Oncophage (Heat Shock Protein Peptide Complex-96) / Agenus - LARVOL DELTA

Radiation Therapy Plus Temozolomide and Pembrolizumab With and Without HSPPC-96 in Newly Diagnosed Glioblastoma (GBM) (clinicaltrials.gov) - P2 | N=90 | Terminated | Sponsor: National Cancer Institute (NCI) | Completed ➔ Terminated; Study closed early due to poor accrual.

Surgery • Trial termination • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • MGMT • PD-L1

Vaccine Therapy With Bevacizumab Versus Bevacizumab Alone in Treating Patients With Recurrent Glioblastoma Multiforme That Can Be Removed by Surgery (clinicaltrials.gov) - P2 | N=90 | Terminated | Sponsor: Alliance for Clinical Trials in Oncology | Active, not recruiting ➔ Terminated; DSMB futility analysis

Trial termination • Brain Cancer • CNS Tumor • Glioblastoma • Gliosarcoma • Oncology • Sarcoma • Solid Tumor

PROGNOSTIC VALUE OF PTEN LOSS IN NEWLY DIAGNOSED GBM PATIENTS TREATED WITH AUTOLOGOUS HEAT SHOCK PROTEIN VACCINE (SNO 2018) - "INTRODUCTION: The safety and efficacy of a heat shock protein peptide complex- 96 vaccine (HSPPC-96, Prophage) has been previously studied in phase II single-arm trials for the treatment of newly diagnosed and recurrent glioblastoma (GBM)... Retained PTEN expression was associated with extended survival in GBM patients treated with HSP vaccine. This finding suggests that PTEN loss may be associated with resistance to vaccine treatment and emphasizes the need for subgroup analysis in further immunotherapy studies."

Clinical • IO biomarker • Brain Cancer • Oncology • Solid Tumor

Radiation Therapy Plus Temozolomide and Pembrolizumab With and Without HSPPC-96 in Newly Diagnosed Glioblastoma (GBM) (clinicaltrials.gov) - P2 | N=90 | Completed | Sponsor: National Cancer Institute (NCI) | Active, not recruiting ➔ Completed | Trial completion date: Jan 2025 ➔ Dec 2022

Surgery • Trial completion • Trial completion date • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • MGMT • PD-L1

Radiation Therapy Plus Temozolomide and Pembrolizumab With and Without HSPPC-96 in Newly Diagnosed Glioblastoma (GBM) (clinicaltrials.gov) - P2; N=74; Active, not recruiting; Sponsor: National Cancer Institute (NCI); Recruiting ➔ Active, not recruiting; N=310 ➔ 74

Clinical • Enrollment change • Enrollment closed • Brain Cancer • Glioblastoma • Oncology • Solid Tumor • MGMT • MRI • PD-L1

GP96 Heat Shock Protein-Peptide Complex Vaccine in Treating Patients With Recurrent or Progressive Glioma (clinicaltrials.gov) - P1/2; N=96; Completed; Sponsor: University of California, San Francisco; N=41 ➔ 96

Clinical • Enrollment change • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor

Radiation Therapy Plus Temozolomide and Pembrolizumab With and Without HSPPC-96 in Newly Diagnosed Glioblastoma (GBM) (clinicaltrials.gov) - P2; N=310; Recruiting; Sponsor: National Cancer Institute (NCI); N=108 ➔ 310; Trial completion date: Jun 2024 ➔ Jan 2025; Trial primary completion date: Mar 2022 ➔ Jan 2023

Clinical • Enrollment change • Trial completion date • Trial primary completion date • Brain Cancer • Glioblastoma • Oncology • Solid Tumor • PD-L1

Vaccine Therapy With Bevacizumab Versus Bevacizumab Alone in Treating Patients With Recurrent Glioblastoma Multiforme That Can Be Removed by Surgery (clinicaltrials.gov) - P2; N=90; Active, not recruiting; Sponsor: Alliance for Clinical Trials in Oncology; Recruiting ➔ Active, not recruiting; N=165 ➔ 90

Enrollment change • Enrollment closed • Biosimilar • Oncology • Reperfusion Injury

Vaccine Therapy With Bevacizumab Versus Bevacizumab Alone in Treating Patients With Recurrent Glioblastoma Multiforme That Can Be Removed by Surgery (clinicaltrials.gov) - P2; N=90; Active, not recruiting; Sponsor: Alliance for Clinical Trials in Oncology; Trial primary completion date: Feb 2017 ➔ Feb 2019

Trial primary completion date • Biosimilar • Glioblastoma • Hematological Malignancies • Oncology • Reperfusion Injury

T cell receptor repertoire as a prognosis marker for heat shock protein peptide complex-96 vaccine trial against newly diagnosed glioblastoma. (PubMed, Oncoimmunology) - P1 | "Indeed, we discovered four TCR clones significantly enriched in the LTS group: the presence of these clones has predictive value for stratifying patients prior to vaccination. Together, these findings uncover a group of preexisting TCR clones shared in LTS that can be utilized as candidate biomarkers to select GBM patients most likely to durably respond to HSPPC-96 treatment."

IO Biomarker • Journal • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor

Heat shock protein peptide complex-96 vaccination for newly diagnosed glioblastoma: a phase I, single-arm trial. (PubMed, JCI Insight) - P1; "The HSPPC-96 vaccination, combined with the standard therapy, is a safe and effective strategy for treatment of newly diagnosed GBM patients. TSIR after vaccination would be a good indicator predicting the vaccine efficacy."

Journal • P1 data

Trial of Heat Shock Protein Peptide Complex-96 (HSPPC-96) Vaccine (clinicaltrials.gov) - P1; N=20; Recruiting; Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago; Trial completion date: May 2019 ➔ May 2020; Trial primary completion date: May 2018 ➔ May 2019

Clinical • Trial completion date • Trial primary completion date