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Metastatic Renal Cell CarcinomaPhase 2CABRAMETNCT03967522

Evaluation of Cabozantinib in Metastatic Renal Cell Carcinoma (mRCC) With Brain Metastases

A Phase 2 study testing Cabozantinib in people with Metastatic Renal Cell Carcinoma, run by Centre Leon Berard at 12 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a multicenter, open-label, exploratory, single-arm, prospective phase II study to assess the efficacy and safety profile of cabozantinib in patients with brain metastases from metastatic renal cell carcinoma (mRCC). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Renal Cell Carcinoma
What is being tested?
Cabozantinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
12 sitesFrance
Study dates
29 Nov 2019to 1 Nov 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • I1. Age ≥ 18 years. I2. Histologically proven metastatic Renal Cell Carcinoma. I3. Brain metastases not requiring corticosteroids at dose > 40 mg/day. I4.At least 1 locally untreated brain lesion ≥8mm in longest diameter or >5mm if > 1 lesion.
  • I5.Not previously treated by cabozantinib. I6.Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 1. I7.Life expectancy ≥ 3 months
  • I8.Adequate organ function as defined by the following criteria:
  • Total serum bilirubin ≤ 2 x ULN (Gilbert's disease exempted)
  • Serum transaminases and alkaline phosphatases ≤ 2.5 x ULN, or in case of liver or bone metastasis ≤ 5.0 x ULN
  • Serum creatinine ≤ 2 x ULN OR creatinine clearance ≥ 50 ml/min
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  • Absolute neutrophil count (ANC) ≥ 1 500/mm3
  • Platelets ≥ 100 000/mm3 (100 G/l)
  • Hemoglobin ≥ 9.0 g/dl. I9. Covered by a medical/health insurance. I10. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
  • I11. Signed and dated IRB/ICE approved informed consent form. I12. Accepting to use effective contraception (barrier contraceptives) during study treatment and within at least 4 months after final dose of study therapy. Oral contraceptives are not acceptable.

Who cannot join

  • E1. Any local previous treatment of current brain metastases. E2. Any anti-coagulation therapy (except preventive treatment at low dose). E3. Contra-indication of Magnetic Resonance Imaging (MRI) (i.e. : pace-maker). E4. Uncontrolled seizures. E5. Any symptoms of intracranial hypertension. E6. Any of the following within 12 months prior to treatment initiation: severe/unstable angina, myocardial infarction, coronary artery bypass graft, symptomatic congestive heart failure, ischemic or hemorrhagic stroke including transient ischemic attack.
  • E7. Uncontrolled hypertension defined as systolic blood pressure >150 mmHg or diastolic pressure >90 mmHg, despite optimal medical treatment.
  • E8. Ongoing cardiac dysrhythmia of grade ≥ 2, atrial fibrillation of any grade, QTc interval > 0.43.
  • E9. Pregnant or breast feeding woman (mandatory negative serum or urinary pregnancy test at study entry for all women of childbearing potential).
  • E10. Any acute or chronic medical or psychiatric condition or laboratory abnormality that would make the patient unsuited to study participation.
  • E11. Any second malignancy within the last 3 years with the exception of basal cell carcinoma, in situ cervical cancer and pT1/a bladder cancer with no evidence of recurrent disease for 12 months.
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  • E12. Patients receiving strong inhibitor or inducer of CYP3A4 especially some anti-epileptic drugs.
  • E13. Psychological, familial, sociological, geographical conditions that would limit compliance with study protocol requirements.
  • E14. Participation to another clinical trial that might interfere with the evaluation of the main criterion.
  • E15. Known hypersensitivity to the active substance or to any of the excipients of cabozantinib.
  • E16. Patient requiring tutorship or curatorship.

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

France12 sites

  • Institut de Cancérologie de l'Ouest-Site Paul Papin

    Angers, 49005

  • CHU Besancon

    Besançon, 25030

  • CHU Bordeaux

    Bordeaux, 33075

  • Centre Jean Perrin

    Clermont-Ferrand, 63011

  • Centre Leon Berard

    Lyon, 69373

  • Institut de Cancérologie de la Lorraine

    Nancy, 54519

  • Hopital Européen Georges Pompidou

    Paris, 75015

  • Institut de Cancérologie de l'Ouest-site René Gauducheau

    Saint-Herblain, 44805

  • ICANS

    Strasbourg, 67000

  • Hopital Foch

    Suresnes, 92150

  • IUCT-Institut Claudius Regaud

    Toulouse, 31059

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

About this study

Official title: CABRAMET: A Phase 2 Study of Cabozantinib in Metastatic Renal Cell Carcinoma (mRCC) With Brain Metastases

This is a multicenter, open-label, exploratory, single-arm, prospective phase II study to assess the efficacy and safety profile of cabozantinib in patients with brain metastases from metastatic renal cell carcinoma (mRCC).

Read the detailed description

Cabozantinib is a small molecule inhibitor of tyrosine kinases which include MET (hepatocyte growth factor receptor protein), VEGFR (vascular endothelial growth factor receptors), AXL, RET (Rearranged during transfection), FLT3 (Fms-like tyrosine kinase-3), KIT (mast/stem cell factor receptor), ROS1, MER, TYRO3, TRKB (Tropomyosin receptor kinase B) and TIE-2 (angiopoietins receptor). Similar to other TKIs, cabozantinib is a reversible, ATP-competitive inhibitor. Cabozantinib has thus demonstrated significant activity in metastatic clear cell renal cell carcinoma after failure of one or 2 tyrosine kinase inhibitors and is now approved in the second line setting in Europe. Some efficacy was also demonstrated in patients in first line treatment when compared to sunitinib.

Brain metastasis in renal cancer are difficult to treat and cytotoxic systemic therapies are still not used, given by the more or less impermeable blood-brain barrier. The interest of cabozantinib in brain renal cell carcinoma metastases is encouraged by 3 recent cases reports of significant responses of brain metastases including a complete response of brain metastases in one case. Moreover MET receptor surexpression appear more frequent in brain metastases than in other renal cell carcinoma tumor sites. Cabozantinib as multitarget inhibitor including VEGF and MET receptors suggest that it could be a good option. Its efficacy in brain metastases from renal cell carcinoma requires further evaluation.

On this basis, the investigators propose to conduct an open-label exploratory single arm, multicenter prospective phase II trial to assess the efficacy of cabozantinib on brain metastases in metastatic renal cell carcinoma patients.

Ancillary studies:

The relationship between serum markers and efficacy data will be investigated. Serum and plasma sample will be collected at Baseline. MET expression and MET sequencing will be also performed on available tumor tissues.

Being tested
Cabozantinib
Keywords
mRCC, cabozantinib, brain metastases
Medical subject headings
Carcinoma, Renal Cell, Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CabozantinibDrug

    All participants will be treated by 60 mg of cabozantinib once daily. Temporary or permanent discontinuation and/or dose reduction of cabozantinib therapy may be required for the management of some adverse reactions. When dose reduction is necessary, it is recommended to reduce to 40 mg daily, and then to 20 mg daily.

Study groups in NCT03967522
Study groupRoleWhat they receive
Cabozantinib treatmentExperimentalAll participants will be treated by 60 mg of cabozantinib once daily.
Receives: Drug: Cabozantinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The non progression rate in brain metastases at 6 months

    Tumor assessment in brain will be performed by cerebral MRI at baseline, 1.5 months, 3 months and 6 months. These cerebral MRI will be reviewed by central review according to the RANO-BM criteria.

    Measured: At 6 months for each patient

Secondary outcomes (6)

  1. Incidence of adverse events

    Assessed using the National Cancer Institute - Common Terminology Criteria for Adverse Event (NCI-CTCAE) v5 grading scale, specific registration of neurological event during study duration.

    Measured: Up to 54 months

  2. Best response in brain metastases

    Evaluated according to RANDO-BM criteria.

    Measured: Up to follow-up visit month 18 for each patient

  3. Duration of response in brain

    From the date of inclusion to the date of first documented disease progression.

    Measured: Up to 18 months for each patient

  4. Progression-free survival

    Measured from the date of inclusion to the date of first documented disease progression or death from any cause.

    Measured: Up to 18 months for each patient

  5. Overall survival

    Measured from the date of inclusion to the date of death from any cause.

    Measured: Up to 54 months

  6. Response rate on the extracranial disease at 3 and 6 months

    Defined as the poportion of patients with a complete or a partial response at 3 and 6 months, evaluated according to RECIST v1.1 criteria.

    Measured: From baseline to 3 months and 6 months for each patients

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2019
  2. Study start29 Nov 2019
  3. Primary completion22 Oct 2024
  4. Study completion1 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03967522
Sponsor's protocol ID
CABRAMET (ET19-006)
Acronym
CABRAMET
Status last verified
Aug 2025
First submitted
27 May 2019
Last updated
8 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Negrier S, Mourey L, Dalban C, Gross-Goupil M, Flechon A, Escudier B, Barthelemy P, Oudard S, Colomba E, Thibault C, Ravaud A, Chevreau C, Boyle HJ, Blanc E, Chabaud S, Perol D, Albiges L, Flippot R; Groupe d'Etude des Tumeurs UroGenitale (Urogenital Tumor Study Group, GETUG) investigators. Cabozantinib in patients with non-locally pretreated brain metastases from renal cell carcinoma: Results of the multicenter phase II trial CABRAMET. Eur J Cancer. 2026 May 15;239:116712. doi: 10.1016/j.ejca.2026.116712. Epub 2026 Apr 1.

    PubMed 41946178

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cabozantinib in people with Metastatic Renal Cell Carcinoma, run by Centre Leon Berard at 12 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The non progression rate in brain metastases at 6 months (time frame: At 6 months for each patient). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03967522, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.

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