Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Metastatic Pancreatic Adenocarcinoma
  • Refractory Pancreatic Adenocarcinoma
  • Stage IV Pancreatic Cancer AJCC v8
Type
Interventional
Phase
Phase 1
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

PRIMARY OBJECTIVES: I. To determine the safety and tolerability of intratumoral cytidine-phospho-guanosine oligodeoxynucleotide (CpG) in combination with nivolumab and radiotherapy (RT) in chemotherapy-refractory metastatic pancreatic adenocarcinoma using Common Terminology Criteria for Adverse Even...

PRIMARY OBJECTIVES: I. To determine the safety and tolerability of intratumoral cytidine-phospho-guanosine oligodeoxynucleotide (CpG) in combination with nivolumab and radiotherapy (RT) in chemotherapy-refractory metastatic pancreatic adenocarcinoma using Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0 criteria. SECONDARY OBJECTIVES: I. To obtain preliminary data on disease control rate (DCR), duration of response (DOR), progression free survival (PFS), and overall survival (OS) of intratumoral CpG in combination with nivolumab and RT in chemotherapy refractory pancreatic adenocarcinoma.

Tracking Information

NCT #
NCT04050085
Collaborators
  • National Cancer Institute (NCI)
  • Bristol-Myers Squibb
  • Dynavax Technologies Corporation
Investigators
Principal Investigator: Edward J Kim, MD, PhD University of California, Davis