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

Advanced Solid Tumor Clinical Trial

— ISCA-CHECK  

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 - a Randomized Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06408688
• Other study ID #: 2023-02373; th23binder
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: June 2024
• Est. completion date: November 2026

Study information

• Verified date: May 2024
• Source: University Hospital, Basel, Switzerland
• Contact: Mascha Binder, Prof. Dr.
• Phone: +41 61 265 50 75
• Email: mascha.binder[@]unibas.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: November 2026
• Est. primary completion date: November 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasm Metastasis

Intervention

Drug:
• Immune checkpoint inhibitors plus Iscador® Qu.
Standard cancer treatment plus subcutaneous injection of mistletoe fermented extract (Iscador® Qu) as per the summary of product characteristics.
• Immune Checkpoint Inhibitors
Standard cancer treatment.

Locations

Country	Name	City	State
Switzerland	Kantosspital Baden AG	Baden
Switzerland	Universitätsspital Basel	Basel
Switzerland	Kantonsspital Baselland	Liestal
Switzerland	Tumor- und Brustzentrum Ostschweiz	Saint Gallen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with a relative increase in T cell richness or diversity of 20% or more	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.	baseline and 12 weeks (+/- 2 weeks)
Primary	Percentage of patients with a relative decrease in T cell clonality of 20% or more	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.	baseline and 12 weeks (+/- 2 weeks)
Primary	Level of T cell richness	Level of T cell richness as measured by peripheral blood T cell receptor Next-generation sequencing.	baseline and 12 weeks (+/- 2 weeks)
Primary	Level of T cell diversity	Level of T cell diversity as measured by peripheral blood T cell receptor Next-generation sequencing.	baseline and 12 weeks (+/- 2 weeks)
Primary	Level of T cell clonality	Level of T cell clonality as measured by peripheral blood T cell receptor Next-generation sequencing.	baseline and 12 weeks (+/- 2 weeks)
Secondary	Safety and tolerability according to the NCI CTC AE v5	Safety and tolerability according to the NCI CTC AE v5 (National Cancer Institute Common Terminology Criteria for Adverse Events)	up to 18 weeks
Secondary	Rate of early immune checkpoint inhibitor-based treatment termination	Rate of early immune checkpoint inhibitor-based treatment termination	up to 24 months
Secondary	Best tumor response	Best tumor response as per investigators assessment	up to 24 months
Secondary	Progression-free survival	Investigator-assessed progression-free survival	up to 24 months
Secondary	Overall survival	Overall survival	up to 24 months
Secondary	EORTC QLQ C30	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.	up to 24 months