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

NCT05043090 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 148

Last updated 2026-05-22

No results posted yet for this 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).

Conditions

  • Papillary Renal Cell Carcinoma

Interventions

DRUG

savolitinib

Tablets : 3 × 200 mg tablets once daily

DRUG

durvalumab

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

DRUG

sunitinib

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

Sponsors & Collaborators

Principal Investigators

  • Toni Choueiri · Dana-Farber Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-28
Primary Completion
2025-12-31
Completion
2027-02-01
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Brazil
  • Canada
  • Chile
  • China
  • Czechia
  • France
  • Germany
  • Hong Kong
  • India
  • Israel
  • Italy
  • Mexico
  • Netherlands
  • Poland
  • Romania
  • Singapore
  • South Korea
  • Spain
  • Taiwan
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05043090 on ClinicalTrials.gov