A Surgical "Window-of-Opportunity" and Phase II Trial of Pembrolizumab, Olaparib and Temozolomide in Recurrent Glioblastoma
L. Nicolas Gonzalez Castro, MD, PhD
Summary
This research study is studying a combination therapy as a possible treatment for recurrent glioblastoma (GBM), a brain tumor that is growing or progressing despite earlier treatment. The names of the study interventions involved in this study are/is: * Pembrolizumab * Olaparib * Temozolomide (Temodar)
Description
This is an open label, multi-center, phase II trial evaluating the safety and efficacy of olaparib, temozolomide and pembrolizumab in participants with recurrent glioblastoma at their first or second relapse. The U.S. Food and Drug Administration (FDA) has not approved pembrolizumab or olaparib for recurrent glioblastoma, but both have been approved for other uses. Pembrolizumab is an antibody designed to block the action of the receptor, PD-1. PD-1 works to help tumor cells inhibit the immune system's response against a tumor. Olaparib is an inhibitor of PARP (poly \[adenosine diphosphate-r…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participants must be able to understand and willing to sign a written informed consent document. * Participants must be able to adhere to the dosing and visit schedules and agree to record medication times accurately and consistently in a daily diary. * Participants must be at least 18 years old on day of signing informed consent. * Women of childbearing potential are eligible to participate if they are not pregnant or breastfeeding. * Participants must have a Karnofsky Performance Status (KPS) ≥ 70 and Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1 (se…
Interventions
- DrugPembrolizumab
Intravenous infusion
- DrugOlaparib
Pill taken by mouth
- DrugTemozolomide
Pill taken by mouth
Locations (4)
- Massachusetts General HospitalBoston, Massachusetts
- Beth Israel Deaconess Medical CenterBoston, Massachusetts
- Dana-Farber Cancer InstituteBoston, Massachusetts
- Memorial Sloan Kettering Cancer CenterNew York, New York