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

Part of paid clinical trials in Duarte, California.

Sponsor
University of Hawaii
Study ID
NCT03024216
Phase
PHASE1
Status
Completed

Conditions

  • Prostate Cancer Metastatic

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab1200 mg IV — DRUG
    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.
  • Sipuleucel-T — DRUG
    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)

Study Details

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.

Key Dates

Start date
Feb 6, 2017
Status verified
May 2021
Primary completion
Dec 31, 2020
Completion
Dec 31, 2020

Study Design

Enrollment
37 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
    Atezolizumab1200 mg IV week 1 and week 4 followed by Sipuleucel-T administered weeks 6, 8, and 10
  • Experimental: Arm 2
    Sipuleucel-T administered week 1, 3, and 5 followed by Atezolizumab1200 mg IV weeks 7 and 10

Primary Outcome Measure

Assessment of AE by CTCAE v4.0 [ Time Frame: 12 months ]

Locations (3)

FacilityCityStateZIPSite coordinators
City of Hope National Medical CenterDuarteCalifornia91010-
Prostate Oncology Specialists, Inc.Marina del ReyCalifornia90292-
University of Hawaii Cancer CenterHonoluluHawaii96813-

Find similar trials in Duarte, CA

By research site
City of Hope National Medical Center· Duarte, CAProstate Oncology Specialists, Inc.· Marina del Rey, CAUniversity of Hawaii Cancer Center· Honolulu, HI

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