drugset / Trial / NCT02988440

Study of Safety and Tolerability of PDR001 in Combination With Sorafenib and to Identify the Maximum Tolerated Dose and/or Phase 2 Dose for This Combination in Advanced Hepatocellular Patients

NCT02988440

Phase 1 Completed 20 enrolled Novartis Pharmaceuticals
NaSingle-groupOpen-labelTreatment

Summary

A two part study to determine the maximum tolerated dose and/or recommended phase 2 dose of PDR001 in combination with sorafenib in patients with advanced hepatocellular carcinoma in first line. There will be a dose escalation part and a dose expansion part.

Timeline

Start
2017-04-20
Primary completion
2020-02-27
Completion
2020-02-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Sorafenib Small molecule 400 mg Oral
Subject Spartalizumab Monoclonal antibody 400 mg Intravenous