Pembrolizumab for Pediatric Brain Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial studies the safety and effectiveness of pembrolizumab in younger patients with aggressive or treatment-resistant brain tumors. Pembrolizumab is an immunotherapy drug that helps the immune system attack cancer by blocking a protein that stops immune cells from working effectively. Pembrolizumab has been used in various cancers, showing effective antitumor activity and is approved by the FDA for multiple uses.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you must have recovered from any recent treatments and meet certain time requirements since your last dose of specific therapies before enrolling.
Is pembrolizumab generally safe for use in humans?
Pembrolizumab, also known as Keytruda, has been used in cancer treatment and is generally considered to have a tolerable safety profile. However, it can cause immune-related side effects, such as type 1 diabetes in rare cases, and other reactions like fatigue, nausea, and diarrhea. Severe side effects, though rare, can include inflammation of organs like the lungs and liver.12345
How is the drug pembrolizumab unique in treating pediatric brain cancer?
What data supports the effectiveness of the drug pembrolizumab for pediatric brain cancer?
Pembrolizumab has shown effectiveness in treating various cancers, including lung cancer and melanoma, by helping the immune system attack cancer cells. It has also been approved for use in both adults and children with certain types of solid tumors, suggesting it might be beneficial for pediatric brain cancer as well.258910
Who Is on the Research Team?
Eugene I Hwang
Principal Investigator
Pediatric Brain Tumor Consortium
Are You a Good Fit for This Trial?
This trial is for young patients under 22 with specific brain tumors (high-grade gliomas, diffuse intrinsic pontine gliomas, hypermutated brain tumors, ependymoma or medulloblastoma) that are recurrent, progressive or refractory. They must have finished previous treatments and recovered from their effects. Participants need a performance score of >=70 and meet various health criteria including stable neurological deficits and adequate blood counts.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive pembrolizumab intravenously every 21 days for up to 34 cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Pembrolizumab
Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:
- Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Hepatocellular carcinoma
- Renal cell carcinoma
- Cervical cancer
- Endometrial carcinoma
- Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Hepatocellular carcinoma
- Renal cell carcinoma
- Cervical cancer
- Endometrial carcinoma
- Untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor