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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.

Authors :
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
Source :
BMJ open [BMJ Open] 2020 Nov 24; Vol. 10 (11), pp. e044036. Date of Electronic Publication: 2020 Nov 24.
Publication Year :
2020

Abstract

Introduction: Treatment with anti-PD-1 immunotherapy does not lead to long-lasting clinical responses in approximately 60% of patients with metastatic melanoma. These refractory patients, however, can still respond to treatment with tumour infiltrating lymphocytes (TIL) and interferon-alpha (IFNa). A combination of TIL, pegylated-interferon-alpha (PEG-IFNa) and anti-PD-1 is expected to provide a safe, feasible and effective therapy for patients with metastatic melanoma, who are refractory to standard of care treatment options.<br />Methods and Analysis: Patients are treated in two phases. In phase I, the safety of the combination TIL and anti-PD-1 is assessed (cohort 1) according to CTCAE 4.03 criteria. Subsequently, the safety of cotreatment with PEG-IFNa is tested in cohort 2. The efficacy will be evaluated in the second phase of the trial. Efficacy is evaluated according to RECIST 1.1 and immune-related response criteria. Clinical and immunological parameters will be evaluated for their relation with clinical responsiveness.<br />Ethics and Dissemination: Ethical approval of the trial was obtained from the Central Committee on Research Involving Human Subjects in the Netherlands. The trial results will be shared with the scientific community at (inter)national conferences and by publication in a peer-reviewed journal.<br />Trial Registration Number: NCT03638375; Pre-results.<br />Competing Interests: Competing interests: None declared.<br /> (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Details

Language :
English
ISSN :
2044-6055
Volume :
10
Issue :
11
Database :
MEDLINE
Journal :
BMJ open
Publication Type :
Academic Journal
Accession number :
33234662
Full Text :
https://doi.org/10.1136/bmjopen-2020-044036