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
- Conditions
- Advanced Solid Tumor
- Interventions
- Drug: Immune Checkpoint InhibitorsDrug: Immune checkpoint inhibitors plus Iscador® Qu.
- Registration Number
- NCT06408688
- Lead Sponsor
- University Hospital, Basel, Switzerland
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm B: Immune checkpoint inhibitors Immune Checkpoint Inhibitors Patients randomized to Arm B will be treated with Immune checkpoint inhibitors only. Arm A: Immune checkpoint inhibitors plus Iscador® Qu Immune checkpoint inhibitors plus Iscador® Qu. Patients randomized to Arm A will be treated with Immune checkpoint inhibitors plus Iscador® Qu.
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method Safety and tolerability according to the NCI CTC AE v5 up to 18 weeks Safety and tolerability according to the NCI CTC AE v5 (National Cancer Institute Common Terminology Criteria for Adverse Events)
Rate of early immune checkpoint inhibitor-based treatment termination up to 24 months Rate of early immune checkpoint inhibitor-based treatment termination
Best tumor response up to 24 months Best tumor response as per investigators assessment
Progression-free survival up to 24 months Investigator-assessed progression-free survival
Overall survival up to 24 months Overall survival
EORTC QLQ C30 up to 24 months Quality of life as measured by EORTC QLQ C30 (European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire). Calculation of the scores follows the validated formulas as issued by the EORTC. Scores range from 0% to 100% for all questionnaire domains with higher values representing better outcome.
Trial Locations
- Locations (4)
Kantosspital Baden AG
🇨🇭Baden, Switzerland
Universitätsspital Basel
🇨🇭Basel, Switzerland
Kantonsspital Baselland
🇨🇭Liestal, Switzerland
Tumor- und Brustzentrum Ostschweiz
🇨🇭Saint Gallen, Switzerland