SD-101, Nivolumab, and Radiation Therapy in Treating Patients With Chemotherapy-Refractory Metastatic Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT04050085|
Recruitment Status : Active, not recruiting
First Posted : August 8, 2019
Last Update Posted : November 25, 2022
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Pancreatic Adenocarcinoma Refractory Pancreatic Adenocarcinoma Stage IV Pancreatic Cancer AJCC v8||Biological: Nivolumab Radiation: Radiation Therapy Drug: TLR9 Agonist SD-101||Phase 1|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Intratumoral SD-101 (Toll-Like Receptor 9 Agonist), Nivolumab, and Radiotherapy for Treatment of Chemotherapy-Refractory Metastatic Pancreatic Adenocarcinoma|
|Actual Study Start Date :||August 15, 2019|
|Actual Primary Completion Date :||December 3, 2021|
|Estimated Study Completion Date :||March 2023|
Experimental: Treatment (SD-101, radiation therapy, nivolumab)
Patients receive TLR9 agonist SD-101 intratumorally on days 1 and 8 of cycle 1 and day 1 of cycles 2-5. Treatment repeats every 2 weeks for up to 5 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo radiation therapy on days 1, 3, 5, 8, and 10 of cycle 1. Patients also receive nivolumab IV over 30 minutes on day 2. Cycles with nivolumab repeat every 2 weeks for 24 months in the absence of disease progression or unacceptable toxicity.
Radiation: Radiation Therapy
Undergo radiation therapy
Drug: TLR9 Agonist SD-101
- Incidence of adverse events [ Time Frame: Up to 30 days ]Adverse events, serious adverse events, and clinical laboratory values outside normal limits will be listed for each patient and summarized by body system and dose level in frequency tables. Severity will be graded by Common Terminology Criteria for Adverse Events version 5.0.
- Disease control rate [ Time Frame: Up to 1 year ]
- Duration of response [ Time Frame: Up to 1 year ]
- Progression free survival [ Time Frame: Up to 1 year ]
- Overall survival [ Time Frame: Up to 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04050085
|United States, California|
|University of California Davis Comprehensive Cancer Center|
|Sacramento, California, United States, 95817|
|Principal Investigator:||Edward J Kim, MD, PhD||University of California, Davis|