Study Stopped
Due to strategic evaluation of PF-06753512 (VBIR-1) within context of Pfizer's oncology portfolio, decision not based on any safety or regulatory concerns.
A Phase 1 Study To Evaluate Escalating Doses Of A Vaccine-Based Immunotherapy Regimen For Prostate Cancer (PrCa VBIR)
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)
2 other identifiers
interventional
91
1 country
19
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Dec 2015
Longer than P75 for phase_1
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 24, 2015
CompletedFirst Posted
Study publicly available on registry
November 26, 2015
CompletedStudy Start
First participant enrolled
December 30, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 23, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 23, 2021
CompletedResults Posted
Study results publicly available
November 2, 2023
CompletedNovember 2, 2023
January 1, 2023
5.2 years
November 24, 2015
January 18, 2022
January 18, 2023
Conditions
Outcome Measures
Primary Outcomes (4)
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a clinical investigation where participant administered a product; the event did not need to have a causal relationship with the treatment. A SAE was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. AEs included both SAEs and non-serious AEs.
Baseline up to 6 months after End of Treatment (EOT; 52 months in maximum)
Number of Participants With AEs as Graded by National Cancer Institute Common Toxicity Criteria for Adverse Events Version 4.03 (NCI CTCAE v4.03) (Grade >= 3)
An AE was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment. Grades of AEs were defined by NCI CTCAE v 4.03. Grade 1=asymptomatic/mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2=minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activity of daily living (ADL); Grade 3=severe or medically significant but not immediately life-threatening, hospitalization of prolongation of hospitalization indicated; disabling limiting self-care ADL; Grade 4=events with life-threatening consequences, urgent intervention indicated; Grade 5= death related to AE. Treatment-emergent adverse events occurred between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
Baseline up to 6 months after EOT (52 months in maximum)
Number of Participants With AEs Leading to Discontinuation or Dose Reduction
An AE was any untoward medical occurrence in a clinical investigation where participant administered a product; the event did not need to have a causal relationship with the treatment.
Baseline up to 6 months after EOT (52 months in maximum)
Number of Participants With Dose-Limiting Toxicities (DLTs)
The following AEs occurring in the first 28 days following the first AdC68 vaccination and not related to disease/progression were DLTs: (a) hematologic (Cohorts 1A to 3A and Cohorts 6A to 9A): Grade 3 neutropenia lasting \>7 days, febrile neutropenia, Grade \>=3 neutropenic infection, Grade \>=3 thrombocytopenia, Grade \>=3 anemia lasting \>7 days, Grade \>=3 lymphopenia lasting \>14 days; (b) non-hematologic (all cohorts): Grade \>=3 laboratory abnormalities either associated with symptoms or associated with worsening of an existing condition or that suggested a new disease process or that required additional active management, Grade \>=3 toxicities, Grade 3 flu like symptoms lasting \>3 days, fever of \>40.0 degree Celsius lasting \>3 days. Other clinically important or persistent toxicities at discretion of investigator and Pfizer.
The first 28 days following the first AdC68 vaccination (on Cycle 1 Day 1)
Secondary Outcomes (37)
Number of Participants With Laboratory Abnormalities in Hematology (Grade 3 or 4)
Baseline up to 6 months after EOT (52 months in maximum)
Number of Participants With Laboratory Abnormalities in Chemistry (Grade 3 or 4)
Baseline up to 6 months after EOT (52 months in maximum)
Number of Participants With Laboratory Abnormalities in Urinalysis (Grade 3 or 4)
Baseline up to 6 months after EOT (52 months in maximum)
Change From Baseline in T Cell Response to Prostate Specific Antigen (PSA) in Part A
At screening; Cycle 1: at Day 1, Day 15, Day 29, Day 43, Day 71; Cycle 2: at Day 1, Day 29, and Day 99; at the EOT visit, and 2, 4 and 6 months after EOT.
Change From Baseline in T Cell Response to Prostate Stem Cell Antigen (PSCA) in Part A
At screening; Cycle 1: at Day 1, Day 15, Day 29, Day 43, Day 71; Cycle 2: at Day 1, Day 29, and Day 99; at the EOT visit, and 2, 4 and 6 months after EOT.
- +32 more secondary outcomes
Study Arms (1)
Dose Escalation
EXPERIMENTALPF-06753512
Interventions
PF-06755992 will be administered on Day 1 of Cycles 1 and 2.
PF-06755990 will be administered using a device on Day 29, 57 and 85 of each cycle.
TDS-IM electroporation device and associated supplies will be used for PF-06755990 administration
PF-06753388 will be administered every 28 days.
Combination of adenovirus (AdC68) + plasmid DNA (pDNA) + tremelimumab
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (19)
Banner-University Medical Center Tucson
Tucson, Arizona, 85719, United States
The University of Arizona Cancer Center-North Campus
Tucson, Arizona, 85719, United States
Smilow Cancer Hospital at Yale-New Haven
New Haven, Connecticut, 06510, United States
Smilow Cancer Hospital Phase 1 Unit
New Haven, Connecticut, 06511, United States
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
GU Research Network
Omaha, Nebraska, 68130, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169, United States
Garden State Urology
Morristown, New Jersey, 07960, United States
Morristown Medical Center
Morristown, New Jersey, 07960, United States
Garden State Urology
Rockaway, New Jersey, 07866, United States
Garden State Urology
Whippany, New Jersey, 07981, United States
Northwell Health
Lake Success, New York, 11042, United States
Memorial Sloan-Kettering Cancer Center 53rd Street
New York, New York, 10022, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Memorial Sloan-Kettering Cancer Center, Sidney Kimmel Center
New York, New York, 10065, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
Related Publications (1)
Autio KA, Higano CS, Nordquist L, Appleman LJ, Zhang T, Zhu XH, Babiker H, Vogelzang NJ, Prasad SM, Schweizer MT, Madan RA, Billotte S, Cavazos N, Bogg O, Li R, Chan K, Cho H, Kaneda M, Wang IM, Zheng J, Tang SY, Hollingsworth R, Kern KA, Petrylak DP. First-in-human, phase 1 study of PF-06753512, a vaccine-based immunotherapy regimen (VBIR), in non-metastatic hormone-sensitive biochemical recurrence and metastatic castration-resistant prostate cancer (mCRPC). J Immunother Cancer. 2023 Mar;11(3):e005702. doi: 10.1136/jitc-2022-005702.
PMID: 36948505DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The study was terminated on 20 August 2020 by the sponsor. The decision to terminate this study was based on the results of a strategic evaluation of VBIR-1 within the current Pfizer oncology portfolio. This decision was not based on any safety or regulatory concerns with the treatment of participants with VBIR-1.
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 24, 2015
First Posted
November 26, 2015
Study Start
December 30, 2015
Primary Completion
February 23, 2021
Study Completion
February 23, 2021
Last Updated
November 2, 2023
Results First Posted
November 2, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will not share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.