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New study tests kidney cancer combo in patients over 70

NCT ID NCT06934057

Disease control Sponsor: Gustave Roussy, Cancer Campus, Grand Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 is looking at how older patients (70 years and older) with advanced kidney cancer handle a combination of two drugs: cabozantinib (a daily pill) and nivolumab (an IV infusion). The goal is to see how doctors actually use these drugs in real life, including starting doses and any needed adjustments. About 50 participants will be followed for up to 12 months to track side effects, dose changes, and how well the cancer responds.

What this could mean

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

Active substance
cabozantinib (a pill taken daily) and nivolumab (an IV infusion given every 2 or 4 weeks)
What this could lead to
If successful, this study could help doctors personalize dosing and management of this combination therapy for older adults with kidney cancer, improving treatment tolerance and outcomes.
What could go wrong
This is a small, single-group, observational study (not a randomized trial), so results may not apply broadly. Side effects from the drugs (e.g., fatigue, high blood pressure, immune reactions) are possible, especially in older patients.

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.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

70 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: 1. Patients ≥ 70 years-old 2. Confirmed advanced or metastatic renal-cell carcinoma 3. Patients not previously treated in metastatic setting 4. Performance Status 0 to 2 5. Sexually active male patients must agree to use condom during the study and for at least 5 months after the last study treatment administration. Also, it is recommended their women of childbearing potential partner use a highly effective method of contraception. 6. Patient should understand, sign, and date the written informed consent form prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol. 7. Patients must be affiliated to a social security system or beneficiary of the same Exclusion Criteria: 1. Participation in another clinical study with an investigational product during the last four weeks and while on study treatment (Patients may be included in CABOLD if they are included in the arm B of CARE1 study EUCT N° 2023-503317-29-00) 2. Performance Status \> 2 3. Any condition that represent a contraindication to Cabozantinib and/or Nivolumab, as described in summaries of products characteristics, including symptomatic untreated brain metastasis or active auto-immune disease requiring systemic immunosuppressant/modulator (thyroid or adrenal disorder are not an exclusion criteria) 4. Any severe cardiovascular or thrombo-embolic event in the last three months 5. Any situation for which exclusive palliative care intervention is recommended 6. Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent

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Conditions

The condition(s) this trial relates to.

childhood kidney cell carcinoma clear cell renal carcinoma kidney cancer renal cell carcinoma

As listed by the trial registrant

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

Kidney cancer Renal cell cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    7 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CHU Tours - Hôpital Bretonneau

    NOT_YET_RECRUITING

    Tours, 37044, France

  • Centre Georges François Leclerc

    NOT_YET_RECRUITING

    Dijon, 21079, France

  • Centre Léon Bérard

    NOT_YET_RECRUITING

    Lyon, 69373, France

  • Gustave Roussy

    RECRUITING

    Villejuif, 94800, France

  • Hôpital Tenon

    NOT_YET_RECRUITING

    Paris, 75020, France

  • Institut Universitaire Du Cancer Toulouse- Oncopole Claudius Regaud

    NOT_YET_RECRUITING

    Toulouse, 31059, France

  • Institut de Cancérologie de l'Ouest - Angers

    NOT_YET_RECRUITING

    Angers, 49055, France

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