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Completed

NCT Number: NCT06599463

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

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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Key information

Conditions

Metastatic Endometrial Cancer Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

ICO Paul Papin, Angers, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Median progression free survival (PFS)

    Time frame: 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 outcomes

  1. Overall survival (OS)

    Time frame: 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

  2. Clinical benefit rate (CBR: SD, CR, PR).

    Time frame: 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.

  3. Safety according to NCI CTCAE criteria v5.0.

    Time frame: 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.

  4. Frequency and type of oncogeriatric testing.

    Time frame: 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.

  5. Objective response rate (ORR: CR, PR)

    Time frame: 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.

  6. PFS with lenvatinib+pembrolizumab according to MMR/MSI status.

    Time frame: 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.

  7. Frequency and type of medical and paramedical follow-up procedures.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

ARCAGY/ GINECO GROUP

Other

Collaborators

  • Institut Curie

Registry information

Acronym: LARENA

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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