In short
This article discusses the ongoing clinical trials investigating the use of Heterodimeric Interleukin-15, also known as NIZ985, in the treatment of advanced cancer. Developed by Novartis Pharma Services AG, this innovative drug is being studied to assess its safety, tolerability, and potential benefits for patients with various types of advanced cancer. The trials aim to provide continued access to this investigational treatment for eligible participants who have previously been involved in Novartis-sponsored studies.
At a glance
- Drug Name
- Heterodimeric Interleukin-15 (NIZ985)
- Developer
- Novartis Pharma Services AG
- Trial Category
- Post-study drug supply trial
- Medical Condition
- Different types of advanced cancer
- Main Objective
- To collect safety and tolerability data
- Administration
- Subcutaneous injection
- Maximum Daily Dose
- 12 micrograms per kilogram
- Maximum Total Dose
- 4.7 milligrams per kilogram
- Maximum Treatment Period
- 533 days
- Primary Endpoint
- Frequency and nature of adverse events and serious adverse events
What is Heterodimeric Interleukin-15?
Heterodimeric Interleukin-15 is an investigational drug being studied for the treatment of various types of advanced cancer. It is also known by its product name NIZ985. This medication is a type of protein that may help boost the immune system's ability to fight cancer cells.
Medical Conditions Targeted
The primary focus of the research involving Heterodimeric Interleukin-15 is on patients with different types of advanced cancer. In medical terms, this is classified under "Neoplasm malignant," which refers to various forms of cancerous tumors that have progressed to an advanced stage.
Drug Information
Heterodimeric Interleukin-15 is being developed by Novartis Pharma Services AG. It comes in the form of a concentrate for solution for injection. This means that the medication is in a concentrated form that needs to be diluted before it can be injected into the patient.
Administration and Dosage
The drug is administered through subcutaneous use, which means it is injected just under the skin. The dosage is measured in micrograms per kilogram of body weight (µg/Kg). The maximum daily dose being studied is 12 µg/Kg, while the maximum total dose amount is 4.7 mg/kg. The treatment period can last up to 533 days, which is about 1.5 years.
Clinical Trial Details
The clinical trial for Heterodimeric Interleukin-15 is part of a larger study involving another drug called spartalizumab. The main objectives of this trial are:
- To allow patients who were previously enrolled in Novartis-sponsored studies to continue receiving the study treatment.
- To collect data on the safety and tolerability of spartalizumab, either alone or in combination with other treatments (which may include Heterodimeric Interleukin-15).
Eligibility Criteria
To participate in this study, patients must meet certain criteria. Some key requirements include:
- Currently enrolled in a pre-defined Novartis-sponsored study and receiving spartalizumab alone or with other treatments.
- Experiencing clinical benefit from the study treatment, as determined by the doctor.
- Demonstrating compliance with the previous study's requirements.
- Willing and able to comply with scheduled visits and treatment plans.
Patients who have been permanently discontinued from spartalizumab treatment in the previous study (except for enrollment in a specific study) are not eligible.
Safety and Monitoring
The primary focus of this study is to monitor the safety and tolerability of the treatment. This includes:
- Tracking the frequency and nature of adverse events (AEs) and serious adverse events (SAEs).
- Monitoring instances where doses need to be interrupted or reduced.
- Recording the number of patients receiving the treatment and the duration of their exposure.
This careful monitoring helps ensure patient safety and provides valuable information about how well the treatment is tolerated.