CURRENT RECRUITING TRIALS
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Glioblastoma (GBM) adaptive, global, innovative learning environment (GBM AGILE) is an international, seamless Phase II/III response adaptive randomization platform trial designed to evaluate multiple therapies in newly diagnosed (ND) and recurrent GBM.
INTRAGO II (Glioblastoma)
INTRAGO II resembles a multicentric, prospective, randomized, 2-arm, open-label clinical phase III trial which tests if the median progression-free survival (PFS) of patients with newly diagnosed glioblastoma multiforme (GBM) can be improved by the addition of intraoperative radiotherapy (IORT) to standard radiochemotherapy.
Orbus OT-15-0011 (Astrocytoma)
A Phase 3, Randomized, Open-Label Study To Evaluate the Efficacy and Safety of Eflornithine with Lomustine Compared to Lomustine Alone in Patients with Anaplastic Astrocytoma That Progress/Recur After Irradiation and Adjuvant Temozolomide Chemotherapy
The purpose of this study is to compare the efficacy and safety of eflornithine in combination with lomustine, compared to lomustine taken alone, in treating patients whose anaplastic astrocytoma has recurred/progressed after radiation and temozolomide chemotherapy.
This study will consist of 4 study periods of up to 50 months in total, consisting of:Screening Period – A maximum screening duration of 4 weeks.
Treatment Period – Treatment Arm A up to 24 months; Treatment Arm B up to 12 months.
End of Treatment Visit – A minimum of 4 weeks post last treatment for both arms.
Follow-Up Period – Up to 24 months.
A total of approximately 280 patients will be randomized in a 1:1 ratio to receive either eflornithine + lomustine or lomustine alone.
Dr. Kevin Petrecca
Dr. Scott Owen
CCTG CEC.6 (Low Grade Glioma)
CCTG CEC6 is a phase III trial designed for patients with 1p/19q co-deleted and IDH mutated Anaplastic Glioma or Low Grade Glioma.
Merck 3475-05A (Glioblastoma)
A Phase 2, Randomized, Open-Label Umbrella Platform Design of Investigational Agents With or Without Pembrolizumab or Pembrolizumab Alone in Participants with Glioblastoma.
Merck 3475-05A is a phase II trial that will enroll patients with recurrent and resectable IDH wild-type Glioblastoma
Histopathological Assessment of Brain Metastasis Invasion to Determine the Need for Surgical Resection Margin Stereotactic Radiosurgery (HABS): An investigator-initiated randomized non-inferiority trial.
HABS is a phase II study for patients with Breast Cancer, Melanoma & Lung Cancer Brain Metastases with minimally invasive histopathology. This clinical trial proposes withholding stereotactic radiosurgery (SRS) from a subset of patients with surgically resected brain metastases that may not benefit from it.
ACTIVE (NOT RECRUITING) TRIALS
A Randomized Phase 3 Single Blind Study of Temozolomide plus Radiation Therapy combined with Nivolumab or Placebo in Newly Diagnosed Adult Subjects with MGMT-Methylated (tumor O6-methylguanine DNA methyltransferase) Glioblastoma
The purpose of this study is to evaluate patients with glioblastoma that is MGMT-methylated (the MGMT gene is altered by a chemical change). Patients will receive temozolomide plus radiation therapy. They will be compared to patients receiving Nivolumab in addition to temozolomide plus radiation therapy.
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 (tumor O6-methylguanine DNA methyltransferase) Glioblastoma
The purpose of this study is to evaluate patients with glioblastoma that is MGMT-unmethylated (the MGMT gene is not altered by a chemical change). Patients will receive Nivolumab every two weeks in addition to radiation therapy, and then every four weeks. They will be compared to patients receiving standard therapy with temozolomide in addition to radiation therapy.
DCVax (Glioblastoma multiforme - GBM)
The primary purpose of this phase III study is to determine the efficacy and safety of an investigational therapy called DCVax(R)-L in patients with de novo glioblastoma (GBM) for whom surgery is indicated. Patients must enter screening at a participating site prior to surgical resection of the tumor. Patients will receive the standard of care, including radiotherapy and chemotherapy with Temozolomide, and two out of three will additionally receive DCVax(R)-L, with the remaining one third receiving a placebo. Patients randomized to the placebo arm will have the option to receive DCVax(R)-L in a crossover arm upon documented disease progression.
The experimental therapy is an immunotherapy treatment for GBM and uses a patient’s own tumor lysate and white blood cells from which precursors of the dendritic cells are isolated. The dendritic cell is the starter engine of the immune system. The white cells are then made into dendritic cells, and they are educated to “teach” the immune system how to recognize brain cancer cells. Eligible patients will receive a series of injections of DCVax(R)-L, to activate and then boost the immune response to the tumor cells.
A presentation with trial results is available at virtualtrials.org/dcvax.cfm