NCT02234921

Pilot Study of DRibble Vaccine for Prostate Cancer Patients

A Pilot Study of DPV-001 DRibble Vaccine With Imiquimod in Advanced Prostate Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: UbiVac · Industry
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

Summary

This is a pilot study of the DRibble vaccine in patients with advanced prostate cancer.

Detailed description

The primary objective of this pilot study is to assess the safety and tolerability of DRibble vaccine, cyclophosphamide, imiquimod, and Ceravix in castrate resistant prostate cancer. This study will also assess: * the immune profile of tumor biopsy specimens if sites amenable to biopsy are present * humoral and cellular responses to cancer antigens after DRibble vaccination * the response to a reporter antigen vaccine (Ceravix) after DRibble vaccination An exploratory objective is to characterize the microbiome before and after study drugs administration and correlate prostate cancer responses.

Conditions

• Adenocarcinoma of the Prostate

Interventions

Type	Name	Description
DRUG	Cyclophosphamide	A single dose of cyclophosphamide, 300 mg/m2, will be administered intravenously 3 Days prior to the first vaccine.
BIOLOGICAL	DRibble Vaccine	DRibble vaccine will be administered at Weeks 1, 4, 7, 10, 13, 16, 19 and 22. Eight vaccinations will be administered. Week 1 and 4 vaccines will be administered by intranodal injections performed using ultrasound guidance.
BIOLOGICAL	HPV Vaccinations	Patients will receive a dose of 0.5-mL CERVARIX at week 1 (Day 4) and week 7 by intramuscular injection at a site distant from the DRibble vaccine.
DRUG	Imiquimod	Imiquimod cream (5%, 250 mg) will be self-applied topically for 5 consecutive days by patients to a 4 x 5-cm outlined area of healthy extremity skin starting on the day of the second vaccine and again during each additional vaccine cycle.

Timeline

• Start date: 2014-10-24
• Primary completion: 2018-08-15
• Completion: 2018-08-15
• First posted: 2014-09-09
• Last updated: 2018-10-11

Locations

1 site across 1 country: United States