Trial results for a combination therapy involving nivolumab, BMS-813160, and GVAX for locally advanced pancreatic ductal adenocarcinomas were posted on ClinicalTrials.gov on 2026-05-11. The study, which enrolled 22 participants, primarily evaluated the safety profile of these agents in various combinations.
Background
Locally advanced pancreatic ductal adenocarcinoma (PDAC) is a challenging malignancy. This trial investigated combination therapies for this condition.
Trial design
This completed Phase 1/2 trial (NCT03767582) enrolled 22 participants with locally advanced pancreatic ductal adenocarcinoma. The study's purpose was to evaluate the safety of combining nivolumab and a CCR2/CCR5 dual antagonist (BMS-813160) with or without GVAX, and to assess if this combination therapy enhances the infiltration of CD8+CD137+ cells in PDACs. The trial included several arms: Phase I Dose Level 1, Phase I Dose Level 2, Phase II Arm A (Nivolumab + BMS-813160), Phase II Arm B (Nivolumab + GVAX + BMS-813160), and Phase II Arm C (Nivolumab + BMS-813160 in Cycle 1, then Nivolumab + GVAX in Cycles 2-5).
Key results
The key results reported focused on Study Drug-related Adverse Events, measured as the count of participants experiencing such events:
- In Phase I - Dose Level 1, 3 participants experienced study drug-related adverse events.
- In Phase I - Dose Level 2, 6 participants experienced study drug-related adverse events.
- In Phase II - Arm A: Nivolumab + BMS-813160, 3 participants experienced study drug-related adverse events.
- In Phase II - Arm B: Nivolumab + GVAX + BMS-813160, 5 participants experienced study drug-related adverse events.
- In Phase II - Arm C: Nivolumab + BMS-813160 (Cycle 1), Nivolumab + GVAX (Cycle 2-5), 2 participants experienced study drug-related adverse events.
- For Phase I - Dose Level 1, 0 participants experienced study drug-related adverse events.
- For Phase I - Dose Level 2, 0 participants experienced study drug-related adverse events.
- For Phase II - Arm A: Nivolumab + BMS-813160, 1 participant experienced study drug-related adverse events.
- For Phase II - Arm B: Nivolumab + GVAX + BMS-813160, 0 participants experienced study drug-related adverse events.
- For Phase II - Arm C: Nivolumab + BMS-813160 (Cycle 1), Nivolumab + GVAX (Cycle 2-5), 0 participants experienced study drug-related adverse events.
- For Phase I - Dose Level 1, 0 participants experienced study drug-related adverse events.
- For Phase I - Dose Level 2, 0 participants experienced study drug-related adverse events.
What this means
The posted results provide initial safety data for the combination of nivolumab, BMS-813160, and GVAX in patients with locally advanced pancreatic ductal adenocarcinoma. The varying counts of participants experiencing study drug-related adverse events across the different arms and dose levels offer preliminary insights into the safety profile of these experimental regimens. As this was a Phase 1/2 study, further research would typically be needed to establish efficacy and a more comprehensive safety profile.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT03767582, titled "Trial of Neoadjuvant and Adjuvant Nivolumab and BMS-813160 With or Without GVAX for Locally Advanced Pancreatic Ductal Adenocarcinomas," were posted on 2026-05-11 on clinicaltrials.gov.