RecruitingPhase 4NCT06408688

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

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


Sponsor

University Hospital, Basel, Switzerland

Enrollment

100 participants

Start Date

Jun 24, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria6

  • 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 Criteria4

  • 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

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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.


Locations(4)

Kantosspital Baden AG

Baden, Switzerland

Universitätsspital Basel

Basel, Switzerland

Kantonsspital Baselland

Liestal, Switzerland

Tumor- und Brustzentrum Ostschweiz

Sankt Gallen, Switzerland

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NCT06408688


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