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

PHASE1RecruitingINTERVENTIONAL
Enrollment

27

Participants

Timeline

Start Date

November 13, 2020

Primary Completion Date

November 4, 2022

Study Completion Date

November 30, 2024

Conditions
Hepatocellular Carcinoma
Interventions
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)"

Trial Locations (1)

94800

RECRUITING

Gustave Roussy, Villejuif

All Listed Sponsors
lead

Gustave Roussy, Cancer Campus, Grand Paris

OTHER