Study of cobimetinib and atezolizumab combination therapy in children and adults with advanced or metastatic soft tissue sarcoma

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What is this study about?

This clinical trial investigates the treatment of soft tissue sarcoma that has spread to other parts of the body (advanced or metastatic). The study focuses on two specific types of soft tissue sarcomas: rhabdomyosarcoma (a type of muscle cancer) and Malignant Peripheral Nerve Sheath Tumors (tumors that form around nerves). The purpose is to evaluate how well two medications work together in treating these cancers in both children and adults.

The treatment combines two medications: cobimetinib (taken as tablets by mouth) and atezolizumab (given through an intravenous infusion into a vein). Cobimetinib works by blocking specific proteins called MEK1 and MEK2 that can cause cancer cells to grow, while atezolizumab helps the immune system fight cancer cells by targeting a protein called PDL1.

The study is conducted in two parts. The first part checks if the combination of medications is safe for children aged 6 months to 12 years. The second part examines how well the treatment works in different groups of patients based on their specific type of sarcoma. Patients will receive the treatment and undergo regular medical evaluations to monitor their response to the medications and any side effects that may occur.

1 Initial medical assessment

Your eligibility will be confirmed through medical tests performed within 7 days before starting treatment

Laboratory tests will check your blood counts, liver function, kidney function, and heart markers

A tumor tissue sample will be analyzed to confirm your diagnosis and check specific markers

2 Treatment initiation

Your treatment will include two medications:

Cobimetinib – tablets taken by mouth

Atezolizumab – given through an intravenous infusion

3 Regular monitoring

Your progress will be checked at 8 weeks and 16 weeks using imaging scans

Regular assessments will track how your tumor responds to treatment

Side effects will be monitored and rated according to standard guidelines

4 Long-term follow-up

Your health status will be monitored throughout the treatment period

The study will continue until February 2026

After completing treatment, you will need to use contraception for 6 months (women) or 5 months (men)

5 Safety monitoring

Any side effects will be closely monitored and treated as needed

Regular blood tests will check your organ function

You can report any health concerns to your healthcare team during the study

Who Can Join the Study?

Must be at least 12 years old when signing the consent form
Must have a confirmed diagnosis of soft tissue sarcomas (either Rhabdomyosarcomas or Malign Peripheral Nerve Sheath Tumors) verified by a pathologist
Must have good physical performance:
– For patients 12 years and older: Karnofsky score of at least 70%
– For adults: ECOG score of 0 or 1 (able to carry out normal or light activities)
Must have a life expectancy of at least 16 weeks
Must have adequate organ function shown by blood tests, including:
– Sufficient blood cell counts
– Normal kidney function
– Acceptable liver function
– Normal blood clotting
Must have recovered from side effects of previous cancer treatments (except hair loss and mild nerve problems)
For women who can become pregnant: must have a negative pregnancy test and agree to use effective contraception for 6 months after treatment ends
For sexually active men: must agree to use contraception for 5 months after treatment ends
Must have received previous chemotherapy treatment
Must have at least one measurable tumor
Must provide written informed consent and agree to follow study procedures
Must have health insurance coverage
Must have suitable tumor tissue sample available for testing
Must have documented disease progression based on imaging tests
Adult patients only: Must have a tumor that can be safely sampled through biopsy

Who Cannot Join the Study?

Children younger than 6 months of age
Children older than 12 years of age
Patients who do not have advanced or metastatic soft tissue sarcoma (soft tissue sarcoma is a type of cancer that starts in soft tissues like muscles or nerves)
Patients who do not have one of these tumor types:
- Rhabdomyosarcoma (RMS) – a cancer that forms in muscle tissue
- Malignant Peripheral Nerve Sheath Tumors (MPNST) – tumors that develop in the covering of nerves
- Complex genomics sarcomas – sarcomas with specific genetic characteristics
Patients who cannot take the study medications cobimetinib and atezolizumab
Patients who are unable to undergo required medical tests and procedures
Patients with certain medical conditions that might interfere with the study treatment

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

Other Sites

Site Name	City	Country
Institut Des Neurosciences De La Timone	Marseille	France
Cbwpyr Lqdj Bepofq	Lyon	France
Cmuftk Opgmh Lnhjsir	Lille	France
Ipywrpre Cyxqz	Paris	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	12.12.2020

Trial locations

Investigated drugs:

Cobimetinib is a MEK inhibitor medication that works by blocking specific proteins involved in cancer cell growth. It is used to treat certain types of soft tissue sarcomas by interfering with signals that cancer cells need to multiply and spread.

Atezolizumab is a type of immunotherapy medication known as a PDL1 inhibitor. It helps the body’s immune system recognize and fight cancer cells by blocking a protein that cancer cells use to hide from immune cells. This allows the immune system to better detect and attack the cancer.

The trial studies these two medications used together as a combination therapy for patients with soft tissue sarcomas, including specific types like rhabdomyosarcoma, malignant peripheral nerve sheath tumors, and other sarcomas with complex genetic features.

Investigated diseases:

Soft tissue sarcoma

Rhabdomyosarcoma – A type of soft tissue cancer that develops in muscle tissue, primarily affecting children and young adults. The cancer cells grow in the soft tissues of the body, particularly in muscles that we control voluntarily. It can occur in various parts of the body, including the head, neck, arms, legs, trunk, and reproductive organs.

Malignant Peripheral Nerve Sheath Tumor – A rare cancer that develops in the protective covering of peripheral nerves. It forms in the soft tissues surrounding the nerves that extend from the spinal cord to various parts of the body. The tumors can develop anywhere along these peripheral nerves and may cause pain, weakness, or numbness in affected areas.

Complex Genomic Sarcoma – A group of soft tissue tumors characterized by complex genetic changes in the cells. These tumors develop in various soft tissues of the body and show multiple chromosomal abnormalities. They typically arise from connective tissues such as fat, muscle, nerves, or blood vessels.

Trial ID:

2024-510712-75-00

Protocol code:

ET-19036

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study of cobimetinib and atezolizumab combination therapy in children and adults with advanced or metastatic soft tissue sarcoma

What is this study about?

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