Pembrolizumab for Recurrent Brain Cancer
Trial Summary
What is the purpose of this trial?
The purpose of this study is to test if the study drug called pembrolizumab could control the growth or shrink the cancer but it could also cause side effects. Researchers hope to learn if the study drug will shrink the cancer by half, or prevent it from growing for at least 6 months. Pembrolizumab is an antibody that targets the immune system and activates it to stop cancer growth and/or kill cancer cells.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop taking your current medications. However, you cannot be on high doses of corticosteroids or have had certain treatments like anti-PD-1 agents before. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the drug pembrolizumab for treating brain cancer?
Is pembrolizumab safe for humans?
Pembrolizumab, also known as Keytruda, has been approved for use in several cancers, including melanoma and lung cancer. Common side effects include fatigue, cough, nausea, and rash, while more serious immune-related side effects can affect the lungs, liver, and thyroid. Overall, its benefits in treating life-threatening conditions have been found to outweigh these risks.12467
What makes the drug pembrolizumab unique for treating recurrent brain cancer?
Pembrolizumab is unique because it is an immunotherapy drug that works by blocking the PD-1 pathway, which helps the immune system attack cancer cells. This mechanism is different from traditional chemotherapy, which directly targets and kills cancer cells, and it has shown promise in treating various cancers, including those with brain metastases.24589
Research Team
Thomas Kaley, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
Eligibility Criteria
Adults with recurrent malignant glioma and a hypermutator phenotype, who've had prior treatments including radiation and chemotherapy. They must have stable vital functions, no severe allergies to pembrolizumab components, no active infections or autoimmune diseases requiring recent treatment, not be pregnant or breastfeeding, agree to contraception use during the study period, and cannot have received certain other cancer drugs before.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive pembrolizumab 200 mg as an IV infusion every 3 weeks. Patients will be followed with DCE perfusion MRI done at baseline and every 9 weeks.
Follow-up
Participants are monitored for safety and effectiveness after treatment, with radiologic assessments using MRI scans.
Treatment Details
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?
Memorial Sloan Kettering Cancer Center
Lead Sponsor
Huntsman Cancer Institute/ University of Utah
Collaborator
University of California, San Francisco
Collaborator
M.D. Anderson Cancer Center
Collaborator
University of California, Los Angeles
Collaborator
Dana-Farber Cancer Institute
Collaborator
University of Miami
Collaborator
Merck Sharp & Dohme LLC
Industry Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University