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

NCT ID: NCT06599463

Last Updated: 2025-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

351 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-19

Study Completion Date

2025-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Metastatic Endometrial Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* Patients who refuse the collection and use of their personal data in the course of this research.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Institut Curie

OTHER

Sponsor Role collaborator

ARCAGY/ GINECO GROUP

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Diana BELLO ROUFAI

Role: PRINCIPAL_INVESTIGATOR

Institut Curie

Locations

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ICO Paul Papin

Angers, , France

Site Status

Sainte Catherine - Institut du Cancer Avignon

Avignon, , France

Site Status

CHU Jean Minjoz

Besançon, , France

Site Status

ICONE

Bezannes, , France

Site Status

Clinique TIVOLI

Bordeaux, , France

Site Status

Centre François Baclesse

Caen, , France

Site Status

Centre Hospitalier William Morey

Chalon-sur-Saône, , France

Site Status

Centre Jean Perrin

Clermont-Ferrand, , France

Site Status

CHU de DIJON

Dijon, , France

Site Status

Centre Georges François Leclerc

Dijon, , France

Site Status

Centre Léon Bérard

Lyon, , France

Site Status

Institut Paoli Calmettes

Marseille, , France

Site Status

ICM Val d'Aurelle

Montpellier, , France

Site Status

Hôpital Européen George Pompidou

Paris, , France

Site Status

Centre CARIO-HPCA

Plérin, , France

Site Status

CHU de Poitiers - Hôpital de la Milétrie

Poitiers, , France

Site Status

CHI de Cornouaille

Quimper, , France

Site Status

Centre Eugène Marquis

Rennes, , France

Site Status

Institut Curie

Saint-Cloud, , France

Site Status

CHU Saint-Etienne - Hôpital Bellevue

Saint-Etienne, , France

Site Status

ICANS

Strasbourg, , France

Site Status

Oncopole Claudius Regaud - IUCT Oncopole

Toulouse, , France

Site Status

CHU Tours - Hôpital Bretonneau

Tours, , France

Site Status

Centre Hospitalier de Valence

Valence, , France

Site Status

Countries

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France

Other Identifiers

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RECF-005767

Identifier Type: REGISTRY

Identifier Source: secondary_id

GINECO-EN204

Identifier Type: -

Identifier Source: org_study_id

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