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NCT04977375 · ClinicalTrials.gov registry record · Phase 1
Trial of Anti-PD-1 Immunotherapy and Stereotactic Radiation in Patients With Recurrent Glioblastoma
A Phase 1 study of Glioblastoma Multiforme, sponsored by Chirag G. Patil.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT04977375: Recruiting Phase 1 study of Glioblastoma Multiforme, sponsored by Chirag G. Patil.
NCT04977375 is a Phase 1 study of Glioblastoma Multiforme that is actively recruiting participants, run by Chirag G. Patil. The registered enrollment target is 10 participants, below the 97-participant average among 88 other Glioblastoma Multiforme trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04977375, a Phase 1 study of Glioblastoma Multiforme, is actively recruiting participants, sponsored by Chirag G. Patil.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to assess the safety/tolerability/feasibility of pembrolizumab and radiation therapy before surgical resection in patients with recurrent glioblastoma as defined by treatment-related AEs and the number of patients who do not necessitate a delay in surgical resection, and to assess overall survival. The secondary objectives are to assess progression free survival, and to assess the T cell clonality, CD8 T cell activation and Tumor Infiltrating Lymphocyte (TIL) score after treatment
Primary Outcome
Safety and tolerability measured by the incidence of adverse events, serious adverse events and grade 3 or above treatment related adverse events as assessed per CTCAE, Version 5.0.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- RADIATION Stereotactic Radiation Therapy
- PROCEDURE Surgical Resection
Study Locations (1)
California
- Cedars-Sinai Medical Center - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2021-12-09 |
| Est. Completion | 2026-12 |
| Phase | Phase 1 |
What NCT04977375 shows while recruiting
NCT04977375 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 97-participant average among 88 other Glioblastoma Multiforme trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Glioblastoma Multiforme appearing as the primary indexed condition, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT04977375 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04977375 about?
NCT04977375 is a clinical study titled "Trial of Anti-PD-1 Immunotherapy and Stereotactic Radiation in Patients With Recurrent Glioblastoma". The purpose of this study is to assess the safety/tolerability/feasibility of pembrolizumab and radiation therapy before surgical resection in patients with recurrent glioblastoma as defined by treatment-related AEs and the number of patients who do not necessitate a delay in surgical resection, and...
What is the current status of trial NCT04977375?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2021-12-09. Estimated completion is 2026-12.
What conditions does trial NCT04977375 study?
This clinical trial studies the following conditions: Glioblastoma Multiforme.
What interventions are being tested in trial NCT04977375?
The interventions under investigation include: Pembrolizumab (DRUG), Stereotactic Radiation Therapy (RADIATION), Surgical Resection (PROCEDURE).
Who is sponsoring clinical trial NCT04977375?
This trial is sponsored by Chirag G. Patil, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04977375 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT04977375's enrollment target sits among peer trials
10 82nd of 88 higher than 4 of 88 other Glioblastoma Multiforme trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glioblastoma Multiforme 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.
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