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 (ISCA-CHECK)

University Hospital Basel

Status and phase: Enrolling; Phase 4

Conditions: Advanced Solid Tumor

Treatments: Drug: Immune checkpoint inhibitors plus Iscador® Qu.; Drug: Immune Checkpoint Inhibitors

Study type: Interventional

Funder types: Other

Identifiers

NCT06408688

2023-02373 th23binder;

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups

Arm A: Immune checkpoint inhibitors plus Iscador® Qu

Active Comparator group

Description:

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

Treatment:

Drug: Immune checkpoint inhibitors plus Iscador® Qu.

Arm B: Immune checkpoint inhibitors

Active Comparator group

Description:

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

Treatment:

Drug: Immune Checkpoint Inhibitors