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

PHASE1CompletedINTERVENTIONAL
Enrollment

37

Participants

Timeline

Start Date

February 6, 2017

Primary Completion Date

December 31, 2020

Study Completion Date

December 31, 2020

Conditions
Prostate Cancer Metastatic
Interventions
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)

Trial Locations (3)

90292

Prostate Oncology Specialists, Inc., Marina del Rey

91010

City of Hope National Medical Center, Duarte

96813

University of Hawaii Cancer Center, Honolulu

Sponsors

Collaborators (2)

All Listed Sponsors
collaborator

Genentech, Inc.

INDUSTRY

collaborator

Dendreon

INDUSTRY

lead

University of Hawaii

OTHER