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
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 - a Randomized Trial
University Hospital, Basel, Switzerland
100 participants
Jun 24, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria6
- 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 Criteria4
- 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
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Interventions
Standard cancer treatment plus subcutaneous injection of mistletoe fermented extract (Iscador® Qu) as per the summary of product characteristics.
Standard cancer treatment.
Locations(4)
View Full Details on ClinicalTrials.gov
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NCT06408688