Trial results for pembrolizumab (Keytruda) in combination with local ablation for hepatocellular carcinoma (HCC) were posted on ClinicalTrials.gov on 2026-03-23. The Phase 2 IMMULAB study reported an Objective Response Rate (ORR) of 4 participants and a median Recurrence Free Survival (RFS) of 12.4 months.
Background
Hepatocellular carcinoma (HCC) is a primary liver cancer. The IMMULAB trial investigated pembrolizumab, an anti-PD1 antibody, in combination with local ablation for HCC patients.
Trial design
The completed Phase 2 IMMULAB trial (NCT03753659) enrolled 30 participants with Hepatocellular Carcinoma (HCC). This was a multicenter, single-arm, prospective, open-label study investigating peri-interventional treatment with pembrolizumab in combination with local ablation (radiofrequency ablation (RFA), microwave ablation (MWA), or brachytherapy) or combination of TACE with RFA, MWA or brachytherapy. The study did not list specific primary outcome measures in the posted results.
Key results
Key measurements from the trial include:
- Objective Response Rate (ORR) according to RECIST 1.1: 4 Participants.
- Median Time to Recurrence (TTR) according to RECIST 1.1: 16.43 months.
- Median Recurrence Free Survival according to RECIST 1.1: 12.4 months.
- Overall Survival (OS): NA.
- Incidence of Adverse Events: 28 Participants reported at least one adverse event.
What this means
The results from this single-arm Phase 2 trial provide initial data on the clinical activity of pembrolizumab in combination with local ablation for Hepatocellular Carcinoma (HCC). An Objective Response Rate of 4 participants out of 30, along with a median Recurrence Free Survival of 12.4 months, suggests potential benefit for this combination therapy. The observation of adverse events in 28 participants indicates the safety profile of the combination therapy warrants further investigation.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT03753659, titled "IMMULAB - Immunotherapy With Pembrolizumab in Combination With Local Ablation in Hepatocellular Carcinoma (HCC)," were posted on 2026-03-23 on clinicaltrials.gov.