A Phase III, Open Label, Randomised, Controlled, Multi-Centre Study To Assess the Efficacy and Safety of Savolitinib Versus Sunitinib in Patients With MET-Driven, Unresectable and Locally Advanced, Or Metastatic Papillary Renal Cell Carcinoma (PRCC)

Status: 
Recruiting
Sponsor: 
AstraZeneca + Hutchinson MediPharma
Enrollment: 
180
Study Design: 
This is a phase III, open label, randomised, multicentre study investigating the efficacy and safety of savolitinib compared to sunitinib in patients with MET-driven, unresectable and locally advanced or metastatic papillary renal cell carcinoma (pRCC). Patients can have had treatment previously (not sunitinib or MET inhibitors) or be treatment naïve.
Rationale: 
pRCC carries a poor prognosis and typically responds less well to standard therapies than clear cell RCC. It is frequently excluded from large scale clinical trials and as such there is little data on the use of specific therapies in this patient population. A single arm phase II study (NCT02127710) evaluating savolitinib, a new MET inhibitor, in pRCC showed an overall response rate of 7% with good tolerability. The response rate was better in those patients with MET-driven tumours irrespective of pathological classification.
Endpoints: 
The primary endpoint for this study is progression free survival (PFS) defined as the time from randomisation to progression or death. There are several secondary endpoints in this study including overall survival (OS), defined as time from randomisation to death by any cause; objective response rate including all patients with complete or partial responses based on RECIST 1.1 criteria; the duration of any response achieved and the disease control rate (number of patients achieving complete or partial responses or stable disease according to RECIST 1.1).
Results: 
No results are currently available.
Comments: 
Papillary cell cancer is poorly represented in clinical trials and the inclusion of patients with papillary cell cancer in this trial provides an interesting option for a difficult to treat subtype of RCC. Standard therapies have typically performed poorly in pRCC and savolitinib may provide a more effective and well tolerated option for MET-driven pRCC.