Monoclonal Antibodies
Pembrolizumab for Brain Tumor
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
Tumor recurrence after previous treatment, which must have included at least radiation therapy and one cytotoxic chemotherapy. There is no limit on number of previous recurrences or lines of treatment.
Be older than 18 years old
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up1 year
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
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.
Eligible Conditions
- Brain Tumor
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
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 2021 Phase 3 trial • 453 Patients • NCT0306677854%
Neutropenia
45%
Anaemia
38%
Nausea
34%
Alopecia
31%
Decreased appetite
29%
Constipation
27%
Fatigue
26%
Thrombocytopenia
22%
Leukopenia
21%
Diarrhoea
20%
Cough
17%
Asthenia
17%
Dyspnoea
16%
Vomiting
14%
Pyrexia
14%
Dizziness
13%
Headache
13%
Arthralgia
13%
Rash
12%
Hypothyroidism
11%
Pruritus
11%
Insomnia
11%
Back pain
10%
Weight decreased
9%
Aspartate aminotransferase increased
9%
Hyponatraemia
8%
Pneumonia
8%
Oedema peripheral
8%
Upper respiratory tract infection
8%
Alanine aminotransferase increased
7%
Abdominal pain
7%
Blood creatinine increased
7%
Hypokalaemia
7%
Febrile neutropenia
6%
Abdominal pain upper
6%
Stomatitis
6%
Dry skin
6%
Erythema
6%
Dysgeusia
5%
Hyperthyroidism
5%
Dyspepsia
5%
Dysphagia
5%
Nasopharyngitis
5%
Blood alkaline phosphatase increased
5%
Musculoskeletal chest pain
5%
Pain in extremity
5%
Musculoskeletal pain
5%
Chest pain
5%
Hypertension
4%
Hypotension
4%
Urinary tract infection
2%
Death
2%
Acute kidney injury
2%
Pneumonitis
2%
Pulmonary embolism
2%
Atrial fibrillation
1%
Clostridium difficile colitis
1%
Neutropenic sepsis
1%
Pleural infection
1%
Sepsis
1%
Infusion related reaction
1%
Diabetes mellitus
1%
Aortic aneurysm
1%
Inappropriate antidiuretic hormone secretion
1%
Pneumothorax
1%
Transient ischaemic attack
1%
Gastritis
1%
Hemiparesis
1%
Superior vena cava syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pembrolizumab+EP
Placebo+EP
Pembrolizumab Second Course
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
FDA approved
Find a site
Who is running the clinical trial?
Dana-Farber Cancer InstituteOTHER
1,049 Previous Clinical Trials
765,054 Total Patients Enrolled
University of California, San FranciscoOTHER
2,414 Previous Clinical Trials
12,301,701 Total Patients Enrolled
University of MiamiOTHER
859 Previous Clinical Trials
384,303 Total Patients Enrolled
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,892 Previous Clinical Trials
587,111 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,794 Previous Clinical Trials
5,001,979 Total Patients Enrolled
Huntsman Cancer Institute/ University of UtahUNKNOWN
University of California, Los AngelesOTHER
1,475 Previous Clinical Trials
10,150,672 Total Patients Enrolled
M.D. Anderson Cancer CenterOTHER
2,887 Previous Clinical Trials
1,783,312 Total Patients Enrolled
Thomas Kaley, MDPrincipal Investigator
Memorial Sloan Kettering Cancer Center8 Previous Clinical Trials
331 Total Patients Enrolled
Media Library
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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
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