Brain Schema March 2018

Transcription

1 Breast Cancer w/brain Mets / Lilly Abemaciclib PO Breast Ca or Melanoma mets allowed Leptomeningeal mets excluded Want brain met tissue Melanoma w/brain Mets / Bristol Myers Squibb Nivolumab + Ipilimumab followed by Nivolumab Prior therapy allowed Symptomatic cohort open

2 Nervous System Biorepository Protocol All CNS tumors (non treatment) Gliadel Wafer Patient Registry PRMS # Neurocognitive testing in adults with radiation treatment to their brain Olfactory Preservation in Meningioma Resection Brain mets all

3 /A Randomized Phase II/III of velaparib/placebo with adjuvant TMZ Patients must have MGMT promoter hypermethylation / AbbVie F Radiological Evident Treatment Effects in Subjects w/gbm Non treatment trial Previous treatment with ABT 414 required GBM First Line GBM /BeiGene Phase 1b/2 to assess safety, tolerability, and efficacy of BGB 290 in combo w/radiation and/or temozolomide in first line or recurrent/refractory glioblastoma first line patients must be MGMT unmethylated Given with radiation /Diffusion label, Randomized, Controlled, Phase 3 Safety and Efficacy Study of Tran Sodium Crocetinate (TSC) with Radiation Therapy and Temozolomide in Newly Diagnosed GBM Biopsy Only Subjects /Kazia Phase 2a study (Part 1): A phase 2a study to evaluate the safety, pharmacokinetics and clinical activity of the PI3K/mTOR inhibitor GDC 0084 administered to patients with glioblastoma multiforme characterized by unmethylated O6 methylguaninemethyltransferase promoter status Phase 2b study (Part 2): A randomized, open label, multicenter, phase 2b study to assess the efficacy and safety of the PI3K/mTOR inhibitor GDC 0084 compared to temozolomide as adjuvant therapy for the treatment of newly diagnosed glioblastoma multiforme with unmethylated O6 methylguanine methyltransferase promoter status following surgical resection and standard concomitant chemoradiation therapy with temozolomide Measurable disease required for expansion cohort required; non measurable allowed in doseescalation No prior treatment except Stupp Optune not allowed while on study Maintenance therapy

4 /Immunomedics Phase I Team/sponsor approval required IMMU 132 for epithelial cancers /BeiGene Phase 1b/2 to assess safety, tolerability, and efficacy of BGB 290 in combo w/radiation and/or temozolomide in first line or recurrent/refractory glioblastoma Recurrent/refractory setting can be MGMT methylated or unmethylated No prior systemic treatment except for TMZ GBM Recurrent GBM /UM1 LAO MAO36/10067 A randomized phase 2 trial of cediranib and olaparib compared to bevacizumab in patients with recurrent glioblastoma who have not received prior VEGF therapy First or second recurrence only No prior use of Parp inhibitors or treatment affecting the VEGF pathway /Tocagen Phase 2/3 of Toca 511, retroviral replicating vector, w/toca FC vs SOC for recurrent GBM or Anaplastic Astrocytoma for first or second recurrence Must be surgical candidates /Medicenna An Label Non Randomized, Multi Center Phase 2 Study of Convection Enhanced Delivery (CED) of MDNA55 in Adults with Recurrent or Progressive Glioblastoma Must be primary (de novo) GBM First or second recurrence Prior Bevacizumab, Gliadel wafers, and Optune are allowed

5 Recurrent Astrocytomas / Tocagen Phase 2/3 of Toca 511, retroviral replicating vector, w/toca FC vs SOC for first of second recurrence Oligodendriomas Meningiomas / A SMO/AKT/NF2 inhibitors for progressive meningiomas Any grade meningioma allowed Prior therapy allowed but not required NF2 cohorts for Grade I and Grade II/III are closed SMO/PTCH1 cohorts for Grade I and Grade II/III remain open

6 CNS Lymphoma / OHSU Maintenance Obinutuzumab for Primary Central Nervous System Lymphoma Complete Responders