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NCT02829931

Hypofractionated Stereotactic Irradiation With Nivolumab, Ipilimumab and Bevacizumab in Patients With Recurrent High Grade Gliomas

Completed Phase 1 Last updated 19 January 2023
What this trial tests

Phase 1 trial testing Hypofractionated Stereotactic Irradiation in Malignant Glioma in 33 participants. Completed in 22 November 2022.

Timeline
22 August 2016
Primary endpoint
11 August 2021
22 November 2022

Quick facts

Lead sponsorH. Lee Moffitt Cancer Center and Research Institute
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment33
Start date22 August 2016
Primary completion11 August 2021
Estimated completion22 November 2022
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Who can join

18 and older, any sex, with Malignant Glioma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The main purpose of this study is to evaluate the safety, and tolerability of nivolumab, ipilimumab, and bevacizumab given in combination with hypofractionated stereotactic re-irradiation of recurrent high grade gliomas.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Recurrent glioma clinical trial, CheckMate-143: the game is not over yet.
    Filley AC, Henriquez M, Dey M. · · 2017 · cited 284× · PMID 29207684 · DOI 10.18632/oncotarget.21586
  2. Current State of Immunotherapy for Treatment of Glioblastoma.
    McGranahan T, Therkelsen KE, Ahmad S, Nagpal S. · · 2019 · cited 209× · PMID 30790064 · DOI 10.1007/s11864-019-0619-4
  3. PD-L1/PD-1 Axis in Glioblastoma Multiforme.
    Litak J, Mazurek M, Grochowski C, Kamieniak P, et al · · 2019 · cited 152× · PMID 31661771 · DOI 10.3390/ijms20215347
  4. Advances in Glioblastoma Therapy: An Update on Current Approaches.
    Angom RS, Nakka NMR, Bhattacharya S. · · 2023 · cited 140× · PMID 38002496 · DOI 10.3390/brainsci13111536
  5. Immune Checkpoint Inhibitors in Human Glioma Microenvironment.
    Ghouzlani A, Kandoussi S, Tall M, Reddy KP, et al · · 2021 · cited 119× · PMID 34305910 · DOI 10.3389/fimmu.2021.679425
  6. PD-1 Inhibitors: Do they have a Future in the Treatment of Glioblastoma?
    Khasraw M, Reardon DA, Weller M, Sampson JH. · · 2020 · cited 110× · PMID 32527943 · DOI 10.1158/1078-0432.ccr-20-1135
  7. Hypofractionated stereotactic re-irradiation with pembrolizumab and bevacizumab in patients with recurrent high-grade gliomas: results from a phase I study.
    Sahebjam S, Forsyth PA, Tran ND, Arrington JA, et al · · 2021 · cited 91× · PMID 33173935 · DOI 10.1093/neuonc/noaa260
  8. Immunotherapy in Glioblastoma: Current Shortcomings and Future Perspectives.
    Weenink B, French PJ, Sillevis Smitt PAE, Debets R, et al · · 2020 · cited 71× · PMID 32235752 · DOI 10.3390/cancers12030751

Verify or expand the search:

Other recruiting trials for Malignant Glioma

Currently open trials in the same condition.

Other H. Lee Moffitt Cancer Center and Research Institute trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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