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

Running, not enrolling · Phase 3

Conditions studied: Papillary Renal Cell Carcinoma

In brief

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).

Key facts

Study ID: NCT05043090
Run by: AstraZeneca
People needed: 148
Starts: 2021-10-28
Expected to finish: 2027-02-01
Last updated by the study team: 2026-05-22

Who can join

Age: 18 and older, up to 130. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Research Site — New York, New York, United States
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 — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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