Trial results for a Phase 2 study (NCT04050462) investigating Nivolumab combined with BMS-986253 in patients with hepatocellular carcinoma were posted on ClinicalTrials.gov on 2025-10-16. The combination arm showed an objective response rate (ORR) of 28.57%, compared to 20% for Nivolumab monotherapy.
Background
Nivolumab is an established immunotherapy. This trial explored its efficacy in combination with BMS-986253 for patients with advanced hepatocellular carcinoma (HCC), a primary liver cancer.
Trial design
The Phase 2 clinical trial (NCT04050462) was designed to investigate the efficacy of Nivolumab in combination with BMS-986253 or Cabiralizumab, compared to Nivolumab monotherapy, in patients with advanced hepatocellular carcinoma. The study enrolled 13 participants and was terminated. Interventions included nivolumab 240 mg iv every 2 weeks alone, or in combination with bms-986253 1200 mg iv every 2 weeks, or cabiralizumab 4 mg/kg iv every 2 weeks. The trial aimed to examine if the combinations offered improved radiographic objective response rates (ORR) over Nivolumab monotherapy.
Key results
Results from the terminated Phase 2 trial provided insights into the efficacy of the combination therapy compared to Nivolumab monotherapy:
- For Objective Response Rate (ORR): The Nivolumab Monotherapy group showed an ORR of 20 percentage of participants. The Nivolumab/BMS-986253 Combination group achieved an ORR of 28.57 percentage of participants.
- For Time to Response (TTR): The median TTR was 126 days for Nivolumab Monotherapy and 116 days for the Nivolumab/BMS-986253 Combination.
- For Disease Control Rate (DOR): The Nivolumab Monotherapy group had a DOR of 80 percentage of participants. The Nivolumab/BMS-986253 Combination group had a DOR of 57.14 percentage of participants.
- For Progression Free Survival (PFS): The median PFS was 191 days for Nivolumab Monotherapy and 171 days for the Nivolumab/BMS-986253 Combination.
- For Overall Survival (OS): The median OS was 465 days for Nivolumab Monotherapy and 409 days for the Nivolumab/BMS-986253 Combination.
What this means
The results from this terminated Phase 2 trial suggest a mixed profile for the combination of Nivolumab and BMS-986253 in advanced hepatocellular carcinoma. While the combination demonstrated a numerically higher objective response rate and a faster time to response compared to Nivolumab monotherapy, the monotherapy arm showed better outcomes for disease control rate, progression-free survival, and overall survival. Given the small enrollment of 13 participants and the trial's termination, these findings are exploratory and require further investigation in larger studies to determine the clinical significance of these differences.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT04050462, titled 'Nivolumab Combined With BMS-986253 in HCC Patients,' were posted on 2025-10-16 on clinicaltrials.gov.