Study Comparing Savolitinib and Durvalumab with Sunitinib and Durvalumab for Patients with Advanced Papillary Renal Cell Carcinoma

1 1 1 1

What is this study about?

This clinical trial is focused on studying a type of kidney cancer called papillary renal cell carcinoma (PRCC), which is driven by a specific factor known as MET. The study is looking at patients whose cancer cannot be removed by surgery and has spread to other parts of the body. The trial will test the effectiveness of a combination of two treatments, savolitinib and durvalumab, compared to another treatment called sunitinib and durvalumab given alone. Savolitinib is a medication that targets the MET factor, while durvalumab is an immunotherapy that helps the immune system fight cancer. Sunitinib is a medication that blocks certain proteins that help cancer cells grow.

The purpose of the study is to see how well these treatments work in stopping the cancer from getting worse. Participants will be randomly assigned to one of three groups: one group will receive savolitinib and durvalumab, another group will receive sunitinib, and the third group will receive durvalumab alone. The study will monitor the participants over time to see how long they live without the cancer getting worse and to check for any side effects from the treatments.

The trial will last for several years, and participants will have regular check-ups and tests to monitor their health and the progress of the cancer. The study aims to provide more information about the best treatment options for people with MET-driven PRCC, helping to improve future care for patients with this type of cancer.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including a diagnosis of MET-driven, unresectable, and locally advanced or metastatic papillary renal cell carcinoma.

A tumor sample is required to assess the condition.

2 randomization

Participants are randomly assigned to one of three groups: savolitinib plus durvalumab, sunitinib, or durvalumab monotherapy.

3 treatment administration

For those receiving savolitinib plus durvalumab:

Savolitinib is taken orally in the form of tablets.

Durvalumab is administered intravenously as a solution for infusion.

For those receiving sunitinib:

Sunitinib is taken orally in the form of capsules.

For those receiving durvalumab monotherapy:

Durvalumab is administered intravenously as a solution for infusion.

4 monitoring and assessments

Regular monitoring is conducted to assess the effectiveness of the treatment.

Progression-free survival (PFS) is evaluated to determine the time from randomization until disease progression or death.

Additional assessments include overall survival (OS), objective response rate (ORR), duration of response (DoR), and disease control rate (DCR).

5 end of study

The study is estimated to conclude by June 29, 2026.

Final evaluations are conducted to assess the outcomes of the treatment.

Who Can Join the Study?

The patient must have a type of kidney cancer called Papillary Renal Cell Carcinoma (PRCC) that cannot be removed by surgery and has spread to nearby areas or other parts of the body.
The cancer must be confirmed as MET-driven, which means it has a specific genetic change, using a special test done by the study’s laboratory.
The patient should not have received any previous treatments for cancer that has spread, and should not have used certain drugs like MET inhibitors, Durvalumab, or Sunitinib before.
The patient must have a Karnofsky Score of 70 or higher, which is a way to measure their ability to carry out daily activities.
There must be at least one cancer area that has not been treated with radiation and can be measured accurately at the start of the study.
The patient must have organs and bone marrow that are working well enough.
The patient should have a life expectancy of at least 12 weeks.
The patient must have normal blood clotting abilities.
The patient must provide a sample of their tumor, preserved in a special way called FFPE, to check if the cancer is MET-driven.
Both male and female patients can participate.
Patients from vulnerable populations can also be included.

Who Cannot Join the Study?

Patients who have a different type of cancer that is not related to the study.
Patients who have had previous treatment with the same or similar medications being tested in the study.
Patients with severe or uncontrolled medical conditions that could interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who are unable to follow the study procedures or attend the required visits.
Patients who have participated in another clinical trial recently.
Patients with known allergies to the study medications.
Patients with a history of certain heart conditions.
Patients with active infections that require treatment.
Patients with a history of drug or alcohol abuse.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Medizinische Hochschule Hannover	Hanover	Germany
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Hospital Universitario De Navarra	Pamplona	Spain
Medisprof S.R.L.	Cluj Napoca	Romania
Hospital Clinico San Carlos	Madrid	Spain
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France

Other Sites

Site Name	City	Country
Istituto Oncologico Veneto	Padua	Italy
Centro Ricerche Cliniche Di Verona S.r.l.	Verona	Italy
Azienda Ospedaliera S Maria Di Terni	Terni	Italy
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Fakultni Nemocnice Bulovka	Prague	Czechia
Europejskie Centrum Zdrowia Otwock Sp. z o.o.	Otwock	Poland
Hospital Universitario Ramon Y Cajal	Madrid	Spain
Jagiellońskie Centrum Innowacji Sp. z o.o.	Cracow	Poland
Centre Hospitalier Intercommunal De Cornouaille	Quimper	France
Pia Fondazione Di Culto E Religione Card G Panico	Tricase	Italy
Hospital Universitario Reina Sofía	Cordoba	Spain
Virgen del Rocío University Hospital	Sevilla	Spain
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Ospedale San Raffaele S.r.l.	Milan	Italy
Hospital Clinic De Barcelona	Barcelona	Spain
Fakultni Nemocnice Brno	Brno	Czechia
Fakultni Nemocnice Hradec Kralove	Novy Hradec Kralove	Czechia
Fakultni Nemocnice Kralovske Vinohrady	Prague	Czechia
Ludwig Maximilian University Of Munich	Munich	Germany
Sint Franciscus Vlietland Groep Stichting	Rotterdam	The Netherlands
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca	Cluj Napoca	Romania
Uniwersytecki Szpital Kliniczny W Poznaniu	Poznan	Poland
University Hospital Olomouc	Olomouc	Czechia
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Fakultni Thomayerova nemocnice	Prague	Czechia
Hospital Universitario Virgen De La Victoria	Malaga	Spain
University Hospital Consorziale Policlinico	Bari	Italy
Uumcrrasrw Mrhitbc Ctjksb Hkazthctuvikqwlog	Hamburg	Germany
Roetpqsak Zvkaoeareg Suwlsdgfr	Arnhem	The Netherlands
Sfmobood Pocpalqyy Sex z onau	Gdynia	Poland
Ftmclhbu nwnpqngik Mcmgr a Hkcybjf	Prague	Czechia
Ibmihqih Rxpwrublt Pca Ln Ssqstq Dby Tamxbn Dwkt Ardltoj Ibgs Sblsbb	Meldola	Italy
Ajrorykhv Uzq	Amsterdam	The Netherlands
Atphsun Uqf Ikmkt Ds Rvlyan Eafpmd	Reggio Emilia	Italy
Aoumsyz Uxtde Smfxfbrmk Ltgudy Du Baacbuw	Bologna	Italy
Umfqdszzniwmmd Chvuton Kqhqmoqco	Gdansk	Poland
Hrefadcg Ds Lr Suujf Cahw I Sowa Phz	Barcelona	Spain
Hnrpuzum Vewx dnukuxjv	Barcelona	Spain
Hqcptdgr Uhbnsyhguvenx dl A Cghugz	A Coruna Galicia	Spain

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	23.10.2021
France	Not recruiting	23.10.2021
Germany	Not recruiting	23.10.2021
Italy	Not recruiting	23.10.2021
Poland	Not recruiting	23.10.2021
Romania	Not recruiting	23.10.2021
Spain	Not recruiting	23.10.2021
The Netherlands	Not recruiting	23.10.2021

Trial locations

Investigated drugs:

Savolitinib is a medication being studied for its potential to treat certain types of kidney cancer. It works by targeting specific pathways in cancer cells that help them grow and spread. In this trial, it is being tested in combination with another medication to see if it can improve outcomes for patients with advanced kidney cancer.

Durvalumab is an immunotherapy drug that helps the body’s immune system recognize and attack cancer cells. It is used in this trial to see if it can enhance the effects of other treatments in patients with advanced kidney cancer.

Sunitinib is a medication that is already used to treat kidney cancer. It works by blocking certain proteins that cancer cells need to grow. In this trial, it is being used as a comparison to see how well the new combination of treatments works against advanced kidney cancer.

Papillary Renal Cell Carcinoma – This is a type of kidney cancer that originates in the lining of the small tubes in the kidney. It is characterized by the formation of small, finger-like projections, or papillae, in the tumor. The disease can be classified into two types: Type 1, which tends to grow slowly, and Type 2, which is more aggressive. When the cancer is described as “MET-driven,” it means that genetic changes in the MET gene are driving the growth of the cancer cells. The condition can become unresectable, meaning it cannot be removed surgically, and may progress to a locally advanced or metastatic stage, where it spreads beyond the kidney to other parts of the body.

Trial ID:

2022-503105-38-00

Protocol code:

D5086C00001

NCT ID:

NCT05043090

Trial Phase:

Therapeutic confirmatory (Phase III)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study Comparing Savolitinib and Durvalumab with Sunitinib and Durvalumab for Patients with Advanced Papillary Renal Cell Carcinoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?