Treatment of Metastatic Melanoma with Lenvatinib + Anti-PD1

Centre Hospitalier Universitaire de Besancon18 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Metastatic Melanoma

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

CHU de Besançon

Besançon, France

Outcomes

Primary Outcomes

Objective response rate

Time frame: Month 18

Secondary Outcomes

Progression-free survival

Time frame: Month 18

Overall survival

Time frame: Month 18

Frequencies of severe toxicities leading to treatment interruption

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

Time frame: Month 18

Data from ClinicalTrials.gov

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