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

Completed

• Conditions: Metastatic Endometrial Cancer

• Registration Number: NCT06599463
• Lead Sponsor: ARCAGY/ GINECO GROUP

Brief 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. We will manually review all files of the participating centers.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-19
• Study First Submitted: 2024-09-11
• Study First Submitted QC: 2024-09-13
• Study First Posted: 2024-09-19
• Primary Completion: 2025-02-28
• Study Completion: 2025-02-28
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-19
• Last Update Posted: 2025-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 351

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Median progression free survival (PFS)	An estimated median follow-up of 5 months from March 2022 to May 2024.	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.

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS)	An estimated median follow-up of 5 months from March 2022 to May 2024.	Time from the initial diagnosis of metastatic endometrial cancer to the date of death
Clinical benefit rate (CBR: SD, CR, PR).	An estimated median follow-up of 5 months from March 2022 to May 2024.	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.
Safety according to NCI CTCAE criteria v5.0.	An estimated median follow-up of 5 months from March 2022 to May 2024.	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.
Frequency and type of oncogeriatric testing.	an estimated median follow-up of 5 months from March 2022 to May 2024.	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.
Objective response rate (ORR: CR, PR)	An estimated median follow-up of 5 months from March 2022 to May 2024.	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.
PFS with lenvatinib+pembrolizumab according to MMR/MSI status.	An estimated median follow-up of 5 months from March 2022 to May 2024.	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.
Frequency and type of medical and paramedical follow-up procedures.	an estimated median follow-up of 5 months from March 2022 to May 2024.	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.

Trial Locations

Locations (24)

Clinique TIVOLI; 🇫🇷 Bordeaux, France

Oncopole Claudius Regaud - IUCT Oncopole; 🇫🇷 Toulouse, France

CHU Tours - Hôpital Bretonneau; 🇫🇷 Tours, France

Centre Hospitalier William Morey; 🇫🇷 Chalon-sur-saone, France

CHU de Poitiers - Hôpital de la Milétrie; 🇫🇷 Poitiers, France

ICO Paul Papin; 🇫🇷 Angers, France

Sainte Catherine - Institut du Cancer Avignon; 🇫🇷 Avignon, France

CHU Jean Minjoz; 🇫🇷 Besancon, France

ICONE; 🇫🇷 Bezannes, France

Centre François Baclesse; 🇫🇷 Caen, France

Centre Jean Perrin; 🇫🇷 Clermont-ferrand, France

CHU de DIJON; 🇫🇷 Dijon, France

Institut Curie; 🇫🇷 Saint-Cloud, France

CHU Saint-Etienne - Hôpital Bellevue; 🇫🇷 Saint-etienne, France

CHI de Cornouaille; 🇫🇷 Quimper, France

ICANS; 🇫🇷 Strasbourg, France

Centre Eugène Marquis; 🇫🇷 Rennes, France

Centre Georges François Leclerc; 🇫🇷 Dijon, France

Centre Léon Bérard; 🇫🇷 Lyon, France

Institut Paoli Calmettes; 🇫🇷 Marseille, France

ICM Val d'Aurelle; 🇫🇷 Montpellier, France

Hôpital Européen George Pompidou; 🇫🇷 Paris, France

Centre CARIO-HPCA; 🇫🇷 Plerin, France

Centre Hospitalier de Valence; 🇫🇷 Valence, France