WO29637. A Study of anti PD-L1 Antibody in Renal Cell Carcinoma (RCC)
Research type
Research Study
Full title
A PHASE III, OPEN-LABEL, RANDOMIZED STUDY OF MPDL3280A (Anti PD-L1 ANTIBODY) IN COMBINATION WITH BEVACIZUMAB VERSUS SUNITINIB IN PATIENTS WITH UNTREATED ADVANCED RENAL CELL CARCINOMA
IRAS ID
171318
Contact name
Thomas Powles
Contact email
Sponsor organisation
F Hoffmann-La Roche Ltd
Eudract number
2014-004684-20
Duration of Study in the UK
3 years, 7 months, 4 days
Research summary
Summary of Research
Metastatic renal cell carcinoma (RCC) is the most lethal urologic cancer and the sixth leading cause of cancer deaths in industrialised countries. It was estimated there were 337,860 new diagnoses and approximately 143,369 deaths secondary to RCC worldwide in 2012.
Cytotoxic chemotherapy and radiotherapy have been largely ineffective for treatment of metastatic RCC. Several agents that target growth signals involved in RCC such as the VEGF pathway (sunitinib, pazopanib, axitinib, bevacizumab) and mTor pathway inhibitors (temsirolimus, everolimus) are approved in the treatment of RCC. However, approved therapies in first-line metastatic setting are associated with significant adverse events and do not result in a sustained, durable clinical benefit.
Immunotherapy historically has had a significant role in the management of metastatic RCC. MPDL3280A, an experimental immune modulator, has demonstrated anti-tumour activity in early-stage clinical studies in metastatic RCC as a single agent, as well as in combination with bevacizumab, a tumour growth factor suppressor.
The primary aim of the study is to look at whether MPDL3280A + bevacizumab is superior compared with sunitinib in participants with inoperable, locally advanced or metastatic renal cell carcinoma.
A total of approximately 550 participants will be recruited into this study globally. In the UK it is expected that 64 participants will be enrolled across 12 participating study centres.
Patients will be treated in 6 weekly (42 day) cycles. They will be randomly allocated (1:1) to:
Arm A - MPDL3280A (1200mg) + bevacizumab (15mg/kg) on days 1 and 21 of each cycle OR
Arm B - Sunitinib (50mg) daily for 4 weeks, followed by 2 weeks of rest.
In the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression patients will receive MPDL3280A and/or bevacizumab or sunitinib as long as they continue to experience clinical benefit in the opinion of the investigator.Summary of Results
for patients.roche.com/en/trials/cancer/rcc/a-study-of-atezolizumab-in-combination-with-bevacizumab-07419.html
REC name
London - Westminster Research Ethics Committee
REC reference
15/LO/0897
Date of REC Opinion
15 Jun 2015
REC opinion
Further Information Favourable Opinion