Menu
Recruiting 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

Phase IV Interventional Advanced Solid Tumor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Immune checkpoint inhibitors plus Iscador® Qu., Immune Checkpoint Inhibitors.
Who it may be relevant to
Registry conditions: Advanced Solid Tumor. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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

  • 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.
  • Drug Immune Checkpoint Inhibitors
    Standard cancer treatment.

Primary outcome measures

  • Percentage of patients with a relative increase in T cell richness or diversity of 20% or more [Time frame: baseline and 12 weeks (+/- 2 weeks)]
  • Percentage of patients with a relative decrease in T cell clonality of 20% or more [Time frame: baseline and 12 weeks (+/- 2 weeks)]
  • Level of T cell richness [Time frame: baseline and 12 weeks (+/- 2 weeks)]
  • Level of T cell diversity [Time frame: baseline and 12 weeks (+/- 2 weeks)]
  • Level of T cell clonality [Time frame: baseline and 12 weeks (+/- 2 weeks)]
Secondary outcome measures (6)
  • Safety and tolerability according to the NCI CTC AE v5 [Time frame: up to 18 weeks]
  • Rate of early immune checkpoint inhibitor-based treatment termination [Time frame: up to 24 months]
  • Best tumor response [Time frame: up to 24 months]
  • Progression-free survival [Time frame: up to 24 months]
  • Overall survival [Time frame: up to 24 months]
  • EORTC QLQ C30 [Time frame: up to 24 months]

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 investigator, his/her family members, employees and other dependent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Switzerland · 4 centers
  • Kantosspital Baden AG — Baden
  • Universitätsspital Basel — Basel
  • Kantonsspital Baselland — Liestal
  • Tumor- und Brustzentrum Ostschweiz — Sankt Gallen

Identifiers

NCT: NCT06408688 · 2023-02373; th23binder

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗