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Pembrolizumab + Vaccine for Glioblastoma
Study Summary
This trial is testing a combination of pembrolizumab and a vaccine therapy (ATL-DC vaccine) to see if it is more effective than the vaccine therapy alone in treating patients with recurrent glioblastoma.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT03004183Trial Design
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- My liver function tests are within the required range.I have recovered from any major surgery before starting the study treatment.My cancer has returned once or twice after treatment.I am eligible for a surgery to remove at least 2 grams of my tumor safely.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.My tumor is mainly in my brainstem or spinal cord.I have an active tuberculosis infection.It's been over 12 weeks since my last radiotherapy, or I have confirmed tumor growth since then.I have not received a live vaccine in the last 30 days.I had radiotherapy over 2 weeks ago, with no ongoing side effects and didn't need steroids.My cancer has returned once or twice after treatment.I agree to use contraception and not donate sperm for 120 days after my last treatment dose.My kidney function, measured by creatinine or GFR, is within the required range.My blood clotting time is normal or managed if I'm on blood thinners.My blood clotting time is normal or near normal, even if I'm on blood thinners.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.I am not pregnant, can test for it, and will use birth control during and after the study.I have another cancer that is getting worse or was treated in the last 3 years.I haven't had a blood transfusion or taken erythropoietin in the last 2 weeks.It has been at least 28 days since my last surgery.I have a history of hepatitis B or active hepatitis C.It has been over a week since my last stereotactic biopsy.I can provide a tissue sample from my brain tumor for testing.I have had or currently have lung inflammation treated with steroids.I am able to care for myself but may not be able to do active work.My glioblastoma has returned or worsened and can be operated on.I have been treated with specific immune therapy targeting cancer.It has been over 23 days since my last chemotherapy session.My recent MRI shows my tumor is growing.I have had cancer treatment, including trial drugs, within the last 4 weeks.I am currently being treated for an infection.My tumor is at least 2cm by 2cm in size, confirmed by MRI.I have recovered from side effects of previous treatments, except for mild neuropathy.I had skin cancer or early-stage breast or cervical cancer but was treated for a cure.It has been over 42 days since my last nitrosureas treatment.
- Group 1: Group A (pembrolizumab, ATL-DC, poly ICLC)
- Group 2: Group B (placebo, ATL-DC, poly ICLC)
- 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
What medical conditions is Pembrolizumab typically employed to treat?
"Pembrolizumab is routinely prescribed to treat unresectable melanoma, but its also proven effective in managing microsatellite instability high, dry eyes, and a heightened risk of recurrence."
How many individuals are actively participating in this research?
"Affirmative. Per the clinicaltrials.gov records, this medical investigation is in need of volunteers and was first uploaded on August 1st 2020. The most recent update to the trial's description occurred on March 29th 2022, and 40 individuals are required for participation at a single site."
Could you please elucidate on prior research involving Pembrolizumab?
"As of now, there are 973 active studies assessing the efficacy of Pembrolizumab; 123 of which have advanced to Phase 3 trials. These scientific investigations span 35785 centres around the globe with a notable concentration in Houston, Texas."
Has Pembrolizumab been officially sanctioned by the FDA?
"The safety rating of Pembrolizumab is 1, as this medical trial is only in the first phase and thus has limited data supporting both efficacy and security."
Is this the inaugural attempt at conducting a trial of this type?
"Currently, there are 973 active trials of Pembrolizumab running in over 2988 cities and 63 countries. The initial clinical study for this drug was sponsored by Baxter Healthcare Corporation and began in 2007 with 4640 participants. Over the last 13 years, 325 studies have been completed satisfactorily reaching Phase 4 approval stages."
Does this experiment have any available openings for participants?
"Affirmative. As per the information published on clinicaltrials.gov, this medical trial is actively accepting patients; it was first posted on August 1st 2020 and its details were last refreshed on March 29th 2022. This research requires 40 volunteers to be enrolled from a single location."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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