Savolitinib plus Durvalumab versus Sunitinib and Durvalumab Monotherapy in MET-Driven, Unresectable and Locally Advanced or Metastatic PRCC - SAMETA

Study identifier:D5086C00001

ClinicalTrials.gov identifier:NCT05043090

EudraCT identifier:2021-000336-55

CTIS identifier:2022-503105-38-00

Recruiting

Official Title

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

Medical condition

Papillary Renal Cell Carcinoma

Phase

Phase 3

Healthy volunteers

No

Study drug

savolitinib, durvalumab, sunitinib

Sex

All

Estimated Enrollment

220

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 28 Oct 2021
Estimated Primary Completion Date: 30 Jun 2025
Estimated Study Completion Date: 12 Jun 2026

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Sept 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria