drugset
drugset / Trial / NCT04823403

Hepatic Intra-Arterial Administration of Ipilimumab in Combination With Intra-venous Nivolumab for Advanced Hepatocellular Carcinoma

NCT04823403 ↗

Phase 1 Recruiting 27 enrolled Gustave Roussy, Cancer Campus, Grand Paris
NaSingle-groupOpen-labelTreatment

Summary

To determine the Maximum Tolerated Dose (MTD), and the recommended Phase 2 dose of HIA Ipilimumab in combination with IV Nivolumab by monitoring the Dose Limiting Toxicity (DLT) within 1 month after IA Ipilimumab administration in dose-escalation phase.

Timeline

Start
2020-11-13
Primary completion
2022-11-04
Completion
2024-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Ipilimumab Monoclonal antibody 25 mg Other
Subject Ipilimumab Monoclonal antibody 50 mg Other
Subject Ipilimumab Monoclonal antibody 100 mg Other
Subject Ipilimumab Monoclonal antibody 150 mg Other
Subject Nivolumab Monoclonal antibody 1 mg/kg Intravenous

Indications

hepatocellular carcinoma