Efficacy Assessment of Lenvatinib Associated with Pembrolizumab in Metastatic Endometrial Cancer: a French Multicentric Retrospective Early Access Program-based Study
LARENA
2 other identifiers
observational
351
1 country
24
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2024
Shorter than P25 for all trials
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 19, 2024
CompletedFirst Submitted
Initial submission to the registry
September 11, 2024
CompletedFirst Posted
Study publicly available on registry
September 19, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2025
CompletedMarch 20, 2025
March 1, 2025
6 months
September 11, 2024
March 19, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
An estimated median follow-up of 5 months from March 2022 to May 2024.
Secondary Outcomes (7)
Overall survival (OS)
An estimated median follow-up of 5 months from March 2022 to May 2024.
Clinical benefit rate (CBR: SD, CR, PR).
An estimated median follow-up of 5 months from March 2022 to May 2024.
Safety according to NCI CTCAE criteria v5.0.
An estimated median follow-up of 5 months from March 2022 to May 2024.
Frequency and type of oncogeriatric testing.
an estimated median follow-up of 5 months from March 2022 to May 2024.
Objective response rate (ORR: CR, PR)
An estimated median follow-up of 5 months from March 2022 to May 2024.
- +2 more secondary outcomes
Eligibility Criteria
Patient who received lenvatinib with pembrolizumab in metatstatic endometrial cancer.
You may qualify if:
- 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.
You may not qualify if:
- Patients who refuse the collection and use of their personal data in the course of this research.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ARCAGY/ GINECO GROUPlead
- Institut Curiecollaborator
Study Sites (24)
ICO Paul Papin
Angers, 49055, France
Sainte Catherine - Institut du Cancer Avignon
Avignon, 84918, France
CHU Jean Minjoz
Besançon, 25000, France
ICONE
Bezannes, 51430, France
Clinique TIVOLI
Bordeaux, 33000, France
Centre François Baclesse
Caen, 14000, France
Centre Hospitalier William Morey
Chalon-sur-Saône, 71100, France
Centre Jean Perrin
Clermont-Ferrand, 63011, France
CHU de DIJON
Dijon, 21079, France
Centre Georges François Leclerc
Dijon, 77980, France
Centre Léon Bérard
Lyon, 69008, France
Institut Paoli Calmettes
Marseille, 13009, France
ICM Val d'Aurelle
Montpellier, 34298, France
Hôpital Européen George Pompidou
Paris, 75015, France
Centre CARIO-HPCA
Plérin, 22190, France
CHU de Poitiers - Hôpital de la Milétrie
Poitiers, 86021, France
CHI de Cornouaille
Quimper, 29107, France
Centre Eugène Marquis
Rennes, 35000, France
Institut Curie
Saint-Cloud, 92210, France
CHU Saint-Etienne - Hôpital Bellevue
Saint-Etienne, 42100, France
ICANS
Strasbourg, 67033, France
Oncopole Claudius Regaud - IUCT Oncopole
Toulouse, 31059, France
CHU Tours - Hôpital Bretonneau
Tours, 37044, France
Centre Hospitalier de Valence
Valence, 26953, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Diana BELLO ROUFAI
Institut Curie
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 11, 2024
First Posted
September 19, 2024
Study Start
August 19, 2024
Primary Completion
February 28, 2025
Study Completion
February 28, 2025
Last Updated
March 20, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share