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

Pfizer

Status and phase: Terminated; Phase 1

Conditions: Prostatic Neoplasms

Treatments: Biological: PF-06755992; Biological: PF-06755990; Biological: PF-06801591; Device: TDS-IM Electroporation Device; Biological: Tremelimumab; Biological: PF-06753512

Study type: Interventional

Funder types: Industry

Identifiers

NCT02616185

B7791001

PRCA VBIR FIP STUDY (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 91 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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91 participants in 1 patient group

Dose Escalation

Experimental group

Description:

PF-06753512

Treatment:

Device: TDS-IM Electroporation Device

Biological: PF-06753512

Biological: Tremelimumab

Biological: PF-06755990

Biological: PF-06801591

Biological: PF-06755992