Overview

GIANT (A Multi-Center, Randomized, Phase 2 Trial of Glioblastoma Immunotherapy Advancement with Nivolumab and Relatlimab) tests whether two immunotherapy drugs, nivolumab and relatlimab, can safely activate the immune system against newly diagnosed glioblastoma.

Participants receive immunotherapy before surgery, allowing researchers to examine the removed tumour and determine how the treatment affects immune activity. Treatment continues after surgery alongside radiotherapy and, where appropriate, temozolomide chemotherapy.

The study aims to assess if the combination of treatments is safe , how the treatment behaves in the body, the effect on the tumour and potential benefit of this treatment approach.

How the trial works

Participants will receive nivolumab alone or nivolumab plus relatlimab by a drip into a vein (IV infusion) before surgery, followed by nivolumab and relatlimab alongside radiotherapy, with or without temozolomide chemotherapy (tablet).

Researchers collect blood, tumour and fluid samples to study:

• Whether the drug reaches the tumour
• How it affects tumour cells
• Safety and side effects

This perioperative approach allows treatments to be studied directly in the tumour.

Who may be eligible

This study may be suitable for people who:

• Are aged 18 years or older
• Have a newly suspected or confirmed diagnosis of glioblastoma
• Have not received previous radiotherapy or systemic treatment for their brain tumour
• Require and are suitable for surgery to remove the tumour
• Are willing to undergo the study’s planned biopsy and surgical procedures
• Are otherwise sufficiently well to receive immunotherapy, surgery, radiotherapy and chemotherapy
• Meet the study’s blood test, organ function and other safety requirements

Your treating doctor will confirm whether this trial is suitable for you.

Participating Centres

Study Sponsor

Study Lead