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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• NeuroBlate® Laser Ablation Laser Interstitial Thermal Therapy — DEVICE
  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.
• Cemiplimab — DRUG
  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.
• Chemotherapy — DRUG
  Adjuvant chemotherapy will be decided by the physician's choice of best fit by patient, including the agent(s), dosing, and schedule.

Study Details

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).

Key Dates

Start date

Aug 31, 2026

Status verified

May 2026

Primary completion

Feb 28, 2031

Completion

Aug 31, 2032

Study Design

Enrollment

99 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Experimental Arm: LiTT + Cemiplimab
  Patients in the Experimental Arm will receive adjuvant cemiplimab (at a dose of 350 mg intravenously (IV)) every 3 weeks after LiTT for a maximum total of 36 months (or until disease progression or intolerable adverse event). The first adjuvant dose of cemiplimab must be given within 14 days post-LiTT.
• Active Comparator: Control Arm: LiTT + adjuvant chemotherapy
  Patients in the Control Arm will undergo LiTT, then will receive adjuvant chemotherapy (chosen by their treating physician) for up to 12 months as per standard of care (SOC), starting within 14 days post-LiTT.

Primary Outcome Measure

Progression-free survival (PFS) at Month 6 (PFS6) [ Time Frame: Start of treatment through 6 months after start of treatment (month 6) ]

Central Contacts

• Omar H Butt, M.D., Ph.D.
  215-279-3388
  [email protected]

Locations (2)

Find similar trials in Rochester, MN

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