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NCT03925246: REVOLUMAB

Efficacy of Nivolumab for Recurrent IDH Mutated High-Grade Gliomas

Completed Phase 2 Last updated 2 April 2024
What this trial tests

Phase 2 trial testing Nivolumab in High Grade Glioma in 43 participants. Completed in 18 August 2021.

Timeline
30 July 2019
Primary endpoint
2 December 2020
18 August 2021

Quick facts

Lead sponsorAssistance Publique - Hôpitaux de Paris
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment43
Start date30 July 2019
Primary completion2 December 2020
Estimated completion18 August 2021
Sites7 locations across France

Drugs / interventions tested

Conditions studied

Sponsor

Assistance Publique - Hôpitaux de Paris — full company profile →

Who can join

Adults 18 to 85, any sex, with High Grade Glioma or Brain Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Immune checkpoint blockade therapies targeting the immunomodulatory effect of cytotoxic T-lymphocyte antigen (CTLA-4) and programmed cell death-1/ Programmed death-ligand 1 (PD-1/PD-L1) have recently demonstrated survival benefit and durable response in phase III trials in several human cancers, especially in tumors that bear high mutation load and/or tumor-associated neoantigen signatures. The aim of these treatments is to restore effector T-cell function and antitumor activity, which could be enhanced in the context of high mutational/neoantigen load. In Isocitrate DeHydrogenase mutated High Grade Gliomas (IDHm HGGs), acquired resistance to alkylating chemotherapy frequently results from the inactivation of mismatch-repair (MMR) proteins which in turn leads to the acquisition of a hypermutator phenotype. These findings suggest that at least in a subset of recurrent IDHm HGGs immune checkpoint blockade therapies may be particularly effective. IDHm HGGs most frequently occur in young adults. The first line treatment consists of maximal safe surgical resection followed by radiotherapy and adjuvant alkylating chemotherapy (Temozolomide or Procarbazine-CCNU-Vincristine regimen (PCV)). Despite these treatments, most IDHm HGGs recurred in few years. There is no standard of care at recurrence and the median overall survival after it is less than 3 years. The investigators make the hypothesis that treatment with the anti-PD-1 monoclonal antibody Nivolumab will improve 24 weeks progression-free survival in IDHm HGGs that have recurred after initial treatment with radiotherapy and alkylating chemotherapy.

Publications & conference data

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

  1. Neoantigens: promising targets for cancer therapy.
    Xie N, Shen G, Gao W, Huang Z, et al · · 2023 · cited 713× · PMID 36604431 · DOI 10.1038/s41392-022-01270-x
  2. Isocitrate dehydrogenase (IDH) mutant gliomas: A Society for Neuro-Oncology (SNO) consensus review on diagnosis, management, and future directions.
    Miller JJ, Gonzalez Castro LN, McBrayer S, Weller M, et al · · 2023 · cited 158× · PMID 36239925 · DOI 10.1093/neuonc/noac207
  3. <i>IDH</i> Mutations in Glioma: Double-Edged Sword in Clinical Applications?
    Kayabolen A, Yilmaz E, Bagci-Onder T. · · 2021 · cited 58× · PMID 34356864 · DOI 10.3390/biomedicines9070799
  4. Translational landscape of glioblastoma immunotherapy for physicians: guiding clinical practice with basic scientific evidence.
    Kreatsoulas D, Bolyard C, Wu BX, Cam H, et al · · 2022 · cited 53× · PMID 35690784 · DOI 10.1186/s13045-022-01298-0
  5. Signaling pathways in brain tumors and therapeutic interventions.
    Li S, Wang C, Chen J, Lan Y, et al · · 2023 · cited 51× · PMID 36596785 · DOI 10.1038/s41392-022-01260-z
  6. Targeting IDH-Mutant Glioma.
    Miller JJ. · · 2022 · cited 45× · PMID 35476295 · DOI 10.1007/s13311-022-01238-3
  7. T lymphocyte-targeted immune checkpoint modulation in glioma.
    Kelly WJ, Giles AJ, Gilbert M. · · 2020 · cited 33× · PMID 32051289 · DOI 10.1136/jitc-2019-000379
  8. Analyzing One Cell at a TIME: Analysis of Myeloid Cell Contributions in the Tumor Immune Microenvironment.
    Davidov V, Jensen G, Mai S, Chen SH, et al · · 2020 · cited 32× · PMID 32983100 · DOI 10.3389/fimmu.2020.01842

Verify or expand the search:

Other trials of Nivolumab

Trials testing the same drug.

Other recruiting trials for High Grade Glioma

Currently open trials in the same condition.

Other Assistance Publique - Hôpitaux de Paris trials

Trials by the same sponsor.

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