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 …
MK van der Kooij, EME Verdegaal, M Visser… - BMJ open, 2020 - bmjopen.bmj.com
MK van der Kooij, EME Verdegaal, M Visser, L de Bruin, CE van der Minne, PM Meij…
BMJ open, 2020•bmjopen.bmj.comIntroduction 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 …
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 …
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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