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Cancer Vaccine
Personalized Cancer Vaccine + RT + Pembrolizumab for Glioblastoma
Phase 1
Recruiting
Led By David A. Reardon, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Karnofsky performance status ≥ 70
Pathologically confirmed WHO grade IV glioblastoma or variants (gliosarcoma, glioblastoma with oligodendroglial features, giant cell glioblastoma) with adequate tumor material for genomic sequencing. Participants will be eligible if the original diagnosis was a lower grade glioma and a subsequent histologic diagnosis of glioblastoma or its variants was made, and patient received no prior therapy other than surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is studying a new type of vaccine as a possible treatment for patients with glioblastoma. It is evaluating the safety of the vaccine and finding the right dose to use.
Who is the study for?
Adults with newly diagnosed glioblastoma who can undergo specific imaging tests, are not pregnant or breastfeeding, and agree to use contraception. They should have a certain performance status indicating they can carry out daily activities and must not be on corticosteroids. Prior cancer treatments other than surgery for glioblastoma are disqualifying.Check my eligibility
What is being tested?
The trial is testing a new vaccine made from the patient's tumor characteristics combined with radiation therapy and Pembrolizumab (an immunotherapy drug). It aims to see if this personalized vaccine can safely stimulate the immune system to fight brain cancer cells.See study design
What are the potential side effects?
Potential side effects include allergic reactions related to vaccines, issues from live vaccines taken recently, autoimmune disease flare-ups, infections requiring treatment, heart problems, planned major surgeries interfering with treatment, or adverse events from previous therapies.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am able to care for myself but may not be able to do active work.
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I have a specific type of brain tumor (glioblastoma) and haven't received treatment other than surgery.
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My post-surgery scan shows remaining tumor is less than 1 cm big.
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My blood, kidney, and liver functions are within normal ranges.
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My tumor is located above the cerebellum, as confirmed by scans before surgery.
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My diagnosis is astrocytoma with features of glioblastoma.
Select...
My cancer's MGMT status was tested and is known.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cohort 1: Number of participants who are clinically able to initiate post-RT vaccine therapy within 12 weeks or less from date of surgery
Cohort 1: Number of participants with at least 10 actionable peptides as a measure of study feasibility
Cohorts 1, 1a, 1b, & 1c: Number of participants with Adverse Events as a measure of safety and tolerability
+1 moreSecondary outcome measures
All Cohorts: Number of participants who achieve IFN-γ T-cell response at week 16 via ELISPOT assessments
Cohort 1d: Number of participants who are alive without progression at 11 months after surgery resection
Cohorts 1, 1a, 1b, & 1c: Number of participants who are alive without progression at eight months after surgery resection
Trial Design
5Treatment groups
Experimental Treatment
Group I: Coh 1d: Std RT+TMZ Followed by 6 Cyc TMZ + NeoVax + PembroExperimental Treatment4 Interventions
• RT: Standard RT (60Gy) + concurrent daily temozolomide (TMZ) over 6 weeks. Concurrent TMZ @ 75 mg/m2/day for 6 weeks.
Followed by:
6 cycles of Adjuvant temozolomide (TMZ): Starts 4-6 weeks after completion of RT. TMZ (150-200 mg/m2/day) on days 1-5 of each 28-day cycle for 6 cycles.
Pembrolizumab: Starts 1-4 weeks after completion of NeoVax priming, and continues every 3 weeks for up to 2 years
NeoVax: Starts in the Adjuvant setting - as soon as available after RT - and is administered on days 1, 4, 8, 15, 22 [priming doses], 78 and 134 [booster doses] o NeoVax Day 1 does not have to coincide with Pembrolizumab dosing
Group II: Coh 1c: Std RT (+ 1 dose Pembro) Followed by NeoVax & PemboExperimental Treatment3 Interventions
RT: Standard RT (60Gy) over 6 weeks
Pembrolizumab: Single dose of pembrolizumab administered within 2 weeks of start of RT; re-starts 1-4 weeks after completion of NeoVax priming, and continues every 3 weeks for up to 2 years.
NeoVax: Starts in the Adjuvant setting - as soon as available after RT - and is administered on days 1, 4, 8, 15, 22 [priming doses], 78 and 134 [booster doses] o NeoVax Day 1 does not have to coincide with Pembrolizumab dosing
Group III: Coh 1b: Std RT Followed by NeoVax + PembrolizumabExperimental Treatment3 Interventions
RT: Standard RT (60Gy) over 6 weeks
Pembrolizumab: Starts 1-4 weeks after completion of NeoVax priming, and continues every 3 weeks for up to 2 years
NeoVax: Starts in the Adjuvant setting - as soon as available after RT - and is administered on days 1, 4, 8, 15, 22 [priming doses], 78 and 134 [booster doses] o NeoVax Day 1 does not have to coincide with Pembrolizumab dosing
Group IV: Coh 1a: Pembrolizumab w Std RT Followed by NeoVax + PembroExperimental Treatment3 Interventions
RT: Standard RT (60Gy) over 6 weeks
Pembrolizumab: Starts within 2 weeks of start of RT, and continues every 3 weeks for up to 2 years
NeoVax: Starts in the Adjuvant setting - as soon as available after RT - and is administered on days 1, 4, 8, 15, 22 [priming doses], 78 and 134 [booster doses] o NeoVax Day 1 does not have to coincide with Pembrolizumab dosing
Group V: Coh 1 (Original Cohort): Standard RT Followed by NeoVaxExperimental Treatment2 Interventions
After the screening procedures confirm participant eligible to participate in the research study (must be registered to within 6 weeks of resection):
~ 6 weeks of standard radiation therapy (RT) followed by an RT-recovery period.
During that time, participant NeoAntigen Vaccine-Preparation is created (process takes ~ 12 weeks)
After participant recovers from RT and vaccine is created, participant will re-screen to confirm participant is eligible to receive study vaccinations. Once registered, participant will proceed to receive study vaccinations:
- NeoAntigen Vaccine: NeoVax will be administered on an individual basis using a dosing schedule that incorporates both priming and boost phases (~ 7 months total: 5 priming followed by 2 boost vaccine administrations)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Temozolomide
2010
Completed Phase 3
~1930
Radiation Therapy
2017
Completed Phase 3
~7250
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
The Ben & Catherine Ivy FoundationOTHER
2 Previous Clinical Trials
40 Total Patients Enrolled
2 Trials studying Glioblastoma
40 Patients Enrolled for Glioblastoma
Accelerate Brain Cancer CureOTHER
3 Previous Clinical Trials
295 Total Patients Enrolled
1 Trials studying Glioblastoma
250 Patients Enrolled for Glioblastoma
Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,924 Total Patients Enrolled
23 Trials studying Glioblastoma
970 Patients Enrolled for Glioblastoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had cancer before but have been cancer-free for 3 years or only had certain types of skin or localized cancers.I am a woman who can have children and have a negative pregnancy test.I am able to care for myself but may not be able to do active work.My tumor is mainly in the lower part of my brain or spinal cord.My cancer has spread to the lining of my brain and spinal cord.I have glioblastoma and my treatment has been limited to surgery, radiotherapy, and specific medications.I have a specific type of brain tumor (glioblastoma) and haven't received treatment other than surgery.My post-surgery scan shows remaining tumor is less than 1 cm big.It has been over 3 weeks since my last surgery or 1 week since my biopsy before starting the study treatment.I agree to use birth control from the start of radiation therapy until 120 days after my last treatment.I had a precise biopsy without further surgery.I haven't needed systemic treatment for an autoimmune disease in the last 2 years, except for allowed conditions.I haven't had cancer treatment in the last 2 weeks or I've recovered from side effects.My blood, kidney, and liver functions are within normal ranges.I have stable brain metastases and haven't used steroids in the last 7 days.My tumor is located above the cerebellum, as confirmed by scans before surgery.I've had radiation and temozolomide for my condition without disease progression and completed a required blood draw.I have or had lung inflammation that needed steroids.I have not received a live vaccine in the last 30 days.My tumor has enough material for genetic testing.I haven't taken any cancer drugs or immunosuppressants in the last 6 months.I have an active tuberculosis infection.I do not have any uncontrolled illnesses like severe infections or heart problems.If you can't undergo an MRI due to medical devices in your body, you can still participate if you have a CT scan that meets quality standards. If you don't have medical devices, you don't need a CT scan for this requirement.You have had a severe allergic reaction to any vaccine for infectious diseases in the past.I have only received the flu shot, not the nasal spray vaccine.You had a CT scan or MRI within the past 2 weeks before starting the study treatment. (Exception: This does not apply to some participants in Cohort 1d who have already started standard care treatment.)I have mild to moderate nerve damage.I have HIV or hepatitis but my viral load is undetectable.I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.You must have undergone certain medical tests within the past two weeks before enrolling in the study.I have fully recovered from any major surgery before starting treatment.I agree to use birth control or abstain from sex during and up to 120 days after the study.My tumor has an IDH mutation.You must use birth control methods that have been approved by the study, such as an intrauterine device, diaphragm with spermicide, cervical cap with spermicide, male or female condoms with spermicide. Using spermicide alone is not enough.I haven't taken corticosteroids 5 days before starting radiation therapy.I agree to undergo or am currently undergoing external beam radiotherapy.My diagnosis is astrocytoma with features of glioblastoma.I am scheduled for a major surgery soon.I am not pregnant or breastfeeding.You understand the study and are willing to sign a document saying you agree to participate.My diagnosis is astrocytoma with glioblastoma features or I have an IDH-mutated tumor.My cancer's MGMT status was tested and is known.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Coh 1 (Original Cohort): Standard RT Followed by NeoVax
- Group 2: Coh 1a: Pembrolizumab w Std RT Followed by NeoVax + Pembro
- Group 3: Coh 1c: Std RT (+ 1 dose Pembro) Followed by NeoVax & Pembo
- Group 4: Coh 1d: Std RT+TMZ Followed by 6 Cyc TMZ + NeoVax + Pembro
- Group 5: Coh 1b: Std RT Followed by NeoVax + Pembrolizumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
How many individuals have registered for the trial thus far?
"Indeed, clinicaltrials.gov reveals that this medical investigation is still actively looking for volunteers. It was first posted on November 1st 2014 and last updated on May 31st 2022. The study requires 56 patients from two different sites to complete the trial process."
Answered by AI
What medical conditions has Temozolomide been proven to alleviate?
"Temozolomide is regularly used to treat cancerous tumours, but it can also be utilized for unresectable melanomas, microsatellite instability high cases and those with a greater risk of recurrence."
Answered by AI
Is this experiment actively seeking participants?
"This study is actively recruiting, as corroborated by clinicaltrials.gov; the trial was initially posted on November 1st 2014 and its information has been updated most recently on May 31st 2022."
Answered by AI
What risks are associated with Temozolomide treatment?
"Taking into account the limited data present on temozolomide, we have assigned a score of 1 to its safety level. This is due to it being at the earliest phases of clinical trials and lacking sufficient evidence for either efficacy or security."
Answered by AI
Could you elaborate on other scientific research conducted with Temozolomide?
"Currently, 1161 Temozolomide trials are in progress with 145 of them at the Phase 3 level. A bulk of these studies is located around Houston, Texas; still, 40446 medical sites offer clinical investigations related to this drug."
Answered by AI
Is this clinical trial the inaugural of its kind?
"Since its initial clinical trial in 2002, sponsored by Schering-Plough and involving 60 participants, Temozolomide has been tested across 64 different countries. 1161 trials are currently live and 642 have been completed since the drug's inception."
Answered by AI
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