Trial Radar
Sign in

NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

NCT05043090

Active Not RecruitingPhase 3

Sponsor: AstraZeneca

Conditions: Papillary Renal Cell Carcinoma

Interventions: savolitinib, durvalumab, sunitinib

Countries: United States, Argentina, Australia, Brazil, Canada, Chile, China, Czechia

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 overview

Sex: ALL

Age: 18 Years to 130 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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 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
Locations (137)
  • Boston, Massachusetts, United States
  • New York, New York, United States
  • CABA, Argentina
  • Ciudad Autónoma Buenos Aires, Argentina
  • Ciudad de Buenos Aires, Argentina
  • Ciudad de Buenos Aires, Argentina
  • La Plata, Argentina
  • Rosario, Argentina
  • San Miguel de Tucumán, Argentina
  • Box Hill, Australia
  • Macquarie University, Australia
  • Belo Horizonte, Brazil
  • Brasília, Brazil
  • Cachoeiro de Itapemirim, Brazil
  • Criciúma, Brazil
  • Curitiba, Brazil
  • Florianópolis, Brazil
  • Fortaleza, Brazil
  • Natal, Brazil
  • Pelotas, Brazil
  • Porto Alegre, Brazil
  • Porto Alegre, Brazil
  • Rio de Janeiro, Brazil
  • Salvador, Brazil
  • São Jose Do Rio Preto, Brazil
  • São Paulo, Brazil
  • São Paulo, Brazil
  • São Paulo, Brazil
  • Vitória, Brazil
  • Calgary, Alberta, Canada
  • + 107 more on CT.gov