Androgen-insensitive Prostate CancerPhase 1BNIT-PR-001NCT00629057
A Safety Trial of MVA-BN®-PRO in Men With Androgen-Insensitive Prostate Cancer
A Phase 1 study testing MVA-BN-PRO in people with Androgen-insensitive Prostate Cancer, run by Bavarian Nordic at 7 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Androgen-insensitive Prostate Cancer
- What is being tested?
- MVA-BN-PRO
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 7 sitesUnited States
- Study dates
- Mar 2008to Sep 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Presbyterian Hospital Center for Cancer Research
Charlotte, North Carolina, 28173
Urology Clinics of North Texas, PA
Dallas, Texas, 75231
Urology Centers of Alabama
Homewood, Alabama, 35209
Lawrenceville Urology
Lawrenceville, New Jersey, 08648
Urology Associates of South Texas
McAllen, Texas, 78503
Urology Associates
Nashville, Tennessee
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307
About this study
Official title: 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.
Read the 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.
- Conditions
- Androgen-insensitive Prostate Cancer
- Being tested
- MVA-BN-PRO
- Keywords
- androgen-insensitive, non-metastatic, prostate, cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MVA-BN-PROBiological
1x10e8 TCID50 q 4 wks x 6
MVA-BN-PROBiological
2 x 10e8 TCID50 q 4 wks x 6
MVA-BN-PROBiological
4 x 10e8 TCID50 q 4 wks x 6
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Lowest dose level Receives: Biological: MVA-BN-PRO |
| 2 | Experimental | Middle level dose Receives: Biological: MVA-BN-PRO |
| 3 | Experimental | Highest dose level Receives: Biological: MVA-BN-PRO |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of single and multiple injection regimens of MVA-BN®-PRO for the treatment of androgen-insensitive prostate cancer.
Measured: Continuous
Secondary outcomes (1)
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.
Measured: Continuous
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionDec 2010
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgen-insensitive Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bavarian Nordic
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Olga Bandman, Study director, Bavarian Nordic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00629057
- Sponsor's protocol ID
- BNIT-PR-001
- Acronym
- BNIT-PR-001
- Status last verified
- Jun 2011
- First submitted
- 25 Feb 2008
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Phase I Dose Escalation Trial of MVA-BN®-PRO in Men With Androgen-Insensitive Prostate Cancer
- ClinicalTrials.gov ID
- NCT00629057
- Acronym / sponsor ID
- BNIT-PR-001 / BNIT-PR-001
- Conditions
- Androgen-insensitive Prostate Cancer
- Keywords
- androgen-insensitive, non-metastatic, prostate, cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Bavarian NordicIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 5 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: MVA-BN-PROLowest dose level |
| 2 | Experimental | Biological: MVA-BN-PROMiddle level dose |
| 3 | Experimental | Biological: MVA-BN-PROHighest dose level |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MVA-BN-PRO1x10e8 TCID50 q 4 wks x 6 | Biological | 1 |
| MVA-BN-PRO2 x 10e8 TCID50 q 4 wks x 6 | Biological | 2 |
| MVA-BN-PRO4 x 10e8 TCID50 q 4 wks x 6 | Biological | 3 |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olga Bandman study director
Bavarian Nordic
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MVA-BN-PRO in people with Androgen-insensitive Prostate Cancer, run by Bavarian Nordic at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2019.