Table 4.
Open in new tab

Ongoing Clinical Trials for IDHm Gliomas Including IDH Inhibitors

Clinicaltrials.gov identifierStudy phaseTreatmentPopulationPrimary endpoints
Single-agent
NCT055774161SafusidenibNewly-diagnosed low-grade gliomaSafety, PFS, OS, and tumor PK and PD parameters
NCT053035192SafusidenibRecurrent grade 2–3 astrocytomaSafety, PFS, OS, and tumor PK and PD parameters
Combinations
NCT056099941PEPIDH1M vaccine in combination with vorasidenibRecurrent, non-enhancing, grade 2–3 gliomaSafety, PFS
NCT054846221Pembrolizumab in combination with vorasidenibRecurrent, enhancing, grade 2–3 astrocytomaSafety, PFS, OS, and tumor PK and PD parameters
NCT064782121/2Temozolomide in combination with vorasidenibRecurrent grade 2–4 glioma, or newly-diagnosed grade 4 astrocytomaSafety, PFS, OS, ORR, and PK parameters
NCT061619742Temozolomide in combination with olutasidenibNewly-diagnosed high-grade gliomaSafety, PFS, OS, and HR-QOL
Clinicaltrials.gov identifierStudy phaseTreatmentPopulationPrimary endpoints
Single-agent
NCT055774161SafusidenibNewly-diagnosed low-grade gliomaSafety, PFS, OS, and tumor PK and PD parameters
NCT053035192SafusidenibRecurrent grade 2–3 astrocytomaSafety, PFS, OS, and tumor PK and PD parameters
Combinations
NCT056099941PEPIDH1M vaccine in combination with vorasidenibRecurrent, non-enhancing, grade 2–3 gliomaSafety, PFS
NCT054846221Pembrolizumab in combination with vorasidenibRecurrent, enhancing, grade 2–3 astrocytomaSafety, PFS, OS, and tumor PK and PD parameters
NCT064782121/2Temozolomide in combination with vorasidenibRecurrent grade 2–4 glioma, or newly-diagnosed grade 4 astrocytomaSafety, PFS, OS, ORR, and PK parameters
NCT061619742Temozolomide in combination with olutasidenibNewly-diagnosed high-grade gliomaSafety, PFS, OS, and HR-QOL

Source: clinicaltrials.gov (searched on July 2024). Only trials recruiting or being activated are shown.

Table 4.
Open in new tab

Ongoing Clinical Trials for IDHm Gliomas Including IDH Inhibitors

Clinicaltrials.gov identifierStudy phaseTreatmentPopulationPrimary endpoints
Single-agent
NCT055774161SafusidenibNewly-diagnosed low-grade gliomaSafety, PFS, OS, and tumor PK and PD parameters
NCT053035192SafusidenibRecurrent grade 2–3 astrocytomaSafety, PFS, OS, and tumor PK and PD parameters
Combinations
NCT056099941PEPIDH1M vaccine in combination with vorasidenibRecurrent, non-enhancing, grade 2–3 gliomaSafety, PFS
NCT054846221Pembrolizumab in combination with vorasidenibRecurrent, enhancing, grade 2–3 astrocytomaSafety, PFS, OS, and tumor PK and PD parameters
NCT064782121/2Temozolomide in combination with vorasidenibRecurrent grade 2–4 glioma, or newly-diagnosed grade 4 astrocytomaSafety, PFS, OS, ORR, and PK parameters
NCT061619742Temozolomide in combination with olutasidenibNewly-diagnosed high-grade gliomaSafety, PFS, OS, and HR-QOL
Clinicaltrials.gov identifierStudy phaseTreatmentPopulationPrimary endpoints
Single-agent
NCT055774161SafusidenibNewly-diagnosed low-grade gliomaSafety, PFS, OS, and tumor PK and PD parameters
NCT053035192SafusidenibRecurrent grade 2–3 astrocytomaSafety, PFS, OS, and tumor PK and PD parameters
Combinations
NCT056099941PEPIDH1M vaccine in combination with vorasidenibRecurrent, non-enhancing, grade 2–3 gliomaSafety, PFS
NCT054846221Pembrolizumab in combination with vorasidenibRecurrent, enhancing, grade 2–3 astrocytomaSafety, PFS, OS, and tumor PK and PD parameters
NCT064782121/2Temozolomide in combination with vorasidenibRecurrent grade 2–4 glioma, or newly-diagnosed grade 4 astrocytomaSafety, PFS, OS, ORR, and PK parameters
NCT061619742Temozolomide in combination with olutasidenibNewly-diagnosed high-grade gliomaSafety, PFS, OS, and HR-QOL

Source: clinicaltrials.gov (searched on July 2024). Only trials recruiting or being activated are shown.

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