Safety and Tolerability of Atezolizumab (ATZ) in Combination With Radium-223 Dichloride (R-223-D) in Metastatic Castrate-Resistant Prostate Cancer (CRPC) Progressed Following Treatment With an Androgen Pathway Inhibitor

Completed · Phase 1

Conditions studied: Castrate-Resistant Prostate Cancer

In brief

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. This adaptive design study includes a cohort phase and a potential randomization phase. An initial concurrent dosing evaluation will evaluate the safety and tolerability of a treatment regimen that employs a concurrent start time for atezolizumab and radium-223 dichloride (Cohort 1). If concurrent dosing is found to be safe and tolerable in Cohort 1, additional participants will be enrolled and eligible participants will be randomized in a 1:1:1 ratio to Arms A, B, and C. If concurrent dosing is not tolerated in Cohort 1, new participants will be enrolled in a staggered dosing evaluation: Cohort 2 (28-day radium-223 dichloride run-in, atezolizumab will begin on Day 1 of Cycle 2) and Cohort 3 (56-day radium-223 dichloride run-in, atezolizumab will begin on Day 1 of Cycle 3). If the Cohort 2 schedule is tolerable, then additional participants will be enrolled using this treatment schedule; If the Cohort 2 schedule is not tolerable, subsequent participants will be enrolled in Cohort 3. If the Cohort 3 schedule is tolerable, then additional participants will be enrolled using this treatment schedule. If Cohort 3 schedule is not tolerable, no additional participant will be enrolled in the study.

Key facts

Study ID: NCT02814669
Run by: Hoffmann-La Roche
People needed: 45
Starts: 2016-09-23
Expected to finish: 2019-07-31
Last updated by the study team: 2019-09-24

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Life expectancy greater than or equal to (>/=) 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
Participants receiving bisphosphonate or denosumab therapy must have been on a stable dose for at least 4 weeks
Visceral metastasis and/or lymphadenopathy
Tumors that are amenable to serial biopsy
Disease progression according to Prostate Cancer Working Group 2 (PCWG2) criteria during or following treatment with at least one second generation androgen pathway inhibitor (for example, enzalutamide, abiraterone) for metastatic prostate cancer
Adequate hematologic and end-organ function
One prior taxane-containing regimen for mCRPC, or refusal or ineligibility of a taxane-containing regimen

You may not qualify if…

History of small-cell or neuroendocrine prostate carcinoma
Treatment with approved anti-cancer therapy (with the exception of abiraterone) within 3 weeks of study drug. Abiraterone must not be administered within 2 weeks prior to initiation of study treatment
Participation in another clinical trial/investigation within 28 days prior to study drug
Brain metastases or active leptomeningeal disease (with the exception of participants with treated epidural disease and no other epidural progression)
Uncontrolled tumor-related pain
Uncontrolled hypercalcemia
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 treatment with cluster of differentiation (CD) 137 agonist, anti-programmed death (PD) 1, or anti-programmed death ligand (PD-L) 1 therapeutic antibody or pathway-targeting agents
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 initiation of study treatment
Spinal compression or structurally unstable bone lesions suggesting impending pathologic fractures based on clinical findings and/or magnetic resonance imaging (MRI)
Bone marrow dysplasia
Unmanageable fecal incontinence

Where it is running

City of Hope — Duarte, California, United States
University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center — San Francisco, California, United States
Yale School of Medicine — New Haven, Connecticut, United States
Georgetown University Medical Center — Washington D.C., District of Columbia, United States
Mayo Clinic Hospital - Florida — Jacksonville, Florida, United States
Indiana University Health Melvin & Bren Simon Cancer Center — Indianapolis, Indiana, United States
Tulane University School of Medicine — New Orleans, Louisiana, United States
University of Michigan Comprehensive Cancer Center — Ann Arbor, Michigan, United States
Karmanos Cancer Institute — Detroit, Michigan, United States
Mayo Clinic - Minnesota — Rochester, Minnesota, United States
Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley — Las Vegas, Nevada, United States
Memorial Sloan-Kettering Cancer Center — Commack, New York, United States
Duke University Hospital — Durham, North Carolina, United States
Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States
University of Pittsburgh - Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
Vanderbilt University Medical Center — Nashville, Tennessee, United States
University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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