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

NCT04050085 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2023-08-01

No results posted yet for this study

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

Interventions

BIOLOGICAL

Nivolumab

Given IV

RADIATION

Radiation Therapy

Undergo radiation therapy

DRUG

TLR9 Agonist SD-101

Given intratumorally

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • Dynavax Technologies Corporation

    collaborator INDUSTRY

  • University of California, Davis

    lead OTHER

Principal Investigators

  • Edward J Kim, MD, PhD · University of California, Davis

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-15
Primary Completion
2021-12-03
Completion
2022-05-14
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04050085 on ClinicalTrials.gov