(2-THE-TOP) Phase 2, Single Arm, Historically Controlled Study Testing The Safety and Efficacy of Adjuvant Temozolomide Plus TTFields (Optune®) Plus Pembrolizumab in Patients with Newly Diagnosed Glioblastoma

Purpose

Glioblastoma multiforme (GBM) is the most common and deadliest primary malignant neoplasm of the central nervous system in adults. Despite an aggressive multimodality treatment approach including surgery, radiation therapy and chemotherapy, overall survival remains poor. Pembrolizumab has recently been approved in the United States for the treatment of patients with advanced and metastatic non-small cell lung cancer, recurrent or metastatic head and neck squamous cell carcinoma, locally advanced urothelial carcinoma, classical Hodgkin lymphoma, unresectable or metastatic melanoma

This study is being performed to determine whether the triple combination of pembrolizumab when added to TTFields (Optune®) and adjuvant temozolomide increases progression-free survival (PFS) in patients with newly diagnosed GBM as compared to historical control data.

Eligibility

  • Ages 18 - 80 years old
  • Disease: Brain tumor
  • Disease type: Newly diagnosed Glioblastoma Multiforme (GBM)
For additional information about eligibility criteria, please contact the study coordinator

Deborah Sampson (deborah.sampson@neurosurgery.ufl.edu

(352) 273-9000

Procedures

  • Drugs: Optune, Pembrolizumab, Temozolomide
  • Drug types: Immunotherapy, Chemotherapy
For additional information about study procedures, please contact the study coordinator Deborah Sampson (deborah.sampson@neurosurgery.ufl.edu

(352) 273-9000

Age

18 to 65
65 and over

Gender

Male
Female

Can be done from home

No

Keywords

Brain tumor - primary - adults, Brain Tumors, Brain Tumor

Principal Investigator

David Tran, MD, PhD

Department

Neurosurgery

Contact Information

deborah.sampson@neurosurgery.ufl.edu

(352) 273-9000

Begin a new search for other research studies

Studies listed on this site have been approved by a UF Institutional Review Board (IRB), which works to ensure the welfare and rights of research participants as required by federal regulations. Study listings are provided by the UF Clinical and Translational Science Institute in collaboration with UF research teams and the UF IRBs.

Be an Informed Participant

Before deciding to participate in a research study, take time to learn about clinical research, how it's conducted and your rights as a research participant. Following are some helpful resources from independent sources. Always remember that a clinical research study is research, not treatment.

Know Who to Contact

  • Eligibility: For questions about a specific study and who is eligible to participate, call or email the contact person listed for that study.
  • Your Rights: For questions about your rights as a research participant, contact the UF Institutional Review Boards at 352-273-9600.
  • Feedback: For general questions or feedback about study listings, email the UF Clinical and Translational Science Institute at UFStudies@health.ufl.edu.

Other Resources

  • HealthStreet: Health-focused services, classes and events, and opportunities to participate in research.
  • ResearchMatch.org: Join a national registry of volunteers willing to be contacted about research studies.

For Research Teams