- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04050085
SD-101, Nivolumab, and Radiation Therapy in Treating Patients With Chemotherapy-Refractory Metastatic Pancreatic Cancer
A Pilot Study of Intratumoral SD-101 (Toll-Like Receptor 9 Agonist), Nivolumab, and Radiotherapy for Treatment of Chemotherapy-Refractory Metastatic Pancreatic Adenocarcinoma
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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 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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
California
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Sacramento, California, United States, 95817
- University of California Davis Comprehensive Cancer Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 - 2
- Able and willing to provide written informed consent
- Pathology confirmed pancreatic adenocarcinoma by histology or cytology
- Life expectancy >= 3 months
- Progression during or after greater than or equal to 1 line of systemic treatment for metastatic pancreatic adenocarcinoma. Patients who do not tolerate 1st line systemic treatment for metastatic pancreatic adenocarcinoma are also eligible
>= 1 metastatic liver lesion amenable for radiation, intratumoral injection, and core biopsy
- Lesion for radiation, intratumoral injection, and biopsy may not be a previously irradiated lesion but may have been previously treated with liver directed therapy (e.g., radiofrequency ablation [RFA], transarterial chemoembolization [TACE], selective internal radiation therapy [SIRT], etc.) provided there is radiographic evidence of disease progression in the interim since last local/regional treatment
- >= 1 target lesion outside the field of radiation, measurable by RECIST v1.1
- Absolute neutrophil count (ANC) >= 1000 cells/mm^3
- Platelet count >= 50,000/mm^3
- Hemoglobin >= 8 g/dL
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT) =< 5 times upper limit of normal (ULN)
- Alkaline phosphatase =< 5 times ULN
- Total bilirubin =< 2 times ULN
- Creatinine =< 2 times ULN
- Patients with hepatitis B virus are allowed if antiviral therapy has been given for > 8 weeks with viral loads < 100 IU/mL prior to the first dose of trial therapy. Subjects with hepatitis C virus are allowed. Viral loads for hepatitis B and C will be monitored every 4 weeks for patients with active hepatitis B and/or C
- Women with childbearing potential and males must be willing to use adequate birth control on trial and until 5 months for women or 7 months for men after the last of study therapy
- Ability to adhere to study schedule and protocol requirements
- Willing to undergo pre-treatment biopsy and on-treatment biopsy
Exclusion Criteria:
- Actively receiving cancer directed, systemic therapy
- Prior systemic treatment for pancreatic adenocarcinoma within 2 weeks of first study treatment
- Known active auto-immune disease or immunodeficiency requiring systemic steroid equivalent to prednisone >= 10 mg/day or immunosuppressive therapy within 14 days or 5 half-lives prior to first dose of trial therapy
- History of non-infectious pneumonitis or interstitial lung disease
- Active infection requiring systemic therapy defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment
- Pregnant or lactating women
- Live attenuated vaccine received =< 30 days before first dose of trial therapy
- Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
- Contraindications to radiotherapy including but not limited to radiation sensitivity syndromes e.g., xeroderma pigmentosum, ataxia telangiectasia
- Any significant medical condition including additional active malignancies, laboratory abnormalities, or psychiatric illness that would prevent the subject from participating and adhering to study related procedures in the view of the principal investigator
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
Given IV
Other Names:
Undergo radiation therapy
Other Names:
Given intratumorally
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 30 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survival
Time Frame: Up to 1 year
|
Up to 1 year
|
Duration of response
Time Frame: Up to 1 year
|
Up to 1 year
|
Progression free survival
Time Frame: Up to 1 year
|
Up to 1 year
|
Disease control rate
Time Frame: Up to 1 year
|
Up to 1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Edward J Kim, MD, PhD, University of California, Davis
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Endocrine System Diseases
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Pancreatic Diseases
- Adenocarcinoma
- Pancreatic Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Immune Checkpoint Inhibitors
- Nivolumab
Other Study ID Numbers
- 1452314
- P30CA093373 (U.S. NIH Grant/Contract)
- NCI-2019-04928 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- UCDCC#281 (Other Identifier: University of California Davis Comprehensive Cancer Center)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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