Publication date: Jun 18, 2025
To assess health-related quality of life (HRQoL) in patients with metastatic melanoma treated with a tumor infiltrating lymphocyte investigational medicinal product (TIL-IMP) or ipilimumab (IPI) after failure of first- or second-line treatment. In a multicenter, randomized phase 3-trial, patients with metastatic melanoma (unresectable stage IIIC-IV) were randomized to TIL-IMP or IPI treatment (NCT02278887). HRQoL was measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 15 Palliative Care (EORTC QLQ-C15-PAL), EuroQol 5D-3L (EQ-5D), and the Impact of Event Scale (IES). HRQoL outcomes were evaluated using a generalized estimating equations model. Sensitivity analyses were performed to assess drop-out assumptions. Results were interpreted for statistically and clinically significant differences. Of 168 patients randomized 1:1, n=143 baseline HRQoL scores (85%) were calculated. Of these, 75 (89%) were in the TIL-IMP-group and 73 (87%) in the IPI-group. TIL-IMP-treated patients reported higher global health status scores at week 24 compared to ipilimumab-treated patients (78. 2 vs 73. 9; p
| Concepts | Keywords |
|---|---|
| Global | cell therapy |
| Medicinal | immunotherapy |
| Nct02278887 | Melanoma |
| Randomized | population-based |
| Tumor | quality of life |
Semantics
| Type | Source | Name |
|---|---|---|
| disease | MESH | melanoma |
| pathway | KEGG | Melanoma |
| disease | MESH | tumor |
| drug | DRUGBANK | Ipilimumab |
| drug | DRUGBANK | Indoleacetic acid |
| disease | MESH | health status |