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NCT Number: 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

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.

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Key information

Conditions

Advanced Solid Tumor

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kantosspital Baden AG, Baden, Switzerland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Immune checkpoint inhibitors plus Iscador® Qu.

Drug

Standard cancer treatment plus subcutaneous injection of mistletoe fermented extract (Iscador® Qu) as per the summary of product characteristics.

Immune Checkpoint Inhibitors

Drug

Standard cancer treatment.

Primary outcomes

  1. 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 increase in T cell richness or diversity of 20% or more as measured by peripheral blood T cell receptor Next-generation sequencing.

  2. Percentage of patients with a relative decrease in T cell clonality 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 as measured by peripheral blood T cell receptor Next-generation sequencing.

  3. Level of T cell richness

    Time frame: baseline and 12 weeks (+/- 2 weeks)

    Level of T cell richness as measured by peripheral blood T cell receptor Next-generation sequencing.

  4. Level of T cell diversity

    Time frame: baseline and 12 weeks (+/- 2 weeks)

    Level of T cell diversity as measured by peripheral blood T cell receptor Next-generation sequencing.

  5. Level of T cell clonality

    Time frame: baseline and 12 weeks (+/- 2 weeks)

    Level of T cell clonality as measured by peripheral blood T cell receptor Next-generation sequencing.

Secondary outcomes

  1. Safety and tolerability according to the NCI CTC AE v5

    Time frame: up to 18 weeks

    Safety and tolerability according to the NCI CTC AE v5 (National Cancer Institute Common Terminology Criteria for Adverse Events)

  2. Rate of early immune checkpoint inhibitor-based treatment termination

    Time frame: up to 24 months

    Rate of early immune checkpoint inhibitor-based treatment termination

  3. Best tumor response

    Time frame: up to 24 months

    Best tumor response as per investigators assessment

  4. Progression-free survival

    Time frame: up to 24 months

    Investigator-assessed progression-free survival

  5. Overall survival

    Time frame: up to 24 months

    Overall survival

  6. EORTC QLQ C30

    Time frame: up to 24 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Benjamin Kasenda, PD Dr. Dr.

CONTACT

[email protected]

+41 61 265 50 75

Mascha Binder, Prof. Dr.

CONTACT

[email protected]

+41 61 265 50 75

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study 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

Acronym: ISCA-CHECK

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 10, 2024
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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