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Study of Spartalizumab and Pazopanib for Patients with Refractory or Recurrent Solid Tumors

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 treatments for people with refractory or recurrent solid tumors, which are types of cancer that have not responded to previous treatments or have returned after treatment. The study involves two medications: spartalizumab, known by its code name PDR001, and pazopanib, marketed as Votrient. Spartalizumab is given as an infusion, which means it is administered directly into the bloodstream, while pazopanib is taken orally in the form of tablets.

The purpose of the study is to find the best dose of spartalizumab when used with a fixed dose of pazopanib for children and to evaluate how effective this combination is in controlling the disease in adults over a period of six months. Participants in the study will receive these medications and will be monitored to see how their tumors respond to the treatment. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the actual treatment.

The study will involve regular check-ups and assessments to monitor the health and progress of the participants. These assessments will help determine the safety and effectiveness of the treatment combination. The trial aims to provide valuable information that could lead to better treatment options for patients with these challenging types of cancer.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    The treatment begins with the administration of two medications: spartalizumab and pazopanib.

    Spartalizumab is given as an infusion. This means it is delivered directly into the bloodstream through a vein.

    Pazopanib is taken orally in the form of film-coated tablets, specifically Votrient 200 mg.

  2. Step 2

    Medication schedule

    During the first cycle, spartalizumab is administered on days 1, 8, and 15.

    Pazopanib is taken daily, starting from day 1 of the cycle.

  3. Step 3

    Monitoring and assessment

    Regular monitoring is conducted to assess the body's response to the treatment.

    This includes checking the levels of the medications in the blood and evaluating the effects on the tumor.

  4. Step 4

    Subsequent cycles

    In the following cycles, spartalizumab is administered on day 1 and day 15.

    Pazopanib continues to be taken daily.

  5. Step 5

    Evaluation of treatment response

    The effectiveness of the treatment is evaluated every two cycles.

    This involves imaging tests to measure the size of the tumor and determine the response.

  6. Step 6

    End of treatment

    The treatment continues until the end of the study period or until it is determined that the treatment is no longer effective.

    The study is estimated to conclude by November 17, 2027.

Who can join the trial?

20 criteria

  • For **pediatric patients** (ages 5 to 17), they must have a **refractory or recurrent solid tumor**. This means the tumor has not responded to treatment or has come back after treatment.
  • For **pediatric patients**, the tumor must have a **high mutational load** (more than 10 mutations) or a **high MSI status**. These terms refer to specific genetic characteristics of the tumor.
  • For **pediatric patients**, the tumor must show **PDL1 expression** (1% or more) or have **mature tertiary lymphoid structure (TLS)**. These are specific features of the tumor that can be identified through tests.
  • For **pediatric patients**, they must be able to **swallow tablets**.
  • For **pediatric patients**, they must have a **life expectancy** of at least 3 months.
  • For **pediatric patients**, they must have **adequate organ function**. This includes specific blood counts, heart function, and liver and kidney function within certain limits.
  • For **pediatric patients**, they must have a **performance status** of at least 70% on the Karnofsky or Lansky scale. This measures their ability to perform daily activities.
  • For **pediatric patients**, they must have **evaluable or measurable disease**. This means the tumor can be measured or evaluated using standard imaging techniques.
  • For **pediatric patients**, **written informed consent** must be obtained from parents or legal representatives, and age-appropriate assent from the child.
  • For **pediatric patients**, they must be affiliated with a **social security regimen** or be a beneficiary according to local requirements.
  • For **adult patients** (18 years and older), they must have a **solid tumor** or a tumor with a **high mutation rate** or **Mismatch repair-deficient syndrome**. These are specific types of tumors or genetic characteristics.
  • For **adult patients**, they must have an **ECOG score** of 0 or 1. This score measures their ability to carry out daily activities.
  • For **adult patients**, they must have **evaluable or measurable disease** using standard imaging criteria.
  • For **adult patients**, they must have a **life expectancy** of at least 3 months.
  • For **adult patients**, they must have **adequate organ function**. This includes specific blood counts, heart function, and liver and kidney function within certain limits.
  • For **adult patients**, they must be able to **comply with scheduled follow-up** and manage any side effects.
  • For **adult patients**, **females of childbearing potential** must have a negative pregnancy test and agree to use effective contraception during the study and for 6 months after.
  • For **adult patients**, **males** must agree to use condoms during the study and for 6 months after.
  • For **adult patients**, **written informed consent** must be obtained before any study-specific procedures.
  • For **adult patients**, they must be affiliated with a **social security regimen** or be a beneficiary according to local requirements.

Who cannot join the trial?

4 criteria

  • Patients who have a type of cancer called a refractory or recurrent solid tumor cannot participate. This means the cancer has not responded to treatment or has come back after treatment.
  • Patients who are not within the specified age range for the study cannot participate. The study includes certain age groups, so if you are outside these groups, you cannot join.
  • Patients who are part of a vulnerable population cannot participate. This means people who might need special protection or care, like those with certain disabilities or conditions, are not included.
  • Patients who do not meet the specific health requirements set by the study cannot participate. This includes having certain medical conditions or health issues that the study does not allow.
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Investigated drugs

  • Spartalizumab

    is a medication being studied for its potential to help the immune system fight cancer. It is used in this trial to see if it can improve outcomes for patients with solid tumors that have not responded to other treatments or have returned after treatment.

  • Pazopanib

    is a medication that works by blocking certain proteins that help cancer cells grow. In this trial, it is given at a fixed dose to see if it can work together with spartalizumab to control the disease in patients with solid tumors.

What is already known about the treatment

  • Spartalizumab

    Spartalizumab is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating refractory or recurrent solid tumors. It is an investigational medication, meaning it is not yet approved for general medical use. The main therapeutic indication is for solid tumors that have not responded to other treatments. Spartalizumab works by targeting and inhibiting specific proteins on cancer cells, helping the immune system to recognize and attack these cells. It is classified as an immune checkpoint inhibitor.

  • Pazopanib

    Pazopanib is taken orally in tablet form and is used in combination with spartalizumab in clinical trials for treating refractory or recurrent solid tumors. It is an approved medication for certain types of cancer, but its use in combination with spartalizumab is still under investigation. The main therapeutic indication is for solid tumors that have not responded to other treatments. Pazopanib works by blocking certain proteins that promote tumor growth and blood vessel formation, thereby inhibiting cancer progression. It is classified as a tyrosine kinase inhibitor.

Investigated diseases

Refractory or Recurrent Solid Tumor – This condition refers to solid tumors that do not respond to standard treatments or that return after treatment. Solid tumors are abnormal masses of tissue that usually do not contain cysts or liquid areas. They can occur in various parts of the body, such as the lungs, liver, or brain. Refractory tumors are those that resist treatment from the beginning, while recurrent tumors are those that reappear after a period of remission. The progression of these tumors can vary widely depending on their location and the specific characteristics of the tumor cells. They may grow slowly or rapidly and can spread to other parts of the body, complicating treatment efforts.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-513535-24-00Protocol codeCHUBX 2020/31Estimated enrolment74 patientsSponsorCentre Hospitalier Universitaire De Bordeaux

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