NCT03753659

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

IMMULAB - A Phase II Trial of Immunotherapy With Pembrolizumab in Combination With Local Ablation for Patients With Early Stage Hepatocellular Carcinoma (HCC)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The multimodal approach of combining peri-interventional administration of an immune checkpoint inhibitor and local ablation via RFA / MWA / brachytherapy or combination of TACE with RFA, MWA or brachytherapy harbors the potential to satisfy the unmet need for an improvement in the outcomes of HCC patients treated with RFA / MWA/ brachytherapy or combination of TACE with RFA, MWA or brachytherapy. Furthermore, early clinical data indicates that the combination of immune checkpoint inhibition with RFA, MWA or brachytherapy displays an acceptable safety profile, resulting in a positive benefit-risk ratio of this trial.

Conditions

• Hepatocellular Carcinoma (HCC)

Interventions

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

Timeline

• Start date: 2019-05-09
• Primary completion: 2024-04-30
• Completion: 2024-04-30
• First posted: 2018-11-27
• Last updated: 2026-03-23
• Results posted: 2026-03-23

Locations

1 site across 1 country: Germany