The main objective of this study is to test if adding the mistletoe extract Iscador® Qu to regular cancer treatment with immune checkpoint inhibitors affects: * The immune system's ability to fight cancer * Safety of the treatment * How well the treatment performs against cancer * How the patient feels during treatment Researchers will compare patients treated with immune checkpoint inhibitors plus Iscador® Qu with patients treated with imune checkpoint inhibitors only.
The impact of mistletoe preparations - that are claimed to have immunostimulatory properties - on cancer treatment with immune checkpoint inhibitors remains unclear. To address this knowledge gap, the current study aims to investigate the modulation of adaptive immunity through the combination of Iscador (a specific mistletoe preparation) and immune checkpoint inhibitors. Additionally, researchers will evaluate the safety profile of this combination therapy in patients with locally advanced non-operable or metastatic cancers except for skin cancers. By examining the modulation of adaptive immunity and safety of this treatment approach, researchers aim to provide valuable insights for clinicians and patients in the context of advanced cancer care.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Standard cancer treatment plus subcutaneous injection of mistletoe fermented extract (Iscador® Qu) as per the summary of product characteristics.
Standard cancer treatment.
Kantosspital Baden AG
Baden, Switzerland
RECRUITINGUniversitätsspital Basel
Basel, Switzerland
RECRUITINGKantonsspital Baselland
Liestal, Switzerland
RECRUITINGTumor- und Brustzentrum Ostschweiz
Sankt Gallen, Switzerland
RECRUITINGPercentage of patients with a relative increase in T cell richness or diversity of 20% or more
Percentage of patients with a relative increase in T cell richness or diversity of 20% or more as measured by peripheral blood T cell receptor Next-generation sequencing.
Time frame: baseline and 12 weeks (+/- 2 weeks)
Percentage of patients with a relative decrease in T cell clonality of 20% or more
Percentage of patients with a relative decrease in T cell clonality of 20% or more as measured by peripheral blood T cell receptor Next-generation sequencing.
Time frame: baseline and 12 weeks (+/- 2 weeks)
Level of T cell richness
Level of T cell richness as measured by peripheral blood T cell receptor Next-generation sequencing.
Time frame: baseline and 12 weeks (+/- 2 weeks)
Level of T cell diversity
Level of T cell diversity as measured by peripheral blood T cell receptor Next-generation sequencing.
Time frame: baseline and 12 weeks (+/- 2 weeks)
Level of T cell clonality
Level of T cell clonality as measured by peripheral blood T cell receptor Next-generation sequencing.
Time frame: baseline and 12 weeks (+/- 2 weeks)
Safety and tolerability according to the NCI CTC AE v5
Safety and tolerability according to the NCI CTC AE v5 (National Cancer Institute Common Terminology Criteria for Adverse Events)
Time frame: up to 18 weeks
Rate of early immune checkpoint inhibitor-based treatment termination
Rate of early immune checkpoint inhibitor-based treatment termination
Time frame: up to 24 months
Best tumor response
Best tumor response as per investigators assessment
Time frame: up to 24 months
Progression-free survival
Investigator-assessed progression-free survival
Time frame: up to 24 months
Overall survival
Overall survival
Time frame: up to 24 months
EORTC QLQ C30
Quality of life as measured by EORTC QLQ C30 (European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire). Calculation of the scores follows the validated formulas as issued by the EORTC. Scores range from 0% to 100% for all questionnaire domains with higher values representing better outcome.
Time frame: up to 24 months
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