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Trial 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
NCT ID:
NCT06408688
Condition:
Advanced Solid Tumor
Conditions: Official terms:
Neoplasm Metastasis
Viscum album peptide
Immune Checkpoint Inhibitors
Conditions: Keywords:
Mistletoe Extract
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Immune checkpoint inhibitors plus Iscador® Qu.
Description:
Standard cancer treatment plus subcutaneous injection of mistletoe fermented extract
(Iscador® Qu) as per the summary of product characteristics.
Arm group label:
Arm A: Immune checkpoint inhibitors plus Iscador® Qu
Intervention type:
Drug
Intervention name:
Immune Checkpoint Inhibitors
Description:
Standard cancer treatment.
Arm group label:
Arm B: Immune checkpoint inhibitors
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.
Detailed description:
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Kantosspital Baden AG
Address:
City:
Baden
Zip:
5404
Country:
Switzerland
Contact:
Last name:
Sacha Rothschild, Prof. Dr. Dr.
Phone:
+41 56 486 27 62
Email:
Sacha.Rothschild@ksb.ch
Investigator:
Last name:
Sacha Rothschild, Prof. Dr. Dr.
Email:
Principal Investigator
Facility:
Name:
Universitätsspital Basel
Address:
City:
Basel
Zip:
4031
Country:
Switzerland
Contact:
Last name:
Benjamin Kasenda, PD. Dr. Dr.
Phone:
+41 61 265 50 75
Email:
Benjamin.Kasenda@usb.ch
Investigator:
Last name:
Benjamin Kasenda, PD. Dr. Dr.
Email:
Principal Investigator
Facility:
Name:
Kantonsspital Baselland
Address:
City:
Liestal
Zip:
4410
Country:
Switzerland
Contact:
Last name:
Bettina Seifert, Dr.
Phone:
+41 61 925 27 15
Email:
bettina.seifert@ksbl.ch
Investigator:
Last name:
Bettina Seifert, Dr.
Email:
Principal Investigator
Facility:
Name:
Tumor- und Brustzentrum Ostschweiz
Address:
City:
Saint Gallen
Zip:
9016
Country:
Switzerland
Contact:
Last name:
Friedemann Honecker, PD Dr. Dr.
Phone:
+41 71 243 02 02
Email:
info@tbz-ost.ch
Investigator:
Last name:
Friedemann Honecker, PD Dr. Dr.
Email:
Principal Investigator
Start date:
June 2024
Completion date:
November 2026
Lead sponsor:
Agency:
University Hospital, Basel, Switzerland
Agency class:
Other
Source:
University Hospital, Basel, Switzerland
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06408688
