Transarterial Chemoembolization in Combination With Nivolumab Performed for Intermediate Stage Hepatocellular Carcinoma

Sponsor
AIO-Studien-gGmbH
Study ID
NCT03572582
Phase
PHASE2
Status
Completed

Conditions

  • Carcinoma, Hepatocellular
  • Hepatic Carcinoma
  • Hepatocellular Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    Nivolumab therapy combined with standard TACE treatment
  • TACE — DRUG
    TACE is performed by using drug eluting beads

Study Details

The IMMUTACE study evaluates the safety and the efficacy of the anti-programmed-death-1 antibody (anti-PD-1) nivolumab in combination with transarterial chemoembolization (TACE) in patients with multinodular, intermediate stage hepatocellular carcinoma (HCC) as first line therapy.

Key Dates

Start date
Jun 14, 2018
Status verified
Jul 2023
Primary completion
Oct 12, 2021
Completion
Dec 10, 2021

Study Design

Enrollment
49 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: TACE in combination with nivolumab
    Treatment will be divided into 4-week cycles from the starting date of TACE. The second TACE will be repeated on day 1 (± 4 days) of cycle 3 (after 8 weeks ± 4 days). Nivolumab will be initiated on day 2-3 after the first TACE session. Nivolumab will be administered every two weeks (240mg fixed dose IV) until disease progression for up to two years.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: Observation period max 42 months ]

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