IMbassador250: A Study of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Enzalutamide in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) After Failure of an Androgen Synthesis Inhibitor And Failure of, Ineligibility For, or Refusal of a Taxane Regime
- Conditions
- Prostatic Neoplasms, Castration-Resistant
- Registration Number
- JPRN-jRCT2080223519
- Lead Sponsor
- CHUGAI PHARMACEUTICAL CO., LTD.
- Brief Summary
Addition of atezolizumab to enzalutamide did not prolong overall survival and progression-free survival in patients with mCRPC after failure of an androgen synthesis inhibitor (e.g., abiraterone) and failure of, ineligibility for, or refusal of a taxane regimen. The safety profile in this trial was consistent with the known safety profile of each individual treatment, and no new safety signals were observed.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- Male
- Target Recruitment
- 771
Eastern Cooperative Oncology Group performance status of 0 or 1
-Life expectancy greater than or equal to (>= 3) months
-Histologically confirmed adenocarcinoma of the prostate
-Known castrate-resistant disease with serum testosterone less than (<)50 nanogram per deciliter (ng/dL) with prior surgical castration or ongoing androgen deprivation for the duration of the study
-Progressive 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
-One prior regimen/line of an androgen synthesis inhibitor for PC
-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
-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
-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
-Active or history of autoimmune disease or immune deficiency
-Prior allogeneic stem cell or solid organ transplantation
-History of idiopathic pulmonary fibrosis/inflammation
-Positive human immunodeficiency virus (HIV) test, active tuberculosis, active hepatitis B or C virus (HCV) infection
-Prior treatment with cluster of differentiation (CD)137 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
-Prior treatment with enzalutamide or any other newer hormonal androgen receptor inhibitor
-History of seizure or any condition that may predispose to seizure including history of unexplained loss of consciousness or transient ischemic attack within 12 months prior to study treatment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>confirmatory<br>Overall survival (OS)<br><br>Observation
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>Observation,PCWG3 criteria,RECIST ver1.1,immuno-modified RECIST