This study will enrol patients with maximally resected (via transurethral resection (TURBT)
non-metastatic muscle invasive bladder cancer, who either wish to attempt bladder
preservation therapy or are ineligible for cystectomy. Patients must have adequate organ
function and performance status to receive cisplatin based chemoradiotherapy, and no
contraindications to the use of pembrolizumab. The study will enrol 30 patients to be treated
with pembrolizumab and radiotherapy.
All patients will be planned to be treated with 64Gy of radiation therapy in 32 fractions
over 6 weeks and 2 days. All patients will receive cisplatin 35mg/m2 IV concurrently weekly
with radiation therapy for 6 doses total. Pembrolizumab will commence concurrently with
radiation and be given 200mg IV every 21 days, continuing until the 12 week cystoscopy and
Surveillance cystoscopy will be performed 12 weeks after the commencement of
chemoradiotherapy, and assess the rate of complete response to therapy. A safety follow up
visit will occur 4 and 12 weeks post cystoscopy. From week 31 survival follow up will
commence with clinical assessment, cystoscopy and CT staging performed at intervals until 5
The objective of the study is to assess the safety and feasibility of combining pembrolizumab
with chemoradiotherapy. The primary endpoint assessed will be safety, as defined by a
satisfactorily low rate of unacceptable toxicity (G3-4 adverse events or failure of
completion of planned chemotherapy and radiotherapy according to defined parameters). The
secondary endpoint will be efficacy, as assessed by complete response rate of the primary
tumour at first post chemoradiotherapy cystoscopic assessment. Exploratory analysis will
include assessment of tumour histopathological, molecular, genetic and immunological
It is expected that it will take two years to accrue the required 30 patients.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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