Study on the Effectiveness of Nivolumab, Ipilimumab, and Pazopanib in Patients with Advanced Rare Sarcomas

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What is this study about?

This clinical trial is focused on studying a group of rare cancers known as metastatic or unresectable advanced sarcomas. These are types of cancer that have spread to other parts of the body or cannot be removed through surgery. The study is comparing two different treatment approaches. One group of patients will receive a combination of two medications, nivolumab and ipilimumab, which are given through an intravenous infusion, meaning they are administered directly into the bloodstream. The other group will receive pazopanib, a medication taken orally, which means it is swallowed in pill form.

The purpose of this study is to evaluate how effective these treatments are in managing the disease. Patients participating in the study will be randomly assigned to one of the two treatment groups. The study will last for a period of up to 24 months, during which patients will receive their assigned treatment and be monitored regularly. The main focus is to see how long patients can live without their cancer getting worse, which is known as progression-free survival. Other aspects being studied include the overall response to the treatment, the duration of the response, and the overall survival of the patients.

Throughout the study, patients’ quality of life will also be assessed using a questionnaire designed to understand how the treatment affects their daily living. Additionally, researchers will conduct further studies to identify potential markers that could predict how well patients respond to the treatment and to explore new targets for future therapies. This research aims to improve understanding and treatment of these rare sarcomas, providing valuable insights for future medical advancements.

1 randomization

Upon joining the study, you will be randomly assigned to one of two groups. One group will receive a combination of nivolumab and ipilimumab, while the other group will receive pazopanib alone. This process is called randomization and ensures that each participant has an equal chance of being assigned to either group.

2 treatment administration

If you are in the group receiving nivolumab and ipilimumab, these medications will be given to you through an intravenous (IV) infusion. This means the medication will be delivered directly into your bloodstream through a vein. The specific dosage and frequency will be determined by the study team.

If you are in the group receiving pazopanib, you will take this medication orally, which means you will swallow it in the form of a pill. The dosage and frequency will also be determined by the study team.

3 regular follow-up visits

Throughout the study, you will have regular follow-up visits with the study team. These visits are important to monitor your health and the effects of the treatment. During these visits, various tests and assessments will be conducted to track your progress.

4 progression-free survival assessment

The main goal of the study is to compare the effectiveness of the treatments in delaying the progression of your sarcoma. This is known as progression-free survival. Your health and the status of your sarcoma will be regularly assessed to determine how well the treatment is working.

5 quality of life evaluation

Your quality of life will be evaluated using a questionnaire called the EORTC QLQ-C30. This questionnaire helps the study team understand how the treatment is affecting your daily life and overall well-being.

6 end of treatment

The treatment phase of the study will continue until the study’s end date or until it is determined that the treatment is no longer beneficial for you. At this point, you will have a final assessment to evaluate your health and the outcomes of the treatment.

Who Can Join the Study?

Must be at least 18 years old.
Must have a type of cancer called sarcoma, which is confirmed by a test called a biopsy. The sarcoma must be one of the following rare types: Angiosarcoma, Alveolar Soft Part Sarcoma, Clear Cell Sarcoma, Desmoplastic Small Round Cell Tumor, Sclerosing Epithelioid Fibrosarcoma, Perivascular Epithelioid Cell Tumor, Intimal Sarcoma, Extraskeletal Myxoid Chondrosarcoma, Solitary Fibrous Tumor, Epithelioid HemangioEndothelioma, Inflammatory Myofibroblastic Tumor, Epithelioid Sarcoma, Fibrosarcoma, SMARCA-4 deficient sarcoma, Malignant Peripheral Nerve Sheath Tumors, Chordoma, Mesenchymal Chondrosarcoma, Low Grade FibroMyxoid Sarcoma, or Kaposi’s Sarcoma.
Must have cancer that has spread to other parts of the body (metastatic) or cannot be removed by surgery (unresectable), and is not responding to standard treatments or there are no standard treatments available.
Must have measurable disease according to specific criteria used by doctors to assess cancer size and spread.
Must have been treated with a type of chemotherapy called anthracycline, unless no standard treatment exists or is not suitable. Participation is allowed even if this is the first treatment.
Must have a good general health status, as measured by a scale called ECOG Performance Status, with a score of 0 or 1. This means the patient is fully active or has some symptoms but does not need bed rest during the day.
Must have normal function of organs and bone marrow, which is the tissue inside bones that makes blood cells.
Women who can have children must have a negative pregnancy test before starting the study.
Women who can have children must agree to use a highly effective form of birth control during the study and for 3 months after the last dose of study drugs.
Must be able to understand and agree to attend follow-up visits.
Must have medical insurance coverage.
Must sign a consent form indicating understanding of the study details before joining.

Who Cannot Join the Study?

Patients who have a different type of cancer than the specific rare sarcomas being studied cannot participate.
Patients who have had another cancer treatment within a certain time frame before the study starts may not be eligible.
Patients with certain medical conditions that could interfere with the study treatment or affect their safety might be excluded.
Patients who are pregnant or breastfeeding cannot take part in the study.
Patients who have an active infection or a serious illness that could affect their ability to participate may be excluded.
Patients who have previously had an allergic reaction to the study drugs or similar drugs cannot participate.
Patients who are unable to follow the study procedures or attend the required visits may not be eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Oncopole Claudius Regaud	Toulouse	France
Centr Georges Francois Leclerc	Dijon	France

Other Sites

Site Name	City	Country
Centre Antoine Lacassagne	Nice	France
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Hopital Beaujon	Clichy	France
Centre De Lutte Contre Le Cancer Eugene Marquis	Rennes	France
Cdgblg Ltqb Bnsvnc	Lyon	France
Cuhboj Piwo Sdpyrip	STRASBOURG, Alsace	France
Bgbrnbmu Uwodpkutcm Housaixr Cwtpot	Besançon	France
Ibslodmx Pzshlfpstzcbsew Cpokwp Cukjmm	Marseille	France
Cxuoqw Odakq Laroyxk	Lille	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	30.03.2021

Trial locations

Investigated drugs:

Nivolumab 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, it is used to treat patients with a specific type of advanced sarcoma, which is a kind of cancer that affects the body’s connective tissues.

Ipilimumab is another immune checkpoint inhibitor. It helps boost the immune system’s response against cancer cells. When used together with nivolumab, it aims to enhance the overall effectiveness of the treatment for patients with advanced sarcoma.

Pazopanib is a medication that targets certain proteins in cancer cells, which can help stop the growth and spread of the cancer. It is used in this trial as a comparison to see how well it works on its own against the combination of nivolumab and ipilimumab in treating advanced sarcoma.

Investigated diseases:

Sarcoma

Metastatic or unresectable advanced rare sarcomas – Sarcomas are a group of cancers that originate in the bones and soft tissues, such as fat, muscles, nerves, fibrous tissues, blood vessels, or deep skin tissues. When these sarcomas are classified as metastatic, it means they have spread from their original site to other parts of the body. If they are unresectable, it indicates that they cannot be removed completely through surgery. The progression of these sarcomas can vary widely depending on the specific type and location, but they generally grow and spread to other tissues and organs. As they advance, they may cause symptoms related to the affected areas, such as pain, swelling, or functional impairment. The rarity of these sarcomas often makes them challenging to study and treat effectively.

Trial ID:

2024-513982-38-00

NCT ID:

NCT04741438

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effectiveness of Nivolumab, Ipilimumab, and Pazopanib in Patients with Advanced Rare Sarcomas

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?