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Monoclonal Antibodies

Relatlimab + Nivolumab for Recurrent Glioblastoma

Phase 2
Recruiting
Led By Michael Lim
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must be neurologically stable off corticosteroids for at least 5 days prior to registration
No active brain metastases or leptomeningeal disease
Must not have
No autoimmune disorders that require systemic treatment (except hyperthyroidism or diabetes mellitus)
No current symptomatic pulmonary disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

"This trial is comparing the safety and effectiveness of two new drugs, relatlimab and nivolumab, with a standard chemotherapy drug called lomustine for treating patients with recurrent glioblast

Who is the study for?
This trial is for adults over 18 with recurrent glioblastoma, confirmed by WHO criteria and RANO criteria. Participants must have stable neurological status without steroids for 5 days, a Karnofsky Performance Status of at least 60%, an ALC of ≥1000/mm^3, no IDH mutation, and are in their first recurrence post radiation therapy and temozolomide. Prior treatments should be completed within specific time frames before joining.
What is being tested?
The trial compares the safety and effectiveness of two monoclonal antibodies (Relatlimab & Nivolumab) against standard chemotherapy drug Lomustine in patients with recurrent glioblastoma. It aims to see if these antibodies can better inhibit tumor growth compared to traditional treatment.
What are the potential side effects?
Potential side effects include immune-related reactions due to antibody interference with cancer cell growth, which may affect organs or cause infusion reactions. Lomustine can damage DNA leading to cell death but also carries risks like fatigue, nausea, and blood disorders.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I haven't taken corticosteroids for 5 days before signing up.
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I do not have active brain tumors or cancer in the lining of my brain.
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My diagnosis is glioblastoma according to WHO 2021 criteria.
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My cancer does not have an IDH mutation.
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I am 18 years old or older.
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I can care for myself but sometimes need help.
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My brain tumor is growing or has come back.
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My glioblastoma has returned for the first time after treatment with radiation and temozolomide.
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I've only had radiation, surgery, temozolomide, TTFields, or Gliadel wafers for my GBM.
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I have never been treated with nivolumab or similar drugs.
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My kidney function, measured by creatinine clearance, is good.
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I am not pregnant or nursing and, if capable of becoming pregnant, I have a recent negative pregnancy test.
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My chronic hepatitis B virus load is undetectable with treatment.
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I had hepatitis C but am cured, or I'm being treated with no detectable virus.
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I can swallow pills without any medical issues.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any autoimmune diseases needing treatment, except possibly thyroid issues or diabetes.
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I do not have any lung problems causing symptoms.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
OS rate
Overall survival (OS)
Secondary study objectives
Incidence of adverse events (AEs)
Radiographic response

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (nivolumab, relatlimab)Experimental Treatment6 Interventions
Patients receive nivolumab IV over 30 minutes followed by relatlimab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo surgery or biopsy, MRI, and blood sample collection throughout study.
Group II: Arm II (lomustine)Active Control5 Interventions
Patients receive lomustine PO on day 1 of each cycle. Cycles repeat every 42 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo surgery or biopsy, MRI, and blood sample collection throughout study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biopsy
2014
Completed Phase 4
~1090
Relatlimab
2019
Completed Phase 2
~1150
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Biospecimen Collection
2004
Completed Phase 3
~2020
Nivolumab
2014
Completed Phase 3
~5220
Surgical Procedure
2020
Completed Phase 2
~160

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,890 Previous Clinical Trials
41,011,833 Total Patients Enrolled
329 Trials studying Glioblastoma
23,171 Patients Enrolled for Glioblastoma
Michael LimPrincipal InvestigatorAlliance for Clinical Trials in Oncology
~123 spots leftby Jul 2028
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