Metastatic Castration-Resistant Prostrate Cancer (mCRPC) MedDRA version: 21.1 Level: PT Classification code 10036909 Term: Prostate cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.1 Level: LLT Classification code 10076506 Term: Castration-resistant prostate cancer
Conditions
Interventions
Product Name: Atezolizumab
Product Code: RO5541267
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: ATEZOLIZUMAB
Current
Sponsors
F. Hoffman-La Roche Ltd.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - Eastern Cooperative Oncology Group performance status of 0 or 1 - Life expectancy >= 3 months - Histologically confirmed adenocarcinoma of the prostate - Progressive, castrate-resistant disease prior to screening by prostate-specific antigen (PSA) or imaging per prostate cancer working group 3 (PCWG3) criteria during or following the direct prior line of therapy in the setting of medical or surgical castration - One prior regimen/line of a taxane-containing regimen for mCRPC or refusal or ineligibility of a taxane-containing regimen - Progression on prior regimen/line of an androgen synthesis inhibitor for prostate cancer - Availability of a representative tumor specimen from a site not previously irradiated that is suitable for determination of programmed death ligand 1 (PD L1) status via central testing - Adequate hematologic and end organ function Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 186 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 585
Exclusion criteria
Exclusion criteria: Cancer-specific exclusions -Prior treatment with enzalutamide or any other newer hormonal androgen receptor inhivitor (e.g. apalutamide, ODM 201) -Treatment with any approved anti-cancer therapy, including chemotherapy, immunotherapy, radiopharmaceutical or hormonal therapy (with the exception of abiraterone), within 4 weeks prior to initiation of study treatment - Treatment with abiraterone within 2 weeks prior to study treatment - Structurally unstable bone lesions suggesting impending fracture - Known or suspected brain metastasis or active leptomeningeal disease General medical exclusions - Major surgical procedure other than for diagnosis within 4 weeks prior to initiation of study treatment or anticipation of need for a major surgical procedure during the course of the study Exclusion criteria related to atezolizumab - Active or history of autoimmune disease or immune deficiency - Prior allogeneic stem cell or solid organ transplantation - History of pulmonary fibrosis/inflammation - Positive HIV test, active hepatitis B or C virus infection, or active tuberculosis - Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti Cytotoxic T Lymphocyte-Associated (CTLA) 4, anti programmed death 1 (PD 1), and anti PD L1 therapeutic antibodies - Treatment with systemic immunostimulatory agents within 4 weeks or five half-lives of the drug, whichever is shorter, prior to initiation of study treatment - Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study Exclusion criteria related to enzalutamide - History of seizure or any condition that may predispose to seizure within 12 months prior to study treatment including history of unexplained loss of consciousness or transient ischemic attack within 12 months prior to study treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of atezolizumab/enzalutamide compared with enzalutamide alone; Secondary Objective: To evaluate the efficacy of atezolizumab/enzalutamide compared with enzalutamide alone To evaluate the safety and tolerability of atezolizumab/enzalutamide compared with enzalutamide alone To characterize the pharmacokinetics (PK)of atezolizumab when given in combination with enzalutamide To characterize the PK of enzalutamide and its active metabolite N-desmethyl enzalutamide when enzalutamide is administered alone or in combination with atezolizumab To evaluate the immune response to atezolizumab ;Primary end point(s): 1. Overall survival (OS);Timepoint(s) of evaluation of this end point: 1. Up to approximately 42 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Time to first symptomatic skeletal event 2. Radiographic progression-free survival (rPFS), as assessed by the investigator and adapted from the PCWG3 criteria 3. PSA response rate 4. Time to PSA progression 5. Objective response rate determined by the investigator through use of PCWG3 criteria and immune modified response evaluation criteria in solid tumors criteria 6. Incidence, nature, frequency, and severity of adverse events, with severity determined through use of the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4 7. Serum concentration of atezolizumab at specified timepoints 8. Plasma concentration of enzalutamide and N-desmethyl enzalutamide at specified timepoints in the safety run in phase and in a PK cohort in the randomized phase 9. Incidence of anti-therapeutic antibodies (ATAs) against atezolizumab ; Timepoint(s) of evaluation of this end point: 1-6. Up to approximately 42 months 7. Cycle (C) 1 Day (D) 1, C2D1, C3D1, C4D1, C8D1, C12D1, C16D1; at atezolizumab discontinuation visit; and 120 days after last dose of atezolizumab 8. C1D1, C3D1, and C8D1 9. C1D1, C2D1, C3D1, C4D1, C8D1, C12D1, C16D1; at atezolizumab discontinuation visit; and 120 days after last dose of atezolizumab | — |
Countries
Australia, Austria, Belgium, Canada, China, Czech Republic, Denmark, European Union, France, Germany, Greece, Hungary, Italy, Japan, Korea, Republic of, Poland, Russian Federation, Spain, Switzerland, Taiwan, United Kingdom, United States
Contacts
Public ContactTrial Information Support Line-TISL
F.Hoffmann-La Roche Ltd.
Outcome results
None listed