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Testing GI-102 with and without pembrolizumab before surgery for a returning grade 4 brain tumor

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

The short version

This trial tests a new immune drug, given before surgery, for a grade 4 brain tumor that has come back or is growing.

Read our full plain-language summary

What the trial team says

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.

Key facts

Registry number

NCT07301268

Stage of testing

Phase 2

Conditions studied

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

Where it is running

This trial lists 1 site.

• Minnesota
  • Mayo Clinic in Rochester (Rochester)

This page is built from the trial's listing on ClinicalTrials.gov, a service of the U.S. National Library of Medicine. That listing is the authority, and it may have changed since we last read it. We do not run this trial and we cannot enroll you in it.