Clinical trial NCT06599463: Efficacy Assessment of Lenvatinib Associated with Pembrolizumab in Metastatic Endometrial Cancer: a French Multicentric Retrospective Early Access Program-based Study
Official title: Efficacy Assessment of Lenvatinib Associated with Pembrolizumab in Metastatic Endometrial Cancer: a French Multicentric Retrospective Early Access Program-based Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Endometrial Cancer
Keywords: metastatic
endometrial
cancer
endometrial cancer
metastatic cancer
Lead sponsor: ARCAGY/ GINECO GROUP
Sponsor class: OTHER
Collaborators: name: Institut Curie
First posted: 2024-09-19
Enrollment: 351
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient who received lenvatinib with pembrolizumab in metatstatic endometrial cancer.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Median progression free survival (PFS)
timeFrame: An estimated median follow-up of 5 months from March 2022 to May 2024.
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: An estimated median follow-up of 5 months from March 2022 to May 2024.
measure: Clinical benefit rate (CBR: SD, CR, PR).
timeFrame: An estimated median follow-up of 5 months from March 2022 to May 2024.
measure: Safety according to NCI CTCAE criteria v5.0.
timeFrame: An estimated median follow-up of 5 months from March 2022 to May 2024.
measure: Frequency and type of oncogeriatric testing.
timeFrame: an estimated median follow-up of 5 months from March 2022 to May 2024.
measure: Objective response rate (ORR: CR, PR)
timeFrame: An estimated median follow-up of 5 months from March 2022 to May 2024.
measure: PFS with lenvatinib+pembrolizumab according to MMR/MSI status.
timeFrame: An estimated median follow-up of 5 months from March 2022 to May 2024.
measure: Frequency and type of medical and paramedical follow-up procedures.
timeFrame: an estimated median follow-up of 5 months from March 2022 to May 2024.
Other outcomes:
Locations:
city: Angers
country: France
facility: ICO Paul Papin
city: Avignon
country: France
facility: Sainte Catherine - Institut du Cancer Avignon
city: Besancon
country: France
facility: CHU Jean Minjoz
city: Bezannes
country: France
facility: ICONE
city: Bordeaux
country: France
facility: Clinique TIVOLI
city: Caen
country: France
facility: Centre François Baclesse
city: Chalon-sur-saone
country: France
facility: Centre Hospitalier William Morey
city: Clermont-ferrand
country: France
facility: Centre Jean Perrin
city: Dijon
country: France
facility: CHU de DIJON
city: Dijon
country: France
facility: Centre Georges François Leclerc
city: Lyon
country: France
facility: Centre Léon Bérard
city: Marseille
country: France
facility: Institut Paoli Calmettes
city: Montpellier
country: France
facility: ICM Val d&#39;Aurelle
city: Paris
country: France
facility: Hôpital Européen George Pompidou
city: Plerin
country: France
facility: Centre CARIO-HPCA
city: Poitiers
country: France
facility: CHU de Poitiers - Hôpital de la Milétrie
city: Quimper
country: France
facility: CHI de Cornouaille
city: Rennes
country: France
facility: Centre Eugène Marquis
city: Saint-Cloud
country: France
facility: Institut Curie
city: Saint-etienne
country: France
facility: CHU Saint-Etienne - Hôpital Bellevue
city: Strasbourg
country: France
facility: ICANS
city: Toulouse
country: France
facility: Oncopole Claudius Regaud - IUCT Oncopole
city: Tours
country: France
facility: CHU Tours - Hôpital Bretonneau
city: Valence
country: France
facility: Centre Hospitalier de Valence
Study officials:
affiliation: Institut Curie
name: Diana BELLO ROUFAI
role: PRINCIPAL_INVESTIGATOR
References: