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Recruiting Phase 4 NCT06408688

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

Trial Parameters

Condition Advanced Solid Tumor
Sponsor University Hospital, Basel, Switzerland
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 100
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-06-24
Completion 2026-11
Interventions
Immune checkpoint inhibitors plus Iscador® Qu.Immune Checkpoint Inhibitors

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.

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 invest

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