CheckMate 275: study design
a
Patients were required to have an evaluable tumour tissue sample for PD-L1 expression testing at
screening, but were not excluded based on PD-L1 status
b
Patients could have been treated beyond progression under protocol-defined circumstances
Galsky et al. ESMO 2016
Primary
•
Estimate ORR based on BIRC
a
(RECIST v1.1) evaluation in all patients and
in patients with tumour PD-L1 expression
≥1% and ≥5%
Secondary and exploratory
•
Progression-free survival
•
Overall survival
•
Safety, quality of life, and biomarkers
associated with efficacy
Nivolumab 3mg/kg IV Q2W
N=270
Treat until progression
b
or unacceptable toxicity
•
Confirmed urothelial carcinoma of the renal pelvis, ureter, bladder, or urethra
•
Patients with mUC or surgically unresectable UC who had progressive disease despite ≥1
prior lines of chemotherapy (including a platinum-containing regimen) for metastatic disease
or recurrence within 1 year of completing prior platinum-based neoadjuvant or adjuvant
therapy
•
ECOG performance status of 0 or 1
•
Measurable disease (RECIST v1.1)
•
Evaluable tumour sample for PD-L1 expression
–
Tumour cell PD-L1 membrane expression was assessed at a central laboratory
(Dako PD-L1 immunohistochemical 28-8 pharmDx kit)
•
Metastatic or locally advanced mUC
•
Disease progression on a prior
platinum-based therapy
•
Evaluable PD-L1 tumour tissue sample
a
Blinded independent review committee (BIRC)
assessment of response using RECIST v1.1
