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Trial of Glioblastoma Immunotherapy Advancement With Nivolumab and Relatlimab

This study is testing new ways to treat newly diagnosed glioblastoma (a type of brain cancer) using immunotherapy drugs, nivolumab and relatlimab, along with standard treatments like radiation and temozolomide (TMZ, a chemotherapy drug). Researchers want to see if these drugs are safe and if they can activate the body's immune system to fight the cancer. You might be able to join if you are an adult (18 or older) with a new or previous diagnosis of glioblastoma who hasn't had radiation or other treatments for your brain tumor yet, and your doctor thinks you need surgery. The study aims to understand the safety and biological effects of these treatments. The current status of this study is unclear, and it plans to enroll 92 patients.

Study design
This is an open-label, multi-center, randomized Phase 2 study with a safety lead-in phase, involving 92 participants. Participants will be assigned to receive nivolumab alone or nivolumab with relatlimab.
What's involved
Participants will receive a single dose of nivolumab (and possibly relatlimab) before surgery. After surgery, all patients will receive two more doses of nivolumab (and relatlimab), along with daily radiation therapy for 6 weeks and oral temozolomide for up to 6 cycles.
Compensation
Not stated in the trial record.
Follow-up
Researchers will monitor adverse events for up to 4 weeks and assess the presence of tumor-infiltrating lymphocytes (immune cells) in the resected tumor for up to 2 years.

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NCT06816927

Trial of Glioblastoma Immunotherapy Advancement With Nivolumab and Relatlimab

Recruiting
PHASE2Ages 18+InterventionalTreatment
Duke University
~92 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:NivolumabRelatlimabTMZRadiation Therapy

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Assess the safety of concomitantly administering nivolumab, relatlimab, RT, and TMZ in MGMT methylated patients by monitoring adverse events utilizing CTC Version 5.0 criteria
Measured over From date of registration up to 4 weeks
+2 more outcomes measured

Conditions

Newly Diagnosed Glioblastoma

Explore related trials

GlioblastomaIDH1 wt Allele

Where it's being run

3 sites across 3 states
New York1
North Carolina1
Victoria1

Who to contact

Mustafa Khasraw
[email protected]
9196845301
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

A newly suspected diagnosis of GBM based on MRI
A previous diagnosis of GBM and who have not received prior RT or systemic therapy for their brain tumor 4. Patients who in the opinion of the treating neurosurgeon require resection 5. Patient is willing to undergo planned surgical procedures 6. Patient agrees to make biospecimens that will be prospectively collected (after date of consent) available for research 7. Patients who have undergone a diagnostic biopsy or open surgical procedure prior to enrolling in this study:
If adequate archival tissue, defined as at least 3 blocks, is readily available, there is clear documentation of its availability, and the patient must consents to provide that tissue, the patient does not need to undergo another biopsy prior to, or on study, in order to be eligible for this trial
If archival tissue is sufficient as described above, patient must have either residual enhancing disease requiring resection, or molecularly confirmed GBM with a clear clinical indication for additional resection, as determined by the country PI (or delegate) and the designated trial surgeon.
If archival tissue is insufficient, or if the patient previously underwent a needle biopsy and there is no clear documentation of tissue availability, and the patient wishes to enroll, the patient must agree to undergo a repeat biopsy as part of this study prior to Screening. 8. Hematological function as follows:
Absolute neutrophil count ≥ 1.5 x 109/L
Platelet count ≥ 100 x 109/L
Haemoglobin \> 90 g/L
Prothrombin time (PT) or partial thromboplastin time (PTT) \< 1.5 x upper limit of normal (ULN) 9. Renal function as follows:
Total bilirubin ≤ 1.5 x ULN (Exception: Patient has known or suspected Gilbert's Syndrome for which additional lab testing of direct and/or indirect bilirubin supports this diagnosis. In these instances, a total bilirubin of ≤ 3.0 x ULN is acceptable)
Alkaline phosphatase (ALP) ≤ 2.5 x ULN
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN
Serum albumin ≥ 25 g/L 11. Eastern Co-operative Oncology Group (ECOG) performance status of 0-1 (Appendix 2) 12. Life expectancy of at least 12 months 13. Negative human immunodeficiency virus (HIV) test at Screening 14. Negative hepatitis B surface antigen (HbsAg) test at Screening or positive test followed by a negative hepatitis B virus (HBV) DNA test at Screening 15. Negative hepatitis C antibody (anti-HCV) test at Screening or positive test followed by a negative HCV RNA test at Screening 16. Able to undergo brain MRI with and without contrast 17. People of childbearing potential must agree to use a highly effective contraceptive method (with a failure rate of \< 1%) during study treatment and for at least 6 months following the last dose of study drug and agree not to donate eggs (ova, oocytes) for the purpose of reproduction for the same time period. Acceptable methods of contraception are:
Combined estrogen and progestin containing hormonal contraception associated with inhibition of ovulation given orally, intravaginally, or transdermally
Progestin-only hormonal contraception associated with inhibition of ovulation given orally, by injection, or by implant
Intrauterine device: Intrauterine hormone-releasing system
Bilateral tubal occlusion
Vasectomised partner
Sexual abstinence: Considered a highly effective method only if defined as refraining from heterosexual intercourse during an entire period of risk associated with the study treatment. The reliability of sexual abstinence needs will be evaluated in relation to the duration of the study and to the usual lifestyle of the patient Note: People are considered post-menopausal and not of childbearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or tubal ligation at least 6 weeks ago. In the case of oophorectomy alone, only when the reproductive status of the person has been confirmed by follow-up hormone level assessment are they considered not of childbearing potential. 18. Sexually active patients that are able to produce a sperm, must use a condom during intercourse and must agree to refrain from sperm donation, from registration on the study until 3 months after the last dose of treatment 19. People of childbearing potential must have a negative highly sensitive serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) at the time of screening and within 48 hours of starting the study drug(s) 20. Ability to adhere to the study visit schedule and all protocol requirements

What this trial measures

  • Assess the safety of concomitantly administering nivolumab, relatlimab, RT, and TMZ in MGMT methylated patients by monitoring adverse events utilizing CTC Version 5.0 criteriaFrom date of registration up to 4 weeks

    Proportion of patients with MGMT methylation who experience an unacceptable toxicity during concomitant nivolumab, relatlimab, RT and TMZ by assessing adverse events reported utilizing CTC Version 5.0 criteria

  • Assess the feasibility of undertaking a peri-operative study of nivolumab with or without relatlimab in patients with ndGBM (Newly diagnosed Glioblastoma)From date of registration up to 4 weeks

    Proportion of registered patients who undergo biopsy, receive one cycle of randomized neoadjuvant immunotherapy, and undergo surgery during the neoadjuvant phase of the study, OR undergo biopsy that documents the patient to not have GBM. Proportion of randomized patients who receive one cycle of randomized neoadjuvant immunotherapy, and undergo surgery.

  • Establish the biological activity of nivolumab with or without relatlimab in patients with ndGBM by demonstrating the presence of Tumor-infiltrating lymphocytes (TILs) in the resected tumorFrom date of registration up to 2 years

    Changes in TILs in formalin-fixed paraffin embedded (FFPE) tumor sections from biopsy to resection during concomitant nivolumab, relatlimab, RT and TMZ