Anti-Lag-3 (Relatlimab) and Anti-PD-1 Blockade (Nivolumab) Versus Standard of Care (Lomustine) for the Treatment of Patients With Recurrent Glioblastoma
Launched by NATIONAL CANCER INSTITUTE (NCI) · Mar 20, 2024
Trial Information
Current as of November 01, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment approach for patients with recurrent glioblastoma, a type of brain cancer that has come back after initial treatment. Researchers are comparing the effectiveness and safety of two drugs, relatlimab and nivolumab, which are designed to help the immune system fight cancer, against the standard chemotherapy drug lomustine. The goal is to see if the new treatment can provide better results with fewer side effects.
To be eligible for this trial, participants must be at least 18 years old and have a confirmed diagnosis of glioblastoma that has progressed after previous treatment. They should have received radiation and a specific chemotherapy called temozolomide before, and they must be stable without corticosteroids for at least five days prior to joining the study. Participants will receive regular medical check-ups throughout the trial to monitor their health and any side effects from the treatments. This trial is currently recruiting participants, and it aims to find new options for patients with this challenging condition.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Histologically-proven glioblastoma (World Health Organization \[WHO\] 2021 criteria)
- • Progressive or recurrent disease per Response Assessment in Neuro-Oncology (RANO) criteria
- • No IDH mutation (IDH1 R132H negative by immunohistochemistry \[IHC\] or sequencing)
- • Patients must be in first recurrence of glioblastoma following radiation therapy and temozolomide
- • 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 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
- • Age: ≥ 18 years
- • Karnofsky Performance Status: ≥ 60% (i.e. patient must be able to care for themselves with occasional help from others)
- • 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
- • Calculated by Cockcroft-Gault equation
- • Not pregnant and not nursing, because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown and an agent that has known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative pregnancy test done within 14 days prior to registration is required
- • Patients with 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
- • No active brain metastases or leptomeningeal disease
- • HIV: HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial
- • Hepatitis B: For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
- • Hepatitis C: Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
- • No known medical condition causing an inability to swallow oral formulations of agents
- • No current symptomatic pulmonary disease
- • No autoimmune disorders that require systemic treatment (except hyperthyroidism or diabetes mellitus)
About National Cancer Institute (Nci)
The National Cancer Institute (NCI) is a prominent component of the National Institutes of Health (NIH), dedicated to advancing cancer research and improving patient outcomes through innovative clinical trials. As a leading sponsor of cancer-related studies, NCI focuses on facilitating the development of new therapies, enhancing prevention strategies, and understanding the biology of cancer. The institute collaborates with academic institutions, healthcare providers, and industry partners to conduct rigorous clinical trials that aim to translate scientific discoveries into effective treatments. NCI’s commitment to fostering a robust research environment supports the mission to eliminate cancer as a major health problem.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
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Patients applied
Trial Officials
Michael Lim
Principal Investigator
Alliance for Clinical Trials in Oncology
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported