New hope for rare kidney cancer: drug combo shows promise in late-stage trial
NCT ID NCT05043090
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 3 study tests whether combining two drugs (savolitinib and durvalumab) works better than the standard drug sunitinib for people with a rare, advanced kidney cancer called papillary renal cell carcinoma that has a specific genetic change (MET-driven). About 148 adults who have not had prior treatment for their advanced cancer will take part. The main goal is to see how long the cancer stays under control and how long patients live.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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148 people
The number who actually took part.
- Started
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Oct 2021
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 130 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Research Site
Boston, Massachusetts, 02215, United States
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New York, New York, 10065, United States
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CABA, C1426ANZ, Argentina
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Ciudad Autónoma Buenos Aires, 1125, Argentina
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Ciudad de Buenos Aires, C1120AAT, Argentina
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Ciudad de Buenos Aires, C1181ACH, Argentina
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La Plata, 1900, Argentina
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Rosario, S2002KDS, Argentina
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San Miguel de Tucumán, T4000IAK, Argentina
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Box Hill, 3128, Australia
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Macquarie University, 2109, Australia
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Belo Horizonte, 30120-320, Brazil
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Brasília, 70200-730, Brazil
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Cachoeiro de Itapemirim, 29308-065, Brazil
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Criciúma, 88811-508, Brazil
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Curitiba, 81520-060, Brazil
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Florianópolis, 88020-210, Brazil
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Fortaleza, 60130-241, Brazil
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Natal, 59075-740, Brazil
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Pelotas, 96020-080, Brazil
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Porto Alegre, 90020-090, Brazil
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Porto Alegre, 90110-270, Brazil
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Rio de Janeiro, 22250-905, Brazil
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Salvador, 40050-410, Brazil
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São Jose Do Rio Preto, 15090-000, Brazil
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São Paulo, 01246-000, Brazil
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São Paulo, 01327-001, Brazil
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São Paulo, 05652-900, Brazil
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Vitória, 29043-260, Brazil
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Calgary, Alberta, T2N 4N2, Canada
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Montreal, Quebec, H3T 1E2, Canada
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Montreal, Quebec, H4A 3J1, Canada
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Providencia, 7510032, Chile
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Santiago, 7500653, Chile
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Santiago, 8420383, Chile
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Temuco, 4810561, Chile
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Beijing, 100039, China
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Changsha, 410011, China
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Changsha, 410013, China
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Chongqing, 400030, China
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Harbin, 150049, China
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Jinan, 250012, China
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Nanjing, 210029, China
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Shanghai, 200032, China
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Shenyang, 110042, China
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Tianjin, 300060, China
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Zhengzhou, 450008, China
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Brno, 625 00, Czechia
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Hradec Králové, 500 05, Czechia
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Olomouc, 775 20, Czechia
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Prague, 100 34, Czechia
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Prague, 140 59, Czechia
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Prague, 15000, Czechia
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Prague, 180 81, Czechia
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Bordeaux, 33075, France
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Quimper, 29107, France
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Toulouse, 31059, France
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Villejuif, 94800, France
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Hamburg, 20246, Germany
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Hanover, 30625, Germany
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München, 81377, Germany
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Ulm, 89081, Germany
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Hong Kong, Hong Kong
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Shatin, 00000, Hong Kong
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Bangalore, 560027, India
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Belagavi, 590010, India
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Jaipur, 302002, India
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Mysore, 570001, India
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Nashik, 422004, India
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Haifa, 91096, Israel
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Petah Tikva, 49100, Israel
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Arezzo, 52100, Italy
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Avellino, 83100, Italy
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Bari, 70124, Italy
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Bologna, 40138, Italy
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Florence, 50134, Italy
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Meldola, 47014, Italy
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Milan, 20132, Italy
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Naples, 80131, Italy
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Padova, 35128, Italy
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Reggio Emilia, 42123, Italy
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Tricase, 73039, Italy
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Verona, 37134, Italy
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Aguascalientes, 20230, Mexico
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Monterrey, 64460, Mexico
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Querétaro, 76090, Mexico
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Toluca, 50090, Mexico
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Amsterdam, 1105 AZ, Netherlands
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Arnhem, 6815 AD, Netherlands
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Rotterdam, 3045 PM, Netherlands
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Gdansk, 80-952, Poland
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Gdynia, 81-519, Poland
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Krakow, 30-348, Poland
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Otwock, 05-400, Poland
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Poznan, 60-569, Poland
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Cluj-Napoca, 400015, Romania
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Cluj-Napoca, 400641, Romania
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Craiova, 200094, Romania
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Singapore, 169610, Singapore
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Daejeon, 35015, South Korea
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Goyang-si, 10408, South Korea
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Incheon, 405-760, South Korea
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Seoul, 03080, South Korea
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Seoul, 03722, South Korea
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Seoul, 05505, South Korea
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Seoul, 06351, South Korea
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A Coruña, 15006, Spain
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Barcelona, 08035, Spain
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Barcelona, 08036, Spain
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Barcelona, ?08041, Spain
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Córdoba, 14004, Spain
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Madrid, 28034, Spain
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Madrid, 28040, Spain
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Madrid, 28041, Spain
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Majadahonda, 28222, Spain
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Málaga, 29010, Spain
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Pamplona, 31008, Spain
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Seville, 41013, Spain
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Valencia, 46026, Spain
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Kaohsiung City, 83301, Taiwan
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Taichung, 40705, Taiwan
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Tainan, 704, Taiwan
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Adana, 01120, Turkey (Türkiye)
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Ankara, 06100, Turkey (Türkiye)
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Ankara, 06200, Turkey (Türkiye)
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Ankara, 06590, Turkey (Türkiye)
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Cordaleo, 35575, Turkey (Türkiye)
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Edirne, 22030, Turkey (Türkiye)
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Istanbul, 32098, Turkey (Türkiye)
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Istanbul, 34218, Turkey (Türkiye)
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Istanbul, 34722, Turkey (Türkiye)
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Izmir, 35040, Turkey (Türkiye)
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Kazımkarabekir, 01230, Turkey (Türkiye)
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Dnipropetrovsk, 49005, Ukraine
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Leicester, LE1 5WW, United Kingdom
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London, EC1A 7BE, United Kingdom
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London, SW3 6JJ, United Kingdom
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Triple-Drug cocktail shows promise for rare kidney cancers
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