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Monoclonal Antibodies
Pembrolizumab + SurVaxM for Recurrent Glioblastoma
Phase 2
Waitlist Available
Research Sponsored by David Peereboom, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
If first recurrence of GBM is documented by MRI, an interval of at least 12 weeks after the end of prior radiation therapy is required unless there is either:
Histologically confirmed diagnosis of World Health Organization Grade IV glioma (glioblastoma or gliosarcoma)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year from enrollment
Awards & highlights
Study Summary
This trial is testing a new cancer treatment combination to see if it is effective in treating brain cancer.
Who is the study for?
This trial is for adults with a confirmed first recurrence of glioblastoma, who have adequate organ function and performance status. They must not be pregnant or breastfeeding and agree to use contraception. Prior anti-PD1 therapy is allowed only in the exploratory arm. Excluded are those with severe hypersensitivity to pembrolizumab, active infections, certain autoimmune diseases, other cancers within 3 years (except some skin cancers), or conditions that might interfere with the study.Check my eligibility
What is being tested?
The study tests Pembrolizumab combined with SurVaxM vaccine against recurrent glioblastoma. It aims to assess their clinical activity together. Participants will also receive Montanide ISA 51 and Sargramostim as part of the treatment regimen.See study design
What are the potential side effects?
Potential side effects include immune-related reactions such as inflammation in various organs, infusion reactions similar to allergic responses, fatigue, blood disorders like anemia or clotting problems, increased risk of infection due to immune system suppression.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My first GBM recurrence was confirmed by MRI, 12 weeks after my last radiation therapy.
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I have been diagnosed with a Grade IV brain tumor (glioblastoma or gliosarcoma).
Select...
I have had radiotherapy, with or without temozolomide, as my first treatment.
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I have provided a recent or past biopsy of my tumor that was not treated with radiation.
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My kidney function, measured by creatinine or GFR, is within the required range.
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I am mostly able to care for myself and carry out daily activities.
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I am a male.
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I am not able to become pregnant.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year from enrollment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year from enrollment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression free survival (PFS)
Secondary outcome measures
Safety and tolerability of Pembrolizumab and SurVaxM as measure by CTCAE v 5 grading as per NCI
Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm B - Have failed prior anti-PD1 therapyExperimental Treatment4 Interventions
Arm B is an exploratory arm of 10 patients who have failed prior anti-PD1 therapy.
Group II: Arm A - Have not received immunotherapyExperimental Treatment4 Interventions
Arm A is patients with first recurrence of glioblastoma who have failed prior chemotherapy and radiation but have not received any immunotherapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Montanide ISA 51
2003
Completed Phase 2
~140
Sargramostim
FDA approved
Find a Location
Who is running the clinical trial?
David Peereboom, MDLead Sponsor
1 Previous Clinical Trials
55 Total Patients Enrolled
David PeereboomLead Sponsor
1 Previous Clinical Trials
27 Total Patients Enrolled
1 Trials studying Glioblastoma
27 Patients Enrolled for Glioblastoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.You have a severe allergic reaction (Grade 3 or higher) to pembrolizumab or any of its ingredients.I have another cancer besides skin or in situ cancers that needed treatment in the last 3 years.My first GBM recurrence was confirmed by MRI, 12 weeks after my last radiation therapy.I have been treated with anti-PD1, but only for exploratory purposes.My hemoglobin level is above 9.0 g/dL without recent blood transfusions.I haven't had cancer treatment or experimental drugs in the last 4 weeks.I don't have severe brain swelling or need high doses of steroids.I have an active infection needing treatment or I am known to have HIV.I have not needed strong medication for an autoimmune disease in the last 2 years.My liver is functioning properly.My brain cancer has come back more than once.I have been diagnosed with a Grade IV brain tumor (glioblastoma or gliosarcoma).I have had radiotherapy, with or without temozolomide, as my first treatment.My liver enzymes are within the required range.I have provided a recent or past biopsy of my tumor that was not treated with radiation.My blood clotting tests are within normal limits, or if I'm on blood thinners, they're in the therapeutic range.I am a female.My kidney function, measured by creatinine or GFR, is within the required range.I agree to follow the study's rules for using contraception and not donate sperm for 180 days after my last treatment.My kidneys are functioning properly.I have an active tuberculosis infection.I am mostly able to care for myself and carry out daily activities.My cancer has spread outside of my brain.I have been treated with specific immune therapy drugs before.I am a male.I have not received a live vaccine in the last 30 days.My blood clotting function is normal.I have recovered from side effects of past treatments, except for mild neuropathy.My brain tumor has returned, confirmed by a recent biopsy or MRI.I have fully recovered from any major surgery before starting the study treatment.I have a history of Hepatitis B or active Hepatitis C.I am not pregnant, not breastfeeding, and meet the study's specific conditions.My blood counts are within normal ranges.I am not able to become pregnant.I have had or currently have lung inflammation treated with steroids.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B - Have failed prior anti-PD1 therapy
- Group 2: Arm A - Have not received immunotherapy
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you list other studies in which Pembrolizumab was used?
"Currently, there are 1037 Pembrolizumab clinical trials underway. 127 of those are Phase 3 studies. Chapel Hill in North carolina is home to many of these trials; however, this treatment is being studied at 37892 different locations worldwide."
Answered by AI
Could you please detail the risks associated with Pembrolizumab?
"Pembrolizumab has received a score of 2. This is due to the fact that, while there are Phase 2 trial data suggesting it is safe, there are no such trials indicating efficacy."
Answered by AI
How many individuals are being enrolled in this research project?
"This clinical trial is no longer recruiting participants. The study was posted on March 19, 2020 and last updated on August 24, 2022. There are currently 1444 other trials for relapse and 1037 trials for Pembrolizumab that are actively enrolling patients."
Answered by AI
For what purpose do people most often take Pembrolizumab?
"Pembrolizumab is a powerful medication used to treat malignant neoplasms. It can also be used as allogenic bone marrow transplantation therapy, unresectable melanoma treatment, or microsatellite instability high conditions."
Answered by AI
Are new patients being sought for this clinical trial?
"Unfortunately, this particular clinical trial is not presently looking for new participants. The original posting was on March 19th, 2020 and there have been no updates since August 24th, 2022. However, if you are interested in other studies, please note that there are 1,444 active trials for relapse patients and 1,037 pembrolizumab trials currently recruiting."
Answered by AI
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