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OpenTrials
Completed

NCT Number: NCT06586580

Treatment of Metastatic Melanoma with Lenvatinib + Anti-PD1

The hypothesis is that treatment with Lenvatinib + Pembrolizumab is less effective in real life than in clinical trials. In fact, an objective response rate < 20% and a worse tolerability of the treatment in real life with ≥50% of severe toxicities are expected.

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Key information

Conditions

Metastatic Melanoma Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Besançon

Besançon, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Metastatic melanoma (stage III non operable or stage IV according to American Joint Committee on Cancer staging rules) refractory to immunotherapy (≥ 2nd treatment line after minimum a failure of immunotherapy)

Exclusion criteria

  • Uveal melanoma

Treatment and study plan

Primary outcomes

  1. Objective response rate

    Time frame: Month 18

Secondary outcomes

  1. Progression-free survival

    Time frame: Month 18

  2. Overall survival

    Time frame: Month 18

  3. Frequencies of severe toxicities leading to treatment interruption

    Time frame: Month 18

    According to Common Terminology Criteria for Adverse Events [CTACE] V5, grade III and IV

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Official study title

Le Traitement Par Lenvatinib + Anti-PD1 Du Mélanome Métastatique

Acronym: LENVAMEL

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

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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