CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 89 enrolled
Drug / intervention
Spartalizumab +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02795429
NCT02795429Phase 2Completed
CompareCT.gov

A Phase Ib/II, Open-label, Multi-center Study of INC280 in Combination With PDR001 or PDR001 Single Agent in Advanced Hepatocellular Carcinoma.

Novartis Pharmaceuticals·interventional·Posted Jun 10, 2016·Updated Jul 3, 2023

In Brief

A Phase 2 clinical trial evaluating Spartalizumab and Capmatinib for Advanced Hepatocellular Carcinoma. Completed, enrolled 89 participants across 17 sites in 8 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Hepatocellular Carcinoma
CountriesCanada, China, France, Germany, Hong Kong, Italy, South Korea, Taiwan
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedJun 10, 2016
Enrollment StartJun 15, 2016
Primary CompletionJun 1, 2021
Study CompletionJun 24, 2021
TodayJul 2, 2026
Enrollment to primary: 5.0 yearsPosted 10.1 years ago

Interventions

Spartalizumabdrug

Spartalizumab administered via intravenous (i.v.) infusion once every 3 weeks (Q3W)

Capmatinibdrug

Capmatinib administered orally as a tablet on a continuous twice daily (BID) dosing schedule