Pilot Study of DRibble Vaccine for Prostate Cancer Patients

UbiVac

Status and phase: Completed; Phase 1

Conditions: Adenocarcinoma of the Prostate

Treatments: Drug: Imiquimod; Biological: DRibble Vaccine; Biological: HPV Vaccinations; Drug: Cyclophosphamide

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02234921

14-116B

Details and patient eligibility

About

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

Full 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.

Enrollment: 3 patients

Sex: Male

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

DRibble Vaccine

Experimental group

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).

Treatment:

Drug: Cyclophosphamide

Biological: HPV Vaccinations

Biological: DRibble Vaccine

Drug: Imiquimod