Advanced Solid Tumor
Conditions
Keywords
Mistletoe Extract
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.
Interventions
DRUGImmune checkpoint inhibitors plus Iscador® Qu.
Standard cancer treatment plus subcutaneous injection of mistletoe fermented extract (Iscador® Qu) as per the summary of product characteristics.
DRUGImmune Checkpoint Inhibitors
Standard cancer treatment.
Sponsors
University Hospital, Basel, Switzerland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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. |
| 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 |
Countries
Switzerland
Contacts
Primary ContactMascha Binder, Prof. Dr.
Backup ContactBenjamin Kasenda, PD Dr. Dr.
Outcome results
None listed