Currently Recruiting Trials – Glioblastoma

Last page update: February 16, 2017

This page has been divided into two major sections – newly diagnosed and recurrent/progressive. The trials for recurrences are found on the bottom half of the page. Additional trials for glioblastoma also found on Currently Recruiting Trials – High Grade Glioma

New Trials (added here in the last month)

Added February 16, 2017
A Phase II, Open-label, Single Arm, Multicenter Study of Avelumab [antibody against PD-L1] With Hypofractionated Radiation in Adult Subjects With Transformed IDH Mutant Glioblastoma. New York NY. Estimated primary completion date: February 2019.
NCT02968940

Newly diagnosed

Vaccines and Cell therapies – Newly diagnosed

Randomized, double-blinded
Evaluation of Overcoming Limited Migration and Enhancing Cytomegalovirus-specific Dendritic Cell Vaccines With Adjuvant Tetanus Pre-conditioning in Patients With Newly-diagnosed Glioblastoma. Duke University. Estimated primary completion date: March 2019. Randomized phase 2 trial. In addition to receiving CMV-specific dendritic cell vaccinations patients will be randomized to receive pre-conditioning with either tetanus/diptheria toxoid or autologous unpulsed dendritic cells in saline. A third, unblinded group will undergo basiliximab infusions and tetanus/diptheria preconditioning in addition to the CMV-specific dendritic cell vaccine.
NCT02366728

Placebo-controlled
A Phase II Randomized, Blinded, and Placebo-controlled Trial of CMV RNA-Pulsed Dendritic Cells With Tetanus-Diphtheria Toxoid Vaccine in Patients With Newly-Diagnosed Glioblastoma (ATTAC-II) . University of Florida, Gainesville. Estimated primary completion date: June 2023.
NCT02465268

Peptide Targets for Glioblastoma Against Novel Cytomegalovirus Antigens (PERFORMANCE). Phase 1. Duke University. Estimated primary completion date: March 2018.
NCT02864368

A Phase I/II Clinical Trial of Autologous Cytomegalovirus (CMV)-Specific Cytotoxic T Cells for Glioblastoma (GBM) Patients. MD Anderson – Houston TX. Estimated primary completion date: June 2020.
For newly diagnosed GBM post-radiotherapy and temozolomide, and for recurrent GBM.
NCT02661282

Placebo-controlled
A Phase 3 Randomized Double-blind, Controlled Study of ICT-107 With Maintenance Temozolomide (TMZ) in Newly Diagnosed Glioblastoma Following Resection and Concomitant TMZ Chemoradiotherapy. Recruiting in California (3 locations), Connecticut (2 locations), Atlanta GA, Kentucky (2 locations), Minneapolis MN, New Jersey (2 locations), New York (4 locations), Ohio (2 locations), Oklahoma City OK, Pennsylvania (2 locations), Portland OR, Charleston SC, Knoxville TN, Texas (3 locations), Charlottesville VA, Seattle WA, Milwaukee WI. Estimated primary completion date: December 2019.
NCT02546102

A Pilot Study to Assess the Safety, Feasibility, and Preliminary Efficacy of a Neoepitope-based Personalized Vaccine Approach in Patients With Newly Diagnosed Glioblastoma. St. Louis MO. Study start date: October 2015. Estimated primary completion date: May 2017.
NCT02510950

A Phase I Study of a Personalized NeoAntigen Cancer Vaccine With Radiotherapy Among MGMT Unmethylated, Newly Diagnosed Glioblastoma Patients. Boston MA (Dana Farber Cancer Institute). Estimated primary completion date: January 2018.
NCT02287428

A Phase II Study of the Safety and Efficacy of SVN53-67/M57-KLH (SurVaxM) in Survivin-Positive Newly Diagnosed Glioblastoma. Buffalo NY, Cleveland OH. Estimated primary completion date: April 2017.
NCT02455557

Pilot Clinical Trial of Allogeneic Tumor Lysate-Pulsed Autologous Dendritic Cell Vaccination in Newly Diagnosed Glioblastoma. Mayo Clinic, Rochester MN, USA. Estimated primary completion date: November 2016.
NCT01957956

Phase I Trial of Vaccination With Autologous Dendritic Cells Pulsed With Lysate Derived From an Allogeneic Glioblastoma Stem-like Cell Line for Patients With Newly Diagnosed or Recurrent Glioblastoma. This trial is recruiting newly diagnosed or recurrent glioblastoma patients at Cedars-Sinai Medical Center in Los Angeles. Newly diagnosed patients will receive the vaccine in conjunction with standard radiochemotherapy. This vaccine differs from other autologous (from the same patient) dendritic cell vaccines in that the lysate is not derived from the patient’s tumour, but from an allogeneic glioblastoma stem cell line. The trial started in December 2013. The principal investigator is Jethro Hu. Estimated primary completion date: October 2018. Allogeneic tumour lysate.
NCT02010606

Adjuvant Dendritic-Cell Immunotherapy Plus Temozolomide Following Surgery and Chemoradiation in Patients With Newly Diagnosed Glioblastoma (ADDIT-GLIO). Antwerp, Belgium. Estimated primary completion date: December 2017.
NCT02649582

An Open Label, Randomised, Phase II Study to Investigate the Efficacy and Safety of ALECSAT Treatment as an add-on Therapy to Radiotherapy and Temozolomide in Patients With Newly Diagnosed Glioblastoma. Recruiting in Göteborg, Sweden. Estimated primary completion date: January 2020. ALECSAT is an acronym for Autologous Lymphoid Effector Cells Specific Against Tumor cells.
NCT02799238

Immune checkpoint inhibitors

A Phase II, Open-label, Single Arm, Multicenter Study of Avelumab [antibody against PD-L1] With Hypofractionated Radiation in Adult Subjects With Transformed IDH Mutant Glioblastoma. New York NY. Estimated primary completion date: February 2019.
NCT02968940

A Randomized Phase 3 Open Label Study of Nivolumab vs Temozolomide Each in Combination With Radiation Therapy in Newly Diagnosed Adult Subjects With Unmethylated MGMT Glioblastoma (CheckMate 498). Locations in the USA, Australia, Austria, Belgium, Canada, Germany, Netherlands, Poland, Spain, Switzerland, United Kingdom. Estimated primary completion date: March 2019.
NCT02617589

Phase I Study of Temozolomide in Combination With Ipilimumab and/or Nivolumab in Treating Patients With Newly Diagnosed Glioblastoma or Gliosarcoma. San Francisco CA, Atlanta GA, Bethesda MD, Boston MA, New York NY, Cleveland OH, Houston TX. Estimated primary completion date: May 2016. Recruitment suspended as of May 2016.
NCT02311920

Suicide gene and immune-mediated gene therapy hybrid

Combined Cytotoxic and Immune-Stimulatory Therapy for Glioma (Dose Escalation of Ad-hCMV-TK and Ad-hCMV-Flt3L gene therapy). Phase I. Ann Arbor, USA. Estimated primary completion date: December 2018.
For newly diagnosed patients who haven’t yet had surgery. This trial is focused on GBM. I was told by the trial contact person that if the patient has a pre-operative biopsy and results come back as anaplastic astrocytoma, the patient would most likely be excluded. On the other hand, if the intraoperative diagnosis of anaplastic astrocytoma is made, the patient would receive the shots regardless. If intraoperative diagnosis is low grade glioma, the patient will not receive the shots. This therapy was highly effective in a syngeneic rat glioma model. This trial is testing a dual gene therapy, using adenoviral vectors to deliver two therapeutic genes to the tumour cells. The adenoviral vectors are infused into the peritumoral area at the time of surgery. One of the therapeutic genes is herpes simplex virus thymidine kinase (HSV1-TK). This is a viral enzyme which converts an inactive prodrug (in this case valacyclovir, administered 1-3 days after adenoviral vector delivery) into a cytotoxic drug which inhibits DNA replication. The second gene, Flt3L, causes maturation and proliferation of dendritic cells and natural killer cells. It is thought that the HSV1-TK/valacyclovir mediated death of tumour cells will expose tumour antigens, activating a subsequent antitumour immune response which will be aided by the Flt3L gene. Standard radiation and chemotherapy will follow the experimental gene therapy.
NCT01811992

Fluorescence-guided resection

Fluorescence-Guided Detection of Malignant Gliomas: A Dose Ranging Study Using 5-Aminolevulinic Acid (ALA) Induced Protoporphyrin (PpIX) in a Multicenter Phase II Clinical Trial. Cleveland, Ohio, USA. Estimated primary completion date: May 2017.
NCT00752323

More trials of fluorescence-guided resection found on Currently Recruiting Trials for High Grade Glioma.

Recurrent and progressive

Vaccines and cell therapies – recurrent

A Phase I/II Clinical Trial of Autologous Cytomegalovirus (CMV)-Specific Cytotoxic T Cells for Glioblastoma (GBM) Patients. MD Anderson – Houston TX. Estimated primary completion date: June 2020.
For newly diagnosed GBM post-radiotherapy and temozolomide, and for recurrent GBM.
NCT02661282

Phase I Trial of Vaccination With Autologous Dendritic Cells Pulsed With Lysate Derived From an Allogeneic Glioblastoma Stem-like Cell Line for Patients With Newly Diagnosed or Recurrent Glioblastoma. This trial is recruiting newly diagnosed or recurrent glioblastoma patients at Cedars-Sinai Medical Center in Los Angeles. Newly diagnosed patients will receive the vaccine in conjunction with standard radiochemotherapy. This vaccine differs from other autologous (from the same patient) dendritic cell vaccines in that the lysate is not derived from the patient’s tumour, but from an allogeneic glioblastoma stem cell line. The trial started in December 2013. The principal investigator is Jethro Hu. Estimated primary completion date: October 2018. Prior and/or continued bevacizumab therapy is allowed
NCT02010606

Randomized, open-label
Heat Shock Protein-Peptide Complex-96 (HSPPC-96) Vaccine Given With Bevacizumab Versus Bevacizumab Alone in the Treatment of Surgically Resectable Recurrent Glioblastoma Multiforme. Randomized Phase II. The Alliance of Clinical Trials in Oncology, National Cancer Institute, and Agenus, Inc. (maker of the Prophage vaccine) are conducting this randomized phase II trial, with 74 participating study locations in the USA and an estimated enrollment of 222 patients. The Prophage vaccine used in this trial, heat-shock protein peptide complex-96 (HSPPC-96) is created from the patient’s tumor, resulting in a personalized vaccine which activates an immune response to the tumor antigens bound to HSP-96. To be eligible for this trial, patients must therefore undergo surgical tumor resection to acquire sufficient tumor tissue to create the vaccine. Patients are randomized into one of three arms: experimental arm 1 receives concomitant bevacizumab and HSPPC-96 vaccine; experimental arm 2 receives the vaccine alone followed by bevacizumab alone at the time of disease progression; the comparator group (arm 3) receives intravenous bevacizumab alone, without vaccine. A phase II trial of HSPPC-96 (Prophage) vaccine alone in recurrent glioblastoma was recently published in Neuro-Oncology. Estimated primary completion date: July 2017. No prior treatment with any anti-angiogenic agent targeting the VEGF pathway including but not limited to bevacizumab
NCT01814813

Placebo-controlled
A Randomized, Double-blinded, Placebo-controlled Study of (ERC1671/GM-CSF/Cyclophosphamide) + Bevacizumab vs. (Placebo Injection/Placebo Pill) + Bevacizumab in the Treatment of Recurrent, Bevacizumab naïve Glioblastoma Multiforme Patients. University of California, Irvine. Estimated primary completion date: March 2019. For recurrent/progressive, bevacizumab-naïve glioblastoma multiforme and gliosarcoma.
NCT01903330

Pilot Study of Autologous T Cells Redirected to EGFRVIII-With a Chimeric Antigen Receptor in Patients With EGFRVIII+ Glioblastoma. Recruiting in San Francisco CA. Estimated primary completion date: July 2017.
NCT02209376

Oncolytic Virotherapy Trials – Recurrent

A Phase II, Multi-center, Open-label Study of a Conditionally Replicative Adenovirus (DNX-2401) With Pembrolizumab (KEYTRUDA®) for Recurrent Glioblastoma or Gliosarcoma (CAPTIVE/KEYNOTE-192)
Recruiting in Salt Lake City UT, Little Rock AR, New York NY, Toronto Canada. Estimated primary completion date: December 2019.
NCT02798406

Poliovirus Vaccine for Recurrent Glioblastoma Multiforme (PVS-RIPO). Duke University, Durham, North Carolina, United States. Phase I. Estimated primary completion date: January 2017. Bevacizumab not allowed less than 4 weeks prior to PVS-RIPO infusion.
NCT01491893

Immune enhancing drugs – Recurrent

A Phase I Trial of Anti-LAG-3 or Anti-CD137 (Urelumab) Alone and in Combination With Anti-PD-1 in Patients With Recurrent GBM. This is a dose finding study to find the maximum tolerated dose of the anti-LAG3 antibody, urelumab, and the combination of these with nivolumab. Estimated primary completion date: August 2018. Birmingham AL, Los Angeles CA, San Francisco CA, Baltimore MD, New York NY, Winston-Salem NC, Cleveland OH, Philadelphia PA, Pittsburgh PA.
NCT02658981

A Pilot Study to Evaluate the Feasibility of the Combined Use of Stereotactic Radiosurgery (Gamma knife) With Nivolumab and Concurrent Valproate in Patients With Recurrent Glioblastoma. University of Virginia. Estimated primary completion date: February 2018.
NCT02648633

A Phase 1a/1b Study of FPA008 in Combination With Nivolumab in Patients With Selected Advanced Cancers. Detroit MI, San Antonio TX. Estimated primary completion date: March 2018.
NCT02526017

Gene therapy – Recurrent

Phase II Study of Combined Temozolomide and Targeted P53 Gene Therapy (SGT-53) for Treatment of Patients With Recurrent Glioblastoma. Houston TX. Estimated primary completion date: December 2017.
Prior chemotherapy for recurrent GBM with nitrosourea compounds including Gliadel® wafers or bevacizumab excluded
NCT02340156

Other

An Open-Label, Phase 1/2A Dose Escalation Study of Safety and Efficacy of NEO100 (Perillyl alcohol) in Recurrent Grade IV Glioma. Currently recruiting in Cleveland OH. Not yet recruiting at University of Southern California (Los Angeles), Seattle WA, Madison WI. Estimated primary completion date: June 2018.
NCT02704858

Phase 2 Study of Sym004 for Adult Patients With Recurrent Glioblastoma. “The purpose of this study is to assess the activity of Sym004, a recombinant antibody mixture that specifically binds to EGFR, in patients diagnosed with recurrent glioblastoma whose tumor is EGFR amplified.” Duke University. Estimated primary completion date: October 2018.
NCT02540161

Not yet recruiting

A Randomized Phase 2 Study of Oncolytic Polio/Rhinovirus Recombinant (PVSRIPO) Alone or in Combination With Lomustine in Recurrent WHO Grade IV Malignant Glioma Patients. Duke University, North Carolina. Study start date: March 2017.
NCT02986178

A Toll-like Receptor Agonist as an Adjuvant to Tumor Associated Antigens (TAA) Mixed With Montanide ISA-51 VG With Bevacizumab for Patients With Recurrent Glioblastoma. New York NY. Study start date: March 2017.
NCT02754362