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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)....
Autores principales: | , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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BMJ Publishing Group
2020
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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. |
format | Online Article Text |
id | pubmed-7689077 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
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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