carcinoma. JHEP Rep. 2024 Jan 28;6(4):101021. doi: 10.1016/j.jhepr.2024.101021. eCollection 2024 Apr.

Drugs

Evaluation	Drug	Modality	Dose	Route
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