Actively Recruiting
Safety and Immune Effects of Iscador® Qu Mistletoe Extract with Immune Checkpoint Inhibitors in Advanced, Recurrent, or Metastatic Solid Tumors: A Randomized Trial
Led by University Hospital, Basel, Switzerland · Updated on 2024-12-27
100
Participants Needed
4
Research Sites
122 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether adding the mistletoe extract Iscador Qu to standard cancer treatment with immune checkpoint inhibitors can influence the immune system's ability to fight cancer. The study also aims to assess the safety of this combination, its effectiveness against cancer, and how patients feel during treatment. This research focuses on patients with locally advanced, non-operable, or metastatic solid tumors, excluding skin cancers. Participants will receive either standard immune checkpoint inhibitor treatment alone or combined with subcutaneous injections of Iscador Qu, a fermented mistletoe extract given according to its product guidelines. The study compares these two groups to observe differences in immune response and treatment outcomes. During the study, researchers will monitor participants' immune system markers, specifically changes in T cell richness, diversity, and clonality over 12 weeks. Patient safety and treatment effects will be carefully evaluated throughout. The study involves adult patients aged 18 and older, with assessments including clinical evaluations and immune measurements at baseline and after 12 weeks of treatment.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have a locally advanced non-operable or metastatic solid tumor, except skin cancer
- Eligible for standard treatment with immune checkpoint inhibitors, with or without chemotherapy or targeted therapy
- Eligible for treatment with mistletoe preparations (including controlled brain metastases, low-dose prednisolone, no known hypersensitivity)
- Have an ECOG performance status score of 0 to 2
- Male or female aged 18 years or older
- Have not received mistletoe treatment previously
You will not qualify if you...
- Known contraindications to Iscador� Qu or immune checkpoint inhibitors, such as hypersensitivity or active autoimmune disorders
- Diagnosis of skin cancer
- Participation in another investigational drug study within 30 days before joining
- Investigator, their family, employees, or dependents involved in the study
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Kantosspital Baden AG
Baden, Switzerland, 5404
Actively Recruiting
2
Universitätsspital Basel
Basel, Switzerland, 4031
Actively Recruiting
3
Kantonsspital Baselland
Liestal, Switzerland, 4410
Actively Recruiting
4
Tumor- und Brustzentrum Ostschweiz
Sankt Gallen, Switzerland, 9016
Actively Recruiting
Research Team
M
Mascha Binder, Prof. Dr.
B
Benjamin Kasenda, PD Dr. Dr.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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