MK-3475 in Combination With MRI-guided Laser Ablation in Recurrent Malignant Gliomas

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

55

Participants

Timeline

Start Date

August 5, 2015

Primary Completion Date

April 15, 2024

Study Completion Date

April 15, 2024

Conditions
Malignant Glioma
Interventions
BIOLOGICAL

MK-3475

Patients currently on pembrolizumab beyond the 2 year/35 cycle limit at the time of the approval of Amendment 13 (approved 07/28/2021) may continue to receive pembrolizumab unless there is progression, toxicity or agreement by the patient and PI to come off therapy. Participants who discontinue pembrolizumab after receiving 35 doses are eligible for retreatment with pembrolizumab if they progress during follow-up provided they meet the requirements. Participants may receive an additional 17 cycles (12 months) of pembrolizumab during the Second Course Phase (Retreatment).

DEVICE

MRI-guided laser ablation

MLA is a minimally invasive laser surgery, which employs a small incision in the scalp and skull, through which a thin laser probe is inserted and guided by MR imaging to the core of the tumor mass where it delivers hyperthermic ablation from the core to the rim.

Trial Locations (2)

32611

University of Florida, Gainesville

63110

Washington University School of Medicine, St Louis

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

Washington University School of Medicine

OTHER

NCT02311582 - MK-3475 in Combination With MRI-guided Laser Ablation in Recurrent Malignant Gliomas | Biotech Hunter | Biotech Hunter