EURURO Vol. 72 No. 4

Study sponsored by Roche Date of Prep: January 2017

RXUKPDGL00017

• Primary Endpoint:

Disease Free Survival (DFS)

• Secondary Endpoints:

Overall Survival, Disease-Specific Survival,

Distant Metastasis-Free Survival, NURFS (non-urinary tract recurrence-free

survival) and Safety Assessment (AEs)

Atezolizumab 1200mg IV q3W

for 16 cycles

Observation

Patients with histologically

confirmed muscle invasive UC

of the bladder or upper urinary

tract who have undergone

radical surgery with lymph

node dissection.

Key Inclusion/Exclusion Criteria

NOW RECRUITING GLOBALLY - IMvigor010 (WO29636) TRIAL:

ADJUVANT ATEZOLIZUMAB IN PATIENTS WITH HIGH-RISK

MUSCLE INVASIVE UROTHELIAL CARCINOMA AFTER

SURGICAL RESECTION

• Received surgical resection within

14 weeks prior to randomization

• No evidence of residual disease

• Centrally confirmed PD-L1 status;

patients with all levels of PD-L1 will

be eligible for the study, subject to

all other inclusion/exclusion criteria

being met

• High risk muscle invasive urothelial

carcinoma of the bladder or upper

urinary tract (i.e. renal pelvis or ureters)

• If no prior neoadjuvant chemotherapy

(NAC): pT3-T4 and/or pN+

• After prior NAC: pT2-4 and/or pN+

• Patients with no prior NAC must be

ineligible or refusing cisplatin-based

adjuvant chemotherapy

For further information on participating centres, please refer to

or contact the Roche TISL Line at

A global Phase III, open-label, randomized, controlled trial designed to

evaluate the efficacy and safety of adjuvant treatment with Atezolizumab

(MPDL3280A) compared with observation in patients muscle-invasive

UC who are at high risk for recurrence following radical resection.