CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 10 enrolled
Drug / intervention
Canakinumab injection; spartalizumab, nab-paclitaxel, gemcitabinedrug
Likely dose
Canakinumab injection; spartalizumab, nab-paclitaxel, gemcitabine 250 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04581343
NCT04581343Phase 1Completed
CompareCT.gov

A Phase 1B Study to Determine the Safety and Tolerability and Confirm the Dose of Canakinumab and Spartalizumab in Combination With Nab-paclitaxel and Gemcitabine for Patients With Metastatic Pancreatic Cancer

Pancreatic Cancer Action Network·interventional·Posted Oct 9, 2020·Updated May 4, 2025

In Brief

A Phase 1 clinical trial evaluating Canakinumab injection; spartalizumab, nab-paclitaxel, gemcitabine for Metastatic Pancreatic Ductal Adenocarcinoma. Completed, enrolled 10 participants across 2 sites.

Detailed Summary

This study combines canakinumab (ACZ885), a high-affinity human anti-interleukin-1β (IL-1β) monoclonal antibody (mAb), and spartalizumab (PDR001), a mAb directed against human Programmed Death-1 (PD-1), with the chemotherapy combination of gemcitabine and nab-paclitaxel. This study will confirm for this 4-drug combination the tolerable doses, the acceptable safety profile, and the dose to be used for a Phase II combination treatment regimen.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Pancreatic Ductal Adenocarcinoma
CountriesUnited States
CollaboratorsNovartis Pharmaceuticals

Timeline

Phase 1CompletedFinished
202120222023202420252026
First PostedOct 9, 2020
Enrollment StartNov 2, 2020
Primary CompletionNov 2, 2022
Study CompletionFeb 27, 2023
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 5.7 years ago

Interventions

Canakinumab injection; spartalizumab, nab-paclitaxel, gemcitabinedrug

Canakinumab 250 mg s.c. injection; Spartalizumab 400 mg IV infusion, nab-paclitaxel 125 mg/m2 IV infusion, gemcitabine 1000 mg/m2 IV infusion