Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bayer
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
Male subjects, aged \>/= 18 years
Subjects with histologically or cytologically proven advanced castration-resistant prostate cancer (CRPC)
* who failed at least 1 taxane regimen and are refractory to abiraterone and/or enzalutamide therapy OR
* who have actively refused any treatment which would be regarded standard.
Subjects should have undergone bilateral orchiectomy or should be on continuous androgen deprivation therapy with a gonadotropin releasing hormone agonist or antagonist.
Subjects must have shown progressive disease after discontinuation of anti-androgen therapy (i.e. flutamide, bicalutamide or nilutamide) before study drug treatment.
Total serum testosterone should be less than 50 ng/ml or 1.7 nmol/L
Evidence of progressive disease, defined as one or more (Prostate Cancer Working Group 2 (PCWG2) criteria):
PSA level of at least 2 ng/ml that has risen on at least 2 successive occasions at least 1 week apart
Nodal (in lymph nodes \>/= 2cm) or visceral progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST)
Appearance of one more new lesions in bone scan
Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2
Life expectancy of at least 3 months
You may not be if
Any anticancer therapy or immunotherapy within 4 weeks of start of first dose
Confirmed history or current autoimmune disease or other diseases resulting in permanent immunosuppression or requiring permanent immunosuppressive therapy
Prior radiotherapy (local palliative radiotherapy is permitted)
History of allergic reactions to monoclonal antibody therapy
History of clinical significant cardiac disease: including unstable angina, acute myocardial infarction within 6 months prior to first study treatment, congestive heart failure ≥New York Heart Association (NYHA) Class III), and arrhythmia requiring therapy except for beta-blockers, calcium channel blockers and digoxin or uncontrolled hypertension, despite optimal medical management
Clinically relevant findings in the electrocardiogram (ECG) such as a second- or third-degree AV block, prolongation of the QRS complex over 120 msec or of the QT interval corrected for heart rate (QTc)-interval over 450 msec
Current evidence or history of uncured (i.a. any absolute risk of latent infection) of hepatitis B or C or human immunodeficiency virus (HIV) infection
Chronic systemic corticosteroid therapy or any other immunosuppressive therapies should have been stopped at screening start
Seizure disorder requiring therapy (such as steroids or anti-epileptics)
Subjects unable to inject the study drug subcutaneously for intended s.c. application
Non-suitable for a central venous access for intended c.i.v. administration
