Savolitinib Plus Durvalumab Versus Sunitinib and Durvalumab Monotherapy in MET-Driven, Unresectable and Locally Advanced or Metastatic PRCC
NCT ID: NCT05043090
Last Updated: 2025-05-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
148 participants
INTERVENTIONAL
2021-10-28
2025-10-30
Brief Summary
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Detailed Description
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Approximately 200 participants will be randomised in a 2:1:1 ratio to one of the following intervention groups: savolitinib (600mg, oral, once daily) plus durvalumab (1500mg IV Q4W), sunitinib (50mg, oral, once daily for 4 consecutive weeks, followed by a sunitinib-free interval of 2-weeks, Q6W), or durvalumab monotherapy (1500mg IV Q4W).
Participants will continue to receive study intervention until objective radiological PD per RECIST 1.1 is assessed by the investigator, unacceptable toxicity occurs, consent is withdrawn or another discontinuation criterion is met.
Depending on the preferred subsequent therapy, participants randomised to the durvalumab monotherapy arm will be eligible to switch to receive savolitinib in combination with durvalumab at the time of objective radiological PD assessed by BICR per RECIST 1.1, without any intervening systemic anti-cancer therapy following discontinuation of durvalumab monotherapy.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A
savolitinib 600mg plus durvalumab 1500mg
savolitinib
Tablets : 3 × 200 mg tablets once daily
durvalumab
Concentrate for solution for IV infusion : 1500 mg durvalumab every 4 weeks
Arm B
sunitinib 50mg
sunitinib
Capsules : 2 x 25mg capsules once daily 4 weeks on, 2 weeks off
Arm C
durvalumab 1500mg
durvalumab
Concentrate for solution for IV infusion : 1500 mg durvalumab every 4 weeks
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
130 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Toni Choueiri
Role: PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute
Locations
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Research Site
Boston, Massachusetts, United States
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New York, New York, United States
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Buenos Aires, , Argentina
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CABA, , Argentina
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Ciudad Autonoma Buenos Aires, , Argentina
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Ciudad Autónoma Buenos Aires, , Argentina
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Córdoba, , Argentina
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La Plata, , Argentina
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Rosario, , Argentina
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San Miguel de Tucumán, , Argentina
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Box Hill, , Australia
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Macquarie University, , Australia
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St Leonards, , Australia
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Belo Horizonte, , Brazil
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Brasília, , Brazil
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Cachoeiro de Itapemirim, , Brazil
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Criciúma, , Brazil
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Curitiba, , Brazil
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Florianópolis, , Brazil
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Fortaleza, , Brazil
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Natal, , Brazil
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Pelotas, , Brazil
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Porto Alegre, , Brazil
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Porto Alegre, , Brazil
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Rio de Janeiro, , Brazil
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Salvador, , Brazil
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São Jose Do Rio Preto, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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Săo Paulo, , Brazil
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Vitória, , Brazil
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Calgary, Alberta, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Providencia, , Chile
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Santiago, , Chile
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Santiago, , Chile
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Temuco, , Chile
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Beijing, , China
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Changsha, , China
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Changsha, , China
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Chongqing, , China
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Harbin, , China
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Jinan, , China
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Nanjing, , China
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Shanghai, , China
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Shenyang, , China
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Tianjin, , China
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Zhengzhou, , China
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Brno, , Czechia
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Hradec Králové, , Czechia
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Olomouc, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Bordeaux, , France
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Quimper, , France
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Toulouse, , France
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Villejuif, , France
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Hamburg, , Germany
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Hanover, , Germany
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München, , Germany
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Ulm, , Germany
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Hong Kong, , Hong Kong
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Shatin, , Hong Kong
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Bangalore, , India
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Belagavi, , India
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Jaipur, , India
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Mysore, , India
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Nashik, , India
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Haifa, , Israel
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Petah Tikva, , Israel
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Arezzo, , Italy
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Avellino, , Italy
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Bari, , Italy
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Bologna, , Italy
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Florence, , Italy
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Meldola, , Italy
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Milan, , Italy
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Napoli, , Italy
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Padua, , Italy
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Reggio Emilia, , Italy
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Tricase, , Italy
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Verona, , Italy
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Aguascalientes, , Mexico
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Monterrey, , Mexico
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Querétaro, , Mexico
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Toluca, , Mexico
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Amsterdam, , Netherlands
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Arnhem, , Netherlands
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Rotterdam, , Netherlands
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Gdansk, , Poland
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Gdynia, , Poland
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Krakow, , Poland
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Otwock, , Poland
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Poznan, , Poland
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Cluj-Napoca, , Romania
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Cluj-Napoca, , Romania
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Craiova, , Romania
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Singapore, , Singapore
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Daejeon, , South Korea
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Goyang-si, , South Korea
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Incheon, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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A Coruña, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Córdoba, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Majadahonda, , Spain
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Málaga, , Spain
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Pamplona, , Spain
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Seville, , Spain
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Valencia, , Spain
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Kaohsiung City, , Taiwan
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Taichung, , Taiwan
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Tainan City, , Taiwan
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Adana, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Edirne, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
Research Site
Karşıyaka, , Turkey (Türkiye)
Research Site
Kazımkarabekir, , Turkey (Türkiye)
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Dnipropetrovsk, , Ukraine
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Leicester, , United Kingdom
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London, , United Kingdom
Research Site
London, , United Kingdom
Countries
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Other Identifiers
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2022-503105-38-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
2021-000336-55
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D5086C00001
Identifier Type: -
Identifier Source: org_study_id
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