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

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 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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 2

    Treatment initiation

    Your treatment will include two medications:

    Cobimetinib - tablets taken by mouth

    Atezolizumab - given through an intravenous infusion

  3. Step 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. Step 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. Step 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 trial?

15 criteria

  • 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 trial?

9 criteria

  • 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
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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.

What is already known about the treatment

  • Cobimetinib

    A MEK inhibitor administered orally that works by blocking specific proteins involved in cancer cell growth. This targeted therapy is used in the treatment of advanced and metastatic soft tissue sarcomas, particularly showing promise in clinical trials for various types including rhabdomyosarcoma and malignant peripheral nerve sheath tumors. The medication belongs to the class of kinase inhibitors and works by interrupting cell signaling pathways that promote tumor growth.

  • Atezolizumab

    An immunotherapy medication administered through intravenous infusion that belongs to the class of PD-L1 inhibitors. This monoclonal antibody works by helping the immune system recognize and attack cancer cells, particularly in the treatment of advanced and metastatic soft tissue sarcomas. The medication functions by blocking the PD-L1 protein that cancer cells use to hide from immune system detection, thereby enabling the body's natural defenses to fight the cancer more effectively.

Investigated diseases

  • 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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-510712-75-00Protocol codeET-19036Estimated enrolment80 patientsSponsorCentre Leon Berard

sourced from the EU Clinical Trials Register and site verification

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