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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

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)....

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Autores principales: van der Kooij, Monique K, Verdegaal, Els M E, Visser, Marten, de Bruin, Linda, van der Minne, Caroline E, Meij, Pauline M, Roozen, Inge C F M, Jonker, Mare A, van den Bosch, Shelley, Liefers, Gerrit-Jan, Speetjens, Frank M, van der Burg, Sjoerd H, Kapiteijn, Ellen
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7689077/
https://www.ncbi.nlm.nih.gov/pubmed/33234662
http://dx.doi.org/10.1136/bmjopen-2020-044036
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author van der Kooij, Monique K
Verdegaal, Els M E
Visser, Marten
de Bruin, Linda
van der Minne, Caroline E
Meij, Pauline M
Roozen, Inge C F M
Jonker, Mare A
van den Bosch, Shelley
Liefers, Gerrit-Jan
Speetjens, Frank M
van der Burg, Sjoerd H
Kapiteijn, Ellen
author_facet van der Kooij, Monique K
Verdegaal, Els M E
Visser, Marten
de Bruin, Linda
van der Minne, Caroline E
Meij, Pauline M
Roozen, Inge C F M
Jonker, Mare A
van den Bosch, Shelley
Liefers, Gerrit-Jan
Speetjens, Frank M
van der Burg, Sjoerd H
Kapiteijn, Ellen
author_sort van der Kooij, Monique K
collection PubMed
description 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. 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. 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. TRIAL REGISTRATION NUMBER: NCT03638375; Pre-results.
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spelling pubmed-76890772020-12-07 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 van der Kooij, Monique K Verdegaal, Els M E Visser, Marten de Bruin, Linda van der Minne, Caroline E Meij, Pauline M Roozen, Inge C F M Jonker, Mare A van den Bosch, Shelley Liefers, Gerrit-Jan Speetjens, Frank M van der Burg, Sjoerd H Kapiteijn, Ellen BMJ Open Oncology 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. 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. 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. TRIAL REGISTRATION NUMBER: NCT03638375; Pre-results. BMJ Publishing Group 2020-11-24 /pmc/articles/PMC7689077/ /pubmed/33234662 http://dx.doi.org/10.1136/bmjopen-2020-044036 Text en © 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. http://creativecommons.org/licenses/by-nc/4.0/ http://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
spellingShingle Oncology
van der Kooij, Monique K
Verdegaal, Els M E
Visser, Marten
de Bruin, Linda
van der Minne, Caroline E
Meij, Pauline M
Roozen, Inge C F M
Jonker, Mare A
van den Bosch, Shelley
Liefers, Gerrit-Jan
Speetjens, Frank M
van der Burg, Sjoerd H
Kapiteijn, Ellen
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
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Oncology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7689077/
https://www.ncbi.nlm.nih.gov/pubmed/33234662
http://dx.doi.org/10.1136/bmjopen-2020-044036
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