Ontology highlight
ABSTRACT:
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.
SUBMITTER: van der Kooij MK
PROVIDER: S-EPMC7689077 | biostudies-literature | 2020 Nov
REPOSITORIES: biostudies-literature
van der Kooij Monique K MK Verdegaal Els M E EME Visser Marten M de Bruin Linda L van der Minne Caroline E CE Meij Pauline M PM Roozen Inge C F M ICFM Jonker Mare A MA van den Bosch Shelley S Liefers Gerrit-Jan GJ Speetjens Frank M FM van der Burg Sjoerd H SH Kapiteijn Ellen E
BMJ open 20201124 11
<h4>Introduction</h4>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 ...[more]