← Back to Search

Monoclonal Antibodies

Pembrolizumab for Recurrent Brain Cancer

N/A

Waitlist Available

Led By Thomas Kaley, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial will test if the study drug pembrolizumab can help control cancer growth or shrink the cancer, and if it does cause side effects.

Who is the study for?

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.Check my eligibility

What is being tested?

The trial is testing pembrolizumab's effectiveness on brain tumors that recur after standard treatments. It aims to see if this drug can shrink tumors by at least half or prevent growth for six months. Pembrolizumab works by activating the immune system against cancer cells.See study design

What are the potential side effects?

Pembrolizumab may cause side effects such as reactions related to infusion of the drug into the body, fatigue, skin issues like rash or itching, digestive problems (nausea or diarrhea), liver function changes, hormonal gland problems (like thyroid dysfunction), lung inflammation (pneumonitis), and it could potentially worsen existing autoimmune diseases.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

response rate

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183

21%

Fatigue

13%

Nausea

11%

Back pain

Shortness of Breath

Anemia

Abdominal pain

Diarrhea

Pneumonia

Kidney Injury and/or Infection

Dyspnea

Weight Loss

Malnutrition, Hypercalcemia and Weakness

Pneumothorax

Intractable pain, back pain, hip pain

Activated partial thromboplastin time prolonged

Pleural effusion

Atrial fibrillation with rapid ventricular response

Thrombocytopenia

Respiratory failure

Skin rash

colitis

100%

80%

60%

40%

20%

Study treatment Arm

Single Arm

Trial Design

1Treatment groups

Experimental Treatment

Group I: Pembrolizumab (MK-3475)Experimental Treatment1 Intervention

Pembrolizumab 200 mg will be administered as an approximately 30 minute (-5/+10 mins) IV infusion every 3 weeks. Sites should make every effort to target infusion timing to be as close to 30 minutes as possible. Patients will be followed with DCE perfusion MRI done at baseline and every 9 weeks (+/- 7 days). Patients will be allowed to stay on treatment in spite of increase in tumor size, provided the patient has no, or manageable, new neurologic symptoms, and at the discretion of treating physician. In that situation, tumor resection should be encouraged for the distinction between tumor progression and immunologic reactions. Patients undergoing surgical resection will have tissue collected for collateral studies. All collected tissue will be stored in the Pathology Core Tissue bank at MSK.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 2

~2010

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterOTHER

2,967 Previous Clinical Trials

1,804,775 Total Patients Enrolled

Dana-Farber Cancer InstituteOTHER

1,079 Previous Clinical Trials

340,921 Total Patients Enrolled

Huntsman Cancer Institute/ University of UtahUNKNOWN

Media Library

Pembrolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT02658279 — N/A

Brain Tumor Research Study Groups: Pembrolizumab (MK-3475)

Brain Tumor Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT02658279 — N/A

Pembrolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02658279 — N/A

Frequently Asked Questions

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

What conditions does Pembrolizumab commonly address?

"Pembrolizumab is frequently used to treat malignant tumors, but it can also be utilized for other ailments such as microsatellite instability high, unresectable melanoma, and disease progression after chemotherapy."

Answered by AI

In which geographic regions is this research taking place?

"Various medical centres are recruiting patients for this clinical trial, including the University of Miami in Florida and Md Anderson Cancer Center in Texas. Moreover, there are 11 other locations where participants can be recruited from."

Answered by AI

Could you enumerate any other experiments utilizing Pembrolizumab?

"Currently, the total number of active trials researching Pembrolizumab is 962 with 122 being in Phase 3. Houston, Texas serves as the primary site for these clinical studies; however, a grand total of 35769 locations are running experiments involving this medication."

Answered by AI

What is the participant cap for this clinical trial?

"At this time, applicants are not being accepted for the specified clinical trial. It was first released on January 22nd 2016 and last modified on March 4th 2022. Luckily, there are 1316 trials seeking individuals with glioma and 962 studies searching for Pembrolizumab participants at present."

Answered by AI

Are recruitment opportunities still available for participants in this trial?

"Data from clinicaltrials.gov confirms that enrollment for this trial has been completed, as the study was first published on January 22nd 2016 and last updated on March 4th 2022. Nonetheless, there are 2278 other medical studies actively seeking participants at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pembrolizumab (MK-3475) in Patients With Recurrent Malignant Glioma With a Hypermutator Phenotype

2016. "Pembrolizumab (MK-3475) in Patients With Recurrent Malignant Glioma With a Hypermutator Phenotype". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02658279.

All > Glioma > Utah