Table 1.
Clinical trials investigating the use of ICIs for treatment of GBM | |||||
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Drug | Target | Name | Year | Clinical Phase | Arms |
PD-1 | Nivolumab | Neoantigen-based personalized Vaccine Combined with Immune Checkpoint Blockade Therapy in Patients with Newly Diagnosed, Unmethylated GBM | Actual Study Start Date: October 31, 2018 Actual Primary Completion Date: May 25, 2020 Estimated Study Completion Date: February 26, 2021 |
I | Arm A: NeoVax + Nivolumab (at progression) Arm B: NeoVax + Nivolumab (at Cycle 2) Arm C: NeoVax + Nivolumab (at Cycle 1) |
GMCI, Nivolumab, and Radiation Therapy in Treating Patients with Newly Diagnosed High-grade Gliomas | Actual Study Start Date: February 27, 2018 Estimated Primary Completion Date: February 28, 2021 Estimated Study Completion Date: February 28, 2021 |
I | Arm A: MGMT Unmethylated patients; AdV-TK injection into resection cavity, valaciclovir 14 days, radiation after 8 days, TMZ after valaciclovir, Nivolumab every 2 weeks to 52 weeks Arm B: MGMT Methylated and undetermined patients; AdV-TK injection into resection cavity, valaciclovir 14 days, radiation after 8 days, TMZ after valaciclovir, Nivolumab every 2 weeks to 52 weeks |
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Translational Study of Nivolumab in Combination with Bevacizumab for Recurrent Glioblastoma | Actual Study Start Date: October 1, 2018 Estimated Primary Completion Date: February 1, 2022 Estimated Study Completion Date: August 1, 2022 |
II | Arm A: Nivolumab + Bevacizumab in patients not undergoing salvage surgery Arm B: Nivolumab + Bevacizumab in patients not undergoing salvage surgery |
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Pembrolizumab | Combination Adenovirus + Pembrolizumab to Trigger Immune Virus Effects (CAPTIVE) | Study Start Date: June 2016 Estimated Primary Completion Date: December 2020 Estimated Study Completion Date: June 2021 |
II | Intratumoral DNX-2401 (a genetically modified oncolytic adenovirus) followed by IV Pembrolizumab | |
Laser Interstitial Thermotherapy (LTTI) Combined with Checkpoint Inhibitor for Recurrent GBM | Actual Study Start Date: November 29, 2017 Estimated Primary Completion Date: December 2020 Estimated Study Completion Date: January 2021 |
l/ll | Arm A: IV Pembrolizumab 7 days pre-surgery with LITT Arm B: IV Pembrolizumab 14 days post-surgery with LITT Arm C: IV Pembrolizumab 35 days post-surgery with LITT |
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PVSRIPO and Pembrolizumab in Patients With Recurrent Glioblastoma | Estimated Study Start Date: September 2020 Estimated Primary Completion Date: March 2023 Estimated Study Completion Date: March 2023 |
I | Single Arm: PVSRIPO intratumoral infusion followed by intravenous Pembrolizumab 14 to 28 days later, and every 3 weeks, thereafter |