MedDataX Logo

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

NCT ID: NCT06408688

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-24

Study Completion Date

2026-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Advanced Solid Tumor

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Mistletoe Extract

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm A: Immune checkpoint inhibitors plus Iscador® Qu

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

Group Type ACTIVE_COMPARATOR

Immune checkpoint inhibitors plus Iscador® Qu.

Intervention Type DRUG

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

Arm B: Immune checkpoint inhibitors

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

Group Type ACTIVE_COMPARATOR

Immune Checkpoint Inhibitors

Intervention Type DRUG

Standard cancer treatment.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

Immune Checkpoint Inhibitors

Standard cancer treatment.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Benjamin Kasenda, PD Dr. Dr.

Role: PRINCIPAL_INVESTIGATOR

USB

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kantosspital Baden AG

Baden, , Switzerland

Site Status RECRUITING

Universitätsspital Basel

Basel, , Switzerland

Site Status RECRUITING

Kantonsspital Baselland

Liestal, , Switzerland

Site Status RECRUITING

Tumor- und Brustzentrum Ostschweiz

Sankt Gallen, , Switzerland

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Mascha Binder, Prof. Dr.

Role: CONTACT

Phone: +41 61 265 50 75

Email: [email protected]

Benjamin Kasenda, PD Dr. Dr.

Role: CONTACT

Phone: +41 61 265 50 75

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Sacha Rothschild, Prof. Dr. Dr.

Role: primary

Benjamin Kasenda, PD. Dr. Dr.

Role: primary

Bettina Seifert, Dr.

Role: primary

Friedemann Honecker, PD Dr. Dr.

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2023-02373; th23binder

Identifier Type: -

Identifier Source: org_study_id