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

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Pfizer
Study ID
NCT02616185
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PF-06755992 — BIOLOGICAL
    PF-06755992 will be administered on Day 1 of Cycles 1 and 2.
  • PF-06755990 — BIOLOGICAL
    PF-06755990 will be administered using a device on Day 29, 57 and 85 of each cycle.
  • TDS-IM Electroporation Device — DEVICE
    TDS-IM electroporation device and associated supplies will be used for PF-06755990 administration
  • Tremelimumab — BIOLOGICAL
    PF-06753388 will be administered every 28 days.
  • PF-06801591 — BIOLOGICAL
    PF-06801591 will be administered every 28 days.
  • PF-06753512 — BIOLOGICAL
    Combination of adenovirus (AdC68) + plasmid DNA (pDNA) + tremelimumab

Study Details

The study will evaluate the safety, pharmacokinetics and pharmacodynamics of increasing doses of a vaccine-based immunotherapy regimen for patients with prostate cancer.

Key Dates

Start date
Dec 30, 2015
Status verified
Jan 2023
Primary completion
Feb 23, 2021
Completion
Feb 23, 2021

Study Design

Enrollment
91 participants (actual)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation
    PF-06753512

Primary Outcome Measure

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to 6 months after End of Treatment (EOT; 52 months in maximum) ]

Locations (19)

FacilityCityStateZIPSite coordinators
Banner-University Medical Center TucsonTucsonArizona85719-
The University of Arizona Cancer Center-North CampusTucsonArizona85719-
Smilow Cancer Hospital at Yale-New HavenNew HavenConnecticut06510-
Smilow Cancer Hospital Phase 1 UnitNew HavenConnecticut06511-
National Institutes of Health Clinical CenterBethesdaMaryland20892-
GU Research NetworkOmahaNebraska68130-
Comprehensive Cancer Centers of NevadaLas VegasNevada89169-
Garden State UrologyMorristownNew Jersey07960-
Morristown Medical CenterMorristownNew Jersey07960-
Garden State UrologyRockawayNew Jersey07866-
Garden State UrologyWhippanyNew Jersey07981-
Northwell HealthLake SuccessNew York11042-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Memorial Sloan-Kettering Cancer Center 53rd StreetNew YorkNew York10022-
Memorial Sloan-Kettering Cancer Center, Sidney Kimmel CenterNew YorkNew York10065-
Duke University Medical CenterDurhamNorth Carolina27710-
UPMC Hillman Cancer CenterPittsburghPennsylvania15232-
Seattle Cancer Care AllianceSeattleWashington98109-
University of Washington Medical CenterSeattleWashington98195-

Find similar trials in Tucson, AZ

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Banner-University Medical Center Tucson· Tucson, AZThe University of Arizona Cancer Center-North Campus· Tucson, AZSmilow Cancer Hospital at Yale-New Haven· New Haven, CTSmilow Cancer Hospital Phase 1 Unit· New Haven, CTNational Institutes of Health Clinical Center· Bethesda, MDGU Research Network· Omaha, NE

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