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Real-World data shows promise for kidney cancer drug combo

NCT ID NCT05361434

Disease control Sponsor: Ipsen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study observed 311 adults with advanced kidney cancer who received cabozantinib (a targeted therapy) plus nivolumab (an immunotherapy) as their first treatment. Researchers tracked how long patients lived and how long tumors stayed under control in real-world settings. The goal was to see if the combination works as well outside clinical trials as it did in earlier studies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
cabozantinib and nivolumab
What this could lead to
If results are positive, this could confirm that the combination works well in everyday clinical settings, offering a standard first-line option for advanced kidney cancer.
What could go wrong
This is an observational study, not a controlled trial, so results may be less reliable. The combination also carries risks like fatigue, high blood pressure, and immune-related side effects.

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.

Participants

311 people

The number who actually took part.

Started

Sep 2022

Finished

Oct 2025

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.

Who is studied

This study will include participants with advanced renal cell carcinoma with clear cell component, for whom a decision to treat with cabozantinib and nivolumab in combination has been made by the treating physician

Ages

18 years and older

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: * Participants with diagnosis of aRCC with clear-cell component * Participants with no prior systemic treatment for aRCC with clear-cell component; * Physician-initiated decision to treat with cabozantinib and nivolumab in combination (prior to study enrolment), according to Cabometyx® and Opdivo® approved local labels; Exclusion Criteria: * Current participation in an investigational program with any intervention which could possibly interfere the treatment and impact this study; * History of allergy or hypersensitivity to Cabometyx® or Opdivo® components.

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Conditions

The condition(s) this trial relates to.

clear cell renal carcinoma renal cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced renal cell carcinoma

Contacts and locations

Locations

  • AOU San Luigi Gonzaga

    Orbassano, Italy

  • ATTIKO University Hospital

    Chaïdári, Greece

  • Akershus Universitetssykehus

    Lørenskog, Norway

  • Belfast City Hospital

    Belfast, United Kingdom

  • CH Dentellières

    Valenciennes, France

  • CHU Charles Nicolle

    Rouen, France

  • CHU Namur Mont-Godinne

    Yvoir, Belgium

  • CHU St Pierre & Brugmann

    Brussels, Belgium

  • Centre Finisterien de Radiotherapie et d'Oncologie

    Brest, France

  • Centre Georges François Leclerc

    Dijon, France

  • Centre Hospitalier Annecy Genevois

    Épagny, France

  • Centre Hospitalier Départemental Vendée

    La Roche-sur-Yon, France

  • Centre Hospitalier Fleyriat

    Bourg-en-Bresse, France

  • Centre Hospitalier Régional D'orléans

    Orléans, France

  • Centre Hospitalier Régional Universitaire de (CHRU) de Tours - Hôpital Bretonneau

    Tours, France

  • Centre Hospitalier Régional Universitaire de Besançon - Jean Minjoz

    Besançon, France

  • Centre Hospitalier Tenon

    Paris, France

  • Centre Hospitalier Universitaire (CHU) Henri Mondor

    Créteil, France

  • Centre Hospitalier Universitaire (CHU) de Angers

    Angers, France

  • Centre Hospitalier Universitaire (CHU) de Nantes - Hôtel-Dieu

    Nantes, France

  • Centre Hospitalier Universitaire (CHU) de Poitiers

    Poitiers, France

  • Centre Hospitalier Universitaire Grenoble Alpes

    La Tronche, France

  • Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-Montpied

    Clermont-Ferrand, France

  • Centre Hospitalier de Boulogne-sur-mer

    Boulogne-sur-Mer, France

  • Centre Hospitalier intercommunal Saint Raphaël Frejus

    Fréjus, France

  • Centre d'Oncologie de l'Estuaire

    Saint-Nazaire, France

  • Centre d'Urologie Site Médipole - Centre Catalan d'Urologie

    Cabestany, France

  • Centre de Lutte Contre le Cancer Jean PERRIN

    Clermont-Ferrand, France

  • Chonnam National University Hwasun Hospital

    Jeongnam, South Korea

  • Clinique Mathilde Oncologie médicale

    Rouen, France

  • Edinburgh Cancer Centre, Western General Hospital

    Edinburgh, United Kingdom

  • Fondazione IRCCS, Istituto Nazionale dei Tumori

    Milan, Italy

  • General Hospital of Athens Alexandra

    Athens, Greece

  • Groupe Hospitalier De La Rochelle - Ré - Aunis

    La Rochelle, France

  • Groupe Hospitalier Saint-André (Bordeaux)

    Bordeaux, France

  • Henry Dunant Hospital

    Athens, Greece

  • Hopital Bichat -Claud Bernard

    Paris, France

  • Hopital Privé Jean Mermoz

    Lyon, France

  • Hopital de Mercy- CHR Metz Thionville

    Ars-Laquenexy, France

  • Hospital Foch - Oncology Service

    Suresnes, France

  • Hospital Foch - Urology Service

    Suresnes, France

  • Hôpital Européen Georges Pompidou (HEGP)

    Paris, France

  • Hôpital Pitié-Salpétrière

    Paris, France

  • Hôpital Privé Le Bois

    Lille, France

  • ICANS - Institut de cancérologie Strasbourg Europe

    Strasbourg, France

  • ICONE

    Bezannes, France

  • IOV - Istituto Oncologico Veneto - IRCCS - Ospedale Busonera

    Padova, Italy

  • Institut Bergonié

    Bordeaux, France

  • Institut Ste Catherine - Institut du Cancer Avignon Provence

    Avignon, France

  • Institut de Cancérologie de Bourgogne

    Dijon, France

  • Institut de Cancérologie de Lorraine Alexis Vautrin

    Vandœuvre-lès-Nancy, France

  • Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"

    Naples, Italy

  • Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori", IRCCS - Oncologia

    Meldola, Italy

  • Jessa Ziekenhuis

    Hasselt, Belgium

  • King Abdulaziz Medical City - Jeddah

    Jeddah, Saudi Arabia

  • King Abdulaziz Medical City- Riyadh

    Riyadh, Saudi Arabia

  • Ospedale "Santa Maria delle Croci" di Ravenna

    Ravenna, Italy

  • Ospedale Generale Provincial

    Province of Macerata, Italy

  • Ospedale San Camillo Forlanini

    Roma, Italy

  • P.O Santa Maria delle Grazie, ASL Napoli 2 Nord

    Pozzuoli, Italy

  • PU A.Gemelli, Università Cattolica del Sacro Cuore

    Roma, Italy

  • Papageorgiou General Hosp of Thessaloniki

    Thessaloniki, Greece

  • Policlinico Universitario Campus Biomedico

    Roma, Italy

  • Samsung Medical Center

    Seoul, South Korea

  • Seoul St Mary's Hospital

    Seoul, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, South Korea

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