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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Immune checkpoint inhibitors plus Iscador® Qu | Active Comparator | Patients randomized to Arm A will be treated with Immune checkpoint inhibitors plus Iscador® Qu. |
|
| Arm B: Immune checkpoint inhibitors | Active Comparator | Patients randomized to Arm B will be treated with Immune checkpoint inhibitors only. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immune checkpoint inhibitors plus Iscador® Qu. | Drug | Standard cancer treatment plus subcutaneous injection of mistletoe fermented extract (Iscador® Qu) as per the summary of product characteristics. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | baseline and 12 weeks (+/- 2 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | up to 18 weeks |
| Rate of early immune checkpoint inhibitor-based treatment termination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mascha Binder, Prof. Dr. | Contact | +41 61 265 50 75 | mascha.binder@unibas.ch | |
| Benjamin Kasenda, PD Dr. Dr. | Contact | +41 61 265 50 75 | Benjamin.Kasenda@usb.ch |
| Name | Affiliation | Role |
|---|---|---|
| Benjamin Kasenda, PD Dr. Dr. | USB | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kantosspital Baden AG | Recruiting | Baden | 5404 | Switzerland |
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| Immune Checkpoint Inhibitors | Drug | Standard cancer treatment. |
|
Rate of early immune checkpoint inhibitor-based treatment termination |
| up to 24 months |
| Best tumor response | Best tumor response as per investigators assessment | up to 24 months |
| Progression-free survival | Investigator-assessed progression-free survival | up to 24 months |
| Overall survival | Overall survival | 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. | up to 24 months |
| Universitätsspital Basel | Recruiting | Basel | 4031 | Switzerland |
|
| Kantonsspital Baselland | Recruiting | Liestal | 4410 | Switzerland |
|
| Tumor- und Brustzentrum Ostschweiz | Recruiting | Sankt Gallen | 9016 | Switzerland |
|
| ID | Term |
|---|---|
| D000082082 | Immune Checkpoint Inhibitors |
| ID | Term |
|---|---|
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000074322 | Antineoplastic Agents, Immunological |
| D000970 | Antineoplastic Agents |
| D045506 | Therapeutic Uses |
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