Clinical trial 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
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Advanced Solid Tumor
Keywords: Mistletoe Extract
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2024-05-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Percentage of patients with a relative increase in T cell richness or diversity of 20% or more
timeFrame: baseline and 12 weeks (+/- 2 weeks)
measure: Percentage of patients with a relative decrease in T cell clonality of 20% or more
timeFrame: baseline and 12 weeks (+/- 2 weeks)
measure: Level of T cell richness
timeFrame: baseline and 12 weeks (+/- 2 weeks)
measure: Level of T cell diversity
timeFrame: baseline and 12 weeks (+/- 2 weeks)
measure: Level of T cell clonality
timeFrame: baseline and 12 weeks (+/- 2 weeks)
Secondary outcomes:
measure: Safety and tolerability according to the NCI CTC AE v5
timeFrame: up to 18 weeks
measure: Rate of early immune checkpoint inhibitor-based treatment termination
timeFrame: up to 24 months
measure: Best tumor response
timeFrame: up to 24 months
measure: Progression-free survival
timeFrame: up to 24 months
measure: Overall survival
timeFrame: up to 24 months
measure: EORTC QLQ C30
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Baden
country: Switzerland
facility: Kantosspital Baden AG
city: Basel
country: Switzerland
facility: Universitätsspital Basel
city: Liestal
country: Switzerland
facility: Kantonsspital Baselland
city: Saint Gallen
country: Switzerland
facility: Tumor- und Brustzentrum Ostschweiz
Study officials:
affiliation: USB
name: Benjamin Kasenda, PD Dr. Dr.
role: PRINCIPAL_INVESTIGATOR
References: