Combining mistletoe extract with immune checkpoint inhibitors for advanced cancer treatment
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
This study is testing if adding a mistletoe extract to standard cancer treatments can help people with advanced cancer fight their disease better and safely.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Locations | 4 sites (Baden and 3 other locations) |
| Trial ID | NCT06408688 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of adding Iscador® Qu, a mistletoe extract, to standard cancer treatment using immune checkpoint inhibitors in patients with advanced, recurrent, or metastatic solid tumors. The primary focus is to evaluate how this combination influences the immune system's ability to combat cancer, the safety of the treatment, and the overall effectiveness compared to immune checkpoint inhibitors alone. Researchers will assess the modulation of adaptive immunity and gather insights on patient experiences during treatment. The study aims to fill a knowledge gap regarding the potential benefits of mistletoe preparations in cancer therapy.
Who should consider this trial
Good fit: Ideal candidates include adults with locally advanced non-operable or metastatic solid tumors who are eligible for immune checkpoint inhibitor therapy.
Not a fit: Patients with skin cancer or those with contraindications to Iscador® Qu or immune checkpoint inhibitors may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the effectiveness of cancer treatments and improve patient outcomes.
How similar studies have performed: While the use of mistletoe extracts in cancer treatment has been explored, this specific combination with immune checkpoint inhibitors is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Baden and 3 other locations
- Kantosspital Baden AG — Baden, Switzerland (Recruiting)
- Universitätsspital Basel — Basel, Switzerland (Recruiting)
- Kantonsspital Baselland — Liestal, Switzerland (Recruiting)
- Tumor- und Brustzentrum Ostschweiz — Sankt Gallen, Switzerland (Recruiting)
Study contacts
- Principal investigator: Benjamin Kasenda, PD Dr. Dr. — Usb
- Study coordinator: Mascha Binder, Prof. Dr.
- Email: mascha.binder@unibas.ch
- Phone: +41 61 265 50 75
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.