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New treatment option for Newly Diagnosed Glioblastoma
Official title Trial of Glioblastoma Immunotherapy Advancement With Nivolumab and Relatlimab
ClinicalTrials.gov ID: NCT06816927
What this study is testing
What is Nivolumab?
Nivolumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for newly diagnosed glioblastoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- GIANT is an open-label, multi-center, randomized, perioperative (neoadjuvant followed by adjuvant), phase 2 trial with a safety lead-in phase to investigate the feasibility, safety and tolerability, and establish the biological activity of nivolumab with or without relatlimab in patients with isocitrate dehydrogenase (IDH) wildtype newly diagnosed glioblastoma (ndGBM).
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Signed informed consent approved by the IRB
- Adults ≥ 18 years of age
- Patients with either:
- 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
You likely can't join if
- Tumors where a gross total resection is not considered feasible by the treating neurosurgeon
- Tumor involves cerebellum, brainstem, or deep basal ganglia
- Patients who require urgent resection for mass effect, cerebral edema, or hydrocephalus in the opinion of the treating neurosurgeon
- Patients with contraindications to MRI or unwilling to undergo MRI
- History of CNS bleeding as defined by stroke within 6 months prior to registration
- Contraindication to surgery
See the full eligibility criteria
Who can join
- Signed informed consent approved by the IRB
- Adults ≥ 18 years of age
- Patients with either:
- 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
- Patients who in the opinion of the treating neurosurgeon require resection
- Patient is willing to undergo planned surgical procedures
- Patient agrees to make biospecimens that will be prospectively collected (after date of consent) available for research
- 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...
- 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...
- 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...
- 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)
- Renal function as follows:
- Serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance ≥ 40 ml/min using the Cockcroft-Gault formula (Appendix 1)
- Hepatic 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...
- Alkaline phosphatase (ALP) ≤ 2.5 x ULN
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN
- Serum albumin ≥ 25 g/L
- Eastern Co-operative Oncology Group (ECOG) performance status of 0-1 (Appendix 2)
- Life expectancy of at least 12 months
- Negative human immunodeficiency virus (HIV) test at Screening
- Negative hepatitis B surface antigen (HbsAg) test at Screening or positive test followed by a negative hepatitis B virus (HBV) DNA test at Screening
- Negative hepatitis C antibody (anti-HCV) test at Screening or positive test followed by a negative HCV RNA test at Screening
- Able to undergo brain MRI with and without contrast
- 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...
- 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...
- 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...
- 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...
- Ability to adhere to the study visit schedule and all protocol requirements
What rules you out
- Tumors where a gross total resection is not considered feasible by the treating neurosurgeon
- Tumor involves cerebellum, brainstem, or deep basal ganglia
- Patients who require urgent resection for mass effect, cerebral edema, or hydrocephalus in the opinion of the treating neurosurgeon
- Patients with contraindications to MRI or unwilling to undergo MRI
- History of CNS bleeding as defined by stroke within 6 months prior to registration
- Contraindication to surgery
- Treatment with immunosuppressive medications Note: Low-dose corticosteroids (≤ 2 mg/day dexamethasone or equivalent) for tumor-associated edema is permitted. Patients who require corticosteroids \> 2mg/day dexamethasone...
- Active autoimmune disease or immune deficiency including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease...
- Active tuberculosis
- Patient has had a previous SARS-CoV-2 infection either suspected or confirmed within 4 weeks prior to screening. Acute symptoms must have resolved and based on treating physician's assessment, there are no sequelae that...
- Evidence of acute intracranial/intra-tumoral hemorrhage, which requires urgent intervention
- Severe infection within 4 weeks prior to registration
- Treatment with a live, attenuated vaccine within 4 weeks prior to registration, or anticipation of need for such a vaccine during study or within 5 months after final dose of nivolumab and relatlimab
- Patients with prior, unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skin or other...
- Major surgical procedure, other than for diagnosis, within 4 weeks prior to registration
- History of idiopathic pulmonary fibrosis, organising pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis Note: History of radiation...
- Patient is pregnant or breastfeeding/chestfeeding
- Prior allogeneic stem cell or solid organ transplantation
- Known allergy or sensitivity nivolumab, relatlimab, temozolomide or their excipients
- Patient has any kind of disorder that, in the opinion of the site PI, may compromise the ability of the patient to give written informed consent and/or to comply with all required study procedures
- Patients with a history of myocarditis
- Patient has troponin T (TnT) or I (TnI) \> 2 × ULN Note: Patients with TnT or TnI levels between \> 1 × to 2 × ULN will be eligible if repeat levels within 24 hours are ≤ 1 × ULN. If TnT or TnI levels are between \> 1 ×...
- Left ventricular ejection fraction (LVEF) \< 50% by either echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 6 months prior to registration
- History or evidence of any other clinically significant disorder, condition, or disease (with the exception of those outlined above) that, in the opinion of the site PI would pose a risk to patient safety or interfere...
The study team makes the final eligibility decision.
Where it's taking place
- Durham, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Durham, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.