Study on Relatlimab and Nivolumab Versus Lomustine for Treating Recurrent Glioblastoma

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06325683

Provider View

This clinical trial is comparing two treatments for glioblastoma that has returned after initial improvement. It tests the safety and effectiveness of a combination of two drugs, relatlimab and nivolumab, against the standard chemotherapy drug lomustine.

Patient Parameters

Program Overview

This study aims to find out if a combination of two drugs, relatlimab and nivolumab, is safer and more effective than the standard chemotherapy drug lomustine for treating glioblastoma that has come back after treatment. Relatlimab and nivolumab are designed to help the immune system fight cancer cells, while lomustine is a chemotherapy drug that works by damaging the DNA of cancer cells. The study will compare how long patients live, how long they live without the cancer getting worse, and how well the treatments work in shrinking the tumors.

Description

The main goal of this study is to compare how long patients live after treatment with either the combination of relatlimab and nivolumab or the standard treatment with lomustine. Researchers will also look at how long patients live without their cancer getting worse, how well the tumors respond to the treatments, and the safety of the treatments.

Participants will be randomly assigned to one of two groups:

  • Group 1: Patients will receive nivolumab and relatlimab through an IV drip every 28 days, as long as the treatment is working and not causing unacceptable side effects. They will also have surgery or a biopsy, MRI scans, and blood tests during the study.

  • Group 2: Patients will take lomustine by mouth every 42 days, as long as the treatment is working and not causing unacceptable side effects. They will also have surgery or a biopsy, MRI scans, and blood tests during the study.

After finishing the study treatment, patients will have follow-up visits every 6 months for up to 5 years.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with glioblastoma that has come back after initial treatment.
  • No specific genetic mutation (IDH mutation) in the tumor.
  • Glioblastoma must have returned after radiation therapy and temozolomide treatment.
  • No previous treatment with nivolumab or similar drugs.
  • Must be stable without needing steroids for at least 5 days before joining the study.
  • Age 18 or older.
  • Able to care for themselves with occasional help.
  • Meet specific blood count and organ function requirements.
  • Not pregnant or breastfeeding, and willing to use birth control if of childbearing potential.
  • No active brain metastases or certain other medical conditions.
  • HIV-positive patients can join if their viral load is undetectable.
  • Hepatitis B and C patients can join if their infections are under control.
  • Able to swallow pills and have no severe lung disease or autoimmune disorders requiring treatment.

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