Pembrolizumab for Brain Cancer

Phase-Based Estimates
1
Effectiveness
2
Safety
Dana Farber Cancer Institute, Boston, MA
Brain Cancer+3 More
Pembrolizumab - Drug
Eligibility
18+
All Sexes
Eligible conditions
Brain Cancer

Study Summary

This study is evaluating whether a drug may help treat cancer that has spread to the brain.

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Eligible Conditions

  • Brain Cancer
  • Brain Neoplasms
  • Neoplasm Metastasis
  • Cancer, Second Primary
  • Tumors Metastatic to Brain
  • Neoplasms, Second Primary

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Pembrolizumab will improve 2 primary outcomes and 6 secondary outcomes in patients with Brain Cancer. Measurement will happen over the course of 6 Weeks.

3 Months
Extracranial Overall Response Rate
Month 6
Extracranial PFS
Intracranial PFS
Overall Survival Rate
6 Months
Extracranial Response Rate
Intracranial Response Rate
6 Weeks
Objective Response Rate
Baseline to 21 Days
Number of Participants with grade-3 or higher hematologic toxicities or grade-3 or higher neurologic toxicities

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

4 Treatment Groups

No Control Group
Previously Untreated Brain Metastases-Cohort A

This trial requires 102 total participants across 4 different treatment groups

This trial involves 4 different treatments. Pembrolizumab is the primary treatment being studied. Participants will be divided into 4 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Previously Untreated Brain Metastases-Cohort A- 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
1-4 Brain Metastases from Melanoma Cohort D1-4 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
Neoplastic Meningitis-Cohort CNeoplastic 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
Progressive Brain Metastases-Cohort B- 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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
MRI
2009
Completed Phase 2
~2270
Stereotactic Radiosurgery
2016
Completed Phase 2
~170
PET/CT
2017
Completed Phase 3
~1060

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 months and 6 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 3 months and 6 months for reporting.

Who is running the study

Principal Investigator
P. B.
Priscilla Brastianos, Principal Investigator/ Physician, Cancer Center
Massachusetts General Hospital

Closest Location

Dana Farber Cancer Institute - Boston, MA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Brain Cancer or one of the other 3 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
is a prerequisite for admission The patient must have a life expectancy of greater than six weeks in order to be admitted. show original
Participants must have a histologically or cytologically confirmed solid tumor and measurable disease in the CNS, defined as at least one lesion that can be accurately measured in at least one dimension as ≥5 mm. show original
The patient's hemoglobin level must be 9 g/dL or higher without needing a transfusion or EPO treatment in the past week. show original
---- This means that the absolute neutrophil count must be at least 1,500 per microliter in order to be eligible for the study. show original
---- Platelets ≥100,000 / mcL
Age ≥18 years.
The person has a very good performance status, with a Karnofsky score of at least 60%. show original
People who want to participate in the clinical trial must have normal organ and marrow function, as defined in Table 1 show original
Adequate Organ Function Laboratory Values
Hematological

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get brain cancer a year in the United States?

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Between 2000 and 2008 the percentage of men with [brain cancer](https://www.withpower.com/clinical-trials/brain-cancer) in the U.S. increased by about 50 percent, while the percentage of women with brain cancer decreased somewhat - from 2.5% in 2000/2001 to 1.4% in 2008/2009. This suggests the prevalence of brain cancer is increasing. As prevalence for any type of cancers is increasing a corresponding increase in survival has not occurred. There are possible contributing factors in this finding including: decreased death from other causes such as cancer as well as decreased death from tobacco use due to decreasing smoking rates in this period; improved treatments; shorter survival times as well as detection methods leading to increased survival of people with brain cancer.

Unverified Answer

What are common treatments for brain cancer?

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These data provide key insight into the treatment of patients with primary brain cancer through the perspective of patients and family/friends of patients with brain cancer. Physicians should expect to see patients with primary brain cancer for whom treatment should be individualized.

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Can brain cancer be cured?

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The treatment of an individual with [brain cancer](https://www.withpower.com/clinical-trials/brain-cancer) varies substantially depending on the particular nature of the condition. This treatment may include some form of surgery, radiation therapy for brain tumors, chemotherapy for brain tumors, and drugs for brain tumors. For most brain tumor patients, the treatment is tailored to the patient's individual circumstances based on specific characteristics of the cancer and overall health, but the general conclusion is the treatment of brain cancer cannot be considered "cured" by any standards.

Unverified Answer

What causes brain cancer?

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Causes include trauma, infections, genetic disorders, environmental toxins and cancers of the brain. It is difficult to ascertain the cause of most types of brain cancer because the disease is often asymptomatic or can present with symptoms in advanced stages. For brain metastases, treatment-related brain radiation is often considered the only factor that has an effect to prevent progression because brain metastases are often asymptomatic.

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What are the signs of brain cancer?

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Notable symptoms of brain cancer include headaches, changes in cognition and behavior, and seizures. Seizures may mimic brain tumors. Headaches caused by a brain tumor may be different from those caused by a hemorrhage or infection. Other symptoms of brain cancer include visual changes, abnormal behavior, numbness, or weakness at the site of a tumor. An MRI is the only way to definitively diagnose a brain tumor. If a tumor is not growing, an ultrasound, CT scan, PET scan, and a chest X-ray may aid in the diagnosis. Other symptoms that may indicate a brain tumor include a loss of balance or coordination, double vision, or weakness in muscle coordination, especially during an epileptic seizure.

Unverified Answer

What is brain cancer?

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Brain cancer is a disease that begins in the brain. It is most probably caused by a combination of genetics and exposure to certain environmental hazards. The majority of brain cancer types happen in the older population; it is more common in men than women.\n

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How serious can brain cancer be?

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The prognosis of [brain cancer](https://www.withpower.com/clinical-trials/brain-cancer) depends on many factors: the size of the tumor and the extent of its invasion; the age of the patient; the underlying cause of the cancer; the general state of the patient's health; and the type of adjuvant treatment that the patient receives. These variables determine what course of treatment a patient will take, how long they will live with their cancer, and whether they're likely to be cured.

Unverified Answer

Does brain cancer run in families?

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Results from a recent paper, no evidence of a genetic basis for the increased risk of cancer was found. If our results are confirmed by larger investigations examining the genetics of the cancer family, this data does not support the idea that cancers run in families.

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Have there been other clinical trials involving pembrolizumab?

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In the absence of a trial in which patients with advanced metastatic pancreatic neuroendocrine tumours or renal cell carcinoma had received pembrolizumab, the results of the aforementioned trial represent one of the largest in clinical practice. Only patients with symptomatic disease had undergone surgery. The patients were mostly elderly, in a frail, old age group. The majority were women, with an unusually high proportion of high-grade cancers (stage 4, 5 and 7). Findings from a recent study of phase III trials in other tumours are less common.

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Is pembrolizumab typically used in combination with any other treatments?

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Among patients with metastatic NSCLC who received combination therapies, ∼60% of patients received pembrolizumab monotherapy. We were surprised by the presence of non-HRs in this study; our results may also be useful to other oncologists treating patients with different diseases.

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How does pembrolizumab work?

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Pembrolizumab is an effective and well-tolerated treatment and is proving to be even more effective than everolimus. It leads to the stabilization or improvement of some endpoints, but does not have a long-term effect on PFS. Pembrolizumab has provided a unique view of the response of all tumours to immune checkpoint inhibitors. Tissue microbiology provides a basis for future study of its precise role.

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What are the chances of developing brain cancer?

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This is a controversial topic because of the lack of a clear, accurate estimate of risk. The following estimate is provided by extrapolating data from five small studies that were undertaken several decades ago.

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