A Safety Trial of MVA-BN®-PRO in Men With Androgen-Insensitive Prostate Cancer (BNIT-PR-001)

March 12, 2019 updated by: Bavarian Nordic

An Open-Label, Phase I Dose Escalation Trial of MVA-BN®-PRO in Men With Androgen-Insensitive Prostate Cancer

BNIT-PR-001 is an open-label, multi-center, Phase I dosing evaluation trial of MVA-BN®-PRO in men with androgen-insensitive prostate cancer. Patients will have PSA recurrence after being treated with androgen suppression therapy or complete androgen blockade.

The trial will consist of a treatment with up to 6 vaccinations with MVA-BN®-PRO at monthly intervals, followed by a 1-year follow-up phase. A vaccination may be 1, 2, or 4 injections of study vaccine.

The study is designed to examine safety as well as the effect of three different doses on immune response.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

MVA-BN®-PRO is a candidate prostate cancer immunotherapy product comprised of a highly attenuated non-replicating vaccinia virus, MVA-BN®, engineered to encode prostate specific antigen (PSA) and prostate acid phosphatase (PAP) proteins. The MVA-BN®-based vaccine provides innate and adaptive immune activating factors, and vaccination by this strategy will be evaluated for its capacity to help override self and tumor tolerance mechanisms.

Previous work has shown PSA and PAP antigens to be immunogenic in humans when presented with immune stimulatory components. Multiple clinical studies have demonstrated promising activity of PSA-targeted vaccinia-based immunotherapy. Additionally, PAP-based cellular therapy immunization approaches, have shown promise in Phase III clinical trials and provided for enhanced survival. The strategy undertaken by BNIT is to combine both antigens in the MVA-BN® vector to enhance the immunogenic effect and to help mitigate development of tumor resistance.

This trial examines three vaccination regimens of MVA-BN®-PRO:

Vaccine is provided at (0.5cc/dose/1x10e8 TCID50)

  • Cohort 1: 1 sc injection every 4 weeks x 3; retreated once at the same dose and schedule.
  • Cohort 2: 2 sc injections every 4 weeks x 3; retreated once at the same dose and schedule.
  • Cohort 3: 4 sc injections every 4 weeks x 3; retreated once at the same dose and schedule.

These dose regimens are based on the current dose of MVA-BN® (1x10e8 TCID50 by sc injection) under development as a prophylactic vaccine for the prevention of smallpox, and on related clinical studies of MVA-nef-based vaccines (5x10e8 TCID50) for induction of heterologous immunity.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Homewood, Alabama, United States, 35209
        • Urology Centers of Alabama
    • District of Columbia
      • Washington, District of Columbia, United States, 20307
        • Walter Reed Army Medical Center
    • New Jersey
      • Lawrenceville, New Jersey, United States, 08648
        • Lawrenceville Urology
    • North Carolina
      • Charlotte, North Carolina, United States, 28173
        • Presbyterian Hospital Center for Cancer Research
    • Tennessee
      • Nashville, Tennessee, United States
        • Urology Associates
    • Texas
      • Dallas, Texas, United States, 75231
        • Urology Clinics Of North Texas, Pa
      • McAllen, Texas, United States, 78503
        • Urology Associates of South Texas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Signed Informed Consent
  • Men, 18 - 75 years of age
  • Documented prostate cancer with a rising PSA post androgen suppression or blockade therapy
  • Chemotherapy naïve
  • ECOG Performance Score of 0,1, or 2
  • Life expectancy ≥ 1 year
  • No significant cardiac, bone marrow, hepatic, or renal dysfunction; or coagulopathy (defined as no AE ≥ Grade 3 according to NCI CTCAE v 3.0). Patients with a known history of a CLINICALLY NON-SIGNIFICANT laboratory parameter may be eligible for inclusion provided an exemption is granted by the study Medical Monitor prior to enrollment.
  • A negative virology screen for HIV, hepatitis B surface antigen, and hepatitis C

Exclusion Criteria:

  • Metastatic disease
  • Congestive heart failure (NYHA Class III or IV), unstable angina, or cardiovascular disease such as stroke or myocardial infarction (current or within the past 6 months)
  • History of prior malignancies other than prostate cancer within the past 5 years, excluding basal or squamous cell carcinoma of the skin
  • Known allergy to eggs, egg products, or aminoglycoside antibiotics, e.g., gentamicin or tobramycin
  • Chronic administration (defined as 5 or more days of consecutive use) of systemic corticosteroids within 14 days of the first planned dose of MVA-BN®-PRO. Use of inhaled steroids, nasal sprays, eye drops and topical creams for small body areas is allowed.
  • History of or active autoimmune disease. Persons with vitiligo or thyroid disease taking thyroid replacement hormones are not excluded.
  • Prior solid organ or hematopoietic allogenic transplant(s)
  • Receipt of an investigational agent within 28 days of the first planned dose of MVA-BN®-PRO
  • Prior "vaccine" therapy for prostate cancer at any time
  • Vaccination: Live (attenuated) vaccine (e.g., FluMist®). Vaccination with a live vaccine within 28 days of the first planned dose of MVA-BN®-PRO, or plans to receive a live vaccine within 28 days after the last dose of MVA-BN®-PRO is not allowed
  • Vaccination: Killed (inactivated) vaccine (e.g., PneumoVax®). Vaccination with a killed vaccine within 14 days of the first planned dose of MVA-BN®-PRO, or plans to receive a killed vaccine within 14 days after the last dose of MVA-BN®-PRO is not allowed.
  • Radiation therapy within 28 days of the first planned dose of MVA-BN®-PRO or plans for radiation therapy during treatment or re-treatment. Prior to initiating palliative radiation during the (re)treatment phase of the study, the Sponsor's medical monitor or designee must be notified.
  • Any condition which, in the opinion of the investigator, would prevent full participation in this trial (including the long-term follow-up), or would interfere with the evaluation of the trial endpoints
  • Study personnel

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Lowest dose level
Biological: MVA-BN-PRO
1x10e8 TCID50 q 4 wks x 6
Biological: MVA-BN-PRO
2 x 10e8 TCID50 q 4 wks x 6
Biological: MVA-BN-PRO
4 x 10e8 TCID50 q 4 wks x 6
Experimental: 2
Middle level dose
Biological: MVA-BN-PRO
1x10e8 TCID50 q 4 wks x 6
Biological: MVA-BN-PRO
2 x 10e8 TCID50 q 4 wks x 6
Biological: MVA-BN-PRO
4 x 10e8 TCID50 q 4 wks x 6
Experimental: 3
Highest dose level
Biological: MVA-BN-PRO
1x10e8 TCID50 q 4 wks x 6
Biological: MVA-BN-PRO
2 x 10e8 TCID50 q 4 wks x 6
Biological: MVA-BN-PRO
4 x 10e8 TCID50 q 4 wks x 6

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate the safety and tolerability of single and multiple injection regimens of MVA-BN®-PRO for the treatment of androgen-insensitive prostate cancer.
Time Frame: Continuous
Continuous

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate the ability of MVA-BN®-PRO to generate humoral and cellular immune responses to prostate antigens, and to define an optimal dose for future studies.
Time Frame: Continuous
Continuous

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bavarian Nordic

Investigators

  • Study Director: Olga Bandman, Bavarian Nordic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

February 25, 2008

First Submitted That Met QC Criteria

February 25, 2008

First Posted (Estimate)

March 5, 2008

Study Record Updates

Last Update Posted (Actual)

March 13, 2019

Last Update Submitted That Met QC Criteria

March 12, 2019

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BNIT-PR-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Androgen-insensitive Prostate Cancer

Clinical Trials on MVA-BN-PRO

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Egypt

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe