In this randomized controlled phase III study the investigators will evaluate whether TIL infusion preceded by non-myeloablative chemotherapy and followed by high dose bolus interleukin-2 can result in an improved progression free survival when randomly compared to ipilimumab in 168 stage IV melanoma patients. A health technology assessment (HTA) will be performed to evaluate the impact of the TIL treatment on patients and organizational processes and cost-effectivity.
In this randomized controlled phase III study the investigators will evaluate whether TIL infusion preceded by non-myeloablative chemotherapy and followed by high dose bolus interleukin-2 can result in an improved progression free survival when randomly compared to ipilimumab in 168 stage IV melanoma patients. A health technology assessment (HTA) will be performed to evaluate the impact of the TIL treatment on patients and organizational processes and cost-effectivity. This will be done via questionnaires at baseline, just after treatment and during follow-up. Also healthcare providers will be interviewed after 6 months after starting the trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
168
Before during and at progression/regression biopsies and blood will be taken for translational research
The patient receives 2 days cyclophosphamide via IV to deplete T-cells.
The patient receives 5 days fludarabine via IV to deplete T-cells.
CCIT Department of Oncology and Haematology Herlev Hospital
Copenhagen, Denmark
Netherlands Cancer Institute
Amsterdam, North Holland, Netherlands
Progression free survival
Progression free survival according to RECIST 1.1
Time frame: 3 years
Immune related progression free survival
Time frame: 3 years
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After infusion of the TIL, the patient receives IL-2 to keep the TIL active.
In arm A patients will be treated with 4 infusion of ipilimumab