metastasized melonama uveal
Conditions
Brief summary
Safety and feasibility of combining percutaneous hepatic perfusion with ipilimumab and nivolumab (phase 1b part)., Efficacy as measured by progression-free survival at one year comparing PHP alone versus patients with the combination of PHP with ipilimumab and nivolumab (randomized phase 2 part).
Detailed description
To evaluate best overall response rate according to RECIST 1.1 and iRECIST of patients treated with PHP alone versus patients with the combination of PHP with ipilimumab and nivolumab., To evaluate overall survival of patients treated with PHP alone versus patients with the combination of PHP with ipilimumab and nivolumab.
Interventions
DRUGIPILIMUMAB
DRUGMELPHALAN
DRUGNIVOLUMAB
Sponsors
Leids Universitair Medisch Centrum (LUMC)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and feasibility of combining percutaneous hepatic perfusion with ipilimumab and nivolumab (phase 1b part)., Efficacy as measured by progression-free survival at one year comparing PHP alone versus patients with the combination of PHP with ipilimumab and nivolumab (randomized phase 2 part). | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate best overall response rate according to RECIST 1.1 and iRECIST of patients treated with PHP alone versus patients with the combination of PHP with ipilimumab and nivolumab., To evaluate overall survival of patients treated with PHP alone versus patients with the combination of PHP with ipilimumab and nivolumab. | — |
Countries
Netherlands
Outcome results
None listed