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NCT05465954 · ClinicalTrials.gov registry record · Phase 2
Efineptakin Alfa and Pembrolizumab for the Treatment of Recurrent Glioblastoma
A Phase 2 study of Recurrent Gliosarcoma and Recurrent Glioblastoma, IDH-Wildtype, sponsored by Mayo Clinic.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 54
- Enrollment target
- 1
- Study location
NCT05465954: Recruiting Phase 2 study of Recurrent Gliosarcoma and Recurrent Glioblastoma, IDH-Wildtype, sponsored by Mayo Clinic.
NCT05465954 is a Phase 2 study of Recurrent Gliosarcoma and Recurrent Glioblastoma, IDH-Wildtype that is actively recruiting participants, run by Mayo Clinic. The registered enrollment target is 54 participants, above the 29-participant average among 7 other Recurrent Gliosarcoma trials with a reported enrollment target (86% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05465954, a Phase 2 study of Recurrent Gliosarcoma and Recurrent Glioblastoma, IDH-Wildtype, is actively recruiting participants, sponsored by Mayo Clinic.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 54 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial tests the safety and side effects of efineptakin alfa and pembrolizumab in treating patients with glioblastoma that has come back (recurrent). Efineptakin alfa is an immunotherapy drug that works by helping the immune system fight tumor cells. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving efineptakin alfa and pembrolizumab may kill more tumor cells in patients with recurrent glioblastoma.
Primary Outcome
9-month overall survival rate (OS9) rate is defined as the number of "successes" (patients who are alive at least 9 months after beginning study therapy) divided by the total evaluable patients. All patients who have signed a consent form, are eligible, and have begun treatment in Cycle 1 (first cycle of neo-adjuvant pembrolizumab + efineptakin alfa \[NT-I7\]) will be considered evaluable for the primary endpoint.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- PROCEDURE Biospecimen Collection
- PROCEDURE Biopsy
- BIOLOGICAL Efineptakin alfa
Study Locations (1)
Minnesota
- Mayo Clinic - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2023-01-24 |
| Est. Completion | 2028-10-15 |
| Phase | Phase 2 |
What NCT05465954 shows while recruiting
NCT05465954 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, above the 29-participant average among 7 other Recurrent Gliosarcoma trials with a reported enrollment target (86% higher).
The record links to 3 conditions, with Recurrent Gliosarcoma appearing as the primary indexed condition, and to 4 interventions - of which Pembrolizumab is the first listed.
NCT05465954 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT05465954 about?
NCT05465954 is a clinical study titled "Efineptakin Alfa and Pembrolizumab for the Treatment of Recurrent Glioblastoma". This phase II trial tests the safety and side effects of efineptakin alfa and pembrolizumab in treating patients with glioblastoma that has come back (recurrent). Efineptakin alfa is an immunotherapy drug that works by helping the immune system fight tumor cells. Immunotherapy with monoclonal antibo...
What is the current status of trial NCT05465954?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 54 participants. The study started on 2023-01-24. Estimated completion is 2028-10-15.
What conditions does trial NCT05465954 study?
This clinical trial studies the following conditions: Recurrent Gliosarcoma, Recurrent Glioblastoma, IDH-Wildtype, High Grade Astrocytic Tumor.
What interventions are being tested in trial NCT05465954?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Biospecimen Collection (PROCEDURE), Biopsy (PROCEDURE), Efineptakin alfa (BIOLOGICAL).
Who is sponsoring clinical trial NCT05465954?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05465954 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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