A Phase 3 Efficacy Study of a Recombinant Vaccinia Virus Vaccine to Treat Metastatic Prostate Cancer (Prospect)
This study is currently recruiting participants.
Verified February 2013 by BN ImmunoTherapeutics
Sponsor:
BN ImmunoTherapeutics
Information provided by (Responsible Party):
BN ImmunoTherapeutics
ClinicalTrials.gov Identifier:
NCT01322490
First received: March 23, 2011
Last updated: May 6, 2013
Last verified: February 2013
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Purpose
The purpose of this study is to determine whether PROSTVAC alone or in combination with GM-CSF is effective in prolonging overall survival in men with few or no symptoms from metastatic, castrate-resistant prostate cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer Metastatic |
Biological: PROSTVAC-V Biological: PROSTVAC-F Drug: GM-CSF Other: GM-CSF Placebo Biological: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC-V/F +/- GM-CSF in Men With Asymptomatic or Minimally Symptomatic Metastatic Castrate-Resistant Prostate Cancer |
Resource links provided by NLM:
Drug Information available for:
Metronidazole
Metronidazole benzoate
Metronidazole hydrochloride
Sargramostim
U.S. FDA Resources
Further study details as provided by BN ImmunoTherapeutics:
Primary Outcome Measures:
- Overall survival [ Time Frame: Survival will be assessed over the life of the study ] [ Designated as safety issue: No ]Overall survival will be measured for all patients until the required number of events per comparison arm is reached.
Secondary Outcome Measures:
- Proportion of event-free patients compared with placebo [ Time Frame: Events will be measured at baseline and 6 months ] [ Designated as safety issue: No ]This endpoint will measure the proportion of patients receiving PROSTVAC with or without GM-CSF who remain event-free (radiological progression, pain progression, initiation of chemotherapy, or death) at 6 months compared to placebo.
| Estimated Enrollment: | 1200 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | August 2015 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
Experimental: PROSTVAC-V/F-TRICOM + GM-CSF
|
Biological: PROSTVAC-V Biological: PROSTVAC-F Drug: GM-CSF |
Experimental: PROSTVAC-V/F-TRICOM + GM-CSF placebo
|
Biological: PROSTVAC-V Biological: PROSTVAC-F Other: GM-CSF Placebo |
|
Placebo Comparator: Placebo Control
PROSTVAC V/F Placebo + GM-CSF Placebo
|
Other: GM-CSF Placebo
Biological: Placebo
PROSTVAC V/F Placebo
|
Detailed Description:
BNIT-PRV-301 is a randomized, placebo-controlled, multi-center, global Phase 3 efficacy trial of PROSTVAC in men with asymptomatic or minimally symptomatic, metastatic, castrate-resistant prostate cancer. It is a 3-arm study and will evaluate overall survival in two separate comparisons, PROSTVAC plus adjuvant dose GM-CSF versus controls, and PROSTVAC without GM-CSF versus controls.
Patients will be randomized with equal probability into one of three double-blind arms. The intended interventions for randomized patients are:
- (Arm V+G) PROSTVAC-V/F plus adjuvant dose GM-CSF
- (Arm V) PROSTVAC-V/F plus GM-CSF placebo
- (Arm P) Double placebo
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
Men, ≥18years of age with documented asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer.
Documented progressive disease post surgical castration or during androgen suppression therapy, or during complete androgen blockade therapy and withdrawal. Documented by either criterion a (Radiological progression), OR criterion b (PSA progression).
Radiological progression defined as any new/enlarging bone metastases or new/enlarging lymph node disease, consistent with prostate cancer.
OR
- PSA progression defined by sequence of rising values separated by > 1 week (2 separate increasing values) over a threshold minimum of 2.0 ng/ml. (PCWG2 PSA eligibility criteria).
Chemotherapy naïve and Vaccinia-experienced (previous smallpox vaccination). Currently using a GnRH agonist or antagonist (unless surgically castrated).
Exclusion Criteria:
Cancer-related pain requiring scheduled opioid narcotics for control (as needed, ≤ 2x per week is allowed).
Metastasis to organ systems other than lymph nodes and/or bone. Estimated PSA doubling time of <1 month as established within 6 months of the anticipated first dose of vaccine or placebo.
Concurrent or prior Provenge (sipuleucel-T) immunotherapy for prostate cancer. Receipt of an investigational agent within 30 days (or 60 days for an antibody-based therapy) of the first planned dose of PROSTVAC-V/F.
History of prior malignancies other than prostate cancer within the past 3 years, excluding successfully resected basal or squamous cell carcinoma of the skin.
Congestive heart failure (NYHA Class II, III, or IV), unstable angina, ventricular or hemodynamically significant atrial arrhythmia, or cardiovascular disease such as stroke or myocardial infarction (current or within the past 6 months) Confirmed positive for HIV, hepatitis B, and /or hepatitis C. Immunodeficiency or splenectomy. History of or active autoimmune disease, persons with vitiligo are not excluded. Diabetics are not excluded if the condition is well controlled.
History of atopic dermatitis or active skin condition (acute, chronic, exfoliative) that disrupts the epidermis.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01322490
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Contacts
| Contact: Paul Collins | paul.collins@ppdi.com | |
| Contact: John Lombardo | john.lombardo@bn-it.com |
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Sponsors and Collaborators
BN ImmunoTherapeutics
Investigators
| Principal Investigator: | James L. Gulley, MD | National Cancer Institute (NCI) |
| Principal Investigator: | Philip Kantoff, MD | Dana-Farber Cancer Institute |
More Information
No publications provided
| Responsible Party: | BN ImmunoTherapeutics |
| ClinicalTrials.gov Identifier: | NCT01322490 History of Changes |
| Other Study ID Numbers: | BNIT-PRV-301 |
| Study First Received: | March 23, 2011 |
| Last Updated: | May 6, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by BN ImmunoTherapeutics:
|
PROSTVAC metastatic prostate cancer castrate-resistant |
vaccine immunotherapy Phase 3 |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Vaccinia Neoplasms Neoplasms, Second Primary Genital Neoplasms, Male Urogenital Neoplasms |
Neoplasms by Site Genital Diseases, Male Prostatic Diseases Poxviridae Infections DNA Virus Infections Virus Diseases |
ClinicalTrials.gov processed this record on May 22, 2013