Randomized Phase II Trial of Anti-Lag-3 and Anti-PD-1 Blockade vs. SOC in Patients with Recurrent Glioblastoma

This 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 and nivolumab are monoclonal antibodies that 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 (DNA) and may kill cancer cells. Relatlimab and nivolumab may be safe, tolerable, and/or effective compared to standard of care lomustine in treating patients with recurrent glioblastoma.

In order to participate you must meet the following criteria:

• Have histologically-proven glioblastoma. (World Health Organization [WHO] 2021 criteria)
• Have progressive or recurrent disease per Response Assessment in Neuro-Oncology (RANO) criteria.
• Have no IDH mutation (IDH1 R132H negative by immunohistochemistry [IHC] or sequencing).
• Are in first recurrence of glioblastoma following radiation therapy and temozolomide.
• Have no prior therapies except radiation, surgery, temozolomide, Tumor Treating Fields (TTFields), and/or Gliadel wafers (placed during the first surgery at diagnosis of glioblastoma multiforme [GBM]). Prior radiation therapy, TTFields, or placement of Gliadel wafers must be completed at least 12 weeks prior to registration. Prior temozolomide must be completed at least 3 weeks prior to registration.
• Have no prior use of nivolumab or other anti-PD1 agents.

You will be excluded from the study if any of the following criteria apply to you: 

• Have a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
• Have no active brain metastases or leptomeningeal disease.
• Have no known medical condition causing an inability to swallow oral formulations of agents.

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.