Trial of Anti-Tim-3 in Combination With Anti-PD-1 and SRS in Recurrent GBM

StatusCompleted
PhasePhase 1
Started

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Record History

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  1. Trial completed Show 5 more changesShow less
    • Study completion date changed from estimate of Sep 2026 to Jul 30, 2026
    • Eligibility criteria expanded, about 32 words
    • Secondary endpoints: details revised at 2 of 4 entries
    • Study description expanded, about 8 words
    • Site details revised at 1 of 2 sites
  2. Re-verified, no change to tracked fieldsv27
  3. Study completion date: Sep 2025 to Sep 2026v26
  4. 4 versions Re-verified since Nov 14, 2023, no change to tracked fieldsv22-v25
  5. Study completion date: Sep 2024 to Sep 2025v21
Show 19 earlier versionsHide 19 earlier versions
  1. Re-verified, no change to tracked fieldsv20
  2. Primary completion date changed from estimate of Nov 2022 to Nov 16, 2022v19
  3. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 15 to confirmed 16
    • Primary completion date: Sep 2022 to Nov 2022
    • Site details revised at 2 of 2 sites
    v18
  4. 2 versions Re-verified since Apr 1, 2022, no change to tracked fieldsv16-v17
  5. Site details revised at 1 of 2 sitesv15
  6. Primary completion date: Feb 2022 to Sep 2022
    • Study sites: 1 to 2
    • Study completion date: Feb 2024 to Sep 2024
    v14
  7. 2 versions Re-verified since Oct 26, 2020, no change to tracked fieldsv12-v13
  8. Trial status: Active, Not Recruiting to Recruiting
    • Eligibility criteria expanded, about 24 words
    • Site details revised
    v11
  9. 2 versions Re-verified since May 7, 2020, no change to tracked fieldsv9-v10
  10. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v8
  11. Trial status: Not Yet Recruiting to Recruitingv7 Show 4 more changesShow less
    • Primary completion date: Jun 2021 to Feb 2022
    • Study completion date: Jun 2023 to Feb 2024
    • Start date changed from estimate of Feb 2020 to Feb 18, 2020
    • Site details revised
  12. Start date: Jan 2020 to Feb 2020v6
  13. Start date: Nov 2019 to Jan 2020v5
  14. Start date: Aug 2019 to Nov 2019v4
  15. Start date: Jun 2019 to Aug 2019v3
  16. Secondary endpoints: details revised at 1 of 4 entriesv2
  1. Study First Submitted
  • 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.
This phase I trial studies the side effects of stereotactic radiosurgery with MBG453 and spartalizumab in treating patients with recurrent glioblastoma multiforme (GBM). Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor to more precisely target the cancer. Monoclonal antibodies, such as MBG453 and spartalizumab may interfere with the ability of tumor cells to grow and spread. Giving stereotactic radiosurgery together with immunotherapy may be a better treatment for GBM.
Trial Details
NCT Number NCT03961971
Lead Sponsor Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators: Novartis Pharmaceuticals
Conditions
(from sponsor)		 Glioblastoma Multiforme
Related terms Glioblastoma
Enrollment 16 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov