NCT02278887

Study Comparing TIL to Standard Ipilimumab in Patients With Metastatic Melanoma

Randomized Phase III Study Comparing a Non-myeloablative Lymphocyte Depleting Regimen of Chemotherapy Followed by Infusion of Tumor Infiltrating Lymphocytes and Interleukin-2 to Standard Ipilimumab Treatment in Metastatic Melanoma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 168 (actual)
• Sponsor: The Netherlands Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Metastatic Melanoma

Interventions

Type	Name	Description
PROCEDURE	Translational research	Before during and at progression/regression biopsies and blood will be taken for translational research
DRUG	Cyclophosphamide	The patient receives 2 days cyclophosphamide via IV to deplete T-cells.
DRUG	Fludarabine	The patient receives 5 days fludarabine via IV to deplete T-cells.
DRUG	Interleukin-2	After infusion of the TIL, the patient receives IL-2 to keep the TIL active.
DRUG	Ipilimumab infusion	In arm A patients will be treated with 4 infusion of ipilimumab

Timeline

• Start date: 2014-09-23
• Primary completion: 2022-09-01
• Completion: 2023-12-31
• First posted: 2014-10-30
• Last updated: 2025-03-10

Locations

2 sites across 2 countries: Denmark, Netherlands