| Methods |
Study type: RCT, phase III, parallel assignment
Blinding: no, open‐label
Accrual period: October 28, 2021 ‐ June 9, 2025 (estimated study completion date)
Countries: multicentre (172 locations in the USA, Argentina, Australia, Brazil, Canada, Chile, Czech Republic, France, Germany, China, India, Isreal, Italy, Korea, Mexico, the Netherlands, Poland, Romania, Russia, Singapore, Spain, Taiwan, Turkey, Ukraine, the UK)
Cross‐over study: no
Status: recruiting (as of May 17, 2022) |
| Participants |
Estimated enrolment: N=220
Inclusion criteria:
histologically confirmed unresectable and locally advanced or metastatic PRCC PRCC must be centrally confirmed as MET‐driven using a sponsor‐designated central laboratory validated NGS assay No prior systemic anti‐cancer treatment in the metastatic setting; no prior exposure to MET inhibitors, Durvalumab or Sunitinib in any setting Karnofsky Score >70 at least one lesion, not previously irradiated, that can be accurately measured at baseline adequate organ and bone marrow function ;life expectancy ≥12weeks at Day 1
Exclusion criteria:
history of liver cirrhosis of any origin and clinical stage; or history of other serious liver disease or chronic disease with relevant liver involvement, with or without normal LFTs spinal cord compression or brain metastases, unless asymptomatic and stable on treatment for at least 14 days prior to study intervention active or prior cardiac disease (within past 6 months) or clinically significant ECG abnormalities and/or factors/medications that may affect QT and/or QTc intervals active infection including HIV, TB, HBV and HCV active or prior documented autoimmune or inflammatory disorders receipt of live attenuated vaccine within 30 days prior to the first dose of study intervention
|
| Outcomes |
Primary outcome(s) :
PFS assessed by BICR ‐ savolitinib plus durvalumab relative to sunitinib (time frame: approximately 28 months post first participant randomised) OS ‐ savolitinib plus durvalumab relative to sunitinib (time frame: approximately 28 months and approximately 42 months post first participant randomised)
Secondary outcome(s):
PFS assessed by BICR ‐ savolitinib plus durvalumab relative to durvalumab monotherapy (time frame: approximately 28 months post first participant randomised) Assessment of patient‐reported symptoms, functioning, and HRQoL
Relevant to this review but not reported: TFST, AEs, SAEs, number of participants who discontinued treatment due to an AE
Other outcomes (not relevant to this review): ORR, DoR, DCR |
