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

NCT04050085 | Completed Phase 1 DMC FDA Drug

• 4 other identifiers: 1452314NCI-2019-04928UCDCC#281P30CA093373
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Pancreatic Adenocarcinoma; Refractory Pancreatic Adenocarcinoma; Stage IV Pancreatic Cancer AJCC v8

Outcome Measures

Primary Outcomes (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.

  Up to 30 days

Secondary Outcomes (4)

• Disease control rate

  Up to 1 year

• Duration of response

  Up to 1 year

• Progression free survival

  Up to 1 year

• Overall survival

  Up to 1 year

Study Arms (1)

Treatment (SD-101, radiation therapy, nivolumab)

EXPERIMENTAL

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; Radiation: Radiation Therapy; Drug: TLR9 Agonist SD-101

Interventions

Nivolumab BIOLOGICAL

Given IV

Also known as: BMS-936558, MDX-1106, NIVO, ONO-4538, Opdivo

Treatment (SD-101, radiation therapy, nivolumab)

Radiation Therapy RADIATION

Undergo radiation therapy

Also known as: Cancer Radiotherapy, Irradiate, Irradiated, irradiation, Radiation, Radiotherapeutics, RADIOTHERAPY, RT, Therapy, Radiation

Treatment (SD-101, radiation therapy, nivolumab)

TLR9 Agonist SD-101 DRUG

Given intratumorally

Also known as: ISS-ODN SD-101, SD-101

Treatment (SD-101, radiation therapy, nivolumab)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead
• National Cancer Institute (NCI): collaborator
• Bristol-Myers Squibb: collaborator
• Dynavax Technologies Corporation: collaborator

Study Sites (1)

University of California Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Nivolumab; Radiotherapy; Radiation

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Therapeutics; Physical Phenomena

Study Officials

• Edward J Kim, MD, PhD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 6, 2019
• First Posted: August 8, 2019
• Study Start: August 15, 2019
• Primary Completion: December 3, 2021
• Study Completion: May 14, 2022
• Last Updated: August 1, 2023

Record last verified: 2023-07

Locations

US (1)