NCT04823403

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

A Phase I Study Evaluating Safety and Efficacy of Hepatic Intra-Arterial Administration of Ipilimumab in Combination With Intra-venous Nivolumab for Advanced Hepatocellular Carcinoma

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (estimated)
• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Nivolumab	Intravenous Nivolumab (1mg/kg) will be given every 6 weeks for a maximal period of 6 months within the study.
DRUG	Ipilimumab	Ipilimumab, single intra-arterial (IA) injection per patient, at 3 dose-levels\*. * (D1) Starting dose : 50 mg; n=3 to 6 * (D2) 2nd dose-level : 100 mg; n=3 to 6 * (D3) Maximal tested dose : 150mg; n=3 to 6 (if no limiting toxicities) \*Dose level (D-1) : 25 mg will be tested if de-escalation is needed at D1 (\>1/3 DLT at D1)

Timeline

• Start date: 2020-11-13
• Primary completion: 2022-11-04
• Completion: 2024-11-01
• First posted: 2021-03-30
• Last updated: 2024-07-26

Locations

1 site across 1 country: France