New hope for rare kidney cancer: drug combo shows promise in late-stage trial

NCT ID NCT05043090

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

148 people

The number who actually took part.

Started

Oct 2021

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 130 years

Sex

Anyone

Healthy volunteers

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

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

  • Research Site

    Boston, Massachusetts, 02215, United States

  • Research Site

    New York, New York, 10065, United States

  • Research Site

    CABA, C1426ANZ, Argentina

  • Research Site

    Ciudad Autónoma Buenos Aires, 1125, Argentina

  • Research Site

    Ciudad de Buenos Aires, C1120AAT, Argentina

  • Research Site

    Ciudad de Buenos Aires, C1181ACH, Argentina

  • Research Site

    La Plata, 1900, Argentina

  • Research Site

    Rosario, S2002KDS, Argentina

  • Research Site

    San Miguel de Tucumán, T4000IAK, Argentina

  • Research Site

    Box Hill, 3128, Australia

  • Research Site

    Macquarie University, 2109, Australia

  • Research Site

    Belo Horizonte, 30120-320, Brazil

  • Research Site

    Brasília, 70200-730, Brazil

  • Research Site

    Cachoeiro de Itapemirim, 29308-065, Brazil

  • Research Site

    Criciúma, 88811-508, Brazil

  • Research Site

    Curitiba, 81520-060, Brazil

  • Research Site

    Florianópolis, 88020-210, Brazil

  • Research Site

    Fortaleza, 60130-241, Brazil

  • Research Site

    Natal, 59075-740, Brazil

  • Research Site

    Pelotas, 96020-080, Brazil

  • Research Site

    Porto Alegre, 90020-090, Brazil

  • Research Site

    Porto Alegre, 90110-270, Brazil

  • Research Site

    Rio de Janeiro, 22250-905, Brazil

  • Research Site

    Salvador, 40050-410, Brazil

  • Research Site

    São Jose Do Rio Preto, 15090-000, Brazil

  • Research Site

    São Paulo, 01246-000, Brazil

  • Research Site

    São Paulo, 01327-001, Brazil

  • Research Site

    São Paulo, 05652-900, Brazil

  • Research Site

    Vitória, 29043-260, Brazil

  • Research Site

    Calgary, Alberta, T2N 4N2, Canada

  • Research Site

    Montreal, Quebec, H3T 1E2, Canada

  • Research Site

    Montreal, Quebec, H4A 3J1, Canada

  • Research Site

    Providencia, 7510032, Chile

  • Research Site

    Santiago, 7500653, Chile

  • Research Site

    Santiago, 8420383, Chile

  • Research Site

    Temuco, 4810561, Chile

  • Research Site

    Beijing, 100039, China

  • Research Site

    Changsha, 410011, China

  • Research Site

    Changsha, 410013, China

  • Research Site

    Chongqing, 400030, China

  • Research Site

    Harbin, 150049, China

  • Research Site

    Jinan, 250012, China

  • Research Site

    Nanjing, 210029, China

  • Research Site

    Shanghai, 200032, China

  • Research Site

    Shenyang, 110042, China

  • Research Site

    Tianjin, 300060, China

  • Research Site

    Zhengzhou, 450008, China

  • Research Site

    Brno, 625 00, Czechia

  • Research Site

    Hradec Králové, 500 05, Czechia

  • Research Site

    Olomouc, 775 20, Czechia

  • Research Site

    Prague, 100 34, Czechia

  • Research Site

    Prague, 140 59, Czechia

  • Research Site

    Prague, 15000, Czechia

  • Research Site

    Prague, 180 81, Czechia

  • Research Site

    Bordeaux, 33075, France

  • Research Site

    Quimper, 29107, France

  • Research Site

    Toulouse, 31059, France

  • Research Site

    Villejuif, 94800, France

  • Research Site

    Hamburg, 20246, Germany

  • Research Site

    Hanover, 30625, Germany

  • Research Site

    München, 81377, Germany

  • Research Site

    Ulm, 89081, Germany

  • Research Site

    Hong Kong, Hong Kong

  • Research Site

    Shatin, 00000, Hong Kong

  • Research Site

    Bangalore, 560027, India

  • Research Site

    Belagavi, 590010, India

  • Research Site

    Jaipur, 302002, India

  • Research Site

    Mysore, 570001, India

  • Research Site

    Nashik, 422004, India

  • Research Site

    Haifa, 91096, Israel

  • Research Site

    Petah Tikva, 49100, Israel

  • Research Site

    Arezzo, 52100, Italy

  • Research Site

    Avellino, 83100, Italy

  • Research Site

    Bari, 70124, Italy

  • Research Site

    Bologna, 40138, Italy

  • Research Site

    Florence, 50134, Italy

  • Research Site

    Meldola, 47014, Italy

  • Research Site

    Milan, 20132, Italy

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    Naples, 80131, Italy

  • Research Site

    Padova, 35128, Italy

  • Research Site

    Reggio Emilia, 42123, Italy

  • Research Site

    Tricase, 73039, Italy

  • Research Site

    Verona, 37134, Italy

  • Research Site

    Aguascalientes, 20230, Mexico

  • Research Site

    Monterrey, 64460, Mexico

  • Research Site

    Querétaro, 76090, Mexico

  • Research Site

    Toluca, 50090, Mexico

  • Research Site

    Amsterdam, 1105 AZ, Netherlands

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    Arnhem, 6815 AD, Netherlands

  • Research Site

    Rotterdam, 3045 PM, Netherlands

  • Research Site

    Gdansk, 80-952, Poland

  • Research Site

    Gdynia, 81-519, Poland

  • Research Site

    Krakow, 30-348, Poland

  • Research Site

    Otwock, 05-400, Poland

  • Research Site

    Poznan, 60-569, Poland

  • Research Site

    Cluj-Napoca, 400015, Romania

  • Research Site

    Cluj-Napoca, 400641, Romania

  • Research Site

    Craiova, 200094, Romania

  • Research Site

    Singapore, 169610, Singapore

  • Research Site

    Daejeon, 35015, South Korea

  • Research Site

    Goyang-si, 10408, South Korea

  • Research Site

    Incheon, 405-760, South Korea

  • Research Site

    Seoul, 03080, South Korea

  • Research Site

    Seoul, 03722, South Korea

  • Research Site

    Seoul, 05505, South Korea

  • Research Site

    Seoul, 06351, South Korea

  • Research Site

    A Coruña, 15006, Spain

  • Research Site

    Barcelona, 08035, Spain

  • Research Site

    Barcelona, 08036, Spain

  • Research Site

    Barcelona, ?08041, Spain

  • Research Site

    Córdoba, 14004, Spain

  • Research Site

    Madrid, 28034, Spain

  • Research Site

    Madrid, 28040, Spain

  • Research Site

    Madrid, 28041, Spain

  • Research Site

    Majadahonda, 28222, Spain

  • Research Site

    Málaga, 29010, Spain

  • Research Site

    Pamplona, 31008, Spain

  • Research Site

    Seville, 41013, Spain

  • Research Site

    Valencia, 46026, Spain

  • Research Site

    Kaohsiung City, 83301, Taiwan

  • Research Site

    Taichung, 40705, Taiwan

  • Research Site

    Tainan, 704, Taiwan

  • Research Site

    Adana, 01120, Turkey (Türkiye)

  • Research Site

    Ankara, 06100, Turkey (Türkiye)

  • Research Site

    Ankara, 06200, Turkey (Türkiye)

  • Research Site

    Ankara, 06590, Turkey (Türkiye)

  • Research Site

    Cordaleo, 35575, Turkey (Türkiye)

  • Research Site

    Edirne, 22030, Turkey (Türkiye)

  • Research Site

    Istanbul, 32098, Turkey (Türkiye)

  • Research Site

    Istanbul, 34218, Turkey (Türkiye)

  • Research Site

    Istanbul, 34722, Turkey (Türkiye)

  • Research Site

    Izmir, 35040, Turkey (Türkiye)

  • Research Site

    Kazımkarabekir, 01230, Turkey (Türkiye)

  • Research Site

    Dnipropetrovsk, 49005, Ukraine

  • Research Site

    Leicester, LE1 5WW, United Kingdom

  • Research Site

    London, EC1A 7BE, United Kingdom

  • Research Site

    London, SW3 6JJ, United Kingdom

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