NCT03024216

Clinical Study of Atezolizumab (Anti-PD-L1) and Sipuleucel-T in Patients With Asymptomatic or Minimally Symptomatic Metastatic Castrate Resistant Prostate Cancer

Phase Ib Study Assessing Different Sequencing Regimens of Atezolizumab (Anti-PD-L1) and Sipuleucel-T in Patients Who Have Asymptomatic or Minimally Symptomatic Metastatic Castrate Resistant Prostate Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: University of Hawaii · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to compare the safety and tolerability of sequential atezolizumab followed by sipuleucel-T (Arm 1) vs. sipuleucel-T followed by atezolizumab (Arm 2) in patients who have asymptomatic or minimally symptomatic metastatic CRPC, not previously treated with docetaxel or cabazitaxel.

Conditions

• Prostate Cancer Metastatic

Interventions

Type	Name	Description
DRUG	Atezolizumab1200 mg IV	Subjects in ARM 1 will receive 2 doses of atezolizumab 1200 mg intravenously (week 1 and week 4). If no dose limiting toxicity continue onto maintenance, week 13 and receive atezolizumab 1200 mg intravenously every 3 weeks until toxicities or lack of clinical benefit. Subjects in ARM 2 will receive 2 doses at approximately 3 weeks each of atezolizumab 1200 mg intravenously (weeks 7 and 10). If no dose limiting toxicity, continue to receive atezolizumab 1200 mg intravenously every 3 weeks, starting week 13, until toxicities or lack of clinical benefit.
DRUG	Sipuleucel-T	Subjects in ARM 1 will receive sipuleucel-T administered in 3 doses at approximately 2-week intervals (weeks 6, 8, 10). Subjects in ARM 2 will receive sipuleucel-T administered in 3 doses at approximately 2-week intervals (weeks 1, 3 and 5)

Timeline

• Start date: 2017-02-06
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2017-01-18
• Last updated: 2021-05-26

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study