NCT05463848 · L. Nicolas Gonzalez Castro, MD, PhD
Surgical Pembro +/- Olaparib w TMZ for rGBM
What this study is about
This research study is studying a two or more treatments used together as a possible treatment for recurrent glioblastoma (GBM), a brain tumor that is growing or progressing despite earlier treatment.
View original scientific description
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.
Interventions
DRUG
Pembrolizumab
Intravenous infusion
DRUG
Olaparib
Pill taken by mouth
DRUG
Temozolomide
Pill taken by mouth
Primary outcome measures
Tumor infiltrating lymphocytes (TIL) Density
Time frame: At surgery. Surgery will occur 14 days +/- 5 days after initiation of treatment.
TIL density quantifies anti-tumor immune response. It is measured in tumor tissue from protocol surgery, analyzed by immunohistochemistry and by next generation sequencing.
6-month Progression-Free Survival (PFS6)
Time frame: 6 months after surgery. Surgery will occur 14 days +/- 5 days after initiation of treatment.
Progression-free survival based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) or death. PD defined by modified RANO as well as iRANO criteria, per protocol section 12.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 (see Appendix A).
- Participants must be able to swallow oral medications. Nature of illness and treatment history
- Participants must have histologically World Health Organization Grade IV IDH wildtype glioblastoma by IDHR132H immunohistochemistry or variants including gliosarcoma or IDH wildtype diffuse glioma with molecularly features of glioblastoma (EGFR amplification, TERT promoter mutation, or
Where
- Boston, Massachusetts
- New York, New York
Collaborators
Merck Sharp & Dohme LLC
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 4, 2026 · Source of record for eligibility and locations