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Sponsor: Hoffmann-La Roche
Conditions: Castrate-Resistant Prostate Cancer
Interventions: Atezolizumab, Radium-223 Dichloride
Countries: United States
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.
Sex: MALE
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria: * 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 Exclusion Criteria: * 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
- Duarte, California, United States
- San Francisco, California, United States
- New Haven, Connecticut, United States
- Washington D.C., District of Columbia, United States
- Jacksonville, Florida, United States
- Indianapolis, Indiana, United States
- New Orleans, Louisiana, United States
- Ann Arbor, Michigan, United States
- Detroit, Michigan, United States
- Rochester, Minnesota, United States
- Las Vegas, Nevada, United States
- Commack, New York, United States
- Durham, North Carolina, United States
- Philadelphia, Pennsylvania, United States
- Pittsburgh, Pennsylvania, United States
- Nashville, Tennessee, United States
- Seattle, Washington, United States