Alliance A072201

Clinical Trial Title Randomized Phase II Trial of Anti-Lag-3 and Anti-PD-1 Blockade vs. SOC in Patients with Recurrent Glioblastoma
Trial Status Open to Enrollment
Start Date 03/03/2025
Location hospitals
Trial Type Cancer - Adult Oncology
Specific Condition Brain Cancer
Description mThis 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.
Eligibility Criteria

Eligibility Criteria

  • Histologic Documentation: Histologically-proven glioblastoma (WHO 2021 criteria)
  • Stage: Progressive or recurrent disease per RANO criteria
  • No IDH mutation (IDH1 R132H negative by IHC or sequencing)
  • Patients must be in first recurrence of glioblastoma following radiation therapy and temozolomide.
  • No prior therapies except radiation, surgery, temozolomide, TTFields, and/or Gliadel wafers (placed during the first surgery at diagnosis of GBM). Prior radiation therapy, TTFields, or placement of Gliadel wafers must be completed at least 2 weeks prior to registration. Prior temozolomide must be completed at least 3 weeks prior to registration.
  • No prior use of nivolumab or other anti-PD1 agents.
  • Patients must be neurologically stable off corticosteroids for at least 5 days prior to registration.
  • Karnofsky Performance Status: ≥ 60% (i.e. patient must be able to care for themselves with occasional help from others)
  • Required Initial Laboratory Values:
  •   Absolute Lymphocyte Count (ALC): ≥ 1000/mm3
      Absolute Neutrophil Count (ANC): ≥ 1500/mm3
      Platelet Count: ≥ 100,000/mm3
      Hemoglobin: ≥ 9.0 g/dL
      APTT or PTT: ≤ 1.5 x upper limit of normal (ULN)
      Total Bilirubin: < 2.0 x ULN*
      AST / ALT: < 3.0 x ULN
      Calc. Creatinine Clearance (CrCl): ≥ 50 mL/min**

Please contact Legacy Oncology Research for additional study inclusion/exclusion information.
IRB Number Central IRB
Notes Study Details | NCT06325683 | Anti-Lag-3 (Relatlimab) and Anti-PD-1 Blockade (Nivolumab) Versus Standard of Care (Lomustine) for the Treatment of Patients With Recurrent Glioblastoma | ClinicalTrials.gov
Principal Investigator Mei Dong, MD
Contact Name Oncology Clinical Research
Contact Phone 503-413-8199
Contact Fax 503-413-6920
Contact E-Mail oncologyresearch@lhs.org