Study Comparing TIL to Standard Ipilimumab in Patients With Metastatic Melanoma

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.

Timeline

Start

2014-09-23

Primary completion

2022-09

Completion

2023-12-31

Publications

• Ten Ham RMT, Rohaan MW, Egeler M, Menezes R, Holz Borch T, Kessels R, Jedema I, Nuijen B, Nijenhuis CM, van de Poll-Franse LV, Geukes Foppen MH, Lindenberg M, Mansfield Noringriis I, Monberg TJ, Donia M, van Harten W, Svane IM, Haanen JBAG, Retel VP. Health-related quality of life of patients with metastatic melanoma treated with tumor-infiltrating lymphocytes compared with ipilimumab in a randomized phase III trial. Ann Oncol. 2025 Oct;36(10):1154-1165. doi: 10.1016/j.annonc.2025.06.005. Epub 2025 Jun 18.
• Tas L, Weitemeyer MB, Rohaan MW, Borch TH, van Akkooi ACJ, Wouters MWJM, Hartemink KJ, Schrage YM, Kuijpers A, Kok NFM, van Zon M, Jedema I, Nijenhuis CM, Nuijen B, Hansen M, Voermans C, Klobuch S, Seijkens TTP, Lalezari F, Met O, Donia M, Svane IM, Haanen JBAG, Holmich LR, van Houdt WJ. Surgical considerations for tumour-infiltrating lymphocyte therapy in melanoma: results from a randomized phase III trial. Br J Surg. 2025 May 31;112(6):znaf090. doi: 10.1093/bjs/znaf090.
• Rohaan MW, Borch TH, van den Berg JH, Met O, Kessels R, Geukes Foppen MH, Stoltenborg Granhoj J, Nuijen B, Nijenhuis C, Jedema I, van Zon M, Scheij S, Beijnen JH, Hansen M, Voermans C, Noringriis IM, Monberg TJ, Holmstroem RB, Wever LDV, van Dijk M, Grijpink-Ongering LG, Valkenet LHM, Torres Acosta A, Karger M, Borgers JSW, Ten Ham RMT, Retel VP, van Harten WH, Lalezari F, van Tinteren H, van der Veldt AAM, Hospers GAP, Stevense-den Boer MAM, Suijkerbuijk KPM, Aarts MJB, Piersma D, van den Eertwegh AJM, de Groot JB, Vreugdenhil G, Kapiteijn E, Boers-Sonderen MJ, Fiets WE, van den Berkmortel FWPJ, Ellebaek E, Holmich LR, van Akkooi ACJ, van Houdt WJ, Wouters MWJM, van Thienen JV, Blank CU, Meerveld-Eggink A, Klobuch S, Wilgenhof S, Schumacher TN, Donia M, Svane IM, Haanen JBAG. Tumor-Infiltrating Lymphocyte Therapy or Ipilimumab in Advanced Melanoma. N Engl J Med. 2022 Dec 8;387(23):2113-2125. doi: 10.1056/NEJMoa2210233.

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