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

NCT06408688 | Recruiting Phase 4 DMC

• 1 other identifier: 2023-02373; th23binder
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 4

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.

Conditions

Advanced Solid Tumor

Keywords

Mistletoe Extract

Outcome Measures

Primary Outcomes (5)

• Percentage of patients with a relative increase in T cell richness or diversity of 20% or more

  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.

  baseline and 12 weeks (+/- 2 weeks)

• Percentage of patients with a relative decrease in T cell clonality of 20% or more

  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.

  baseline and 12 weeks (+/- 2 weeks)

• Level of T cell richness

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

  baseline and 12 weeks (+/- 2 weeks)

• Level of T cell diversity

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

  baseline and 12 weeks (+/- 2 weeks)

• Level of T cell clonality

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

  baseline and 12 weeks (+/- 2 weeks)

Secondary Outcomes (6)

• Safety and tolerability according to the NCI CTC AE v5

  up to 18 weeks

• Rate of early immune checkpoint inhibitor-based treatment termination

  up to 24 months

• Best tumor response

  up to 24 months

• Progression-free survival

  up to 24 months

• Overall survival

  up to 24 months

Study Arms (2)

Arm A: Immune checkpoint inhibitors plus Iscador® Qu

ACTIVE COMPARATOR

Patients randomized to Arm A will be treated with Immune checkpoint inhibitors plus Iscador® Qu.

Drug: Immune checkpoint inhibitors plus Iscador® Qu.

Arm B: Immune checkpoint inhibitors

ACTIVE COMPARATOR

Patients randomized to Arm B will be treated with Immune checkpoint inhibitors only.

Drug: Immune Checkpoint Inhibitors

Interventions

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.

Arm A: Immune checkpoint inhibitors plus Iscador® Qu

Immune Checkpoint Inhibitors DRUG

Standard cancer treatment.

Arm B: Immune checkpoint inhibitors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (4)

Kantosspital Baden AG

Baden, 5404, Switzerland

RECRUITING

Universitätsspital Basel

Basel, 4031, Switzerland

RECRUITING

Kantonsspital Baselland

Liestal, 4410, Switzerland

RECRUITING

Tumor- und Brustzentrum Ostschweiz

Sankt Gallen, 9016, Switzerland

RECRUITING

MeSH Terms

Interventions

Immune Checkpoint Inhibitors

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Study Officials

• Benjamin Kasenda, PD Dr. Dr.

  USB

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mascha Binder, Prof. Dr.

CONTACT

+41 61 265 50 75; mascha.binder@unibas.ch

Benjamin Kasenda, PD Dr. Dr.

CONTACT

+41 61 265 50 75; Benjamin.Kasenda@usb.ch

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 10, 2024
• Study Start: June 24, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (4)