Correction of Table 1
It has come to our attention that the previously published manuscript contained an outdated iteration of Table 1 [1].
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 |
The revised version incorporates the accurate table encompassing all pertinent studies with the appropriate NCT identifiers. Additionally, we have restructured the arrangement of studies, commencing with phase I and progressing to later-phase trials.
The authors apologize for any inconvenience caused and state that the changes do not affect the scientific results. This correction was approved by the Academic Editor. The original publication has also been updated.
Footnotes
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Reference
- 1.Gallus M., Kwok D., Lakshmanachetty S., Yamamichi A., Okada H. Immunotherapy Approaches in Isocitrate-Dehydrogenase-Mutant Low-Grade Glioma. Cancers. 2023;15:3726. doi: 10.3390/cancers15143726. [DOI] [PMC free article] [PubMed] [Google Scholar]