TIL and Anti-PD1 in Metastatic Melanoma

Phase 1/2 Unknown 34 enrolled Leiden University Bristol-Myers Squibb · collab

Non-randomizedSequentialOpen-labelTreatment

Summary

The ACTME study is an investigator initiated, single center phase I/II clinical trial for patients with progressive unresectable stage III or stage IV melanoma. The trial consists of both a phase I part to determine safety and feasibility and a phase II part to evaluate first clinical activity of IFN-alpha, nivolumab and TIL. The treatment with IFN-alpha will be added after the combination of TIL and nivolumab has proven to be safe.

Timeline

Start: 2018-07-31
Primary completion: 2025-11-29
Completion: 2025-11-29

Publications

van der Kooij MK, Verdegaal EME, Visser M, de Bruin L, van der Minne CE, Meij PM, Roozen ICFM, Jonker MA, van den Bosch S, Liefers GJ, Speetjens FM, van der Burg SH, Kapiteijn E. Phase I/II study protocol to assess safety and efficacy of adoptive cell therapy with anti-PD-1 plus low-dose pegylated-interferon-alpha in patients with metastatic melanoma refractory to standard of care treatments: the ACTME trial. BMJ Open. 2020 Nov 24;10(11):e044036. doi: 10.1136/bmjopen-2020-044036.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nivolumab	Monoclonal antibody	3 mg/kg	Intravenous
Subject	Tumor Infiltrating Lymphocytes	Cell therapy	2.5e+08 cells	Intravenous
Subject	Tumor Infiltrating Lymphocytes	Cell therapy	7.5e+08 cells	Intravenous
Subject	interferon alfa-2b	Protein / enzyme biologic	3e+06 iu	Subcutaneous

TIL and Anti-PD1 in Metastatic Melanoma

Summary

Timeline

Publications

Drugs

Indications