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Study on the Effectiveness of Tislelizumab and Spartalizumab in Patients with Advanced or Metastatic Cancer with High PD1 Biomarker Levels

Verified siteRegistered drugNo placebo
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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 effectiveness of two medications, tislelizumab and spartalizumab, in treating patients with advanced or metastatic tumors. These tumors express high levels of a specific protein called PD1, which is a biomarker that can influence how cancer cells grow and respond to treatment. The trial aims to understand how these medications, which are antibodies targeting the PD1 protein, can help in managing different types of cancer.

Participants in the study will receive either tislelizumab or spartalizumab through an intravenous infusion, which means the medication is given directly into a vein. The study will compare the effects of these medications on the tumors over a period of time. Some participants may receive a placebo, which is a substance with no active medication, to help researchers understand the true effects of the treatments. The study will monitor how the tumors respond, whether they shrink, remain stable, or grow, and will also track any side effects experienced by the participants.

The purpose of this study is to assess the overall response rate, which is the proportion of patients whose tumors show a complete or partial response to the treatment. Other aspects being evaluated include the duration of response, time to response, and overall survival of the participants. The study will also look at the clinical benefit rate, which includes patients whose disease remains stable for a certain period. This research is important for developing new treatment options for patients with advanced cancers that express high levels of the PD1 biomarker.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon joining the trial, the participant will provide written informed consent. This confirms understanding of the trial procedures and agreement to participate.

    Eligibility is confirmed based on specific criteria, including age, medical condition, and previous treatments.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate the participant's health status. This includes physical examinations, laboratory tests, and imaging studies.

    The assessment ensures the participant meets all necessary health requirements to proceed with the trial.

  3. Step 3

    Treatment administration

    The participant receives the medication tislelizumab or spartalizumab through an intravenous infusion. This means the medication is delivered directly into the bloodstream through a vein.

    The dosage and frequency of administration are determined by the trial protocol and the participant's specific health needs.

  4. Step 4

    Ongoing monitoring

    Regular monitoring is conducted to assess the participant's response to the treatment. This includes follow-up visits, additional laboratory tests, and imaging studies.

    The participant's health and any side effects experienced are closely observed to ensure safety and effectiveness of the treatment.

  5. Step 5

    Completion of treatment

    Upon completion of the treatment phase, a final assessment is conducted to evaluate the overall response to the medication.

    The participant's health status is reviewed, and any necessary follow-up care is discussed.

Who can join the trial?

10 criteria

  • Participants must be male or female and at least 18 years old on the day they sign the consent form.
  • Participants must have a confirmed diagnosis of high or low PD1 mRNA expression in their tumor sample. This is a specific test done on the tumor to measure certain genetic expressions.
  • Participants must have a life expectancy of more than 3 months, as judged by the study doctor.
  • Participants or their legal representative must provide written consent to participate in the study.
  • Participants must have measurable disease based on specific medical criteria (RECIST 1.1 or RANO), which means the cancer can be measured using imaging tests.
  • Participants must show evidence of disease progression or recurrence after previous cancer treatment.
  • Participants must have an ECOG performance status of 0 to 2. This is a scale used to assess how the disease affects the daily living abilities of the patient.
  • Participants must have adequate organ function as defined by the study protocol, confirmed by tests done within 28 days before starting the study treatment.
  • Participants may have received up to 3 lines of prior chemotherapy in the advanced or metastatic setting. A line of chemotherapy is a treatment regimen given for at least 28 days.
  • Any side effects from previous treatments, except for hair loss, must be at Grade 1 or lower at the time of joining the study. This refers to the severity of side effects, with Grade 1 being mild.

Who cannot join the trial?

1 criterion

  • Patients with **metastatic disease** cannot participate. This means the cancer has spread to other parts of the body.
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Investigated drugs

  • Tislelizumab

    is a type of medication known as an immune checkpoint inhibitor. It works by helping your immune system recognize and attack cancer cells more effectively. In this trial, tislelizumab is being tested to see how well it works in treating different types of cancer in patients whose tumors have high levels of a specific marker called PD1.

  • Spartalizumab

    is another immune checkpoint inhibitor similar to tislelizumab. It also helps your immune system target and destroy cancer cells. The trial is exploring how spartalizumab performs in patients with various cancers that show high levels of the PD1 marker, aiming to understand its effectiveness in shrinking or controlling tumors.

What is already known about the treatment

Tislelizumab – Tislelizumab is administered as an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently being studied in clinical trials for its effectiveness in treating various types of cancer, particularly in patients with tumors that have high levels of a specific protein called PD1. The main therapeutic use of tislelizumab is to help the immune system recognize and attack cancer cells. It works by blocking the PD1 protein, which can prevent the immune system from attacking cancer cells. Tislelizumab is classified as an immune checkpoint inhibitor, a type of drug that helps the immune system fight cancer.

Investigated diseases

Metastatic Cancer – Metastatic cancer occurs when cancer cells spread from the primary site to other parts of the body. This process involves cancer cells breaking away from the original tumor, traveling through the bloodstream or lymphatic system, and forming new tumors in other organs or tissues. The progression of metastatic cancer can vary depending on the type of primary cancer and the organs affected. Common sites for metastasis include bones, liver, lungs, and brain. As the disease progresses, it can lead to a range of symptoms depending on the location and size of the metastatic tumors. The spread of cancer cells can disrupt the normal function of affected organs, leading to further complications.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-508549-41-00Estimated enrolment184 patientsSponsorSolti Group

sourced from the EU Clinical Trials Register and site verification

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