Trial results for a Phase Ib/II study (NCT03785873) investigating nivolumab in combination with nanoliposomal-irinotecan, 5-fluorouracil, and leucovorin for patients with advanced biliary tract cancer were posted on ClinicalTrials.gov on 2026-02-13. The study reported a median progression-free survival (PFS) of 4.1 months for the combination therapy.

Background

Nivolumab was investigated in this study as part of a second-line treatment regimen for patients with advanced or metastatic biliary tract cancer who had progressed on first-line systemic therapy. The trial aimed to assess the effectiveness, safety, and tolerability of the drug combination of nivolumab plus nanoliposomal-irinotecan, 5-fluorouracil, and leucovorin.

Trial design

The study (NCT03785873) was a Phase Ib/II trial that enrolled 34 participants with advanced biliary tract cancer. The trial investigated the investigational drug combination of nivolumab plus nanoliposomal-irinotecan, 5-fluorouracil, and leucovorin as a second-line treatment after progression on first-line systemic therapy. The Phase Ib portion focused on dose-limiting toxicities, while the Phase II portion assessed effectiveness, safety, and tolerability.

Key results

The trial results provided insights into the safety and effectiveness of the combination therapy. For the Phase Ib portion, the incidence of dose-limiting toxicities (DLTs) of the drug combination nanoliposomal-irinotecan, 5-fluorouracil, leucovorin and nivolumab was observed in 4 participants. The median progression-free survival (PFS) for the combination therapy was reported as 4.1 months. Incidence of treatment-related adverse events was also measured.

What this means

The reported median PFS of 4.1 months suggests that the combination of nivolumab with nanoliposomal-irinotecan, 5-fluorouracil, and leucovorin may offer a potential second-line treatment option for patients with advanced biliary tract cancer who have progressed on prior therapies. The safety profile, including the incidence of DLTs, will be important for further evaluation of this regimen.

Source

The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT03785873, titled 'Phase Ib/II Trial of Nal-Irinotecan and Nivolumab as Second-Line Treatment in Patients With Advanced Biliary Tract Cancer,' were posted on 2026-02-13 on clinicaltrials.gov.