Table 2.
Clinical trials of immunotherapies for GBM.
| Identifier | Study title | Interventions | Number expected to be enrolled | Primary completion |
|---|---|---|---|---|
| Phase III clinical trials | ||||
| NCT04277221 | ADCTA for adjuvant immunotherapy in standard treatment of recurrent glioblastoma multiforme (GBM) | Biological: Autologous dendritic cell/tumor antigen, ADCTA | 118 | December 31, 2022 |
| NCT03548571 | Dendritic cell immunotherapy against cancer stem cells in glioblastoma patients receiving standard therapy | Biological: Dendritic cell immunization Drug: Adjuvant temozolomide |
60 | May 1, 2021 |
| NCT02667587 | An investigational immuno-therapy study of temozolomide plus radiation therapy with nivolumab or placebo, for newly diagnosed patients with glioblastoma (GBM, a malignant brain cancer) | Drug: Nivolumab Drug: temozolomide Radiation: Radiotherapy Other: Nivolumab Placebo |
693 | February 11, 2022 |
| NCT02617589 | An investigational immuno-therapy study of nivolumab compared to temozolomide, each given with radiation therapy, for newly-diagnosed patients with glioblastoma (GBM, a malignant brain cancer) | Drug: Nivolumab Drug: Temozolomide Radiation: Radiotherapy |
550 | January 17, 2019 |
| Phase II clinical trials | ||||
| NCT04145115 | A study testing the effect of immunotherapy (ipilimumab and nivolumab) in patients with recurrent glioblastoma with elevated mutational burden | Biological: Ipilimumab Biological: Nivolumab |
37 | May 31, 2023 |
| NCT02649582 | Adjuvant dendritic cell-immunotherapy plus temozolomide in glioblastoma patients | Biological: Dendritic cell vaccine plus temozolomide chemotherapy | 20 | December 2020 |
| NCT03927222 | Immunotherapy targeted against cytomegalovirus in patients with newly-diagnosed WHO grade IV unmethylated glioma | Biological: Human CMV pp65-LAMP mRNA-pulsed autologous DCs containing GM CSF Drug: Temozolomide Biological: Tetanus-Diphtheria Toxoid (Td) (and 2 more.) |
48 | December 2023 |
| NCT03916757 | V-Boost immunotherapy in glioblastoma multiforme brain cancer | Biological: V-Boost | 20 | April 15, 2020 |
| NCT03650257 | A large-scale research for immunotherapy of glioblastoma with autologous heat shock protein gp96 | Biological: gp96 Drug: Temozolomide radiation: Radiotherapy |
150 | August 20, 2021 |
| NCT03548571 | Dendritic cell immunotherapy against cancer stem cells in glioblastoma patients receiving standard therapy | Biological: Dendritic cell immunization Drug: Adjuvant temozolomide |
60 | May 1, 2021 |
| NCT04013672 | Study of pembrolizumab plus SurVaxM for glioblastoma at first recurrence |
Drug: Pembrolizumab Drug: SurVaxM Drug: Sargramostim Drug: Montanide ISA 51 |
51 | December 31, 2020 |
| NCT01567202 | Study of DC vaccination against glioblastoma | Procedure: Surgery Drug: Chemotherapy Radiation: Radiotherapy (and 2 more.) |
100 | December 1, 2019 |
| NCT02799238 | Autologous lymphoid effector cells specific against tumor (ALECSAT) as add on to standard of care in patients with glioblastoma | Biological: ALECSAT Radiation: Radiotherapy Drug: Temozolomide |
62 | June 2020 |
| NCT02799238 | Cediranib maleate and olaparib compared to bevacizumab in treating patients with recurrent glioblastoma | Biological: Bevacizumab Drug: Cediranib Drug: Cediranib maleate Drug: Olaparib |
70 | May 31, 2020 |
| NCT02337686 | Pembrolizumab in treating patients with recurrent glioblastoma | Other: Laboratory Biomarker Analysis Biological: Pembrolizumab Other: Pharmacological study Procedure: Therapeutic Conventional Surgery |
20 | December 31, 2020 |
| NCT01174121 | Immunotherapy using tumor infiltrating lymphocytes for patients with metastatic cancer | Biological: Young TIL Drug: Aldesleukin Drug: Cyclophosphamide (and 2 more.) |
332 | December 29, 2023 |
| NCT04225039 | Anti-GITR/Anti-PD1/Stereotactic radiosurgery, in recurrent glioblastoma | Drug: INCMGA00012 Drug: INCAGN01876 Drug: SRS Procedure: Brain surgery |
32 | February 2025 |
| NCT04049669 | Pediatric trial of indoximod with chemotherapy and radiation for relapsed brain tumors or newly diagnosed DIPG | Drug: Indoximod Radiation: Partial Radiation Radiation: Full-dose Radiation (and 4 more.) |
140 | October 2, 2024 |
| NCT03491683 | INO-5401 and INO-9012 delivered by electroporation (EP) in COMBINATION WITH cemiplimab (REGN2810) in newly-diagnosed glioblastoma (GBM) | Biological: INO-5401 Biological: INO-9012 Biological: Cemiplimab (and 2 more.) |
52 | January 18, 2021 |
| NCT03047473 | Avelumab in patients with newly diagnosed glioblastoma multiforme | Biological: Avelumab | 30 | September 2022 |
| NCT03174197 | Atezolizumab in combination with temozolomide and radiation therapy in treating patients with newly diagnosed glioblastoma | Drug: Atezolizumab Radiation: Radiation therapy Drug: Temozolomide |
60 | June 30, 2020 |
| NCT03395587 | Efficiency of vaccination with lysate-loaded dendritic cells in patients with newly diagnosed glioblastoma | Biological: Autologous, tumor lysate-loaded, mature dendritic cells (DC) Drug: Standard therapy |
136 | September 6, 2022 |
| NCT03158389 | NCT neuro master match–N2M2 (NOA-20) | Drug: APG101 Drug: Alectinib Drug: Idasanutlin (and 4 more.) |
350 | September 30, 2023 |
| NCT03532295 | INCMGA00012 and epacadostat in combination with radiation and bevacizumab in patients with recurrent gliomas | Drug: Epacadostat Drug: Bevacizumab Radiation: Radiation therapy Procedure: Peripheral blood draw |
55 | April 30, 2023 |
| NCT03866109 | A phase I/IIa study evaluating temferon in patients with glioblastoma & unmethylated MGMT | Drug: Temferon | 21 | December 2022 |
| NCT03899857 | Pembrolizumab for newly diagnosed glioblastoma | Drug: Pembrolizumab | 56 | December 2022 |
| NCT01204684 | Dendritic cell vaccine for patients with brain tumors | Biological: Autologous tumor lysate-pulsed DC vaccination Biological: Tumor lysate-pulsed DC vaccination+0.2% resiquimod Biological: Tumor-lysate pulsed DC vaccination +adjuvant polyICLC |
60 | January 31, 2021 |
| NCT02968940 | Avelumab with hypofractionated radiation therapy in adults with isocitrate dehydrogenase (IDH) mutant glioblastoma | Biological: Avelumab Radiation: Hypofractionated radiation therapy (HFRT) |
43 | April 2020 |
| NCT02336165 | Phase 2 Study of Durvalumab (MEDI4736) in Patients With Glioblastoma | Drug: Durvalumab Radiation: Standard radiotherapy Biological: Bevacizumab |
159 | November 2018 |
| NCT04102436 | Non-viral TCR gene therapy | Drug: Fludarabine Drug: Cyclophosphamide Drug: aldesleukin Biological: Sleeping Beauty Transposed PBL |
210 | December 31, 2028 |
| NCT03412877 | Administration of autologous T-cells genetically engineered to express T-cell receptors reactive against mutated neoantigens in people with metastatic cancer |
Drug: Cyclophosphamide Drug: Fludarabine Drug: Aldesleukin (and 2 more.) |
270 | March 23, 2027 |
| NCT02794883 | Tremelimumab and durvalumab in combination or alone in treating patients with recurrent malignant glioma | Biological: Durvalumab Other: Laboratory Biomarker Analysis Procedure: Surgical Procedure Biological: Tremelimumab |
36 | December 2019 |
| NCT03382977 | Study to evaluate safety, tolerability, and optimal dose of candidate GBM vaccine VBI-1901 in recurrent GBM subjects | Biological: VBI-1901 | 38 | October 2020 |
| NCT03382977 | Study to evaluate safety, tolerability, and optimal dose of candidate GBM vaccine VBI-1901 in recurrent GBM subjects | Biological: DNX-2401 Biological: Pembrolizumab |
49 | December 2020 |
| Phase I clinical trials | ||||
| NCT02649582 | Adjuvant dendritic cell-immunotherapy plus temozolomide in glioblastoma patients | Biological: Dendritic cell vaccine plus temozolomide chemotherapy | 20 | December 2020 |
| NCT04165941 | Novel gamma-delta γδ T cell therapy for treatment of patients with newly diagnosed glioblastoma | Biological: DRI cell therapy | 12 | January 2022 |
| NCT03961971 | Trial of anti-tim-3 in combination with anti-PD-1 and SRS in recurrent GBM | Drug: MBG453 | 15 | February 2022 |
| NCT03426891 | Pembrolizumab and vorinostat combined with temozolomide for newly diagnosed glioblastoma | Drug: Pembrolizumab Drug: Vorinostat Drug: Temozolomide Radiation: Radiotherapy |
32 | April 2021 |
| NCT02208362 | Genetically modified T-cells in treating patients with recurrent or refractory malignant glioma | Biological: IL13Rα2-specific, hinge-optimized, 41BB-costimulatory CAR/truncated CD19-expressing Autologous T lymphocytes Other: Laboratory biomarker analysis Other: Quality-of-life assessment (and 5 more.) |
92 | May 2020 |
| NCT04323046 | Immunotherapy (nivolumab and ipilimumab) before and after surgery for the treatment of recurrent or progressive high grade glioma in children and young adults | Biological: Ipilimumab Biological: Nivolumab Drug: Placebo Administration (and 2 more.) |
45 | March 1, 2022 |
| NCT04047706 | Nivolumab, BMS-986205, and radiation therapy with or without temozolomide in treating patients with newly diagnosed glioblastoma | Biological: IDO1 inhibitor BMS-986205 Biological: nivolumab Radiation: Radiation Therapy Drug: Temozolomide |
30 | June 9, 2022 |
| NCT04201873 | Pembrolizumab and a vaccine (ATL-DC) for the treatment of surgically accessible recurrent glioblastoma | Biological: Dendritic cell tumor cell lysate vaccine Biological: Pembrolizumab Other: Placebo Administration Drug: Poly ICLC |
40 | August 1, 2024 |
| NCT04003649 | IL13Ralpha2-targeted chimeric antigen receptor (CAR) T cells with or without nivolumab and ipilimumab in treating patients with recurrent or refractory glioblastoma | Biological: IL13Ralpha2-specific Hinge-optimized 4-1BB-co-stimulatory CAR/Truncated CD19-expressing autologous TN/MEM cells Biological: Ipilimumab Biological: Nivolumab (and 2 more.) |
60 | January 22, 2022 |
| NCT03714334 | DNX-2440 oncolytic adenovirus for recurrent glioblastoma | Drug: DNX-2440 injection | 24 | April 16, 2022 |
| NCT02852655 | A pilot surgical trial to evaluate early immunologic pharmacodynamic parameters for The PD-1 checkpoint inhibitor, pembrolizumab (MK-3475), in patients with surgically accessible recurrent/progressive glioblastoma | Drug: MK-3475 | 35 | March 28, 2018 |
| NCT04270461 | NKG2D-based CAR T-cells immunotherapy for patient with r/r NKG2DL+ solid tumors | Biological: NKG2D-based CAR T-cells | 10 | December 1, 2022 |
| NCT03491683 | INO-5401 and INO-9012 delivered by electroporation (EP) in combination with cemiplimab (REGN2810) in newly-diagnosed glioblastoma (GBM) | Biological: INO-5401 Biological: INO-9012 Biological: Cemiplimab (and 2 more.) |
52 | January 18, 2021 |
| NCT03174197 | Atezolizumab in Combination with temozolomide and radiation therapy in treating patients with newly diagnosed glioblastoma | Drug: Atezolizumab Radiation: Radiation Therapy Drug: Temozolomide |
60 | June 30, 2020 |
| NCT03389230 | Memory-enriched T cells in treating patients with recurrent or refractory grade III-IV glioma | Biological: CD19CAR-CD28-CD3zeta-EGFRt-expressing Tcm-enriched T-lymphocytes Biological: CD19CAR-CD28-CD3zeta-EGFRt-expressing Tn/mem-enriched T-lymphocytes Other: Laboratory Biomarker Analysis Procedure: Leukapheresis |
42 | June 14, 2021 |
| NCT03344250 | Phase I EGFR BATs in newly diagnosed glioblastoma | Drug: EGFR BATs with TMZ following SOC RT/TMZ Drug: Weekly EGFR BATs following SOC RT/TMZ |
18 | October 1, 2020 |
| NCT03158389 | NCT neuro master match–N2M2 (NOA-20) | Drug: APG101 Drug: Alectinib Drug: Idasanutlin (and 4 more.) |
350 | September 30, 2023 |
| NCT03866109 | A phase I/IIa study evaluating temferon in patients with glioblastoma & unmethylated MGMT | Drug: temFeron | 21 | December 2022 |
| NCT03392545 | Combination of immunization and radiotherapy for malignant gliomas (InSituVac1) | Combination product: Combined immune adjuvants and radiation | 30 | April 1, 2020 |
| NCT03341806 | Avelumab with laser interstitial therapy for recurrent glioblastoma | Drug: Avelumab Combination Product: MRI-guided LITT therapy |
30 | September 2020 |
| NCT02062827 | Genetically engineered HSV-1 phase 1 study for the treatment of recurrent malignant glioma | Biological: M032 (NSC 733972) | 36 | September 2020 |
| NCT03223103 | Safety and immunogenicity of personalized genomic vaccine and tumor treating fields (TTFields) to treat glioblastoma | Drug: Poly-ICLC Device: Tumor Treating Fields Biological: Peptides |
20 | May 22, 2020 |
| NCT02766699 | A study to evaluate the safety, tolerability and immunogenicity of EGFR(V)-EDV-dox in subjects with recurrent glioblastoma multiforme (GBM) | Drug: EGFR(V)-EDV-Dox | 20 | December 2019 |
| NCT03619239 | Dose-escalation study to evaluate the safety and tolerability of GX-I7 in patients with glioblastoma | Drug: GX-I7 | 15 | January 31, 2021 |
| NCT02010606 | Phase I study of a dendritic cell vaccine for patients with either newly diagnosed or recurrent glioblastoma | Biological: Dendritic cell vaccination, in addition to standard temozolomide chemotherapy and involved field radiation therapy Biological: Dendritic cell vaccination, with optional bevacizumab treatment for patients previously treated with bevacizumab |
39 | April 2020 |
| NCT02502708 | Study of the IDO Pathway inhibitor, indoximod, and temozolomide for pediatric patients with progressive primary malignant brain tumors | Drug: Indoximod Drug: Temozolomide Radiation: Conformal radiation (and 2 more.) |
81 | December 12, 2019 |
| NCT03382977 | Study to evaluate safety, tolerability, and optimal dose of candidate GBM vaccine VBI-1901 in recurrent GBM subjects | Biological: VBI-1901 | 38 | October 2020 |
| NCT03043391 | Phase 1b study PVSRIPO for recurrent malignant glioma in children | Biological: Polio/Rhinovirus Recombinant (PVSRIPO) | 12 | July 1, 2020 |
| NCT03576612 | GMCI, nivolumab, and radiation therapy in treating patients with newly diagnosed high-grade gliomas | Biological: AdV-tk Drug: Valacyclovir Radiation: Radiation (and 3 more.) |
36 | February 28, 2021 |
| NCT03657576 | Trial of C134 in patients with recurrent GBM | Biological: C134 | 24 | September 2022 |
| NCT03152318 | A study of the treatment of recurrent malignant glioma with rQNestin34.5v.2 | Drug: rQNestin Drug: Cyclophosphamide Procedure: Stereotactic biopsy |
108 | July 2021 |
| NCT03911388 | HSV G207 in children with recurrent or refractory cerebellar brain tumors | Biological: G207 | 15 | September 1, 2022 |
| NCT02457845 | HSV G207 alone or with a single radiation dose in children with progressive or recurrent supratentorial brain tumors | Biological: G207 | 18 | October 2020 |
| NCT00634231 | A phase I study of AdV-tk + prodrug therapy in combination with radiation therapy for pediatric brain tumors | Biological: AdV-tk Drug: Valacyclovir Radiation: Radiation |
12 | December 2015 |