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Heterodimeric Interleukin-15

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.

Table of Contents

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[1]. 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[1]. In medical terms, this is classified under “Neoplasm malignant,” which refers to various forms of cancerous tumors that have progressed to an advanced stage[1].

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[1]. 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[1]. 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[1]. The treatment period can last up to 533 days, which is about 1.5 years[1].

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:

  1. To allow patients who were previously enrolled in Novartis-sponsored studies to continue receiving the study treatment[1].
  2. To collect data on the safety and tolerability of spartalizumab, either alone or in combination with other treatments (which may include Heterodimeric Interleukin-15)[1].

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[1].
  • Experiencing clinical benefit from the study treatment, as determined by the doctor[1].
  • Demonstrating compliance with the previous study’s requirements[1].
  • Willing and able to comply with scheduled visits and treatment plans[1].

Patients who have been permanently discontinued from spartalizumab treatment in the previous study (except for enrollment in a specific study) are not eligible[1].

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)[1].
  • Monitoring instances where doses need to be interrupted or reduced[1].
  • Recording the number of patients receiving the treatment and the duration of their exposure[1].

This careful monitoring helps ensure patient safety and provides valuable information about how well the treatment is tolerated.

Aspect Details
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

FAQ

  • What is Heterodimeric Interleukin-15 (NIZ985)? Heterodimeric Interleukin-15, also known as NIZ985, is an investigational drug developed by Novartis Pharma Services AG. It is a protein-based medication being studied for its potential in treating various types of advanced cancer.
  • What is the main objective of the clinical trials involving NIZ985? The main objective of these trials is to collect safety and tolerability data for NIZ985 (Heterodimeric Interleukin-15) when used alone or in combination with other study treatments in patients with advanced cancer.
  • Who is eligible to participate in these clinical trials? Eligible participants are those who are currently enrolled in a pre-defined Novartis-sponsored study and are receiving NIZ985 alone or in combination with other study treatments. They must be deriving clinical benefit from the treatment and have demonstrated compliance with the parent protocol requirements.
  • How is NIZ985 administered in these trials? NIZ985 is administered as a concentrate for solution for injection, given subcutaneously (under the skin). The maximum daily dose is 12 micrograms per kilogram of body weight.
  • What are the primary endpoints of the NIZ985 clinical trials? The primary endpoints of these trials are the frequency and nature of adverse events (AEs) and serious adverse events (SAEs), as well as the number of subjects requiring dose interruptions and dose reductions during treatment with NIZ985.

Ongoing Clinical Trials on Heterodimeric Interleukin-15

  • Study on the Safety and Tolerability of Spartalizumab for Patients with Advanced Cancer

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Czechia France Germany Hungary Italy +2

Glossary

  • Heterodimeric Interleukin-15: A protein-based investigational drug developed by Novartis Pharma Services AG, being studied for its potential in treating various types of advanced cancer.
  • Advanced cancer: Cancer that has spread from its original site to other parts of the body or has progressed to a stage where it is difficult to treat effectively.
  • Clinical benefit: A positive effect of a treatment on a patient's health or quality of life, as determined by the treating physician.
  • Adverse event (AE): Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure.
  • Serious adverse event (SAE): An adverse event that results in death, is life-threatening, requires hospitalization or extends a current hospital stay, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect.
  • Dose interruption: A temporary stoppage of treatment administration, usually due to side effects or other medical reasons.
  • Dose reduction: Lowering the amount of medication given to a patient, often to manage side effects while maintaining treatment effectiveness.
  • Subcutaneous use: Administration of a medication by injection into the tissue layer between the skin and the muscle.
  • Concentrate for solution for injection: A liquid medication that needs to be diluted before it can be injected into the body.
  • Investigational treatment: A medication or therapy that is still being studied and has not yet been approved for general use by regulatory authorities.

References

  1. http://clinicaltrials.eu/trial/study-on-the-safety-and-tolerability-of-spartalizumab-for-patients-with-advanced-cancer/