Savolitinib Plus Durvalumab Versus Sunitinib and Durvalumab Monotherapy in MET-Driven, Unresectable and Locally Advanced or Metastatic PRCC
- Conditions
- Papillary Renal Cell Carcinoma
- Registration Number
- NCT05043090
- Lead Sponsor
- AstraZeneca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Histologically confirmed unresectable and locally advanced or metastatic PRCC<br><br> - PRCC must be centrally confirmed as MET-driven using a sponsor-designated central<br> laboratory validated NGS assay<br><br> - No prior systemic anti-cancer treatment in the metastatic setting; no prior exposure<br> to MET inhibitors, Durvalumab or Sunitinib in any setting<br><br> - Karnofsky Score >70<br><br> - At least one lesion, not previously irradiated, that can be accurately measured at<br> baseline<br><br> - Adequate organ and bone marrow function<br><br> - Life expectancy =12weeks at Day 1<br><br>Exclusion Criteria:<br><br> - History of liver cirrhosis of any origin and clinical stage; or history of other<br> serious liver disease or chronic disease with relevant liver involvement, with or<br> without normal LFTs<br><br> - Spinal cord compression or brain metastases, unless asymptomatic and stable on<br> treatment for at least 14 days prior to study intervention<br><br> - Active or prior cardiac disease (within past 6 months) or clinically significant ECG<br> abnormalities and/or factors/medications that may affect QT and/or QTc intervals<br><br> - Active infection including HIV, TB, HBV and HCV<br><br> - Active or prior documented autoimmune or inflammatory disorders<br><br> - Receipt of live attenuated vaccine within 30 days prior to the first dose of study<br> intervention
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-Free Survival (PFS) /savolitinib plus durvalumab relative to sunitinib
- Secondary Outcome Measures
Name Time Method