Metastatic Melanoma
Conditions
Brief summary
Evaluation of the safety and toxicity of TIL and nivolumab, followed by the evaluation of the safety and toxicity of PEG-IFNa, nivolumab and TIL, according to CTCAE 4.0 criteria. Given the nature and severity of the disease, toxicity grade 3 or less and SAE related to treatment, but that do not result in treatment termination, are considered acceptable for continuation of the study.
Detailed description
Secondary endpoints include the evaluation of the disease control rate assessed by physical examination and imaging studies (CTand/or MRI) and will be evaluated according to RECIST 1.1 and immune related response criteria (irRC). Furthermore, overallsurvival (OS) and progression-free survival (PFS) will be evaluated and immune related parameters will be analysed. Quality of lifeis already measured by the DMTR and will be assessed.
Interventions
Sponsors
Leids Universitair Medisch Centrum (LUMC)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of the safety and toxicity of TIL and nivolumab, followed by the evaluation of the safety and toxicity of PEG-IFNa, nivolumab and TIL, according to CTCAE 4.0 criteria. Given the nature and severity of the disease, toxicity grade 3 or less and SAE related to treatment, but that do not result in treatment termination, are considered acceptable for continuation of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include the evaluation of the disease control rate assessed by physical examination and imaging studies (CTand/or MRI) and will be evaluated according to RECIST 1.1 and immune related response criteria (irRC). Furthermore, overallsurvival (OS) and progression-free survival (PFS) will be evaluated and immune related parameters will be analysed. Quality of lifeis already measured by the DMTR and will be assessed. | — |
Countries
Netherlands
Outcome results
None listed