Study Comparing Tivozanib and Nivolumab Combination to Tivozanib Alone in Patients with Renal Cell Carcinoma After Previous Immune Therapy

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What is this study about?

This clinical trial is focused on studying a type of kidney cancer known as Renal Cell Carcinoma. The study is investigating the effectiveness of a treatment using two medications: Tivozanib and Nivolumab. Tivozanib is taken orally in the form of a capsule, while Nivolumab, also known by its code name BMS936558, is given through an intravenous infusion, which means it is administered directly into a vein.

The purpose of the study is to compare the combination of Tivozanib and Nivolumab with Tivozanib alone in patients whose cancer has progressed after one or two previous treatments, including a type of treatment called an immune checkpoint inhibitor. This study will help determine if the combination of these medications can help patients live longer without their cancer getting worse.

Participants in the study will receive either the combination of Tivozanib and Nivolumab or Tivozanib alone. The study will monitor the participants over a period to see how their cancer responds to the treatment. The study will also assess the safety and any side effects of the treatments. The results will provide valuable information on the potential benefits of combining these medications for treating Renal Cell Carcinoma.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and current health status.

Eligibility criteria include being 18 years or older, having a life expectancy of at least 3 months, and having a confirmed diagnosis of renal cell carcinoma with a clear cell component.

2 randomization

Participants are randomly assigned to one of two groups: one receiving tivozanib alone, and the other receiving a combination of tivozanib and nivolumab.

3 treatment administration

For those receiving tivozanib alone, the medication is taken orally. The specific dosage and frequency are determined by the study protocol.

For those receiving the combination treatment, tivozanib is taken orally, and nivolumab is administered through an intravenous infusion. The dosage and frequency are specified in the study protocol.

4 regular monitoring

Participants undergo regular monitoring to assess the effectiveness of the treatment and to check for any side effects.

This includes physical examinations, blood tests, and imaging studies to track the progression of the disease.

5 progress evaluation

The primary goal is to evaluate progression-free survival, which means the length of time during and after treatment that the cancer does not get worse.

Secondary evaluations include overall survival, response rate, and duration of response.

6 completion of study

The study is estimated to end by July 31, 2025. Participants will be informed about the results and any further steps if necessary.

Who Can Join the Study?

Must be 18 years or older and have a life expectancy of at least 3 months.
Must have experienced disease progression (worsening of the disease) during or after at least 6 weeks of treatment with an immune checkpoint inhibitor (ICI) for advanced kidney cancer with a clear cell component, either as the first or second treatment option.
Must have recovered from side effects of previous treatments to a level that is considered mild or back to the original state.
Must have kidney cancer confirmed by a laboratory test, showing a clear cell component.
Must have measurable disease according to specific criteria used by doctors to assess cancer.
Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, which means being fully active or having some symptoms but still able to carry out light work.
All participants must follow specific contraceptive measures as defined by the study protocol.

Who Cannot Join the Study?

Patients who have not been diagnosed with renal cell carcinoma (a type of kidney cancer) cannot participate.
Patients who have not received 1 or 2 previous treatments that included an immune checkpoint inhibitor (a type of drug that helps the immune system fight cancer) cannot participate.
Patients who are part of a vulnerable population (groups that may need special protection) cannot participate.

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
Institut De Cancerologie De Lorraine	Vandoeuvre Les Nancy	France
Hospital Clinico San Carlos	Madrid	Spain
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany
Osrodek Badan Klinicznych Przy Szpitalu Specjalistycznym Im. Ludwika Rydygiera W Krakowie Sp. z o.o.	Cracow	Poland
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
CHU Grenoble Alpes	La Tronche	France
Unidade Local De Saúde De Santa Maria, E.P.E.	Lisbon	Portugal

Other Sites

Site Name	City	Country
Centre Antoine Lacassagne	Nice	France
Institut Jules Bordet	Anderlecht	Belgium
Azienda Socio Sanitaria Territoriale Di Cremona	Cremona	Italy
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Hospital Foch	Suresnes	France
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Universita Cattolica Del Sacro Cuore	Rome	Italy
Universitair Ziekenhuis Gent	Gent	Belgium
Azienda Ospedaliera S Maria Di Terni	Terni	Italy
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital Del Mar	Barcelona	Spain
San Camillo Forlanini Hospital	Rome	Italy
Fundacion Instituto Valenciano De Oncologia	Valencia	Spain
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.	Porto	Portugal
Algemeen Ziekenhuis Groeninge	Kortrijk	Belgium
Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza	Brzozow	Poland
Copernicus Podmiot Leczniczy Sp. z o.o.	Gdansk	Poland
Europejskie Centrum Zdrowia Otwock Sp. z o.o.	Otwock	Poland
Mruk-Med I Sp. z o.o.	Rzeszow	Poland
Institut De Cancerologie Strasbourg Europe	STRASBOURG, Alsace	France
Wojewodzki Szpital Specjalistyczny W Bialej Podlaskiej	Biala Podlaska	Poland
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
Fakultni Nemocnice Hradec Kralove	Novy Hradec Kralove	Czechia
Fakultni Nemocnice Kralovske Vinohrady	Prague	Czechia
Jessa Ziekenhuis	Hasselt	Belgium
Gasthuiszusters Antwerpen	Antwerp	Belgium
Uniwersytecki Szpital Kliniczny W Poznaniu	Poznan	Poland
Azienda Sanitaria Locale 2 Lanciano Vasto Chieti	Chieti	Italy
Azienda USL Toscana Sud Est	Arezzo	Italy
University Childrens Hospital Queen Fabiola	Brussels	Belgium
Servei De Salut De Les Illes Balears	Palma	Spain
Clinique Victor Hugo	Le Mans	France
Chmubi Lxub Bqregj	Lyon	France
Igckhskz Crvfjc Djimswwbuynmfskwb	L'hospitalet De Llobregat	Spain
Plnr Tcqig Hxrduyhs Usjbiuwjnbmh	Sabadell	Spain
Hvz Nako	Lille	France
Idncmdxt Rtjvejxhj Pge Ld Scmqpk Dpl Taxxet Dwhi Amkghke Ivlc Snvrxj	Meldola	Italy
Cggmir Hoyrohumcnz Rgdhlvxx Uzdtlhnbjrbwu Dc Tadns	Tours	France
Nriyzfmr Izzthvrs Oloeqdene Iit Mmncr Sypyinwuiaxatnlbbgouzclarftt Iakueucz Bxnrasjv	Cracow	Poland
Hruppdos Dz Lo Ssuna Ccwp I Soxc Pgi	Barcelona	Spain
Uapxwlstki Merad Gwgcbhw Oc Ckpucwbul	Catanzaro	Italy
Fqcazcypw Pjuv Lg Inphvwyyfuflk Bptdahvbh Dpv Hfhhuqij Ukktkegcvaegd Lr Pth	Madrid	Spain
Hehhfsgx Vodb dcdgsdpp	Barcelona	Spain
Itcyvwdb Pwcnwarzshkkngs Cwqtto Cyasov	Marseille	France

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	01.11.2021
Czechia	Not recruiting	01.11.2021
France	Not recruiting	01.11.2021
Germany	Not recruiting	01.11.2021
Italy	Not recruiting	01.11.2021
Poland	Not recruiting	01.11.2021
Portugal	Not recruiting	01.11.2021
Spain	Not recruiting	01.11.2021

Trial locations

Investigated drugs:

Tivozanib is a medication used in this clinical trial to treat kidney cancer, specifically renal cell carcinoma. It works by blocking certain proteins that help cancer cells grow and spread. By doing this, tivozanib can help slow down or stop the progression of the cancer.

Nivolumab is another medication used in this trial, often in combination with tivozanib. It is an immune checkpoint inhibitor, which means it helps the body’s immune system recognize and attack cancer cells more effectively. Nivolumab works by blocking a protein that prevents the immune system from attacking cancer cells, thereby boosting the body’s natural defenses against the cancer.

Investigated diseases:

Renal cell carcinoma

Renal cell carcinoma – Renal cell carcinoma is a type of kidney cancer that originates in the lining of the small tubes in the kidney. It typically begins as a single mass or tumor in one kidney, but it can also occur in both kidneys simultaneously. As the disease progresses, the tumor may grow larger and can spread to nearby tissues and organs, such as the lymph nodes, lungs, or bones. The cancer cells can invade the blood vessels, allowing the disease to metastasize to distant parts of the body. Symptoms may include blood in the urine, a lump in the abdomen, or persistent pain in the side. The progression of renal cell carcinoma can vary, with some tumors growing slowly over time while others may advance more rapidly.

Trial ID:

2024-514570-43-00

Protocol code:

AV-951-20-304

NCT ID:

NCT04987203

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Tivozanib and Nivolumab Combination to Tivozanib Alone in Patients with Renal Cell Carcinoma After Previous Immune Therapy

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?