At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 129 enrolled
Drug / intervention
APX005M +3 moredrug
Likely dose
Not stated in 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.
Open-label, Multicenter, Phase 1b/2 Clinical Study to Evaluate the Safety and Efficacy of CD40 Agonistic Monoclonal Antibody (APX005M) Administered Together With Gemcitabine and Nab-Paclitaxel With or Without PD-1 Blocking Antibody (Nivolumab) in Patients With Previously Untreated Metastatic Pancreatic Adenocarcinoma
In Brief
A Phase 2 clinical trial evaluating APX005M, Nivolumab, and 2 other interventions for Metastatic Pancreatic Adenocarcinoma. Completed, enrolled 129 participants across 7 sites.
Detailed Summary
The main purposes of this study are to learn how effective the study drug combinations are in treating patients with metastatic pancreatic adenocarcinoma. The drug combinations are APX005M+Nivolumab+Gemcitabine+nab-Paclitaxel, or APX005M+Gemcitabine+nab-Paclitaxel.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Pancreatic Adenocarcinoma
CountriesUnited States
Timeline
Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedJul 2017
Enrollment StartJul 2017
Primary CompletionFeb 2021
Study CompletionFeb 2022
TodayJul 2026
First PostedJul 11, 2017
Enrollment StartJul 21, 2017
Primary CompletionFeb 11, 2021
Study CompletionFeb 25, 2022
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 9.0 years ago
Interventions
APX005Mdrug
Administer intravenously once every 28-day Cycle
Nivolumabdrug
Administer intravenously twice every 28-day cycle
Nab-Paclitaxeldrug
Administer intravenously on 3 times every 28-day cycle
Gemcitabinedrug
Administer intravenously 3 times every 28-day cycle