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Real-World data shows promise for kidney cancer drug combo

NCT ID NCT04941768

Disease control Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed study looked at how well avelumab (BAVENCIO) plus axitinib (INLYTA) works for advanced kidney cancer in everyday medical practice. Researchers tracked 105 patients across multiple EU countries to see survival rates at 12 and 24 months. The goal was to understand the treatment's effectiveness and safety outside of controlled clinical trials.

What this could mean

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

Active substance
avelumab (BAVENCIO) and axitinib (INLYTA)
What this could lead to
If results are positive, this could confirm that the combination is effective for advanced kidney cancer in real-world settings, supporting its use as a standard first-line therapy.
What could go wrong
This is an observational study, not a controlled trial, so results may be less reliable. The small size (105 participants) and lack of a comparison group limit how much we can conclude.

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

105 people

The number who actually took part.

Started

Aug 2021

Finished

Apr 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

Participants with a confirmed diagnosis of advanced RCC will be observed in this study.

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 the Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 * Participants with a histologically confirmed diagnosis of RCC with any histological origin * Participants with a locally advanced/metastatic disease (that is \[ie\], newly diagnosed Stage 4 RCC per American Joint Committee on Cancer) or has recurrent disease * Participants has received 1 or 2 cycles of Avelumab plus Axitinib treatment as a first-line therapy according to the approved Summary of Product Characteristics (SmPC) * Participants willing to sign the written informed consent form (ICF) to participate in this study Exclusion Criteria: * Participants with contraindications for Avelumab or Axitinib according to the approved SmPC * Participants who have participated in any interventional clinical study of a drug or device within 28 days prior to the start of Avelumab plus Axitinib

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Conditions

The condition(s) this trial relates to.

renal cell adenocarcinoma renal cell carcinoma

As listed by the trial registrant

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

Carcinoma, renal cell

Contacts and locations

Locations

  • AZ KLINA

    Brasschaat, Belgium

  • AZ Sint-Jan

    Bruges, Belgium

  • Agios Loukas Hospital

    Thessaloniki, Greece

  • Attikon

    Chaïdári, Greece

  • Attikon Hospital

    Attiki, Greece

  • Biberach

    Biberach an der Riss, Germany

  • Bioclinic (GRC)

    Thessaloniki, Greece

  • Donauisar Klinikum Deggendorf

    Deggendorf, Germany

  • Evangelisches Klinikum Bethel

    Bielefeld, Germany

  • Evangelisches Krankenhaus Bielefeld

    Bielefeld, Germany

  • GPR Klinikum Rüsselsheimg GmbH

    Rüsselsheim am Main, Germany

  • Gen. Hos. "Alexandra"

    Athens, Greece

  • General Hospital "Venizelio"

    Heraklion, Greece

  • General Hospital of Athens G.Gennimatas

    Athens, Greece

  • General Hospital of Patras "o Agios Andreas"

    Pátrai, Greece

  • Henry Dunant Hospital Center

    Athens, Greece

  • Hämatologie und Onkologie Stolberg

    Stolberg, Germany

  • Imelda Ziekenhuis

    Bonheiden, Belgium

  • Johannes Wesling Klinikum Minden der Mühlenkreiskliniken (AöR)

    Minden, Germany

  • Kavala General Hospital

    Kavala, Greece

  • Klinikum Aschaffenburg Medizinische Klinik

    Aschaffenburg, Germany

  • Klinikum Friedrichshafen GmbH daVinci® -Zentrum Bodensee

    Friedrichshafen, Germany

  • Klinikum Osnabrück GmbH

    Osnabrück, Germany

  • Klinikum St. Marien Amberg

    Amberg, Germany

  • Lahn Dill Kliniken GmbH

    Wetzlar, Germany

  • MVZ Onkologische Kooperation Harz GbR

    Goslar, Germany

  • Marienhospital Osnabrück - Standort Natruper Holz

    Osnabrück, Germany

  • Medizinische Hochschule Hannover

    Hanover, Germany

  • Medizinische Studiengesellschaft Nord-West GmbH

    Westerstede, Germany

  • Metaxa Hospital

    Piraeus, Greece

  • Metropolitan Hospital Greece

    Piraeus, Greece

  • Onkologische GP Dres. Wilke/Wagner/Petzoldt

    Fürth, Germany

  • Onkologische SP Praxis Fürth

    Fürth, Germany

  • Papageorgiou Hospital

    Thessaloniki, Greece

  • Paracelsus Klinik Osnabrück

    Osnabrück, Germany

  • Praxis Dr. Maas

    Halberstadt, Germany

  • Praxis Kretz

    Heinsberg, Germany

  • Praxis Troisdorf

    Troisdorf, Germany

  • Regional Oncology Dispensary - Irkutsk

    Irkutsk, Russia

  • SRH Kliniken Landkreis Sigmaringen (DEU)

    Sigmaringen, Germany

  • Saint Luke Hospital

    Thessaloniki, Greece

  • Schwerpunktpraxis für Hämatologie und Onkologie

    Magdeburg, Germany

  • St. Georg Klinikum Eisenach gGmbH

    Eisenach, Germany

  • Uniklinikum Münster

    Münster, Germany

  • Universitaetsklinikum Essen Uroonkologie

    Essen, Germany

  • Universitatsklinik Schleswig-Holstein

    Lübeck, Germany

  • Universitatsklinikum Erlangen

    Erlangen, Germany

  • University Hospital of Athens Sotiria

    Athens, Greece

  • University Hospital of Ioannina

    Ioannina, Greece

  • University Hospital of Larissa

    Larissa, Greece

  • University of Munster

    Münster, Germany

  • Universitätskinderklinik Jena

    Jena, Germany

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, Germany

  • Urologie im Schlosscarree

    Braunschweig, Germany

  • Urologische Gemeinschaftspraxis

    Dresden, Germany

  • Urologische Praxis Dipl.-Med. Susanne Kloß

    Luckenwalde, Germany

  • Urologische Praxis Dr. Ralf Eckert

    L.-Eisleben, Germany

  • Vinzenzkrankenhaus Hannover

    Hanover, Germany

  • Wissenschaftskontor Nord GmbH & Co. KG

    Rostock, Germany

  • Zentrum für urologische Onkologie

    Berlin, Germany

  • medius Klinik Ostfildern-Ruit

    Ostfildren, Germany

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