Study on Combining MAPK Inhibitors with Anti-PD1 Therapy for Children with BRAF-Altered Brain Tumors
Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials ID:NCT06712875
This clinical trial is testing a new treatment approach for children with certain types of brain tumors that have changes in the BRAF gene. The study combines MAPK inhibitors with anti-PD1 therapy to see if this combination can better control the tumors.
Patient Parameters
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Program Overview
The study aims to find out if combining MAPK inhibitors (like dabrafenib and trametinib) with anti-PD1 therapy (like nivolumab) can help treat brain tumors in children that have specific changes in the BRAF gene. These changes can make the tumors hard to treat with standard therapies. The study will look at how safe this combination is and whether it can effectively shrink the tumors.
Description
This study is exploring a new treatment for children with brain tumors that have specific changes in the BRAF gene. These changes can make the tumors difficult to treat. The study will test a combination of drugs: MAPK inhibitors (dabrafenib and trametinib) and an anti-PD1 therapy (nivolumab). These drugs have been used separately in children before, but this is the first time they are being tested together in children.
The study will include children with different types of brain tumors:
- Low-grade gliomas with BRAF changes that have come back or are not responding to treatment.
- High-grade gliomas with BRAF changes that are newly diagnosed or have come back.
- Gliomas with NF1 changes that are newly diagnosed or have come back.
The main goal is to see if this combination of drugs is safe for children and if it can help control the tumors better than previous treatments. The study will also compare the results to past treatments that used MAPK inhibitors alone.
Eligibility Criteria
Inclusion Criteria
- Children aged 1 to 26 years with specific types of brain tumors that have BRAF or NF1 changes.
- Tumors must be either low-grade gliomas that have come back or are not responding to treatment, or high-grade gliomas that are newly diagnosed or have come back.
- Children must be in good overall health and able to perform daily activities.
- Must have good organ and bone marrow function.
- Must agree to use birth control if they are of childbearing age or capable of producing sperm.
- Must have stable neurological symptoms for at least one week before joining the study.
- Must have tried previous treatments with BRAF or MEK inhibitors and have information on how they responded to those treatments.
- Must have recovered from any side effects of previous treatments before starting the study.
Exclusion Criteria
- Children with cancer that has spread widely throughout the body.
- Children who have had radiation therapy within 12 weeks before joining the study.
- Children who have not recovered from side effects of previous cancer treatments.
- Children taking other experimental drugs or treatments.
- Children with allergies to the study drugs.
- Children who have tried a combination of MAPK inhibitors and anti-PD1 therapy before.
- Children with autoimmune diseases or immune system problems.
- Children with inflammatory bowel diseases like Crohn's or ulcerative colitis.
- Children with active lung diseases or a history of lung inflammation.
- Children with active infections like HIV, Hepatitis B, or Hepatitis C.
- Children who have had major surgery within 28 days before starting the study.
- Children using herbal supplements or cannabis products.
- Children who are pregnant or breastfeeding.
- Children with other serious health conditions that could affect their ability to participate in the study.
- Children with large or bulky tumors that could cause pressure on the brain.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Children's National Hospital | 20010 | Washington DC | District of Columbia |
| Ann & Robert H. Lurie Children's Hospital of Chicago | 60611 | Chicago | Illinois |
| Memorial Sloan Kettering Cancer Center | 10065 | New York | New York |
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