GI-102 Alone or With Pembrolizumab Before Surgery for Treatment of Recurrent or Progressive IDH Wildtype Glioblastoma and IDH Mutated Grade 4 Astrocytoma

Summary

This phase II trial compares the effect of GI-102 alone and in combination with pembrolizumab given before surgery in treating patients with IDH wildtype glioblastoma and IDH mutated grade 4 astrocytoma that has come back after a period of improvement (recurrent) or that is growing, spreading, or getting worse (progressive). Glioblastoma is the most common and the most aggressive primary brain tumor in adults. Current standard of care includes surgical resection, radiation and chemotherapy. Treatment is often given before surgery (neoadjuvant therapy) to shrink the tumor and make it easier to remove. Treatment with GI-102, a bispecific fusion protein, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving GI-102 alone and in combination with pembrolizumab between neoadjuvant therapy and surgery may be safe, tolerable, and effective in treating patients with recurrent or progressive IDH wildtype glioblastoma and IDH mutated grade 4 astrocytoma.

Conditions

• Glioblastoma, IDH-Wildtype
• Progressive Astrocytoma, IDH-Mutant, Grade 4
• Progressive Glioblastoma
• Progressive Gliosarcoma
• Recurrent Astrocytoma, IDH-Mutant, Grade 4
• Recurrent Glioblastoma, IDH-Wildtype
• Recurrent Gliosarcoma
• Resectable Astrocytoma
• Resectable Glioblastoma

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

DRUG

Bispecific CD80-lgG4Fc-IL-2v Fusion Protein GI-102

Given IV

PROCEDURE

Computed Tomography

Undergo CT

PROCEDURE

Echocardiography Test

Undergo echocardiography

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

PROCEDURE

Multigated Acquisition Scan

Undergo MUGA

BIOLOGICAL

Pembrolizumab

Given IV

PROCEDURE

Surgical Procedure

Undergo surgery

Sponsors & Collaborators

• Mayo Clinic

  lead OTHER

Principal Investigators

• Jian L Campian, MD, PhD · Mayo Clinic

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-04-01

Primary Completion

2029-04-30

Completion

2034-04-30

FDA Drug

Yes

Countries

• United States

Study Locations