Trial · NCT02411786
A Phase I Study of a DNA Vaccine Encoding Androgen Receptor Ligand-Binding Domain (AR LBD) +/-GMCSF
NCT02411786, Phase 1, Completed, University of Wisconsin, Madison
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase I Study of a DNA Vaccine Encoding Androgen Receptor Ligand-Binding Domain (AR LBD) +/-GMCSF. Trials, record NCT02411786. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02411786
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase I Study of a DNA Vaccine Encoding Androgen Receptor Ligand-Binding Domain (AR LBD) +/-GMCSF
- NCT number
- NCT02411786
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 40 participants, actual
- Lead sponsor
- University of Wisconsin, Madison
- Conditions
- Prostate Cancer
- Interventions
- pTVG-AR, gm-csf
- First posted
- 2015-04-08
- Last updated
- 2021-02-04
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number and severity of adverse events following serial intradermal vaccinations of a DNA vaccine encoding AR LBD, with or without GM-CSF as an adjuvant, in patients with metastatic prostate cancer | From first immunization to Week 72 | |
| Primary | Immune Response Rate | From first immunization to Week 72 | |
| Secondary | Median Progression-Free Survival | From first immunization to Week 72 | Median time to PSA progression will be determined as a function of the date the participant started on androgen deprivation and as a function of treatment start date (week 0). Development of new metastases or discontinuation of study to begin other therapy, while not expected to precede a PSA progression endpoint, would also constitute a progression endpoint. |
| Secondary | 18-Month Progression-Free Survival | 18 months | |
| Secondary | The proportion of patients with a T-cell immune response. | From first immunization to Week 72 | Generation of AR LBD-specific peptide-specific CD8+ T cells as defined by ELISPOT and tetramer staining |
| Secondary | The number of patients that generate antigen specific tolerance | From first immunization to Week 72 | Antigen-specific tolerance generation following multiple immunizations |
| Secondary | Association between pre-existing immune responses to the AR LBD and development of subsequent effector and memory T-cell immune response | From first immunization to Week 72 | |
| Secondary | Association between development of antigen-specific T cells and 18-month progression-free survival | From first immunization to Week 72 |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32513836 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02411786
GET https://conductscience.org/api/trials/v1/NCT02411786/registered