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

• Status: Recruiting
• Trial end date: 0000-00-00
• Target enrollment: 108
• Participant gender: Male

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Sunitinib; Tremelimumab
• Last Updated: 2016-12-07

Criteria

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

• Progressive disease post-surgical castration or during androgen suppression therapy (pre-secondary hormone CRPC) OR

• Failed prior therapy with a secondary hormone (e.g. enzalutamide, abiraterone) with documented progressive disease (post-secondary hormone CRPC)

Exclusion Criteria:

• Cancer-related pain requiring scheduled opioid narcotics for control

• ECOG performance status greater than or equal to 2

• Concurrent immunotherapy for prostate cancer

• History of or active autoimmune disorders or history of inflammatory bowel disorders

• 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 pre-secondary hormone patients, no prior or concurrent treatment with a secondary hormone (e.g. enzalutamide, abiraterone) and no metastasis to organ systems other than lymph nodes and/or bone

• For post-secondary hormone patients, no concurrent treatment with a secondary hormone (e.g. enzalutamide, abiraterone), no metastasis to the liver or brain