CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 66 enrolled
Drug / intervention
Pembrolizumab +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02499835
NCT02499835Phase 2Completed
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Pilot Trial of pTVG-HP DNA Vaccine and Pembrolizumab in Patients With Castration-Resistant, Metastatic Prostate Cancer

University of Wisconsin, Madison·interventional·Posted Jul 16, 2015·Updated Aug 1, 2023

In Brief

A Phase 2 clinical trial evaluating Pembrolizumab and pTVG-HP Plasmid DNA Vaccine for Hormone-Resistant Prostate Cancer and 6 related conditions. Completed, enrolled 66 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHormone-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
CountriesUnited States
CollaboratorsProstate Cancer Foundation, Madison Vaccines Incorporated

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 16, 2015
Enrollment StartJul 1, 2015
Primary CompletionAug 9, 2021
Study CompletionJul 27, 2023
TodayJul 2, 2026
Enrollment to primary: 6.1 yearsPosted 11.0 years ago

Interventions

Pembrolizumabbiological

Given IV

pTVG-HP Plasmid DNA Vaccinebiological

Given ID