A Phase 4 interventional study of Immune checkpoint inhibitors plus Iscador® Qu. and Immune Checkpoint Inhibitors in Advanced Solid Tumor, sponsored by University Hospital, Basel, Switzerland. Recruiting at 4 sites in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-27.
Sponsored by University Hospital, Basel, Switzerland · Phase 4, Interventional, and Treatment
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:
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.
3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.
This study's planned enrollment of 100 is above the median of 54 across 2,767 interventional studies indexed under Neoplasm Metastasis.
Browse Neoplasm Metastasis studies →University Hospital, Basel, Switzerland is the lead sponsor of 968 studies on the registry; 191 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients randomized to Arm A will be treated with Immune checkpoint inhibitors plus Iscador® Qu.
Drug: Immune checkpoint inhibitors plus Iscador® Qu.
Patients randomized to Arm B will be treated with Immune checkpoint inhibitors only.
Drug: Immune Checkpoint Inhibitors
Standard cancer treatment plus subcutaneous injection of mistletoe fermented extract (Iscador® Qu) as per the summary of product characteristics.
Standard cancer treatment.
Percentage 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
Plan to share: No
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University Hospital, Basel, Switzerland