A Phase III, Open Label, Randomised, 3 Arm, Multi Centre Study of Savolitinib plus Durvalumab versus Sunitinib and Durvalumab Monotherapy in Participants with MET Driven, Unresectable and Locally Advanced or Metastatic Papillary Renal Cell Carcinoma (PRCC)

Phase 3

Recruiting

Conditions: 10038430
Renal tumour
10038364

Registration Number: NL-OMON54072

Lead Sponsor: Astra Zeneca

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 14

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 serious liver disease, with or without, normal LFTs, such as
cirrhosis or Wilson*s disease
• 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Endpoint:<br /><br>- Progression-Free Survival<br /><br><br /><br>More details see protocol v1.0 par 9.5.2.1</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary Endpoints:<br /><br>- Overall Survival<br /><br>- Objective Response Rate<br /><br>- Duration of Response<br /><br>- Disease Control Rate<br /><br>- Time from Randomisation to Second Progression or Death (PFS2)<br /><br>- Clinical Outcome Assessments<br /><br><br /><br>More details see protocol v1.0 par 9.5.2.2</p><br>