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NCT02287428 · ClinicalTrials.gov registry record · Phase 1
Personalized NeoAntigen Cancer Vaccine w RT Plus Pembrolizumab for Patients With Newly Diagnosed GBM
A Phase 1 study of Glioblastoma, sponsored by Dana-Farber Cancer Institute.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 56
- Enrollment target
- 2
- Study locations
NCT02287428: Recruiting Phase 1 study of Glioblastoma, sponsored by Dana-Farber Cancer Institute.
NCT02287428 is a Phase 1 study of Glioblastoma that is actively recruiting participants, run by Dana-Farber Cancer Institute. The registered enrollment target is 56 participants, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (49% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02287428, a Phase 1 study of Glioblastoma, is actively recruiting participants, sponsored by Dana-Farber Cancer Institute.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 56 participants
- Enrollment target
- 2
- Study locations
Study Summary
This research study is studying a new type of vaccine as a possible treatment for patients with glioblastoma. This research study is a Phase I clinical trial, which tests the safety of an investigational intervention and also tries to define the appropriate dose of the intervention to use for further studies. "Investigational" means that the intervention is being studied and that research doctors are trying to find more about it. It also means that the FDA (U.S. Food and Drug Administration) has not approved the Personalized NeoAntigen Cancer Vaccine for any use in patients, including people with glioblastoma. The purpose of the initial study cohort (Cohort 1) is to determine if it is possible to make and administer safely a vaccine against glioblastoma by using information gained from specific characteristics of the participants tumor. It is known that glioblastomas have mutations (changes in genetic material) that are specific to an individual patient's tumor. These mutations can cause the tumor cells to produce proteins that appear very different from the body's own cells. It is possible that these proteins used in a vaccine may induce strong immune responses, which may help the body fight any tumor cells that could cause the glioblastoma to come back in the future. Three additional cohorts (1a, 1b, \& 1c) were added to the study following completion of accrual to the original study cohort (cohort 1). Each new cohort receives NeoVax and radiation therapy as administered to cohort 1 and will also receive pembrolizumab: cohort 1a patients will start pembrolizumab w/in 2 weeks after start of RT, and continue every 3 weeks for up to 2 years; cohort 1b patients will start pembrolizumab 2-4 weeks after completion of NeoVax priming, and continue every 3 weeks for up to 2 years; cohort 1c patients will receive a single dose of pembrolizumab administered within 2 weeks after start of RT, re-start 2-4 weeks after completion of NeoVax priming, and continue every 3 weeks f
Primary Outcome
To evaluate the safety and tolerability of administering NeoVax plus pembrolizumab among newly diagnosed glioblastoma patients with MGMT unmethylated tumors
Conditions Studied
Interventions
- DRUG Pembrolizumab
- RADIATION Radiation Therapy
- DRUG Temozolomide
- BIOLOGICAL Personalized NeoAntigen Peptides
Study Locations (2)
Massachusetts
- Massachusetts General Hospital - Boston
- Dana Farber Cancer Institute - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2014-11 |
| Est. Completion | 2028-02 |
| Phase | Phase 1 |
What NCT02287428 shows while recruiting
NCT02287428 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (49% lower).
The record links to 1 condition, with Glioblastoma appearing as the primary indexed condition, and to 4 interventions - of which Pembrolizumab is the first listed.
NCT02287428 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT02287428 about?
NCT02287428 is a clinical study titled "Personalized NeoAntigen Cancer Vaccine w RT Plus Pembrolizumab for Patients With Newly Diagnosed GBM". This research study is studying a new type of vaccine as a possible treatment for patients with glioblastoma. This research study is a Phase I clinical trial, which tests the safety of an investigational intervention and also tries to define the appropriate dose of the intervention to use for furthe...
What is the current status of trial NCT02287428?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 56 participants. The study started on 2014-11. Estimated completion is 2028-02.
What conditions does trial NCT02287428 study?
This clinical trial studies the following conditions: Glioblastoma.
What interventions are being tested in trial NCT02287428?
The interventions under investigation include: Pembrolizumab (DRUG), Radiation Therapy (RADIATION), Temozolomide (DRUG), Personalized NeoAntigen Peptides (BIOLOGICAL).
Who is sponsoring clinical trial NCT02287428?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02287428 being conducted?
This trial has 2 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Glioblastoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02287428's enrollment target sits among peer trials
56 83rd of 199 higher than 116 of 199 other Glioblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glioblastoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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