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Cancer Vaccine
Pembrolizumab + Vaccine for Glioblastoma
Phase 1
Recruiting
Led By Timothy F Cloughesy
Research Sponsored by Jonsson Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Creatinine =< 1.5 x upper limit of normal (ULN) OR measured or calculated creatinine clearance >= 30 mL/min for participant with creatinine levels > 1.5 x institutional ULN (collected within 14 days prior to the start of study treatment) (glomerular filtration rate [GFR] can also be used in place of creatinine or creatinine clearance [CrCl])
Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 years
Awards & highlights
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.
Who is the study for?
This trial is for adults with recurrent glioblastoma that can be surgically removed. They must have a tumor of a certain size, not be on immunosuppressive therapy, and agree to use contraception. Excluded are pregnant or breastfeeding women, those with recent other cancer treatments or live vaccines, severe allergies to pembrolizumab, active infections like HIV or hepatitis B/C, and autoimmune diseases treated within the last 2 years.Check my eligibility
What is being tested?
The trial tests how well pembrolizumab (an antibody) works alongside an ATL-DC vaccine in treating recurrent glioblastoma compared to the vaccine alone. The study aims to see if this combination helps the immune system better attack cancer cells and prevent their growth.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site from the vaccine and typical immune-related adverse effects from pembrolizumab such as fatigue, skin issues, inflammation of organs like lungs or intestines (pneumonitis/colitis), hormonal imbalances due to thyroid gland problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function, measured by creatinine or GFR, is within the required range.
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I haven't had a blood transfusion or taken erythropoietin in the last 2 weeks.
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It has been at least 28 days since my last surgery.
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I can provide a tissue sample from my brain tumor for testing.
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I am able to care for myself but may not be able to do active work.
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My glioblastoma has returned or worsened and can be operated on.
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My tumor is at least 2cm by 2cm in size, confirmed by MRI.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cell cycle-related signature
Expansion of T cell receptor (TCR) clones
Incidence of adverse events (AEs)
Secondary outcome measures
6 month progression-free survival (PFS6)
Overall survival (OS)
Other outcome measures
Biomarker analysis
T cell subset and activation markers within peripheral blood measured by flow cytometry
TIL (tumor infiltrating lymphocyte) density and TCR (T cell receptor) Clonality in the tumor quantitatively measured by next generation TCR sequencing
+4 moreSide 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%
Pneumothorax
5%
Malnutrition, Hypercalcemia and Weakness
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
Active Control
Group I: Group A (pembrolizumab, ATL-DC, poly ICLC)Experimental Treatment3 Interventions
Beginning 14 days prior to scheduled surgery, patients receive pembrolizumab IV over 30 minutes. After surgery, patients receive pembrolizumab IV over 30 minutes on day 1. Cycle repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive ATL-DC ID with poly ICLC IM every 2 weeks for up to 3 doses in the absence of disease progression or unacceptable toxicity.
Group II: Group B (placebo, ATL-DC, poly ICLC)Active Control3 Interventions
Beginning 14 days prior to scheduled surgery, patients receive placebo IV. After surgery, patients receive placebo IV on day 1. Cycle repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive ATL-DC ID with poly ICLC IM every 2 weeks for up to 3 doses in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Poly ICLC
2014
Completed Phase 2
~270
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCIndustry Sponsor
3,899 Previous Clinical Trials
5,062,822 Total Patients Enrolled
30 Trials studying Glioblastoma
3,011 Patients Enrolled for Glioblastoma
Phase One FoundationOTHER
3 Previous Clinical Trials
143 Total Patients Enrolled
1 Trials studying Glioblastoma
19 Patients Enrolled for Glioblastoma
National Cancer Institute (NCI)NIH
13,704 Previous Clinical Trials
40,931,438 Total Patients Enrolled
324 Trials studying Glioblastoma
23,132 Patients Enrolled for Glioblastoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My liver function tests are within the required range.I have recovered from any major surgery before starting the study 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.
Research Study Groups:
This trial has the following groups:- Group 1: Group A (pembrolizumab, ATL-DC, poly ICLC)
- Group 2: Group B (placebo, ATL-DC, poly ICLC)
Awards:
This trial has 0 awards, including: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.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
Who else is applying?
What state do they live in?
California
What site did they apply to?
UCLA / Jonsson Comprehensive Cancer Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
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