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Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Male
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Dose Escalation 		PF-06753512
  • Biological: PF-06755992
    PF-06755992 will be administered on Day 1 of Cycles 1 and 2.
    Other names:
    • AdC68
  • Biological: PF-06755990
    PF-06755990 will be administered using a device on Day 29, 57 and 85 of each cycle.
    Other names:
    • 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 names:
    • 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 names:
    • VBIR-1 or PrCa VBIR

More Details

Status
Terminated
Sponsor
Pfizer

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.