Checkpoint Inhibitor

Nivolumab + Relatlimab for Glioblastoma (GIANT Trial)

Durham, NC

Phase 2

Waitlist Available

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adults ≥ 18 years of age

Patients with a previous diagnosis of GBM and who have not received prior RT or chemotherapy

Must not have

Contraindication to surgery

Recent SARS-CoV-2 infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of registration up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

"This trial is testing the safety and effectiveness of nivolumab with or without relatlimab in patients with a specific type of brain cancer called newly diagnosed glioblastoma. The goal is to

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Who is the study for?

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.Check my eligibility

What is being tested?

The GIANT study tests the combination of Nivolumab and Relatlimab immunotherapies with radiation and TMZ chemotherapy in patients with newly diagnosed glioblastoma. It's designed to see if this treatment is safe and how well it works.See study design

What are the potential side effects?

Potential side effects include immune-related reactions affecting various organs, infusion reactions similar to allergic responses, fatigue, skin issues, hormonal imbalances, and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have GBM and haven't had radiation or chemotherapy before.

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I use protection during sex and do not donate sperm.

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My MRI suggests I might have a brain tumor called GBM.

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I am fully active or can carry out light work.

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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot undergo surgery due to health risks.

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I have recently tested positive for COVID-19.

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I am currently being treated for another type of cancer.

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I have had a major surgery recently.

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I have had a stem cell or organ transplant before.

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My heart's pumping ability is below normal.

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I am able to understand and follow the study's requirements.

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My tumor cannot be completely removed by surgery.

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My tumor is located in the cerebellum, brainstem, or deep basal ganglia.

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I have received immunotherapy before.

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I have had myocarditis in the past.

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I need urgent surgery for my condition.

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I cannot or do not want to have an MRI.

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I have not received a live vaccine in the last 4 weeks.

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I am not on high doses of immunosuppressive medications.

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I have active tuberculosis.

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I have a history of lung conditions.

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I have not had a severe infection in the last 4 weeks.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of registration up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of registration up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of registration up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Assess the feasibility of undertaking a peri-operative study of nivolumab with or without relatlimab in patients with ndGBM (Newly diagnosed Glioblastoma)

Assess the safety of concomitantly administering nivolumab, relatlimab, RT, and TMZ in MGMT methylated patients by monitoring adverse events utilizing CTC Version 5.0 criteria

Establish the biological activity of nivolumab with or without relatlimab in patients with ndGBM by demonstrating the presence of Tumor-infiltrating lymphocytes (TILs) in the resected tumor

Secondary study objectives

Assess the safety of nivolumab and relatlimab in combination with standard of care chemoradiation in patients with ndGBM.

Assess the safety of planned craniotomy and resection after stereotactic biopsy and treatment with nivolumab with or without relatlimab in patients with ndGBM

Describe Overall Survival (OS) and Progression Free Survival (PFS) of patients who have been randomized or assigned (as in the Stage 1 safety lead-in) or randomized (Stage 2) to receive neoadjuvant nivolumab administered with or without relatlimab

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Nivolumab and RelatlimabExperimental Treatment4 Interventions

In Arm 2 and Safety Lead-In phase, patients will receive treatment in 4 stages as below: 1. Neoadjuvant Treatment: Patient will receive a single dose of 480 mg by IV infusion with 480 mg of relatimab on Day 1. 2. Resection 3. Part 1 Adjuvant Treatment: Patient will receive 480 mg of nivolumab and 480 mg of relatimab for up to 12 cycles with concomitant radiation 2Gy/day (60 Gy in total). All MGMT methylated patients under Part 1 Adjuvant Treatment setting will also receive 75 mg/m2 TMZ from Day 1 to Day 42 orally. 4. Part 2 Adjuvant Treatment: Part 1 Adjuvant Treatment will continue without concomitant radiation.

Group II: NivolumabExperimental Treatment3 Interventions

4 stages of treatment on Arm 1 are: 1. Neoadjuvant Treatment: Patient will receive a single dose of 480 mg by IV infusion on Day 1. 2. Resection 3. Part 1 Adjuvant Treatment: Patient will receive 480 mg of nivolumab and 380 mg of relatimab for up to 12 cycles with concomitant radiation 2Gy/day (60 Gy in total). All MGMT methylated patients under Part 1 Adjuvant Treatment setting will also receive 75 mg/m2 TMZ from Day 1 to Day 42 orally. 4. Part 2 Adjuvant Treatment: Part 1 Adjuvant Treatment will continue without concomitant radiation.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

2014

Completed Phase 3

~3880

TMZ

2007

Completed Phase 3

~1530