Advanced Solid TumorPhase 4ISCA-CHECKNCT06408688
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 Phase 4 study testing Immune checkpoint inhibitors plus Iscador® Qu. and Immune Checkpoint Inhibitors in people with Advanced Solid Tumor, run by University Hospital, Basel, Switzerland at 4 sites in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- Immune checkpoint inhibitors plus Iscador® Qu. and Immune Checkpoint Inhibitors
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 4 sitesSwitzerland
- Study dates
- 24 Jun 2024to Nov 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland4 sites, 4 recruiting
- Recruiting
Kantosspital Baden AG
Baden, 5404
Sacha Rothschild, Prof. Dr. Dr., +41 56 486 27 62, Sacha.Rothschild@ksb.ch
Sacha Rothschild, Prof. Dr. Dr.
- Recruiting
Universitätsspital Basel
Basel, 4031
Benjamin Kasenda, PD. Dr. Dr., +41 61 265 50 75, Benjamin.Kasenda@usb.ch
Benjamin Kasenda, PD. Dr. Dr.
- Recruiting
Kantonsspital Baselland
Liestal, 4410
Bettina Seifert, Dr., +41 61 925 27 15, bettina.seifert@ksbl.ch
Bettina Seifert, Dr.
- Recruiting
Tumor- und Brustzentrum Ostschweiz
Sankt Gallen, 9016
Friedemann Honecker, PD Dr. Dr., +41 71 243 02 02, info@tbz-ost.ch
Friedemann Honecker, PD Dr. Dr.
About this study
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
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.
Read the 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.
- Conditions
- Advanced Solid Tumor
- Being tested
- Immune checkpoint inhibitors plus Iscador® Qu., Immune Checkpoint Inhibitors
- Keywords
- Mistletoe Extract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 InhibitorsDrug
Standard cancer treatment.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Immune Checkpoint Inhibitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline and 12 weeks (+/- 2 weeks)
Secondary outcomes (6)
Safety and tolerability according to the NCI CTC AE v5
Safety and tolerability according to the NCI CTC AE v5 (National Cancer Institute Common Terminology Criteria for Adverse Events)
Measured: up to 18 weeks
Rate of early immune checkpoint inhibitor-based treatment termination
Rate of early immune checkpoint inhibitor-based treatment termination
Measured: up to 24 months
Best tumor response
Best tumor response as per investigators assessment
Measured: up to 24 months
Progression-free survival
Investigator-assessed progression-free survival
Measured: up to 24 months
Overall survival
Overall survival
Measured: up to 24 months
EORTC QLQ C30
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.
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2024
- Study start24 Jun 2024
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin Kasenda, PD Dr. Dr., Principal investigator, USB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06408688
- Sponsor's protocol ID
- 2023-02373; th23binder
- Other IDs
- 2023
- Acronym
- ISCA-CHECK
- Status last verified
- Dec 2024
- First submitted
- 7 May 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06408688
- Acronym / sponsor ID
- ISCA-CHECK / 2023-02373; th23binder
- Conditions
- Advanced Solid Tumor
- Keywords
- Mistletoe Extract
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 24 Jun 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 10 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Immune checkpoint inhibitors plus Iscador® Qu | Active comparator | Drug: Immune checkpoint inhibitors plus Iscador® Qu.Patients randomized to Arm A will be treated with Immune checkpoint inhibitors plus Iscador® Qu. |
| Arm B: Immune checkpoint inhibitors | Active comparator | Drug: Immune Checkpoint InhibitorsPatients randomized to Arm B will be treated with Immune checkpoint inhibitors only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Arm A: Immune checkpoint inhibitors plus Iscador® Qu |
| Immune Checkpoint InhibitorsStandard cancer treatment. | Drug | Arm B: Immune checkpoint inhibitors |
Primary outcome
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.
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.
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.
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.
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.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Benjamin Kasenda, PD Dr. Dr. principal investigator
USB
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Immune checkpoint inhibitors plus Iscador® Qu. and Immune Checkpoint Inhibitors in people with Advanced Solid Tumor, run by University Hospital, Basel, Switzerland at 4 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mascha Binder, Prof. Dr. (+41 61 265 50 75, mascha.binder@unibas.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.