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OncoMatch/Clinical Trials/NCT06325683

Anti-Lag-3 (Relatlimab) and Anti-PD-1 Blockade (Nivolumab) Versus Standard of Care (Lomustine) for the Treatment of Patients With Recurrent Glioblastoma

Is NCT06325683 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Nivolumab and Relatlimab for progressive glioblastoma.

Phase 2RecruitingNational Cancer Institute (NCI)NCT06325683Data as of May 2026

Treatment: Lomustine · Nivolumab · RelatlimabThis phase II trial compares the safety, side effects and effectiveness of anti-lag-3 (relatlimab) and anti-PD-1 blockade (nivolumab) to standard of care lomustine for the treatment of patients with glioblastoma that has come back after a period of improvement (recurrent). Relatlimab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Lomustine is a chemotherapy drug and in a class of medications called alkylating agents. It damages the cell's deoxyribonucleic acid and may kill tumor cells. Giving relatlimab and nivolumab may be safe, tolerable, and/or effective compared to standard of care lomustine in treating patients with recurrent glioblastoma.

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Extracted eligibility criteria

Cancer type

Glioblastoma

Biomarker criteria

Required: IDH1 wild-type

Prior therapy

Must have received: radiation therapy — first-line

Patients must be in first recurrence of glioblastoma following radiation therapy and temozolomide

Must have received: temozolomide (temozolomide) — first-line

Patients must be in first recurrence of glioblastoma following radiation therapy and temozolomide

Cannot have received: anti-PD-1 therapy (nivolumab)

No prior use of nivolumab or other anti-PD1 agents

Lab requirements

Blood counts

Absolute lymphocyte count (ALC): ≥ 1000/mm^3; Absolute neutrophil count (ANC): ≥ 1500/mm^3; Platelet count: ≥ 100,000/mm^3; Hemoglobin: ≥ 9.0 g/dL; Activated partial thromboplastin time (APTT) or partial thromboplastin time (PTT): ≤ 1.5 x upper limit of normal (ULN)

Kidney function

Calculated (calc.) creatinine clearance (CrCl): ≥ 50 mL/min (Calculated by Cockcroft-Gault equation)

Liver function

Total bilirubin: < 2.0 x ULN (Except for patients with Gilbert's syndrome, who must have direct bilirubin < 2.0 x ULN); AST/ALT: < 3.0 x ULN

Absolute lymphocyte count (ALC): ≥ 1000/mm^3; Absolute neutrophil count (ANC): ≥ 1500/mm^3; Platelet count: ≥ 100,000/mm^3; Hemoglobin: ≥ 9.0 g/dL; Activated partial thromboplastin time (APTT) or partial thromboplastin time (PTT): ≤ 1.5 x upper limit of normal (ULN); Total bilirubin: < 2.0 x ULN (Except for patients with Gilbert's syndrome, who must have direct bilirubin < 2.0 x ULN); Aspartate aminotransferase (AST) / alanine aminotransferase (ALT): < 3.0 x ULN; Calculated (calc.) creatinine clearance (CrCl): ≥ 50 mL/min

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro · Jonesboro, Arkansas
  • Sutter Auburn Faith Hospital · Auburn, California
  • City of Hope Comprehensive Cancer Center · Duarte, California
  • Kaiser Permanente Dublin · Dublin, California
  • Kaiser Permanente-Fremont · Fremont, California

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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