Back to resultsA Phase 1 Study To Evaluate Escalating Doses Of A Vaccine-Based Immunotherapy Regimen For Prostate Cancer (PrCa VBIR)
Primary Purpose
Prostatic Neoplasms
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PF-06755992
PF-06755990
TDS-IM Electroporation Device
Tremelimumab
PF-06801591
PF-06753512
Sponsored by
About this trial
This is an interventional treatment trial for Prostatic Neoplasms
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Sites / Locations
- Banner-University Medical Center Tucson
- The University of Arizona Cancer Center-North Campus
- Smilow Cancer Hospital at Yale-New Haven
- Smilow Cancer Hospital Phase 1 Unit
- National Institutes of Health Clinical Center
- GU Research Network
- Comprehensive Cancer Centers of Nevada
- Garden State Urology
- Morristown Medical Center
- Garden State Urology
- Garden State Urology
- Northwell Health
- Memorial Sloan-Kettering Cancer Center 53rd Street
- Memorial Sloan Kettering Cancer Center
- Memorial Sloan-Kettering Cancer Center, Sidney Kimmel Center
- Duke University Medical Center
- UPMC Hillman Cancer Center
- Seattle Cancer Care Alliance
- University of Washington Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dose Escalation
Arm Description
PF-06753512
Outcomes
Primary Outcome Measures
Part A. Incidence and grade of treatment-emergent adverse events including DLTs
DLTs in order to determine the maximum tolerated dose and safety beyond DLT assessment period
Secondary Outcome Measures
Immune response to the selected prostate cancer tumor-antigens
Antibody response specific to the PSMA antigen
Maximum observed plasma concentration of tremelimumab (Cmax)
Time to maximum concentration of tremelimumab (Tmax)
Area under the curve from time zero extrapolated to infinity of tremelimumab
Trough concentrations after multiple doses of tremelimumab (Ctrough)
Incidence and titers of anti-drug antibodies against tremelimumab
Incidence and titers of neutralizing antibodies against PF-06801591
Maximum observed plasma concentration of PF-06801591 (Cmax)
Time to maximum concentration of PF-06801591 (Tmax)
Area under the curve from time zero extrapolated to infinity of PF-06801591
Trough concentrations after multiple doses of PF-06801591 (Ctrough)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02616185
Brief Title
A Phase 1 Study To Evaluate Escalating Doses Of A Vaccine-Based Immunotherapy Regimen For Prostate Cancer (PrCa VBIR)
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Terminated
Why 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.
Study Start Date
December 30, 2015 (Actual)
Primary Completion Date
February 23, 2021 (Actual)
Study Completion Date
February 23, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Masking
None (Open Label)
Allocation
N/A
Enrollment
91 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dose Escalation
Arm Type
Experimental
Arm Description
PF-06753512
Intervention Type
Biological
Intervention Name(s)
PF-06755992
Other Intervention Name(s)
AdC68
Intervention Description
PF-06755992 will be administered on Day 1 of Cycles 1 and 2.
Intervention Type
Biological
Intervention Name(s)
PF-06755990
Other Intervention Name(s)
pDNA
Intervention Description
PF-06755990 will be administered using a device on Day 29, 57 and 85 of each cycle.
Intervention Type
Device
Intervention Name(s)
TDS-IM Electroporation Device
Intervention Description
TDS-IM electroporation device and associated supplies will be used for PF-06755990 administration
Intervention Type
Biological
Intervention Name(s)
Tremelimumab
Other Intervention Name(s)
PF-06753388
Intervention Description
PF-06753388 will be administered every 28 days.
Intervention Type
Biological
Intervention Name(s)
PF-06801591
Intervention Description
PF-06801591 will be administered every 28 days.
Intervention Type
Biological
Intervention Name(s)
PF-06753512
Other Intervention Name(s)
VBIR-1 or PrCa VBIR
Intervention Description
Combination of adenovirus (AdC68) + plasmid DNA (pDNA) + tremelimumab
Primary Outcome Measure Information:
Title
Part A. Incidence and grade of treatment-emergent adverse events including DLTs
Description
DLTs in order to determine the maximum tolerated dose and safety beyond DLT assessment period
Time Frame
Baseline for up to 3 years
Secondary Outcome Measure Information:
Title
Immune response to the selected prostate cancer tumor-antigens
Time Frame
Baseline up to Cycle 1 Day 85; Day 1, Day 29 and Day 99 of Cycle 2; every 6 months thereafter up to 3 years
Title
Antibody response specific to the PSMA antigen
Time Frame
Baseline up to Cycle 1 Day 85; Day 1 and Day 99 of Cycle 2; every 4 months thereafter for up to 3 years
Title
Maximum observed plasma concentration of tremelimumab (Cmax)
Time Frame
Pre-dose on Day 1, Day 3, Day 8, Day 15, Day 22, Day 29, Day 57 and Day 85 of Cycle 1; pre-dose on Day 2 and Day 29 of Cycle 2; every 4 months thereafter for up to 3 years
Title
Time to maximum concentration of tremelimumab (Tmax)
Time Frame
Pre-dose on Day 1, Day 3, Day 8, Day 15, Day 22, Day 29, Day 57 and Day 85 of Cycle 1; pre-dose on Day 2 and Day 29 of Cycle 2; every 4 months thereafter for up to 3 years
Title
Area under the curve from time zero extrapolated to infinity of tremelimumab
Time Frame
Pre-dose on Day 1, Day 3, Day 8, Day 15, Day 22, Day 29, Day 57 and Day 85 of Cycle 1; pre-dose on Day 2 and Day 29 of Cycle 2; every 4 months thereafter for up to 3 years
Title
Trough concentrations after multiple doses of tremelimumab (Ctrough)
Time Frame
Pre-dose on Day 1, Day 3, Day 8, Day 15, Day 22, Day 29, Day 57 and Day 85 of Cycle 1; pre-dose on Day 2 and Day 29 of Cycle 2; every 4 months thereafter for up to 3 years
Title
Incidence and titers of anti-drug antibodies against tremelimumab
Time Frame
Day 1, Day 29, and Day 85 of Cycle 1 (each Cycle is 16 weeks); Day 29 of Cycle 2; every 4 months thereafter for up to 3 years
Title
Incidence and titers of neutralizing antibodies against PF-06801591
Time Frame
Day 1, Day 29 and Day 85 of Cycle 1 (each Cycle is 16 weeks); Day 29 of Cycle 2; every 4 months thereafter for up to 3 years
Title
Maximum observed plasma concentration of PF-06801591 (Cmax)
Time Frame
Pre-dose on Day 1, Day 3, Day 8, Day 15, Day 22, Day 29, Day 57, Day 85 of Cycle 1 (each Cycle is 16 weeks); pre-dose on Day 1 and Day 29 of Cycle 2; every 4 months thereafter for up to 3 years
Title
Time to maximum concentration of PF-06801591 (Tmax)
Time Frame
Pre-dose on Day 1, Day 3, Day 8, Day 15, Day 22, Day 29, Day 57, Day 85 of Cycle 1 (each Cycle is 16 weeks); pre-dose on Day 1 and Day 29 of Cycle 2; every 4 months thereafter for up to 3 years
Title
Area under the curve from time zero extrapolated to infinity of PF-06801591
Time Frame
Pre-dose on Day 1, Day 3, Day 8, Day 15, Day 22, Day 29, Day 57, Day 85 of Cycle 1 (each Cycle is 16 weeks); pre-dose on Day 1 and Day 29 of Cycle 2; every 4 months thereafter for up to 3 years
Title
Trough concentrations after multiple doses of PF-06801591 (Ctrough)
Time Frame
Pre-dose on Day 1, Day 3, Day 8, Day 15, Day 22, Day 29, Day 57, Day 85 of Cycle 1 (each Cycle is 16 weeks); pre-dose on Day 1 and Day 29 of Cycle 2; every 4 months thereafter for up to 3 years
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Banner-University Medical Center Tucson
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Facility Name
The University of Arizona Cancer Center-North Campus
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Facility Name
Smilow Cancer Hospital at Yale-New Haven
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Smilow Cancer Hospital Phase 1 Unit
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
National Institutes of Health Clinical Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
Facility Name
GU Research Network
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Facility Name
Garden State Urology
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
Morristown Medical Center
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
Garden State Urology
City
Rockaway
State/Province
New Jersey
ZIP/Postal Code
07866
Country
United States
Facility Name
Garden State Urology
City
Whippany
State/Province
New Jersey
ZIP/Postal Code
07981
Country
United States
Facility Name
Northwell Health
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center 53rd Street
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center, Sidney Kimmel Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
UPMC Hillman Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
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.
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B7791001
Description
To obtain contact information for a study center near you, click here.
Learn more about this trial
A Phase 1 Study To Evaluate Escalating Doses Of A Vaccine-Based Immunotherapy Regimen For Prostate Cancer (PrCa VBIR)
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