Savolitinib Plus Durvalumab Versus Sunitinib and Durvalumab Monotherapy in MET-Driven, Unresectable and Locally Advanced or Metastatic PRCC

• Status: Not yet recruiting
• Trial end date: 2025-05-20
• Target enrollment: 0
• Participant gender: All

Summary

A clinical trial to compare the effectiveness of savolitinib plus durvalumab versus sunitinib in MET-driven (hepatocyte growth factor receptor), unresectable and locally advanced or metastatic PRCC (Papillary Renal Cell Carcinoma)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Durvalumab; Sunitinib

Criteria

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