A Study of Atezolizumab (Anti PD L1 Antibody) in Combination With Enzalutamide Versus Enzalutamide Alone in Patients With Metastatic Castration-Resistant Prostrate Cancer After Failure of an Androgen Synthesis Inhibitor And Failure of, Ineligibility For, or Refusal of a Taxane Regime
- Conditions
- Therapeutic area: Diseases [C] - Cancer [C04]Metastatic Castration-Resistant Prostrate Cancer (mCRPC)MedDRA version: 21.1Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: LLTClassification code 10076506Term: Castration-resistant prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- Registration Number
- EUCTR2016-003092-22-DE
- Lead Sponsor
- F. Hoffman-La Roche Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 771
- 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) yes
F.1.3.1 Number of subjects for this age range 585
Cancer-specific exclusions
- Prior treatment with enzalutamide or any other newer hormonal
androgen receptor inhibitor (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 unexplained loss of
consciousness or transient ischemic attack
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 <br>To evaluate the safety and tolerability of atezolizumab/enzalutamide compared with enzalutamide alone<br>To characterize the pharmacokinetics (PK)of atezolizumab when given in combination with enzalutamide<br>To characterize the PK of enzalutamide and its active metabolite N-desmethyl enzalutamide when enzalutamide is administered alone or in combination with atezolizumab<br>To evaluate the immune response to atezolizumab<br>;Primary end point(s): 1.Overall survival (OS);Timepoint(s) of evaluation of this end point: 1. Up to approximately 42 months
- Secondary Outcome Measures
Name Time Method