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

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.

Study Overview

• Status: Completed
• Conditions: Metastatic Endometrial Cancer

• Study Type: Observational
• Enrollment (Actual): 351

Contacts and Locations

Study Locations

• France
  • Angers, France, 49055
    • ICO Paul Papin
  • Avignon, France, 84918
    • Sainte Catherine - Institut du Cancer Avignon
  • Besancon, France, 25000
    • Chu Jean Minjoz
  • Bezannes, France, 51430
    • ICONE
  • Bordeaux, France, 33000
    • Clinique Tivoli
  • Caen, France, 14000
    • Centre Francois Baclesse
  • Chalon-sur-saone, France, 71100
    • Centre Hospitalier William Morey
  • Clermont-ferrand, France, 63011
    • Centre Jean Perrin
  • Dijon, France, 21079
    • Chu de Dijon
  • Dijon, France, 77980
    • Centre Georges François Leclerc
  • Lyon, France, 69008
    • Centre Leon Berard
  • Marseille, France, 13009
    • Institut Paoli Calmettes
  • Montpellier, France, 34298
    • Icm Val D'Aurelle
  • Paris, France, 75015
    • Hôpital Européen George Pompidou
  • Plerin, France, 22190
    • Centre CARIO-HPCA
  • Poitiers, France, 86021
    • CHU de Poitiers - Hôpital de La Milétrie
  • Quimper, France, 29107
    • CHI de Cornouaille
  • Rennes, France, 35000
    • Centre Eugène Marquis
  • Saint-Cloud, France, 92210
    • Institut Curie
  • Saint-etienne, France, 42100
    • CHU Saint-Etienne - Hôpital Bellevue
  • Strasbourg, France, 67033
    • ICANS
  • Toulouse, France, 31059
    • Oncopole Claudius Régaud - IUCT Oncopole
  • Tours, France, 37044
    • CHU Tours - Hôpital Bretonneau
  • Valence, France, 26953
    • Centre Hospitalier de Valence

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patient who received lenvatinib with pembrolizumab in metatstatic endometrial cancer.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival (OS)	Time from the initial diagnosis of metastatic endometrial cancer to the date of death	An estimated median follow-up of 5 months from March 2022 to May 2024.
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.	An estimated median follow-up of 5 months from March 2022 to May 2024.
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.	An estimated median follow-up of 5 months from March 2022 to May 2024.
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.	an estimated median follow-up of 5 months from March 2022 to May 2024.
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.	An estimated median follow-up of 5 months from March 2022 to May 2024.
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.	An estimated median follow-up of 5 months from March 2022 to May 2024.
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.	an estimated median follow-up of 5 months from March 2022 to May 2024.

Collaborators and Investigators

• Sponsor: ARCAGY/ GINECO GROUP
• Collaborators: Institut Curie
• Investigators: Principal Investigator: Diana BELLO ROUFAI, Institut Curie

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2024
• Primary Completion (Actual): February 28, 2025
• Study Completion (Actual): February 28, 2025

Study Registration Dates

• First Submitted: September 11, 2024
• First Submitted That Met QC Criteria: September 13, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 19, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: cancer; endometrial cancer; metastatic cancer; metastatic; endometrial
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Uterine Neoplasms; Endometrial Neoplasms
• Other Study ID Numbers: GINECO-EN204; RECF-005767 (Registry Identifier: INCA)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No