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Metastatic Endometrial CancerLARENANCT06599463

Efficacy Assessment of Lenvatinib Associated with Pembrolizumab in Metastatic Endometrial Cancer: a French Multicentric Retrospective Early Access Program-based Study

An observational study of Metastatic Endometrial Cancer, run by ARCAGY/ GINECO GROUP at 24 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

LARENA is a multicentric retrospective study (secondary use of data) of consecutive patients prospectively registered in the lenvatinib plus pembrolizumab French early access program (Temporary Authorisation for Use). The source of data will be the patient's medical file. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Metastatic Endometrial Cancer
How many people
351 participants
Where
24 sitesFrance
Study dates
19 Aug 2024to 28 Feb 2025
Phase
Observational
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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: Patient who received lenvatinib with pembrolizumab in metatstatic endometrial cancer.

Who may be able to join

  • Patients having received at least one dose of lenvatinib plus pembrolizumab in the context of the French early access program (Temporary Authorisation for Use) approved by the French Health Autority.
  • Patients with advanced or recurrent endometrial cancer whose disease is progressing during or following prior platinum-based chemotherapy at any stage and who are not eligible for curative surgery or radiotherapy, according to the French early access program (Temporary Authorisation for Use) approved by the French Health Autority criteria.

Who cannot join

  • Patients who refuse the collection and use of their personal data in the course of this research.

Trial locations and contacts

24 sites in 1 country.

24 sites in 1 country

France24 sites

  • ICO Paul Papin

    Angers, 49055

  • Sainte Catherine - Institut du Cancer Avignon

    Avignon, 84918

  • CHU Jean Minjoz

    Besançon, 25000

  • ICONE

    Bezannes, 51430

  • Clinique TIVOLI

    Bordeaux, 33000

  • Centre François Baclesse

    Caen, 14000

  • Centre Hospitalier William Morey

    Chalon-sur-Saône, 71100

  • Centre Jean Perrin

    Clermont-Ferrand, 63011

  • CHU de DIJON

    Dijon, 21079

  • Centre Georges François Leclerc

    Dijon, 77980

  • Centre Léon Bérard

    Lyon, 69008

  • Institut Paoli Calmettes

    Marseille, 13009

  • ICM Val d'Aurelle

    Montpellier, 34298

  • Hôpital Européen George Pompidou

    Paris, 75015

  • Centre CARIO-HPCA

    Plérin, 22190

  • CHU de Poitiers - Hôpital de la Milétrie

    Poitiers, 86021

  • CHI de Cornouaille

    Quimper, 29107

  • Centre Eugène Marquis

    Rennes, 35000

  • Institut Curie

    Saint-Cloud, 92210

  • CHU Saint-Etienne - Hôpital Bellevue

    Saint-Etienne, 42100

  • ICANS

    Strasbourg, 67033

  • Oncopole Claudius Regaud - IUCT Oncopole

    Toulouse, 31059

  • CHU Tours - Hôpital Bretonneau

    Tours, 37044

  • Centre Hospitalier de Valence

    Valence, 26953

Other trials in France

About this study

LARENA is a multicentric retrospective study (secondary use of data) of consecutive patients prospectively registered in the lenvatinib plus pembrolizumab French early access program (Temporary Authorisation for Use). The source of data will be the patient's medical file. We will manually review all files of the participating centers.

Keywords
metastatic, endometrial, cancer, endometrial cancer, metastatic cancer
Medical subject headings
Endometrial Neoplasms, Neoplasm Metastasis, Neoplasms

What is being measured

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

  1. Median progression free survival (PFS)

    Time from the first administration of lenvatinib + pembrolizumab to the date of the first documented disease progression according to RECIST1.1 or death due to any cause whichever occurs first.

    Measured: An estimated median follow-up of 5 months from March 2022 to May 2024.

Secondary outcomes (7)

  1. Overall survival (OS)

    Time from the initial diagnosis of metastatic endometrial cancer to the date of death

    Measured: An estimated median follow-up of 5 months from March 2022 to May 2024.

  2. Clinical benefit rate (CBR: SD, CR, PR).

    Time from the first administration of lenvatinib + pembrolizumab to the date of the first documented disease progression according to RECIST1.1 or death due to any cause whichever occurs first.

    Measured: An estimated median follow-up of 5 months from March 2022 to May 2024.

  3. Safety according to NCI CTCAE criteria v5.0.

    Time from the first administration of lenvatinib + pembrolizumab to the date of the first documented disease progression according to RECIST1.1 or death due to any cause whichever occurs first.

    Measured: An estimated median follow-up of 5 months from March 2022 to May 2024.

  4. Frequency and type of oncogeriatric testing.

    Time from the first administration of lenvatinib + pembrolizumab to the date of the first documented disease progression according to RECIST1.1 or death due to any cause whichever occurs first.

    Measured: an estimated median follow-up of 5 months from March 2022 to May 2024.

  5. Objective response rate (ORR: CR, PR)

    Time from the first administration of lenvatinib + pembrolizumab to the date of the first documented disease progression according to RECIST1.1 or death due to any cause whichever occurs first.

    Measured: An estimated median follow-up of 5 months from March 2022 to May 2024.

  6. PFS with lenvatinib+pembrolizumab according to MMR/MSI status.

    Time from the first administration of lenvatinib + pembrolizumab to the date of the first documented disease progression according to RECIST1.1 or death due to any cause whichever occurs first.

    Measured: An estimated median follow-up of 5 months from March 2022 to May 2024.

  7. Frequency and type of medical and paramedical follow-up procedures.

    Time from the first administration of lenvatinib + pembrolizumab to the date of the first documented disease progression according to RECIST1.1 or death due to any cause whichever occurs first.

    Measured: an estimated median follow-up of 5 months from March 2022 to May 2024.

Timeline

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

  1. First posted19 Sep 2024
  2. Study start19 Aug 2024
  3. Primary completion28 Feb 2025
  4. Study completion28 Feb 2025

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
351 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06599463
Sponsor's protocol ID
GINECO-EN204
Other IDs
RECF-005767
Acronym
LARENA
Status last verified
Mar 2025
First submitted
11 Sep 2024
Last updated
20 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Metastatic Endometrial Cancer, run by ARCAGY/ GINECO GROUP at 24 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 2 inclusion and 1 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 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 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.

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?

Median progression free survival (PFS) (time frame: An estimated median follow-up of 5 months from March 2022 to May 2024.). 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 NCT06599463.

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 20 Mar 2025.

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