Sacituzumab Govitecan in Recurrent Glioblastoma
Trial Parameters
Brief Summary
This is an open-label single arm study. All patients will receive the study drug. The aim of the study is to compare overall survival (OS) of patients with recurrent brain tumor, known as Glioblastoma (GBM) having high levels of a protein, Trophoblast cell surface antigen 2 (Trop-2), expression on treatment with Sacituzumab Govitecan (SG) versus lomustine only which has been used in the past.
Eligibility Criteria
Inclusion Criteria: 1. At least 18 years of age. 2. Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's IRB/Ethics Committee. 3. Histologically confirmed IDH wild type (primary) GBM. Molecular GBM (as per cIMPACT-NOW 3) is allowed as is gliosarcoma and epithelioid glioblastoma. IDH-mutant glioma is not allowed. 4. Progression following standard combined modality treatment with radiation and temozolomide chemotherapy if O6-Methylguanine-DNA Methyltransferase (MGMT) methylated. * Prior temozolomide is not required for MGMT unmethylated, but patient must have received standard doses of radiation. * Inclusion of additional investigational therapy with standard frontline therapy is not exclusionary. No additional lines of therapy given for recurrent disease. * Prior tumor-treating field therapy is not excluded, nor considered and additional line of therapy as this is often given concurrently with other thera