Metastatic Melanoma
Conditions
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.
Interventions
None listed
Sponsors
Centre Hospitalier Universitaire de Besancon
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate | Month 18 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
France
Outcome results
None listed