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

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

  • Prostatic Neoplasms

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