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Clinical Trials in the UK / NCT05043090
Active, not recruiting Phase 3

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

NCT05043090 · tracked via the Priya Life Science UK tracker
Sponsor
AstraZeneca
Phase
Phase 3
Started
2021-10-28
Last updated
2026-05-22

Condition(s) studied

Papillary Renal Cell Carcinoma

Investigational drug(s) / intervention(s)

savolitinibdurvalumabsunitinib

savolitinib: Tablets : 3 × 200 mg tablets once daily

durvalumab: Concentrate for solution for IV infusion : 1500 mg durvalumab every 4 weeks

sunitinib: Capsules : 2 x 25mg capsules once daily 4 weeks on, 2 weeks off

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
130 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (137)

FacilityCityRegionStatus
Research Site Boston Massachusetts
Research Site New York New York
Research Site CABA Argentina
Research Site Ciudad Autónoma Buenos Aires Argentina
Research Site Ciudad de Buenos Aires Argentina
Research Site Ciudad de Buenos Aires Argentina
Research Site La Plata Argentina
Research Site Rosario Argentina
Research Site San Miguel de Tucumán Argentina
Research Site Box Hill Australia
Research Site Macquarie University Australia
Research Site Belo Horizonte Brazil
Research Site Brasília Brazil
Research Site Cachoeiro de Itapemirim Brazil
Research Site Criciúma Brazil
Research Site Curitiba Brazil
Research Site Florianópolis Brazil
Research Site Fortaleza Brazil
Research Site Natal Brazil
Research Site Pelotas Brazil
Research Site Porto Alegre Brazil
Research Site Porto Alegre Brazil
Research Site Rio de Janeiro Brazil
Research Site Salvador Brazil
Research Site São Jose Do Rio Preto Brazil
Research Site São Paulo Brazil
Research Site São Paulo Brazil
Research Site São Paulo Brazil
Research Site Vitória Brazil
Research Site Calgary Alberta
Research Site Montreal Quebec
Research Site Montreal Quebec
Research Site Providencia Chile
Research Site Santiago Chile
Research Site Santiago Chile
Research Site Temuco Chile
Research Site Beijing China
Research Site Changsha China
Research Site Changsha China
Research Site Chongqing China

+ 97 more sites — see the full list on the official registry below.

On this site

📄 Imfinzi (durvalumab) drug profile →

More AstraZeneca trials in the UK

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05043090 on ClinicalTrials.gov ↗ ← All trials in the UK