Pembrolizumab for Brain Tumor
Trial Summary
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, but you cannot be on high-dose corticosteroids or other investigational agents. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the drug pembrolizumab for brain tumors?
Is pembrolizumab generally safe for humans?
What makes the drug pembrolizumab unique for treating brain tumors?
Pembrolizumab is unique because it is a PD-1 inhibitor that helps the immune system attack cancer cells by blocking a pathway that usually suppresses immune responses. This mechanism is different from traditional treatments, as it specifically targets the immune system's interaction with the tumor, which may be beneficial for brain tumors where standard treatments are limited.12359
What is the purpose of this trial?
This research study is studying Pembrolizumab as a possible treatment for this diagnosis for metastases in the central nervous system (brain and spinal cord).
Research Team
Priscilla K. Brastianos
Principal Investigator
Massachusetts General Hospital
Eligibility Criteria
This trial is for adults with confirmed solid tumor metastases in the brain or spinal cord. Participants must have a measurable lesion, be in good physical condition (ECOG ≤2), and have a life expectancy over 6 weeks. Specific cohorts include untreated asymptomatic brain metastases, carcinomatous meningitis, and melanoma with limited brain metastases suitable for radiosurgery.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Pembrolizumab is administered every 3 weeks, with stereotactic radiosurgery between cycles for Cohort D
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- MRI
- Pembrolizumab
- PET/CT
- Stereotactic Radiosurgery
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?
Massachusetts General Hospital
Lead Sponsor
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