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Metastatic Pancreatic AdenocarcinomaPhase 1NCT04050085

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

A Phase 1 study testing Nivolumab, Radiation Therapy and TLR9 Agonist SD-101 in people with Metastatic Pancreatic Adenocarcinoma and Refractory Pancreatic Adenocarcinoma, run by University of California, Davis at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Nivolumab, Radiation Therapy and TLR9 Agonist SD-101
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteUnited States
Study dates
15 Aug 2019to 14 May 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of California Davis Comprehensive Cancer Center

    Sacramento, California, 95817

Other trials in United States

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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.
Being tested
Nivolumab, Radiation Therapy, TLR9 Agonist SD-101
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NivolumabBiological

    Also called BMS-936558, MDX-1106, NIVO, ONO-4538

    Given IV

  • Radiation TherapyRadiation

    Also called Cancer Radiotherapy, Irradiate, Irradiated, irradiation

    Undergo radiation therapy

  • TLR9 Agonist SD-101Drug

    Also called ISS-ODN SD-101, SD-101

    Given intratumorally

Study groups in NCT04050085
Study groupRoleWhat they receive
Treatment (SD-101, radiation therapy, nivolumab)ExperimentalPatients 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.
Receives: Biological: Nivolumab; Radiation: Radiation Therapy; Drug: TLR9 Agonist SD-101

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of adverse events

    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.

    Measured: Up to 30 days

Secondary outcomes (4)

  1. Disease control rate

    Measured: Up to 1 year

  2. Duration of response

    Measured: Up to 1 year

  3. Progression free survival

    Measured: Up to 1 year

  4. Overall survival

    Measured: Up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2019
  2. Study start15 Aug 2019
  3. Primary completion3 Dec 2021
  4. Study completion14 May 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04050085
Sponsor's protocol ID
1452314
Other IDs
NCI-2019-04928, UCDCC#281, P30CA093373
Status last verified
Jul 2023
First submitted
6 Aug 2019
Last updated
1 Aug 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Nivolumab, Radiation Therapy and TLR9 Agonist SD-101 in people with Metastatic Pancreatic Adenocarcinoma and Refractory Pancreatic Adenocarcinoma, run by University of California, Davis at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse events (time frame: Up to 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04050085.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.

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