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A Phase 1 Study To Evaluate Escalating Doses Of A Vaccine-Based Immunotherapy Regimen For Prostate Cancer (PrCa VBIR)

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ClinicalTrials.gov Identifier: NCT02616185
Recruitment Status : Completed
First Posted : November 26, 2015
Last Update Posted : March 9, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE November 24, 2015
First Posted Date  ICMJE November 26, 2015
Last Update Posted Date March 9, 2021
Actual Study Start Date  ICMJE December 30, 2015
Actual Primary Completion Date February 10, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 30, 2020)
Part A. Incidence and grade of treatment-emergent adverse events including DLTs [ Time Frame: Baseline for up to 3 years ]
DLTs in order to determine the maximum tolerated dose and safety beyond DLT assessment period
Original Primary Outcome Measures  ICMJE
 (submitted: November 24, 2015)
Incidence and grade of treatment-emergent adverse events including DLTs [ Time Frame: Baseline up to Day 29 ]
DLTs in order to determine the maximum tolerated dose
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2020)
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 24, 2015)
  • Immune response to the selected prostate cancer tumor-antigens [ Time Frame: Baseline up to Cycle 1 Day 85 and then every 29 and 99 days thereafter up to 3 years ]
  • Antibody response specific to the PSMA antigen [ Time Frame: Baseline up to Cycle 1 Day 85 and then every 29 and 99 days thereafter up to 3 years ]
  • Maximum observed plasma concentration of tremelimumab (Cmax) [ Time Frame: Pre-dose on Day 1, Day 29, Day 85 of Cycle 1; pre-dose on Day 29 of Cycle 2 and subsequent cycle up to 3 years ]
  • Time to maximum concentration of tremelimumab (Tmax) [ Time Frame: Pre-dose on Day 1, Day 29, Day 85 of Cycle 1; pre-dose on Day 29 of Cycle 2 and subsequent cycle up to 3 years ]
  • Area under the curve from time zero extrapolated to infinity of tremelimumab [ Time Frame: Pre-dose on Day 1, Day 29, Day 85 of Cycle 1; pre-dose on Day 29 of Cycle 2 and subsequent cycle up to 3 years ]
  • Trough concentrations after multiple doses of tremelimumab (Ctrough) [ Time Frame: Pre-dose on Day 1, Day 29, Day 85 of Cycle 1; pre-dose on Day 29 of Cycle 2 and subsequent cycle up to 3 years ]
  • Incidence and titers of anti-drug antibodies against tremelimumab [ Time Frame: From baseline up to Cycle 1 Day 85 and then on Day 1 and Day 29 of each cycle thereafter up to 3 years ]
  • Maximum observed plasma concentration of sunitinib (Cmax) [ Time Frame: Day -15, Day -1 at 0 hour, 2, 4 and any time between 6 to 12 hours after sunitinib dosing; Day 1 and Day 29 of Cycle 1; Day 29 of Cycle 2 and subsequent cycles up to 3 years ]
  • Time to maximum concentration of sunitinib (Tmax) [ Time Frame: Day -15, Day -1 at 0 hour, 2, 4 and any time between 6 to 12 hours after sunitinib dosing; Day 1 and Day 29 of Cycle 1; Day 29 of Cycle 2 and subsequent cycles up to 3 years ]
  • Steady state area under the curve during one dose interval of sunitinib (AUCtau) [ Time Frame: Day -15, Day -1 at 0 hour, 2, 4 and any time between 6 to 12 hours after sunitinib dosing; Day 1 and Day 29 of Cycle 1; Day 29 of Cycle 2 and subsequent cycles up to 3 years ]
  • Incidence and titers of neutralizing antibodies against tremelimumab [ Time Frame: From baseline up to Cycle 1 Day 85 and then on Day 1 and Day 29 of each cycle thereafter up to 3 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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
  • Biological: PF-06755992
    PF-06755992 will be administered on Day 1 of Cycles 1 and 2.
    Other Name: AdC68
  • Biological: PF-06755990
    PF-06755990 will be administered using a device on Day 29, 57 and 85 of each cycle.
    Other Name: pDNA
  • Device: TDS-IM Electroporation Device
    TDS-IM electroporation device and associated supplies will be used for PF-06755990 administration
  • Biological: Tremelimumab
    PF-06753388 will be administered every 28 days.
    Other Name: PF-06753388
  • Biological: PF-06801591
    PF-06801591 will be administered every 28 days.
  • Biological: PF-06753512
    Combination of adenovirus (AdC68) + plasmid DNA (pDNA) + tremelimumab
    Other Name: VBIR-1 or PrCa VBIR
Study Arms  ICMJE Experimental: Dose Escalation
PF-06753512
Interventions:
  • Biological: PF-06755992
  • Biological: PF-06755990
  • Device: TDS-IM Electroporation Device
  • Biological: Tremelimumab
  • Biological: PF-06801591
  • Biological: PF-06753512
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 Completed
Actual Enrollment  ICMJE
 (submitted: March 5, 2021)
91
Original Estimated Enrollment  ICMJE
 (submitted: November 24, 2015)
78
Actual Study Completion Date  ICMJE February 10, 2021
Actual Primary Completion Date February 10, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
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
Plan to Share IPD: No
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.
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP