drugset / Trial / NCT03395587
Efficiency of Vaccination with Lysate-loaded Dendritic Cells in Patients with Newly Diagnosed Glioblastoma
Phase 2
Active not recruiting
136 enrolled
Heinrich-Heine University, Duesseldorf
German Federal Ministry of Education and Research · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The primary objective of the study is to determine whether overall survival of newly diagnosed glioblastoma patients treated with lysate-loaded, mature dendritic cell vaccines as add-on to the standard of care consisting of resection, radiotherapy with concomitant temozolomide chemotherapy and subsequent adjuvant temozolomide chemotherapy is superior to the treatment with the standard of care alone.
Timeline
- Start
- 2018-03-06
- Primary completion
- 2027-05
- Completion
- 2027-05
Publications
- Naulaerts S, Datsi A, Borras DM, Antoranz Martinez A, Messiaen J, Vanmeerbeek I, Sprooten J, Laureano RS, Govaerts J, Panovska D, Derweduwe M, Sabel MC, Rapp M, Ni W, Mackay S, Van Herck Y, Gelens L, Venken T, More S, Bechter O, Bergers G, Liston A, De Vleeschouwer S, Van Den Eynde BJ, Lambrechts D, Verfaillie M, Bosisio F, Tejpar S, Borst J, Sorg RV, De Smet F, Garg AD. Multiomics and spatial mapping characterizes human CD8+ T cell states in cancer. Sci Transl Med. 2023 Apr 12;15(691):eadd1016. doi: 10.1126/scitranslmed.add1016. Epub 2023 Apr 12.
- Rapp M, Grauer OM, Kamp M, Sevens N, Zotz N, Sabel M, Sorg RV. A randomized controlled phase II trial of vaccination with lysate-loaded, mature dendritic cells integrated into standard radiochemotherapy of newly diagnosed glioblastoma (GlioVax): study protocol for a randomized controlled trial. Trials. 2018 May 25;19(1):293. doi: 10.1186/s13063-018-2659-7.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Autologous, tumor lysate-loaded, mature dendritic cells | Cell therapy | 2e+06 cells | Other |
| Subject | Autologous, tumor lysate-loaded, mature dendritic cells | Cell therapy | 1e+07 cells | Other |
| Background | Temozolomide | Small molecule | 150 mg/m2 | — |
| Background | Temozolomide | Small molecule | 200 mg/m2 | — |