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Vaccine Therapy and Pembrolizumab in Treating Patients With Hormone-Resistant, Metastatic Prostate Cancer

NCT02499835 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2023-08-01

Study results available
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Summary

This randomized pilot trial studies vaccine therapy and pembrolizumab in treating patients with prostate cancer that does not respond to treatment with hormones (hormone-resistant) and has spread to other places in the body (metastatic). Vaccines made from deoxyribonucleic acid (DNA), such as pTVG-HP plasmid DNA vaccine, may help the body build an effective immune response to kill tumor cells. Monoclonal antibodies, such as pembrolizumab, may find tumor cells and help kill them. Giving pTVG-HP plasmid DNA vaccine and pembrolizumab may kill more tumor cells.

Conditions

  • Hormone-Resistant Prostate Cancer
  • Metastatic Malignant Neoplasm in the Bone
  • Metastatic Malignant Neoplasm in the Soft Tissues
  • Metastatic Prostate Carcinoma
  • Prostate Adenocarcinoma
  • Recurrent Prostate Carcinoma
  • Stage IV Prostate Cancer

Interventions

BIOLOGICAL

Pembrolizumab

Given IV

BIOLOGICAL

pTVG-HP Plasmid DNA Vaccine

Given ID

Sponsors & Collaborators

  • Prostate Cancer Foundation

    collaborator OTHER

  • Madison Vaccines Incorporated

    collaborator INDUSTRY

  • University of Wisconsin, Madison

    lead OTHER

Principal Investigators

  • Douglas G McNeel, MD PhD · University of Wisconsin, Madison

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-01
Primary Completion
2021-08-09
Completion
2023-07-27
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT02499835 on ClinicalTrials.gov