Nivolumab + Relatlimab for Glioblastoma
(GIANT Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, it mentions that patients cannot be on certain treatments like immunosuppressive medications or anticoagulation therapy close to the trial start. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the drug Nivolumab + Relatlimab for Glioblastoma?
Is Nivolumab + Relatlimab safe for humans?
Nivolumab, used alone or with other drugs, has been generally safe in humans, but it can cause some serious side effects like liver injury and aplastic anemia (a condition where the body stops producing enough new blood cells). Nivolumab combined with Relatlimab has shown a manageable safety profile in patients with melanoma.15678
How is the drug Nivolumab + Relatlimab unique for treating glioblastoma?
Nivolumab + Relatlimab is unique because it combines two immune checkpoint inhibitors, which are designed to enhance the body's immune response against cancer cells. This approach is different from traditional treatments as it specifically targets the immune system to fight glioblastoma, a strategy that has shown promise in other types of cancer.4591011
What is the purpose of this trial?
GIANT is an open-label, multi-center, randomized, perioperative (neoadjuvant followed by adjuvant), phase 2 trial with a safety lead-in phase to investigate the feasibility, safety and tolerability, and establish the biological activity of nivolumab with or without relatlimab in patients with isocitrate dehydrogenase (IDH) wildtype newly diagnosed glioblastoma (ndGBM).
Eligibility Criteria
This trial is for adults with a new diagnosis of glioblastoma, which is an aggressive type of brain cancer. Participants must have a specific genetic feature in their tumor (IDH wildtype). Details on who can't join are not provided here.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Neoadjuvant Treatment
Patients receive a single dose of nivolumab with or without relatlimab followed by tumor resection
Part 1 Adjuvant Treatment
Patients receive nivolumab and relatlimab with concomitant radiation and TMZ for MGMT methylated patients
Part 2 Adjuvant Treatment
Continuation of nivolumab and relatlimab with TMZ for up to 6 cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Nivolumab
- Relatlimab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Duke University
Lead Sponsor