Safety and Modulation of Adaptive Immunity by Iscador® Qu Viscum Album Extract in Patients With Advanced, Recurrent or Metastatic Cancers Treated With Immune Checkpoint Inhibitors
Immune checkpoint inhibitors plus Iscador® Qu.Immune Checkpoint Inhibitors
Immune checkpoint inhibitors plus Iscador® Qu.: Standard cancer treatment plus subcutaneous injection of mistletoe fermented extract (Iscador® Qu) as per the summary of product characteristics.
Immune Checkpoint Inhibitors: Standard cancer treatment.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Locally advanced non-operable or metastatic solid tumor, except for skin cancer
* Eligible for routine (standard) treatment with immune checkpoint inhibitor (+/- chemo/targeted therapy) as per the discretion of the local investigator
* Subjects must be eligible for treatment with mistletoe preparations (controlled brain metastases, prednisolone equivalent below 10mg, no known hypersensitivity)
* ECOG (Eastern Cooperative Oncology Group) performance status score of 0-2
* Males and Females at least 18 years of age; no subjects under tutelage
* No previous mistletoe treatment
Exclusion Criteria:
* Contraindications to Iscador® Qu or immune checkpoint inhibitors, e.g. hypersensitivity, active autoimmune disorder
* Patients with skin cancer
* Participation in another study with investigational drug within 30 days prior to enrolment (participation in observational studies or diagnostic studies without a particular drug intervention are allowed)
* Enrolment of the investigator, his/her family members, employees and other dependent
Primary outcome measure(s)
Percentage of patients with a relative increase in T cell richness or diversity of 20% or more — baseline and 12 weeks (+/- 2 weeks) 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.
Percentage of patients with a relative decrease in T cell clonality of 20% or more — baseline and 12 weeks (+/- 2 weeks) 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.
Level of T cell richness — baseline and 12 weeks (+/- 2 weeks) Level of T cell richness as measured by peripheral blood T cell receptor Next-generation sequencing.
Level of T cell diversity — baseline and 12 weeks (+/- 2 weeks) Level of T cell diversity as measured by peripheral blood T cell receptor Next-generation sequencing.
Level of T cell clonality — baseline and 12 weeks (+/- 2 weeks) Level of T cell clonality as measured by peripheral blood T cell receptor Next-generation sequencing.
Trial sites (4)
Facility
City
Region
Status
Kantosspital Baden AG
Baden
Switzerland
Recruiting
Universitätsspital Basel
Basel
Switzerland
Recruiting
Kantonsspital Baselland
Liestal
Switzerland
Recruiting
Tumor- und Brustzentrum Ostschweiz
Sankt Gallen
Switzerland
Recruiting
More University Hospital, Basel, Switzerland trials in Switzerland
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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