Trial results for a Phase 2 study (NCT04891770) investigating nivolumab in combination therapies for chronic hepatitis B were posted on ClinicalTrials.gov on 2025-07-24. The study reported functional cure rates ranging from 0.0% to 2.5% across different nivolumab-containing treatment arms, indicating limited efficacy in achieving this primary endpoint.
Background
The study, titled "Study to Evaluate the Safety and Efficacy of Selgantolimod (SLGN)-Containing Combination Therapies for the Treatment of Chronic Hepatitis B (CHB)," aimed to assess various combination regimens for patients with chronic hepatitis B.
Trial design
The Phase 2 trial (NCT04891770) enrolled 103 participants with chronic hepatitis B. The primary objectives were to evaluate the safety, tolerability, and efficacy of selgantolimod-containing combination therapies. Efficacy was measured by the proportion of participants achieving functional cure, defined as hepatitis B surface antigen (HBsAg) loss and hepatitis B virus (HBV) deoxyribonucleic acid (DNA) below the lower limit of quantitation (LLOQ) at Follow-up Week 24.
The study included several intervention arms:
- Cohort 1: tenofovir alafenamide + vir-2218 + selgantolimod + nivolumab
- Cohort 2 Group A: vir-2218 + selgantolimod + nivolumab
- Cohort 2 Group B: selgantolimod + nivolumab
Key results
The trial evaluated the percentage of participants who achieved functional cure across the different cohorts:
- In Cohort 1 (TAF + VIR-2218 + SLGN + Nivolumab), 2.4% of participants achieved functional cure.
- In Cohort 2 Group A (VIR-2218 + SLGN + Nivolumab), 2.5% of participants achieved functional cure.
- In Cohort 2 Group B (SLGN + Nivolumab), 0.0% of participants achieved functional cure.
For the outcome of "Percentage of Participants With HBsAg Loss With and Without Anti-HBsAg Seroconversion," 0% of participants in all three cohorts (Cohort 1, Cohort 2 Group A, and Cohort 2 Group B) achieved this endpoint.
One key analysis reported a percentage difference of 2.5 (95.0% CI: -2.3 to 7.3), though specific groups for this comparison were not detailed in the available data.
What this means
The results from this Phase 2 trial indicate that the tested nivolumab-containing combination therapies yielded very low functional cure rates in participants with chronic hepatitis B. The highest observed functional cure rate was 2.5%, and no participants achieved HBsAg loss with or without anti-HBsAg seroconversion in any cohort. These findings suggest limited efficacy for these specific combinations in achieving the defined functional cure endpoint for chronic hepatitis B.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT04891770, titled "Study to Evaluate the Safety and Efficacy of Selgantolimod (SLGN)-Containing Combination Therapies for the Treatment of Chronic Hepatitis B (CHB)," were posted on 2025-07-24 on clinicaltrials.gov.