Trial results concerning the safety and tolerability of nivolumab in patients with advanced hepatocellular carcinoma were posted on ClinicalTrials.gov on 2025-12-24. The study, which included various treatment arms and patient cohorts, reported adverse events across all groups, with a maximum of 13 participants experiencing adverse events in one specific treatment arm.
Background
Nivolumab is an immunotherapy agent. This study focused on its use, alone or in combination with other agents, for patients with advanced hepatocellular carcinoma (HCC). The trial's initial phase aimed to establish the safety of nivolumab at different dose levels across various patient populations, including uninfected, hepatitis C virus (HCV)-infected, and hepatitis B virus (HBV)-infected HCC subjects. A later phase was designed to gather additional clinical data and compare nivolumab's efficacy against sorafenib in advanced HCC.
Trial design
This completed Phase 1/2 trial (NCT01658878) enrolled 657 participants with Hepatocellular Carcinoma. The study was designed in two parts: a Dose Escalation Phase to establish the safety of nivolumab at different dose levels, and an Expansion Phase to generate additional clinical data. Interventions included nivolumab, sorafenib, ipilimumab, and cabozantinib, with some cohorts comparing nivolumab to sorafenib.
Key results
The trial results posted focused on the number of participants who experienced adverse events (AEs) across different cohorts and treatment arms. The key measurements for adverse events were as follows:
- Cohort 1 Uninfected HCC: Treatment 1: 1 Participant
- Cohort 1 Uninfected HCC: Treatment 2: 3 Participants
- Cohort 1 Uninfected HCC: Treatment 3: 3 Participants
- Cohort 1 Uninfected HCC: Treatment 4: 3 Participants
- Cohort 1 Uninfected HCC: Treatment 5: 13 Participants
- Cohort 1 HCV Infected: Treatment 6: 3 Participants
- Cohort 1 HCV Infected: Treatment 7: 4 Participants
- Cohort 1 HCV Infected: Treatment 8: 3 Participants
- Cohort 1 HBV Infected: Treatment 9: 5 Participants
- Cohort 1 HBV Infected: Treatment 10: 3 Participants
- Cohort 1 HBV Infected: Treatment 11: 3 Participants
- Cohort 1 HBV Infected: Treatment 12: 4 Participants
What this means
The posted results provide safety data for nivolumab, both as a monotherapy and in combination with other agents, across various populations of patients with advanced hepatocellular carcinoma. The observed counts of participants experiencing adverse events vary across the different treatment cohorts, ranging from 1 to 13 participants. These figures contribute to the overall safety profile understanding for nivolumab in this challenging patient population, informing clinicians and researchers about the frequency of adverse events observed in this study.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT01658878, titled "An Immuno-therapy Study to Evaluate the Effectiveness, Safety and Tolerability of Nivolumab or Nivolumab in Combination With Other Agents in Patients With Advanced Liver Cancer," were posted on 2025-12-24 on clinicaltrials.gov.