Study Comparing TIL to Standard Ipilimumab in Patients With Metastatic Melanoma (TIL)

  • STATUS
    Not Recruiting
  • End date
    Sep 30, 2023
  • participants needed
    168
  • sponsor
    The Netherlands Cancer Institute
Updated on 20 July 2022

Summary

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.

Description

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.

Details
Condition Metastatic Melanoma
Treatment cyclophosphamide, Fludarabine, Interleukin-2, Translational research, Translational research, Ipilimumab infusion
Clinical Study IdentifierNCT02278887
SponsorThe Netherlands Cancer Institute
Last Modified on20 July 2022

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