Clinical trial · Interventional
Pilot Study of DRibble Vaccine for Prostate Cancer Patients
A Pilot Study of DPV-001 DRibble Vaccine With Imiquimod in Advanced Prostate Cancer
NCT02234921CI-TRIAL-00035233DRibblecompletedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a pilot study of the DRibble vaccine in patients with advanced prostate cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma of the Prostate | Prostate Adenocarcinoma | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| DRibble Vaccine | Biological | — | UNRESOLVED |
| HPV Vaccinations | Biological | — | UNRESOLVED |
| Imiquimod | Drug | Imiquimod | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- DRibble Vaccine
- description
- Patients will receive cyclophosphamide 3 days prior to the first of 9 planned DRibble vaccine injections. Imiquimod will be applied following 6 injections. Patients will receive 2 HPV vaccinations (Human papillomavirus).
- interventionNames
- Drug: Cyclophosphamide
- Biological: DRibble Vaccine
- Biological: HPV Vaccinations
- Drug: Imiquimod
Primary outcomes (1)
- measure
- Safety Assessment
- timeFrame
- 28 Weeks
- description
- Patients will come to clinic 10 times over a 28 week period and have blood tests and vital sign measurements at each visit. In addition, patients will have 8 physical exams and performance status evaluations during this time period to evaluate possible toxicities related to study treatment.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
Inclusion Criteria: * Subjects have measurable or evaluable metastatic castrate resistant adenocarcinoma of the prostate with progression after chemotherapy, combined androgen blockade and/or peripheral androgen or androgen receptor suppression. Either histologic or serum marker diagnosis is acceptable. * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Ability to give informed consent and comply with the protocol. * Prior therapy with investigational agents must have been completed at least 3 weeks prior to study enrollment. * Patients must have normal organ and marrow function as determined by routine blood tests Exclusion Criteria: * Active autoimmune disease except vitiligo or hypothyroidism. * Active other malignancy. * Known HIV positive and/or Hepatitis B or C positive. * Other medical or psychiatric conditions that in the opinion of the Principal Investigator would preclude safe participation in protocol.
References
Publications (0)
Data not yet available
No reference posted for this study.