101 Participants Needed

Pembrolizumab for Brain Tumor

Recruiting at 1 trial location
PB
Overseen ByPriscilla Brastianos, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Massachusetts General Hospital
Must be taking: Dexamethasone
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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?

Pembrolizumab has shown effectiveness in treating various cancers, such as non-small cell lung cancer and melanoma, by helping the immune system attack cancer cells. While specific data for brain tumors is limited, its success in other cancers suggests potential benefits.12345

Is pembrolizumab generally safe for humans?

Pembrolizumab has been approved for use in certain cancers and is generally considered safe, but it can cause side effects like fatigue, cough, nausea, and more serious immune-related issues like pneumonitis (lung inflammation) and type 1 diabetes in rare cases.12678

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 Brastianos | Breast Cancer ...

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

You must have a confirmed diagnosis of cancer from a tissue sample or cells.
You must have a detectable brain tumor that can be accurately measured and is at least 5 millimeters in size.
You have not received treatment for brain tumors and do not show any symptoms related to them for Cohort A.
See 13 more

Exclusion Criteria

Participants who are receiving any other investigational agents
You need to have surgery or radiation treatment for brain metastases right away.
You have had chemotherapy or other specific treatments within the last 14 days, or you have not fully recovered from side effects of previous treatments.
See 19 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Pembrolizumab is administered every 3 weeks, with stereotactic radiosurgery between cycles for Cohort D

6 weeks
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months
Brain MRI and PET/CT every 6 weeks

Treatment Details

Interventions

  • MRI
  • Pembrolizumab
  • PET/CT
  • Stereotactic Radiosurgery
Trial Overview The study tests Pembrolizumab's effectiveness on central nervous system metastases from various tumors. It includes MRI and PET/CT imaging to track changes, along with Stereotactic Radiosurgery for certain patients. The trial has multiple cohorts based on different disease characteristics.
Participant Groups
4Treatment groups
Experimental Treatment
Group I: Progressive Brain Metastases-Cohort BExperimental Treatment3 Interventions
- Progressive Brain Metastases * Baseline Brain MRI and PET CT * For all cohorts, pembrolizumab will be administered every 3 weeks, with 21 consecutive days defined as a treatment cycle. Treatment will be administered on an outpatient basis. * Brain MRI and PET/CT
Group II: Previously Untreated Brain Metastases-Cohort AExperimental Treatment3 Interventions
- Previously Untreated Brain Metastases * Baseline Brain MRI and PET CT * For all cohorts, pembrolizumab will be administered every 3 weeks, with 21 consecutive days defined as a treatment cycle. Treatment will be administered on an outpatient basis. * Brain MRI and PET/CT
Group III: Neoplastic Meningitis-Cohort CExperimental Treatment3 Interventions
* Neoplastic Meningitis * Histologically confirmed solid malignancy * Positive Cytology * Baseline Brain MRI * For all cohorts, pembrolizumab will be administered every 3 weeks, with 21 consecutive days defined as a treatment cycle. Treatment will be administered on an outpatient basis. * Brain MRI and PET/CT
Group IV: 1-4 Brain Metastases from Melanoma Cohort DExperimental Treatment4 Interventions
* 1-4 Brain Metastases from Melanoma * Clinical indication for stereostatic radiosurgery * Evaluable extracranial focus * For all cohorts, pembrolizumab will be administered every 3 weeks, with 21 consecutive days defined as a treatment cycle. In Cohort D, cycle 1 and 2 of pembrolizumab will be administered 3 weeks apart and stereotactic radiosurgery will be administered between cycles. Treatment will be administered on an outpatient basis. * Brain MRI and PET CT

Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:

🇺🇸
Approved in United States as KEYTRUDA for:
  • 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
🇪🇺
Approved in European Union as KEYTRUDA for:
  • 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
🇬🇧
Approved in United Kingdom as KEYTRUDA for:
  • 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

Trials
3,066
Recruited
13,430,000+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials
4,096
Recruited
5,232,000+
Chirfi Guindo profile image

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 profile image

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

Findings from Research

Pembrolizumab, a PD-1 inhibitor, has demonstrated clinical effectiveness in treating various solid tumors, particularly in patients with PD-L1-positive non-small-cell lung cancer and unresectable/metastatic melanoma.
Early-phase trials and ongoing studies are focused on further confirming the clinical benefits of pembrolizumab in thoracic malignancies, highlighting its potential as a significant treatment option in cancer therapy.
Pembrolizumab for the treatment of thoracic malignancies: current landscape and future directions.Karim, S., Leighl, N.[2017]
In a phase II trial involving 15 patients with resectable non-small cell lung cancer (NSCLC), neoadjuvant treatment with pembrolizumab showed a major pathologic response in 27% of patients, indicating promising antitumor activity before surgery.
The treatment was found to be feasible and safe, with only 33% of patients experiencing moderate adverse events, and no postoperative mortality, suggesting that pembrolizumab does not compromise surgical outcomes.
Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First clinical experience.Eichhorn, F., Klotz, LV., Kriegsmann, M., et al.[2022]
In a phase II trial involving 15 patients with recurrent glioblastoma, pembrolizumab treatment did not lead to significant immune activation within the tumor microenvironment, which was characterized by a lack of T cells and a predominance of CD68+ macrophages.
Despite no treatment-related deaths and a median overall survival of 20 months, the study found that pembrolizumab alone was insufficient to induce a robust immune response in most patients, suggesting that additional strategies may be needed to enhance its efficacy in glioblastoma.
Window-of-opportunity clinical trial of pembrolizumab in patients with recurrent glioblastoma reveals predominance of immune-suppressive macrophages.de Groot, J., Penas-Prado, M., Alfaro-Munoz, K., et al.[2021]

References

Pembrolizumab for the treatment of thoracic malignancies: current landscape and future directions. [2017]
Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First clinical experience. [2022]
Window-of-opportunity clinical trial of pembrolizumab in patients with recurrent glioblastoma reveals predominance of immune-suppressive macrophages. [2021]
FDA Approval Summary: Pembrolizumab for Treatment of Metastatic Non-Small Cell Lung Cancer: First-Line Therapy and Beyond. [2022]
Pembrolizumab joins the anti-PD-1 armamentarium in the treatment of melanoma. [2017]
Recurrent and atypical immune checkpoint inhibitor-induced pneumonitis. [2023]
FDA Approval Summary: Accelerated Approval of Pembrolizumab for Second-Line Treatment of Metastatic Melanoma. [2021]
Programmed Cell Death-1 Inhibitor-Induced Type 1 Diabetes Mellitus. [2022]
Long-Term Survival of Patients With Melanoma With Active Brain Metastases Treated With Pembrolizumab on a Phase II Trial. [2020]
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