Study Comparing TIL to Standard Ipilimumab in Patients With Metastatic Melanoma

Sponsor
The Netherlands Cancer Institute
Study ID
NCT02278887
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Sep 23, 2014
Status verified
Mar 2025
Primary completion
Sep 30, 2022
Completion
Dec 31, 2023

Study Design

Enrollment
168 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Ipilimumab
    4 cycles of ipilimumab treatment, the standard treatment
  • Experimental: TIL treatment
    non-myeloablative lymphocyte depleting regimen of chemotherapy followed by infusion of tumor infiltrating lymphocytes and interleukin-2

Primary Outcome Measure

Progression free survival [ Time Frame: 3 years ]

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