Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06816927

Trial of Glioblastoma Immunotherapy Advancement With Nivolumab and Relatlimab

Led by Duke University · Updated on 2026-01-09

92

Participants Needed

1

Research Sites

287 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

Trial of Glioblastoma Immunotherapy Advancement With Nivolumab and Relatlimab

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent approved by the IRB
  • Adults 18 years of age or older
  • Newly suspected diagnosis of glioblastoma based on MRI or previous diagnosis without prior radiation or systemic therapy
  • Require tumor resection as determined by neurosurgeon
  • Willing to undergo planned surgical procedures
  • Agree to provide biospecimens for research
  • If prior biopsy or surgery, must have adequate archival tissue or agree to repeat biopsy if needed
  • Hematological function: neutrophils ≥ 1.5 x 10^9/L, platelets ≥ 100 x 10^9/L, hemoglobin > 90 g/L, PT/PTT < 1.5 x ULN
  • Renal function: serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 40 ml/min
  • Hepatic function: total bilirubin ≤ 1.5 x ULN (up to 3.0 x ULN for Gilbert's Syndrome), ALP ≤ 2.5 x ULN, AST/ALT ≤ 2.5 x ULN, serum albumin ≥ 25 g/L
  • ECOG performance status 0-1
  • Life expectancy of at least 12 months
  • Negative HIV test at screening
  • Negative hepatitis B surface antigen or negative HBV DNA if positive
  • Negative hepatitis C antibody or negative HCV RNA if positive
  • Able to undergo brain MRI with and without contrast
  • Use highly effective contraception if of childbearing potential during treatment and 6 months after
  • Use condom and refrain from sperm donation if sexually active and able to produce sperm during study and 3 months after
  • Negative pregnancy test within 48 hours before starting treatment
  • Ability to follow study visits and procedures
Not Eligible

You will not qualify if you...

  • Tumor not suitable for gross total resection
  • Tumor located in cerebellum, brainstem, or deep basal ganglia
  • Require urgent surgery due to mass effect, edema, or hydrocephalus
  • Contraindications to or unwillingness to undergo MRI
  • History of central nervous system bleeding within 6 months
  • Contraindication to surgery
  • Current treatment with immunosuppressive medications except low-dose corticosteroids (≤ 2 mg/day dexamethasone)
  • Active autoimmune disease or immune deficiency
  • Active tuberculosis
  • COVID-19 infection within 4 weeks prior to screening
  • Acute intracranial or intratumoral hemorrhage needing urgent intervention
  • Severe infection within 4 weeks prior to registration
  • Live attenuated vaccine within 4 weeks prior or planned within 5 months after treatment
  • Prior unrelated malignancy requiring active treatment except certain skin and cervical cancers in remission for 2+ years
  • Major surgery other than diagnosis within 4 weeks prior
  • History or evidence of pneumonitis or pulmonary fibrosis except radiation fibrosis
  • Pregnant or breastfeeding
  • Prior allogeneic stem cell or organ transplant
  • Known allergy or sensitivity to study drugs or excipients
  • Any disorder impairing ability to consent or comply with study
  • History of myocarditis
  • Elevated troponin T or I above 2 times upper limit of normal
  • Left ventricular ejection fraction below 50%
  • Other significant medical conditions posing safety risk or interfering with study participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Duke University

Durham, North Carolina, United States, 27750

Actively Recruiting

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Research Team

M

Mustafa Khasraw

CONTACT

M

Monika Anand

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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