IMMULAB - Immunotherapy With Pembrolizumab in Combination With Local Ablation in Hepatocellular Carcinoma (HCC)

Sponsor
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Study ID
NCT03753659
Phase
PHASE2
Status
Completed

Conditions

  • Hepatocellular Carcinoma (HCC)

Eligibility Criteria

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

Interventions

  • Pembrolizumab — DRUG
    IV infusion
  • Radio Frequency Ablation (RFA) — PROCEDURE
    Local ablation via RFA will be performed via ultrasound- or CT-guided placement of a needle electrode / probe penetrating into the lesion center
  • Microwave Ablation (MWA) — PROCEDURE
    Local ablation via MWA will be performed via ultrasound- or CT-guided placement of a needle electrode / probe penetrating into the lesion center
  • Brachytherapy — RADIATION
    Local ablation via brachythwerapy will be performed via ultrasound- or CT-guided placement of a needle electrode / probe penetrating into the lesion center
  • Transarterial Chemoembolisation (TACE) — DRUG
    According to Investigator's choice, TACE using drug eluting beads can be performed combined with RFA, MWA or brachytherapy

Study Details

This is a multicenter, single arm, prospective, open-label phase II trial investigating the clinical activity of peri-interventional treatment with the anti-PD1 antibody pembrolizumab in HCC patients who are candidates for local ablation via either radiofrequency ablation (RFA) or microwave ablation (MWA) or brachytherapy or combination of TACE with RFA, MWA or brachytherapy.

Key Dates

Start date
May 9, 2019
Status verified
Mar 2026
Primary completion
Apr 30, 2024
Completion
Apr 30, 2024

Study Design

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

Arms

  • Experimental: Pembrolizumab with local ablation
    * Pembrolizumab 200mg IV Q3W on day 1 of cycle 1 and 2 * Radio Frequency Ablation (RFA) / Microwave Ablation (MWA) / brachytherapy or combination of TACE with RFA, MWA or brachytherapy will be performed on day 1 of cycle 3 * Pembrolizumab 200mg IV administration 2 days after local ablation * Pembrolizumab 200mg IV Q3W for up to 12 months total treatment duration

Primary Outcome Measure

Objective Response Rate (ORR) According to RECIST 1.1 [ Time Frame: After 6 weeks (2 cycles) of treatment ]

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