SD-101, Nivolumab, and Radiation Therapy in Treating Patients With Chemotherapy-Refractory Metastatic Pancreatic Cancer
Last updated on July 2021Recruitment
- 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