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Efineptakin Alfa and Pembrolizumab for the Treatment of Recurrent Glioblastoma

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment closed, study ongoing Primary completion date changed from estimate of Oct 15, 2027 to Sep 2, 2026 · Completion pushed from Oct 15, 2028 to Sep 2, 2031 · Enrollment target: estimated 54 to confirmed 53 · 4 more Show 7 more changesShow less
    • Primary completion date changed from estimate of Oct 15, 2027 to Sep 2, 2026
    • Completion pushed from Oct 15, 2028 to Sep 2, 2031
    • Enrollment target: estimated 54 to confirmed 53
    • Eligibility criteria shortened, about 75 words
    • Secondary endpoints: details revised at 4 of 4 entries
    • Site details revised
    • Collaborators: details revised at 1 of 3 entries
  2. Re-verified, no change to tracked fieldsv18
  3. Enrollment target: 44 to 54v17
  4. Re-verified, no change to tracked fieldsv16
  5. Site contact updated Collaborators: 2 to 3v15 Show 1 more changeShow less
    • Collaborators: 2 to 3

    See this version in full on ClinicalTrials.gov ↗

Show 13 earlier versionsHide 13 earlier versions
  1. Primary completion date: Oct 15, 2024 to Oct 15, 2027 Completion date: Oct 15, 2025 to Oct 15, 2028 · Start date: Jan 20, 2023 to Jan 24, 2023 · Site contact updatedv14 Show 3 more changesShow less
    • Completion date: Oct 15, 2025 to Oct 15, 2028
    • Start date: Jan 20, 2023 to Jan 24, 2023
    • Site contact updated
  2. Enrollment target: 34 to 44 Interventions: Biospecimen Collection (Procedure), Efineptakin alfa (Biological), Pembrolizumab (Biological) to Biopsy (Procedure), Biospecimen Collection (Procedure), Efineptakin alfa (Biological), Pembrolizumab (Biological) · Eligibility criteria expanded, about 23 words · Study description expanded, about 28 wordsv13 Show 3 more changesShow less
    • Interventions: Biospecimen Collection (Procedure), Efineptakin alfa (Biological), Pembrolizumab (Biological) to Biopsy (Procedure), Biospecimen Collection (Procedure), Efineptakin alfa (Biological), Pembrolizumab (Biological)
    • Eligibility criteria expanded, about 23 words
    • Study description expanded, about 28 words

    See this version in full on ClinicalTrials.gov ↗

  3. Collaborators expanded, about 6 wordsv12 See this version in full on ClinicalTrials.gov ↗
  4. Trial status: Suspended to Recruiting Eligibility criteria revised · Site details revisedv11 Show 2 more changesShow less
    • Eligibility criteria revised
    • Site details revised

    See this version in full on ClinicalTrials.gov ↗

  5. Eligibility criteria shortened, about 4 wordsv10 See this version in full on ClinicalTrials.gov ↗
  6. Trial status: Active, Not Recruiting to Suspended Sponsor's reason: Per protocol designv9
  7. Trial status: Recruiting to Active, Not Recruiting Site details revisedv8 Show 1 more changeShow less
    • Site details revised
  8. Trial status: Suspended to Recruiting Site details revisedv7 Show 1 more changeShow less
    • Site details revised
  9. Trial status: Recruiting to Suspended Sponsor's reason: Per protocol design Site details revisedv6 Show 1 more changeShow less
    • Site details revised
  10. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jan 15, 2023 to Jan 20, 2023 · Site details revisedv5 Show 2 more changesShow less
    • Start date changed from estimate of Jan 15, 2023 to Jan 20, 2023
    • Site details revised
  11. Collaborators shortened, about 4 wordsv4 See this version in full on ClinicalTrials.gov ↗
  12. Start date: Nov 15, 2022 to Jan 15, 2023v3
  13. Start date: Aug 15, 2022 to Nov 15, 2022v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Mayo Clinic
1,019 trials monitored
See 121 trials at risk
Glioblastoma
670 trials monitored
See 44 trials at risk
Glioma
668 trials monitored
See 40 trials at risk
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.
Trial Details
NCT Number NCT05465954
Lead Sponsor Mayo Clinic
Collaborators: NeoImmuneTech, Merck Sharp & Dohme LLC, National Cancer Institute (NCI)
Conditions High Grade Astrocytic Tumor, Recurrent Glioblastoma, IDH-Wildtype, Recurrent Gliosarcoma
Enrollment 53 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov