Treatment of Metastatic Melanoma with Lenvatinib + Anti-PD1
Completed
- Conditions
- Metastatic Melanoma
- Registration Number
- NCT06586580
- Lead Sponsor
- Centre Hospitalier Universitaire de Besancon
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
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)
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Exclusion Criteria
- Uveal melanoma
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Objective response rate Month 18
- Secondary Outcome Measures
Name Time Method Progression-free survival Month 18 Overall survival Month 18 Frequencies of severe toxicities leading to treatment interruption Month 18 According to Common Terminology Criteria for Adverse Events \[CTACE\] V5, grade III and IV
Trial Locations
- Locations (1)
CHU de Besançon
🇫🇷Besançon, France