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Study Comparing TIL to Standard Ipilimumab in Patients With Metastatic Melanoma

NCT02278887 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2025-03-10

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Copenhagen University Hospital at Herlev

    collaborator OTHER

  • The Netherlands Cancer Institute

    lead OTHER

Principal Investigators

  • John B.A.G. Haanen, Prof. · The Netherlands Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-23
Primary Completion
2022-09-30
Completion
2023-12-31

Countries

  • Denmark
  • Netherlands

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02278887 on ClinicalTrials.gov