NCT03214250

Safety and Efficacy of APX005M With Gemcitabine and Nab-Paclitaxel With or Without Nivolumab in Patients With Previously Untreated Metastatic Pancreatic Adenocarcinoma

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 129 (actual)
• Sponsor: Parker Institute for Cancer Immunotherapy · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Pancreatic Adenocarcinoma

Interventions

Type	Name	Description
DRUG	APX005M	Administer intravenously once every 28-day Cycle
DRUG	Nivolumab	Administer intravenously twice every 28-day cycle
DRUG	Nab-Paclitaxel	Administer intravenously on 3 times every 28-day cycle
DRUG	Gemcitabine	Administer intravenously 3 times every 28-day cycle

Timeline

• Start date: 2017-07-21
• Primary completion: 2021-02-11
• Completion: 2022-02-25
• First posted: 2017-07-11
• Last updated: 2022-12-23
• Results posted: 2022-08-11

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study