Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Anti-Infective Agents

Analgesics

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Aldesleukin

Ipilimumab

Interleukin-2

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Analgesics, Non-Narcotic

4 cycles of ipilimumab treatment, the standard treatment

non-myeloablative lymphocyte depleting regimen of chemotherapy followed by infusion of tumor infiltrating lymphocytes and interleukin-2

Before during and at progression/regression biopsies and blood will be taken for translational research

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.

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

Ipilimumab infusion

John B.A.G. Haanen, Prof.

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 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

Adverse events will be assessed during treatment and follow-up

Progression free survival according to RECIST 1.1

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study Comparing TIL to Standard Ipilimumab in Patients With Metastatic Melanoma	NCT02278887	Metastatic Mela...	Translational r... Cyclophosphamid... Fludarabine Interleukin-2 Ipilimumab infu...	18 Years - 75 Years	The Netherlands Cancer Institute
Study Comparing TIL to Standard Ipilimumab in Patients With Metastatic Melanoma	NCT02278887	Metastatic Mela...	Translational r... Cyclophosphamid... Fludarabine Interleukin-2 Ipilimumab infu...	18 Years - 75 Years	The Netherlands Cancer Institute

Spots Global Cancer Trial Database for ipilimumab infusion