Laser Interstitial Thermotherapy (LITT) Combined With Checkpoint Inhibitor for Recurrent GBM (RGBM)
NCT03277638 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 32
Last updated 2026-04-09
Summary
The purpose of this study is to test the side effects and efficacy of using Laser Interstitial Thermotherapy (LITT) combined with Pembrolizumab. LITT is a minimally invasive surgical technique that uses a laser to heat brain tumors.
Pembrolizumab is an investigational (experimental) drug that works by helping participants' immune system work correctly to detect and fight cancer cells. Pembrolizumab is experimental because it is not approved by the Food and Drug Administration (FDA), for this use, though it is approved to treat other cancers.
Conditions
- Glioblastoma, Adult
Interventions
- DRUG
-
Pembrolizumab at 7 days prior
Pembrolizumab injections 7 days before surgery
- DRUG
-
Pembrolizumab at 14 days post
Pembrolizumab injections 14 days after surgery
- DRUG
-
Pembrolizumab at 35 days post
Pembrolizumab injections 35 days after surgery
- PROCEDURE
-
Laser Interstitial Thermotherapy
surgical procedure to heat hard to reach tumors with a laser beam
Sponsors & Collaborators
-
Case Comprehensive Cancer Center
lead OTHER
Principal Investigators
-
Tiffany Hodges, MD · University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-11-29
- Primary Completion
- 2026-06-30
- Completion
- 2026-06-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Stereotactic Radiosurgery and Immunotherapy (Pembrolizumab) for the Treatment of Recurrent Meningioma
NCT04659811 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Recurrent GBM With Maximal Neurosurgical Removal and Treatment With IORT
NCT04763031 ·Status: TERMINATED ·Phase: NA
-
Assessment of Safety and Feasibility of ExAblate Blood-Brain Barrier (BBB) Disruption for Treatment of Glioma
NCT03616860 ·Status: COMPLETED ·Phase: NA
-
Intensity-Modulated Stereotactic Radiation Therapy in Treating Patients With Grade II-IV Glioma
NCT03251027 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
The Efficacy and Safety of Low-dose Radiotherapy Combined With Sintilimab and Temozolomide in Recurrent Glioblastoma
NCT06220552 ·Status: RECRUITING ·Phase: PHASE2
-
Trial of Anti-PD-1 Immunotherapy and Stereotactic Radiation in Patients With Recurrent Glioblastoma
NCT04977375 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Dose-Escalated Photon IMRT or Proton Beam Radiation Therapy Versus Standard-Dose Radiation Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma
NCT02179086 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Pembrolizumab for Newly Diagnosed Glioblastoma
NCT03899857 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Pembrolizumab in Treating Patients With Recurrent Glioblastoma
NCT02337686 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Phase IIa Safety and Light Dose-escalation Study in Patients With Primary or Recurrent/High-grade Glioma Using the Litx™ System to Confirm the Zone of Tumor Destruction During the Intraoperative Treatment of Glioma
NCT00409214 ·Status: COMPLETED ·Phase: PHASE2
-
Whole Brain Radiation Therapy With Standard Temozolomide Chemo-Radiotherapy and Plerixafor in Treating Patients With Glioblastoma
NCT03746080 ·Status: COMPLETED ·Phase: PHASE2
-
Biological Therapy and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
NCT00052715 ·Status: TERMINATED ·Phase: PHASE2
-
Exablate Blood-Brain Barrier Disruption With Carboplatin for the Treatment of rGBM
NCT04440358 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Radiation Therapy, Temozolomide, and Erlotinib in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
NCT00274833 ·Status: COMPLETED ·Phase: PHASE2
-
Exablate Blood-Brain Barrier Disruption for the Treatment of rGBM in Subjects Undergoing Carboplatin Monotherapy
NCT04417088 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Erlotinib and Temozolomide With Radiation Therapy in Treating Patients With Glioblastoma Multiforme or Other Brain Tumors
NCT00039494 ·Status: COMPLETED ·Phase: PHASE2
-
Super-selective Intra-arterial Repeated Infusion of Cetuximab for the Treatment of Newly Diagnosed Glioblastoma
NCT02861898 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
A Dose Finding Study of [177Lu]Lu-DOTA-TATE in Newly Diagnosed Glioblastoma in Combination With Standard of Care and in Recurrent Glioblastoma as a Single Agent.
NCT05109728 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
Radiation Boost for Newly Diagnosed Glioblastoma Multiforme
NCT00376103 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
Study to Evaluate Safety and Activity of Crizotinib With Temozolomide and Radiotherapy in Newly Diagnosed Glioblastoma
NCT02270034 ·Status: COMPLETED ·Phase: PHASE1
-
ExAblate Blood-Brain Barrier Disruption for Glioblastoma in Patients Undergoing Standard Chemotherapy
NCT03712293 ·Status: COMPLETED ·Phase: NA
-
The Assessment of Immune Response in Newly Diagnosed Glioblastoma Patients Treated With Pembrolizumab
NCT05235737 ·Status: RECRUITING ·Phase: PHASE4
-
Ketogenic Diet With Radiation and Chemotherapy for Newly Diagnosed Glioblastoma
NCT02046187 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
A Study of 177Lu-PSMA-617 in People With Gliomas
NCT07223034 ·Status: RECRUITING ·Phase: PHASE1
-
Surgical Tissue Flap to Bypass the Blood Brain Barrier in GBM
NCT03630289 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA