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

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What is this study about?

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.

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 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 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 subsequent cycles

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

Pazopanib continues to be taken daily.

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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut Gustave Roussy Villejuif France
Centre Hospitalier Universitaire De Bordeaux Bordeaux France

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Nantes Nantes France
Clqbls Lofa Bdwwck Lyon France
Azrwaqtjwo Pwtheexh Hqbrsxkt Dq Mpuyxgjea Marseille France
Cmiqgt Hcvnhyaomny Rjyjabxt Dqnxhxwoelgbjd Angers France
Cfjphp Oukzs Lzmkcpl Lille France
Hxisxzze Umxcwerabqkonk Slbaihbbca &vrvzcb Hfteehp dr Hutculpdhge STRASBOURG, Alsace France
Ipnqohae Cxeee Paris France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not yet recruiting
17.05.2022

Trial locations

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.

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 ID:
2024-513535-24-00
Protocol code:
CHUBX 2020/31
NCT ID:
NCT05210413
Trial Phase:
Human Pharmacology (Phase I) – Other

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