Table 1.
Clinical trials investigating immunotherapy for low-grade glioma.
| Children/Adults | Study Phase | ClinicalTrials.gov Identifier | Experimental Treatment | Cohort Size | Primary Endpoint/Outcomes | Results for Primary Outcome | Study Start | Current Status |
|---|---|---|---|---|---|---|---|---|
| IDH-Inhibitor | ||||||||
| Adults | Phase 1 | NCT03343197 | AG-120 (Ivosidenib), AG881 (Vorasidenib) | 49 | 2HG concentration in resected tumors | Decreased tumor cell proliferation and immune cell activation | March 2018 | Active, not recruiting |
| Adults | Phase 1 | NCT03030066 | DS-1001b | 47 | Percentage of participants with dose-limiting toxicities | No dose-limiting toxicities | January 2017 | Active, not recruiting |
| Adults | Phase 1 | NCT04762602 | HMPL-306 | 90 | Treatment emergent adverse events (TEAEs), dose-limiting toxicities | Not yet posted for glioma patients that were included | February 2021 |
Recruiting |
| Adults | Phase 2 | NCT04056910 | Ivosidenib + Nivolumab | 35 | 6-month progression-free survival, best overall response (time frame: 8 weeks–14 months) | Not yet posted | September 2021 | Active, not recruiting |
| Adults | Phase 2 | NCT04458272 | DS-1001b | 25 | Objective Response Rate: complete response (CR) + partial response (PR), number of patients with TEAEs | Not yet posted | July 2020 | Active, not recruiting |
| Adults | Phase 2 | NCT05303519 | Safusidenib | 95 | TEAEs, proportion of patients with the best overall confirmed response of CR or PR | Not yet posted | May 2023 | Recruiting |
| Children, Adults | Phase 3 | NCT04164901 | Vorasidenib | 331 | Progression-free survival | Significantly higher PFS in the AG-881 group (27.7 months vs. 11.1 months) | January 2020 | Active, not recruiting |
| Vaccines/immune-adjuvants | ||||||||
| Adults | Phase 1 | NCT02924038 | IMA950, poly-ICLC, varlilumab | 14 | Incidence of AEs, evaluation of CD4/CD8+ T cell response | Well-tolerated, vaccine-reactive T-cell expansion in the peripheral blood, but not in the tumor | April 2017 | Active, not recruiting |
| Children, Adults | Phase 1 | NCT01130077 | HLA-A2-restricted glioma antigen peptide vaccine, poly-ICLC | 60 | Safety | No dose-limiting non-CNS toxicity, 21 of 26 children showed positive anti-GAA immune responses | February 2009 | Active, not recruiting |
| Adults | Phase 1 | NCT00795457 | GAA/TT-peptide vaccine and poly-ICLC | 13 | Induction of GAA-specific T-cell response and safety | Well tolerated, robust-GAA-specific responses | January 2009 | Completed |
| Adults | Phase 1 | NCT02549833 | GBM6-AD, poly-ICLC | 28 | Toxicity, immune response in the tumor | No dose-limiting toxicity, effector CD8 T-cell response in blood and tumor microenvironment | October 2016 | Active, not recruiting |
| Adults | Phase 1 | NCT05609994 | PEPIDH1M vaccine in combination + Vorasidenib | 48 | Proportion of patients with unacceptable toxicity, progression-free survival | Not yet posted | Estimated: July 2023 |
Not yet recruiting |
| Adults | Phase 2 | NCT01635283 | Tumor lysate pulsed autologous dendritic cell vaccine | 5 | Progression-free survival (up to 44 months) | Time without being affected by tumor recurrence or progression: >30 months (n = 2/5) | January 2012 | Completed |
| Children, Adults | Phase 2 | NCT02358187 | HLA-A2 Restricted Glioma Antigen-Peptides with Poly-ICLC | 25 | Tumor shrinkage or stable disease | Not yet posted | January 2015 | Recruiting |
| Children, Adults | Phase 2 | NCT04544007 | Poly-ICLC | 20 | Objective Response Rate (PR + CR) | Not yet posted | December 2021 | Recruiting |
| Children, Adults | Phase 2 | NCT01188096 | Poly-ICLC | 23 | Objective Response Rate (PR + CR) | 43% stable disease, 17% partial responses | August 2010 | Completed |
| PD-1 Inhibition | ||||||||
| Adults | Phase 2 | NCT03718767 | Nivolumab | 70 | 6-month progression-free survival | Not posted yet | March 2019 | Recruiting |
| Adults | Phase 2 | NCT03557359 | Nivolumab | 20 | Objective Response Rate (PR + CR) | Not posted yet | June 2018 | Active, not recruiting |