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SD-101, Nivolumab, and Radiation Therapy in Treating Patients With Chemotherapy-Refractory Metastatic Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04050085
Recruitment Status : Active, not recruiting
First Posted : August 8, 2019
Last Update Posted : November 25, 2022
National Cancer Institute (NCI)
Bristol-Myers Squibb
Dynavax Technologies Corporation
Information provided by (Responsible Party):
Edward Kim, University of California, Davis

Brief Summary:
This phase I trial studies the side effects of SD-101 when given together with nivolumab and radiation therapy in treating patients with pancreatic cancer that does not respond to treatment with chemotherapy (chemotherapy refractory) and has spread to other places in the body (metastatic). Drugs used in chemotherapy, such as SD-101, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving SD-101, nivolumab, and radiation therapy may work better in treating patients with pancreatic cancer compared to nivolumab or radiation therapy alone.

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

Detailed Description:


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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

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.
Biological: Nivolumab
Given IV
Other Names:
  • BMS-936558
  • MDX-1106
  • NIVO
  • ONO-4538
  • Opdivo

Radiation: Radiation Therapy
Undergo radiation therapy
Other Names:
  • Cancer Radiotherapy
  • Irradiate
  • Irradiated
  • irradiation
  • Radiation
  • Radiotherapeutics
  • RT
  • Therapy, Radiation

Drug: TLR9 Agonist SD-101
Given intratumorally
Other Names:
  • ISS-ODN SD-101
  • SD-101

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Disease control rate [ Time Frame: Up to 1 year ]
  2. Duration of response [ Time Frame: Up to 1 year ]
  3. Progression free survival [ Time Frame: Up to 1 year ]
  4. Overall survival [ Time Frame: Up to 1 year ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT04050085

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United States, California
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
National Cancer Institute (NCI)
Bristol-Myers Squibb
Dynavax Technologies Corporation
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Principal Investigator: Edward J Kim, MD, PhD University of California, Davis
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Responsible Party: Edward Kim, Principal Investigator, University of California, Davis Identifier: NCT04050085    
Other Study ID Numbers: 1452314
NCI-2019-04928 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
UCDCC#281 ( Other Identifier: University of California Davis Comprehensive Cancer Center )
P30CA093373 ( U.S. NIH Grant/Contract )
First Posted: August 8, 2019    Key Record Dates
Last Update Posted: November 25, 2022
Last Verified: November 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action