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Search / Trial NCT05361434

A Study of the Effectiveness of Cabozantinib in Combination With Nivolumab as First-line Treatment of Advanced Renal Cell Carcinoma (aRCC) in Adults

Launched by IPSEN · Apr 29, 2022

Trial Information

Current as of July 21, 2025

Active, not recruiting

Keywords

ClinConnect Summary

This clinical trial is investigating how effective and safe a combination treatment of cabozantinib and nivolumab is for adults with advanced renal cell carcinoma (aRCC) that has a clear cell component. This means that the study is looking at how well these two medications work together when given as the first treatment option for this specific type of kidney cancer. It's important to note that the decision to use this combination treatment will be made by the doctor before the patient joins the study.

To be eligible for this trial, participants need to be adults who have been diagnosed with aRCC that has a clear cell component and have not received any prior systemic treatments for it. They also should not have any allergies to the medications being studied. If someone qualifies and decides to participate, they will receive the combination treatment as part of their care, and researchers will collect data on how well the treatment works and any side effects experienced. The trial is currently active but not recruiting new participants.

Gender

ALL

Eligibility criteria

  • 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.

About Ipsen

Ipsen is a global biopharmaceutical group dedicated to innovation and specialty care, focusing on the discovery, development, and commercialization of transformative medicines for patients with serious diseases. With a strong emphasis on oncology, neuroscience, and rare diseases, Ipsen leverages cutting-edge research and advanced technologies to deliver high-quality therapies that address unmet medical needs. Committed to scientific excellence and ethical practices, Ipsen collaborates with healthcare professionals and stakeholders to drive patient-centered solutions and improve health outcomes worldwide.

Locations

Bordeaux, , France

Seoul, , Korea, Republic Of

Suresnes, , France

Seoul, , Korea, Republic Of

Belfast, , United Kingdom

Roma, , Italy

Dijon, , France

Rouen, , France

Edinburgh, , United Kingdom

Seoul, , Korea, Republic Of

Paris, , France

Seoul, , Korea, Republic Of

Athens, , Greece

Napoli, , Italy

Lyon, , France

Athens, , Greece

Lille, , France

Hasselt, , Belgium

Orbassano, , Italy

Lørenskog, , Norway

Athens, , Greece

Clermont Ferrand, , France

Roma, , Italy

Angers, , France

Athens, , Greece

Clermont Ferrand, , France

Orléans, , France

Jeongnam, , Korea, Republic Of

Dijon, , France

Bourg En Bresse, , France

La Roche Sur Yon, , France

Paris, , France

Roma, , Italy

épagny, , France

Jeddah, , Saudi Arabia

Boulogne Sur Mer, , France

Avignon, , France

Besançon, , France

Bordeaux, , France

Brest, , France

Cabestany, , France

Créteil, , France

La Rochelle, , France

La Tronche, , France

Nantes, , France

Orléans, , France

Paris, , France

Paris, , France

Paris, , France

Poitiers, , France

Rouen, , France

Saint Nazaire, , France

Strasbourg, , France

Suresnes, , France

Tours, , France

Valenciennes, , France

Vandœuvre Lès Nancy, , France

Poitiers, , France

Avignon, , France

Boulogne Sur Mer, , France

Orléans, , France

Athens, , Greece

Suresnes, , France

Chaïdári, , Greece

Thessaloníki, , Greece

Milano, , Italy

Pozzuoli, , Italy

Meldola, , Italy

Ravenna, , Italy

Padova, , Italy

Riyadh, , Saudi Arabia

Ars Laquenexy, , France

Bezannes, , France

Fréjus, , France

Bruxelles, , Belgium

Yvoir, , Belgium

Macerata, , Italy

Patients applied

0 patients applied

Trial Officials

Ipsen Medical Director

Study Director

Ipsen

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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