Skip to main content
Eligibility
for males ages 18 years and up
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:
Principal Investigator

Description

Summary

This study is designed to assess the safety and tolerability of atezolizumab when given in combination with radium-223 dichloride in participants with metastatic CRPC who have progressed after treatment with an androgen pathway inhibitor. An adaptive design is planned to first investigate the tolerability with concurrent administration (both treatments to begin in Cycle 1). However, if the combination is not tolerated, additional cohorts may be enrolled to evaluate the tolerability of radium-223 dichloride (to begin in Cycle 1) with delayed atezolizumab (to begin in Cycle 2 and/or 3).

Official Title

A Phase Ib, Open-Label Study of the Safety and Tolerability of Atezolizumab in Combination With Radium-223 Dichloride in Patients With Castrate-Resistant Prostate Cancer Who Have Progressed Following Treatment With an Androgen Pathway Inhibitor

Keywords

Castrate-Resistant Prostate Cancer Androgens Succinylcholine Radium Ra 223 dichloride Antibodies, Monoclonal

Eligibility

You can join if…

Open to males ages 18 years and up

  • Eastern Cooperative Oncology Group (ECOG) status of 0 or 1
  • Life expectancy>/=12 weeks
  • Histologically confirmed, castrate-resistant adenocarcinoma of the prostate
  • Measurable disease according to RECIST v1.1
  • Multiple bone metastases within 12 weeks prior to study drug
  • Visceral metastasis (excluding liver metastases) and/or lymphadenopathy>/=2 centimeters (cm) in short-axis diameter
  • Tumors that are amenable to serial biopsy
  • Disease progression according to PCWG2 criteria during or following treatment with an androgen pathway inhibitor (i.e., enzalutamide, abiraterone) for metastatic CRPC
  • Adequate hematologic and end-organ function

You CAN'T join if...

  • History of small-cell or neuroendocrine prostate carcinoma
  • Treatment with approved anti-cancer therapy within 3 weeks of study drug
  • Anti-androgen therapy within 6 weeks prior to study drug
  • Participation in another clinical trial/investigation within 28 days prior to study drug
  • Eligible for treatment with docetaxel, unless docetaxel was declined after an informed decision
  • Prior chemotherapy for treatment of CRPC, except when docetaxel has been given for hormone-sensitive prostate cancer
  • Brain metastases or active leptomeningeal disease
  • Uncontrolled tumor-related pain
  • Uncontrolled hypercalcemia or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab
  • Significant cardiovascular disease
  • History of autoimmune disease except controlled/treated hypothyroidism, type 1 diabetes mellitus, or certain skin disorders
  • Prior allogeneic stem cell or solid organ transplant
  • History of pulmonary fibrosis/inflammation, including active tuberculosis
  • Human immunodeficiency virus (HIV) or hepatitis B or C
  • Prior cluster of differentiation (CD) 137 agonist, anti-programmed death (PD) 1, or anti-programmed death ligand (PD-L) 1 therapeutic antibody
  • Immunostimulants within 4 weeks or immunosuppressants within 14 days prior to study drug
  • Prior radium-223 dichloride or hemibody external radiotherapy
  • Systemic strontium-89, samarium-153, rhenium-186, or rhenium-188 for bone metastases within 24 weeks prior to study drug
  • Spinal compression or pathologic fractures
  • Bone marrow dysplasia
  • Unmanageable fecal incontinence

Locations

  • City of Hope accepting new patients
    Duarte, California, 91010, USA

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Hoffmann-La Roche
ID
NCT02814669
Phase
Phase 1
Lead Scientist
Lawrence Fong
Study Type
Interventional
Last Updated
March 2017
I'm interested in this study!