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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the safety and tolerability of a medication called spartalizumab. The study involves participants who have previously been part of a Novartis-sponsored trial where they received spartalizumab either alone or in combination with other treatments. The main goal is to gather information on how safe and tolerable spartalizumab is for patients with different types of advanced cancer.

Participants in this study will continue to receive spartalizumab, and researchers will monitor them for any side effects or adverse reactions. The study will also track how long participants are exposed to the medication. This trial is open-label, meaning both the researchers and participants know which treatment is being administered. The study is designed to ensure that participants who are benefiting from spartalizumab can continue their treatment while contributing valuable data to the research.

The trial will run until March 2030, allowing for a comprehensive collection of data over an extended period. This information will help in understanding the long-term effects and safety profile of spartalizumab in treating advanced cancer. Participants are expected to comply with scheduled visits and treatment plans as part of the study requirements.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after signing an informed consent form. This confirms understanding of the study and agreement to participate.

    Eligibility requires current enrollment in a specific Novartis-sponsored study, receiving spartalizumab alone or with other treatments, and deriving clinical benefit as determined by the investigator.

  2. Step 2

    Treatment administration

    The study involves the administration of spartalizumab, which may be given alone or with other medications. The route of administration is intravenous.

    Other medications may include taminadenant, capmatinib, batoprotafib, naporafenib, trametinib dimethyl sulfoxide, ieramilimab, dabrafenib mesylate, canakinumab, lacnotuzumab, and heterodimeric interleukin-15. These are administered either orally, intravenously, or subcutaneously, depending on the specific medication.

  3. Step 3

    Monitoring and follow-up

    Regular visits are scheduled to monitor safety and tolerability. This includes checking for any adverse events or serious adverse events.

    The primary focus is on the frequency and nature of these events, as well as any dose interruptions or reductions.

  4. Step 4

    Study duration

    The study is expected to continue until March 7, 2030. Participation involves ongoing treatment and monitoring until this date or until the investigator determines that the treatment is no longer beneficial.

Who can join the trial?

5 criteria

  • The patient must sign an informed consent form before joining the study. This means they agree to participate after understanding the study details.
  • The patient must already be part of a specific study sponsored by Novartis and be receiving a treatment called spartalizumab, either alone or with other treatments.
  • The patient must be benefiting from the study treatment, as judged by the doctor in charge of the study.
  • The patient must have followed the rules and requirements of the original study, as checked by the doctor.
  • The patient must be willing and able to attend scheduled visits and follow the treatment plans.

Who cannot join the trial?

5 criteria

  • Patients who do not have advanced cancer cannot participate. Advanced cancer means the cancer has spread to other parts of the body and is more serious.
  • Patients who are not within the specified age range cannot participate. The age range for this study is not specified here, but it usually means only certain ages are allowed.
  • Patients who are not part of the specified clinical trial group cannot participate. This means only certain groups of patients are allowed, based on specific characteristics.
  • Patients who are not female or male cannot participate. This means the study is open to both genders.
  • Patients who are not considered part of a vulnerable population cannot participate. Vulnerable populations may include groups like children, pregnant women, or others who need special protection.
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Investigated drugs

Spartalizumab is a medication being studied for its safety and tolerability. It is used as a single agent, meaning it is given by itself, or in combination with other treatments. The trial aims to gather more information about how safe spartalizumab is for patients and how well patients can tolerate it.

What is already known about the treatment

Spartalizumab – This medication is administered intravenously, meaning it is given directly into a vein. Currently, spartalizumab is being studied in clinical trials to assess its safety and tolerability, particularly for patients with various types of advanced cancer. It is primarily used to help the immune system recognize and attack cancer cells. At the molecular level, spartalizumab works by blocking a protein called PD-1, which can prevent the immune system from effectively targeting cancer cells. It is classified as an immune checkpoint inhibitor, a type of drug that helps the immune system fight cancer.

Investigated diseases

Advanced Cancer – Advanced cancer refers to cancer that has spread from its original site to other parts of the body. It is characterized by the growth of cancer cells that invade nearby tissues and organs. As the disease progresses, it can affect various bodily functions and lead to symptoms such as pain, fatigue, and weight loss. The progression of advanced cancer varies depending on the type of cancer and the organs involved. It often requires complex management to address symptoms and maintain quality of life. Advanced cancer is typically not curable, but treatments may help control its spread and alleviate symptoms.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-508841-42-00Protocol codeCPDR001X2X01BEstimated enrolment119 patientsSponsorNovartis Pharma AG

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).