Alliance 072201

Summary

Glioblastoma is the most aggressive form of primary brain cancer. It's also the most common, accounting for nearly half of all primary brain tumors. Typical signs of glioblastoma include headaches, nausea, vomiting, and drowsiness. In most cases, the exact underlying cause of this tumor is unknown, but some inherited conditions (for example, Li–Fraumeni syndrome, neurofibromatosis) can increase a person’s chances for developing it. 

The standard treatment for glioblastoma starts with surgery, to remove as much of the tumor as can be done safely. However, surgery typically doesn’t get all of the tumor. This is because glioblastoma often forms microscopic branches that spread throughout the brain. To control these tumor remnants, patients often receive radiation therapy and/or chemotherapy. These strategies may suppress tumor growth for years. However, because it's impossible to destroy all of the glioblastoma cells, the tumor eventually comes back (recurs).

The Alliance 072201 study investigates the safety and effectiveness of 2 new medications (relatlimab and nivolumab) for treating patients with recurrent glioblastoma. These 2 drugs boost the activity of special cells (T cells) that destroy abnormal cells, like cancer cells. Relatlimab and nivolumab may help the body’s immune system attack tumor cells, inhibiting their growth and spread.

Alliance 072201 compares the safety and effectiveness of the relatlimab–nivolumab combination treatment with lomustine, a standard chemotherapy drug for glioblastoma. Participants in Alliance 072201 are assigned to receive either relatlimab and nivolumab or lomustine. Nivolumab and relatlimab are given into a vein (through an IV. Lomustine is an oral medication (a pill). Throughout the study, all participants undergo surgery or biopsy, MRI, and blood sample collection. After the treatment phase, research team members will contact participants for follow-up activities every 6 months for up to 5 years.

To be included in Alliance 072201, participants must be / have

• Confirmed diagnosis of glioblastoma
• Progressive disease or first recurrence of glioblastoma after radiation therapy and temozolomide
• Neurologically stable
• Karnofsky Performance Status ≥ 60% (i.e., patient must be able to care for themselves with occasional help from others)
• Protocol-appropriate blood, kidney, and liver values

To be included in Alliance 072201, participants must not be / have

• IDH1 R132H mutation
• 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])
• Active brain metastases or leptomeningeal disease

Keywords
Brain tumor; Cancer; Glioblastoma; Lomustine; Nivolumab; Progressive glioblastoma; Recurrent glioblastoma; Relatlimab; Tumor