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

NCT04823403 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2024-07-26

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • Gustave Roussy, Cancer Campus, Grand Paris

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-13
Primary Completion
2022-11-04
Completion
2024-11-30

Countries

  • France

Study Locations

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Drugs
Diseases

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 NCT04823403 on ClinicalTrials.gov