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

Last updated: December 23, 2024
Sponsor: University Hospital, Basel, Switzerland
Overall Status: Active - Recruiting

Phase

4

Condition

Neoplasm Metastasis

Treatment

Immune Checkpoint Inhibitors

Immune checkpoint inhibitors plus Iscador® Qu.

Clinical Study ID

NCT06408688
2023-02373; th23binder
  • Ages > 18
  • All Genders

Study 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

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 (controlledbrain 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

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 toenrolment (participation in observational studies or diagnostic studies without aparticular drug intervention are allowed)

  • Enrolment of the investigator, his/her family members, employees and other dependent

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Immune Checkpoint Inhibitors
Phase: 4
Study Start date:
June 24, 2024
Estimated Completion Date:
November 30, 2026

Study 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.

Connect with a study center

  • Kantosspital Baden AG

    Baden, 5404
    Switzerland

    Active - Recruiting

  • Universitätsspital Basel

    Basel, 4031
    Switzerland

    Active - Recruiting

  • Kantonsspital Baselland

    Liestal, 4410
    Switzerland

    Active - Recruiting

  • Tumor- und Brustzentrum Ostschweiz

    Saint Gallen, 9016
    Switzerland

    Active - Recruiting

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