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Laser Interstitial Thermal Therapy (LiTT) With Cemiplimab or Other Chemotherapy in Recurrent Glioblastomas

NCT07620548 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2026-06-02

No results posted yet for this study

Summary

This study will assess the therapeutic efficacy of the combination of Laser Interstitial Thermal Therapy (LiTT) with adjuvant cemiplimab compared to the therapeutic efficacy of the combination of LiTT with physician's choice of adjuvant chemotherapy in patients with recurrent glioblastoma. Patients will be enrolled and randomized on a 2:1 ratio to either the experimental arm (LiTT + cemiplimab) or the control arm (LiTT + physician/s choice chemotherapy).

Conditions

  • Glioblastoma
  • Glioblastoma, IDH-wildtype
  • Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype

Interventions

DEVICE

NeuroBlate® Laser Ablation Laser Interstitial Thermal Therapy

LiTT, or magnetic resource imaging (MRI)-guided laser ablation, is a minimally invasive surgery approved for cytoreductive treatment of brain tumors. It employs a small incision in the scalp and skull, through which a thin laser probe is inserted and guided by MRI imaging to the core of a tumor mass where it delivers hyperthermic ablation from the core to the rim.

DRUG

Cemiplimab

Cemiplimab is a programmed death receptor-1 (PD-1)-blocking antibody that is administered intravenously at 350mg over 30 minutes every 3 weeks on an outpatient basis.

DRUG

Chemotherapy

Adjuvant chemotherapy will be decided by the physician's choice of best fit by patient, including the agent(s), dosing, and schedule.

Sponsors & Collaborators

Principal Investigators

  • Omar H Butt, M.D., Ph.D. · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2031-02-28
Completion
2032-08-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07620548 on ClinicalTrials.gov