RecruitingPHASE2INTERVENTIONAL

Combination of Pembrolizumab and Cabozantinib in Patients With Advanced Sarcomas

This study explores a new treatment combining pembrolizumab and cabozantinib for advanced sarcomas, which are cancers that develop in supportive body tissues like bone, muscle, or fat. The trial focuses on three specific types: undifferentiated pleomorphic sarcoma, osteosarcoma, and Ewing sarcoma. Researchers want to see if this drug combination can help people whose cancer has spread or come back after standard treatments. This is a Phase II study, meaning it's still in the earlier stages of testing and aims to understand how well the treatment works and if it's safe. It's hoped this could offer a new option for patients with these challenging cancers.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Institut Bergonié

Enrolment target

119

Start

25 Apr 2022

Estimated completion

01 Dec 2027

Soft Tissue Sarcoma Adult Advanced Soft-tissue Sarcoma Ewing Sarcoma Osteosarcoma Undifferentiated Pleomorphic Sarcoma

What is this study about?

This study is investigating a new treatment approach for specific types of advanced sarcomas. Sarcomas are rare cancers that can develop in various parts of the body, including bone, muscle, fat, and cartilage. When we talk about "advanced" sarcoma, it means the cancer has either grown significantly, spread to other parts of the body (metastasised), or has come back after previous treatments. For these situations, finding effective new treatments is really important.

The study combines two different drugs: pembrolizumab and cabozantinib. Pembrolizumab is an immunotherapy drug, which works by helping your body's own immune system fight cancer cells. Cabozantinib is a targeted therapy that blocks certain signals cancer cells use to grow and spread. The hope is that by using these two drugs together, they might be more effective at treating the cancer than either drug alone.

This is a Phase II clinical trial, which means researchers are checking how well the treatment works and if it's safe for patients. They are studying three main types of sarcoma separately within this trial: undifferentiated pleomorphic sarcoma, osteosarcoma, and Ewing sarcoma. By looking at each type individually, the researchers can see if the treatment has a valuable effect on these specific cancers, potentially leading to new treatment options in the future.

Key takeaways

This study is testing a new combination of two drugs for advanced sarcoma.
It focuses on three specific types of sarcoma: undifferentiated pleomorphic sarcoma, osteosarcoma, and Ewing sarcoma.
The treatment aims to use the body's immune system and block cancer growth signals.
It's a Phase II trial, looking for effectiveness and safety.
Participation involves regular hospital visits for treatment, tests, and monitoring.
You can stop participating at any time if you wish.

Who may be eligible?

To join this study, you would need to have certain types of advanced sarcoma that can't be removed by surgery or have spread to other parts of your body. This includes specific types such as undifferentiated pleomorphic sarcoma, osteosarcoma, and Ewing sarcoma. The cancer must have either come back or not responded well to previous standard treatments, and doctors would need to see signs that the cancer has progressed recently.

You should be at least 18 years old. You couldn't have had more than three different types of drug treatments for your advanced cancer before enrolling in this study. Also, your general health, as assessed by your doctor, would need to be good, and your organs like your kidneys and liver must be working properly. There are also specific requirements about having some healthy tumour tissue available for examination.

There are also some things that might prevent you from joining. For example, if your cancer has caused symptoms in your brain, or if you're taking steroids regularly. You also need to have recovered from any serious side effects from previous treatments before starting in this study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have advanced undifferentiated pleomorphic sarcoma, osteosarcoma, or Ewing sarcoma?
Has your cancer spread or come back after other treatments?
Have you had 3 or fewer previous courses of drug treatment for your advanced cancer?
Is your general health good enough to take part?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the combination of two drugs, pembrolizumab and cabozantinib. These drugs would be given according to a specific schedule, which your study doctor and nurse would explain in detail. You would have regular appointments at the hospital for treatments, blood tests, and scans to monitor your health and how the treatment is affecting your cancer. These appointments are important to track the treatment's effectiveness and to check for any side effects.

The total duration of your participation would depend on how your cancer responds to the treatment and if you experience any side effects. You would continue treatment as long as it is helping you and you are tolerating it well. Throughout the study, you would have access to the study team for any questions or concerns. There would also be a follow-up period after you stop treatment to continue monitoring your health.

Potential risks and benefits

While this study offers a chance to try a new treatment combination that might help with your cancer, there are no guarantees it will work for everyone. Potential benefits could include slowing down your cancer's growth or shrinking tumours. However, like all medications, these drugs can cause side effects. These could range from mild to more serious, and the study team would carefully monitor you for any issues. You would be fully informed about all known risks before joining, and you are free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (10)

Institut Bergonie
Verified postcode
Bordeaux, France· Recruiting
Centre Georges François Leclerc
Verified postcode
Dijon, France· Recruiting
Centre Oscar Lambret
Verified postcode
Lille, France· Not yet recruiting
Centre Leon Berard
Verified postcode
Lyon, France· Not yet recruiting
Institut Paoli Calmettes
Verified postcode
Marseille, France· Recruiting
Hôpital La Timone
Verified postcode
Marseille, France· Recruiting
Institut Curie
Verified postcode
Paris, France· Not yet recruiting
Institut de Cancérologie de l'Ouest - Site René Gauducheau
Verified postcode
Saint-Herblain, France· Recruiting
IUCT Oncopole
Verified postcode
Toulouse, France· Not yet recruiting
Institut Gustave Roussy
Verified postcode
Villejuif, France· Recruiting

Common questions

What is sarcoma?

Sarcoma is a rare type of cancer that develops in the body's connective and supportive tissues, such as bone, muscle, fat, nerves, cartilage, or blood vessels.

What does 'advanced' sarcoma mean?

Advanced sarcoma means the cancer has either spread to other parts of the body (metastasised), grown significantly, or come back after previous treatments.

What are pembrolizumab and cabozantinib?

Pembrolizumab is a type of immunotherapy that helps your immune system fight cancer. Cabozantinib is a targeted therapy designed to block signals that help cancer cells grow.

Is this a new treatment?

Yes, this study is looking at a new combination of these two drugs for advanced sarcomas. While the drugs might be used individually for other conditions, their combination for these specific sarcomas is investigational.

What is a Phase II trial?

A Phase II clinical trial is an early stage of research where doctors test a new treatment on a larger group of patients than in Phase I to see if it is effective and to further assess its safety.

How to find out more

Maud TOULMONDE, MD

m.toulmonde@bordeaux.unicancer.fr +33556333333 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.