A Phase 1 Study To Evaluate Escalating Doses Of A Vaccine-Based Immunotherapy Regimen For Prostate Cancer (PrCa VBIR)
NCT02616185
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
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1-800-718-1021
- Histological or cytological diagnosis of prostate cancer
- Adequate bone marrow, kidney and liver function
- Hormone sensitive relapsing prostate cancer after definitive local therapy (biochemical relapse) OR
- Failed prior therapy with a novel hormone (e.g. enzalutamide, abiraterone) with documented progressive disease (post-novel hormone therapy CRPC)
- ECOG performance status greater than or equal to 2
- Concurrent immunotherapy for prostate cancer
- History of or active autoimmune disorders (including but not limited to: myasthenia
gravis, thyroiditis, pneumonitis, rheumatoid arthritis, multiple sclerosis, systemic
lupus erythematosus, scleroderma) and other conditions that disorganize or alter the
immune system.
- History of inflammatory bowel disease.
- Current use of any implanted electronic stimulation device
- For biochemically relapsed patients, no concurrent use of ADT or orchiectomy and no
known prior or current evidence of any metastatic involvement of distant organs
- For post-novel hormone patients, no concurrent treatment with a secondary hormone
(e.g. enzalutamide, abiraterone), no metastasis to the liver or brain
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Descriptive Information | |||||
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Brief Title ICMJE | A Phase 1 Study To Evaluate Escalating Doses Of A Vaccine-Based Immunotherapy Regimen For Prostate Cancer (PrCa VBIR) | ||||
Official Title ICMJE | A PHASE 1 STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS AND PHARMACODYNAMICS OF ESCALATING DOSES OF A VACCINE-BASED IMMUNOTHERAPY REGIMEN (VBIR) FOR PROSTATE CANCER (PF-06753512) | ||||
Brief Summary | The study will evaluate the safety, pharmacokinetics and pharmacodynamics of increasing doses of a vaccine-based immunotherapy regimen for patients with prostate cancer. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: N/A Masking: None (Open Label) Primary Purpose: Treatment | ||||
Condition ICMJE | Prostatic Neoplasms | ||||
Intervention ICMJE |
| ||||
Study Arms ICMJE | Experimental: Dose Escalation
PF-06753512 Interventions:
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Actual Enrollment ICMJE | 62 | ||||
Original Estimated Enrollment ICMJE | 78 | ||||
Estimated Study Completion Date ICMJE | March 1, 2021 | ||||
Estimated Primary Completion Date | March 1, 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT02616185 | ||||
Other Study ID Numbers ICMJE | B7791001 PRCA VBIR FIP STUDY ( Other Identifier: Alias Study Number ) | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||
Study Sponsor ICMJE | Pfizer | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||
Verification Date | October 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |