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

NCT02795429 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2023-07-03

Study results available
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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).

Conditions

Interventions

DRUG

Spartalizumab

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

DRUG

Capmatinib

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-15
Primary Completion
2021-06-01
Completion
2021-06-24
FDA Drug
Yes

Countries

  • Canada
  • China
  • France
  • Germany
  • Hong Kong
  • Italy
  • South Korea
  • Taiwan

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02795429 on ClinicalTrials.gov