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New treatment option for High Grade Glioma
Official title A Pilot Study Investigating Upfront Adaptive Immunotherapy Approach in Children, Adolescent and Young Adult (CAYA) Patients With Replication-Repair Deficient (RRD) High-Grade Gliomas (HGG)
ClinicalTrials.gov ID: NCT06519682
What this study is testing
What is Nivolumab?
Nivolumab is an investigational medicine, being studied as a potential treatment for high grade glioma.
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
- This is open label, multicentre, single arm, pilot study of upfront nivolumab in patients with RRD-glioblastoma with favorable immune/genomic biomarkers. The purpose of the study is to use upfront immune checkpoint inhibitor (ICI) to delay/avoid radiation for patients with RRD-glioblastoma with favorable clinical (Gross total resection (GTR) or near total resection (NTR)) and biological (RRD, hypermutation, immune activation) biomarkers.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 25
You may be able to join if
- 3.1.1 Age: Patients must be ≥12 months and ≤25 years of age at the time of signing informed consent/assent. 3.1.2 Diagnosis: Patients must have a...
- Cytotoxic chemotherapy: At least 21 days prior to initiation of protocol therapy from the last dose of cytotoxic or myelosuppressive chemotherapy; at...
- Hematopoietic growth factors: At least 7 days prior to initiation of protocol therapy from the last dose of short-acting growth factor; at least 14...
- Anti-cancer agents not known to be myelosuppressive: At least 7 days prior to initiation of protocol therapy from the last dose.
- Interleukins, interferons, and cytokines (other than hematopoietic growth factors): At least 21 days prior to initiation of protocol therapy from the...
You likely can't join if
- 3.2.1 Concomitant Medications:
- Corticosteroids: Patients requiring systemic corticosteroids or other forms of immunosuppressive therapy within 7 days prior to initiation of...
- Following initiation of protocol therapy, systemic corticosteroids or other forms of immunosuppressive therapy are permitted if administered for the...
- Physiologic corticosteroids up to 5 mg/day prednisone or equivalent are permitted.
- Topical, ocular, intra-articular, intra-nasal, and inhaled corticosteroids are permitted.
- Patients with CNS tumors receiving steroids must be able to discontinue these at least 7 days prior to initiation of protocol therapy.
See the full eligibility criteria
Who can join
- 3.1.1 Age: Patients must be ≥12 months and ≤25 years of age at the time of signing informed consent/assent. 3.1.2 Diagnosis: Patients must have a histologically confirmed diagnosis of glioblastoma. 3.1.3 Proof of RRD...
- Cytotoxic chemotherapy: At least 21 days prior to initiation of protocol therapy from the last dose of cytotoxic or myelosuppressive chemotherapy; at least 42 days if prior nitrosourea (such as lomustine, CCNU).
- Hematopoietic growth factors: At least 7 days prior to initiation of protocol therapy from the last dose of short-acting growth factor; at least 14 days for long-acting.
- Anti-cancer agents not known to be myelosuppressive: At least 7 days prior to initiation of protocol therapy from the last dose.
- Interleukins, interferons, and cytokines (other than hematopoietic growth factors): At least 21 days prior to initiation of protocol therapy from the last dose.
- Antibodies: At least 21 days prior to initiation of protocol therapy from the last dose and toxicity related to prior antibody therapy must be recovered to Grade ≤1.
- Radiotherapy: At least 14 days prior to initiation of protocol therapy from local radiotherapy; at least 150 days from total body irradiation (TBI), craniospinal radiotherapy, or radiation to ≥50% of the pelvis; at...
- Radiopharmaceutical therapy (e.g., 131I-MIBG): At least 42 days prior to initiation of protocol therapy from systemically administered radiopharmaceutical therapy.
- Autologous stem cell infusion including boost infusion: At least 42 days prior to initiation of protocol therapy.
- Cellular therapy: At least 42 days prior to initiation of protocol therapy from any type of cellular therapy. 3.1.8 Performance Status: Lansky play score ≥50 if ≤16 years of age; Karnofsky performance scale ≥50 if \>16...
- peripheral absolute neutrophil count (ANC) ≥750/mm3 (0.75x109/L)
- platelet count ≥75,000/mm3 (75x109/L), transfusion independent, defined as not receiving platelet transfusions at least 7 days prior to initiation of protocol therapy 3.1.9.2 Adequate renal function defined as...
- bilirubin (sum of conjugated and unconjugated) ≤1.5 x upper limit of normal (ULN) for age
- ALT (SGPT) ≤135 U/L (i.e., 3 x ULN). For the purposes of this study, the ULN for ALT (SGPT) is 45 U/L 3.1.9.4 Adequate pulmonary function defined as: -no evidence of dyspnea at rest, no exercise intolerance due to...
- no signs or symptoms of heart failure in a patient who has no history of congestive heart failure, no prior exposure to cardiotoxic drugs, and no radiotherapy to the heart; OR
- shortening fraction of ≥27% or ejection fraction of ≥50% by echocardiogram 3.1.9.6 Adequate pancreatic function defined as: -serum lipase ≤ ULN at screening 3.1.9.7 Viral Infection:
- Human immunodeficiency virus (HIV): Infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months prior to initiation of protocol therapy are eligible.
- Hepatitis B virus (HBV): Patients with evidence of chronic infection with undetectable viral load are eligible. Suppressive therapy, if indicated, is allowed.
- Hepatitis C virus (HCV): Infected patients currently on treatment with undetectable viral load are eligible. Patients with a history of infection must have been treated and cured. Note: Routine screening for HBV, HCV or...
What rules you out
- 3.2.1 Concomitant Medications:
- Corticosteroids: Patients requiring systemic corticosteroids or other forms of immunosuppressive therapy within 7 days prior to initiation of protocol therapy are not eligible.
- Following initiation of protocol therapy, systemic corticosteroids or other forms of immunosuppressive therapy are permitted if administered for the treatment of toxicity, tumor flare, or pseudo-progression and can be...
- Physiologic corticosteroids up to 5 mg/day prednisone or equivalent are permitted.
- Topical, ocular, intra-articular, intra-nasal, and inhaled corticosteroids are permitted.
- Patients with CNS tumors receiving steroids must be able to discontinue these at least 7 days prior to initiation of protocol therapy.
- Anti-cancer agents: Patients who are currently receiving other anti-cancer agents are not eligible.
- Other investigational agents: Patients who are currently receiving or have received any other investigational agent within 14 days prior to initiation of protocol therapy are not eligible. 3.2.2 CNS Tumor Bulk: Patients...
- Tumor with any evidence of uncal herniation or mass effect leading to severe midline shift
- Tumor that in the opinion of the local investigator, shows significant mass effect after initial surgery or after second-look surgery. 3.2.3 Uncontrolled Intercurrent Illness: Patients with uncontrolled intercurrent...
- Asymptomatic laboratory abnormalities (e.g., ANA, rheumatoid factor, altered thyroid studies) will not render a patient ineligible in the absence of a diagnosis of an autoimmune disorder.
- Patients with atopy-related conditions such as asthma, allergic rhinitis, or atopic dermatitis are not excluded.
- Replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroid replacement therapy) is not considered a form of systemic treatment. 3.2.6 Interstitial Lung Disease: Patients with history of interstitial...
- Surgery: Patient who cannot have surgery/biopsy at recurrence/progression on Domain 1 will be discontinued from the study.
- CNS Tumor Bulk: Patients with CNS tumors with any of the following characteristics on imaging post-surgery/biopsy at progression/recurrence on Domain 1 are not eligible:
- Tumor \>= 5cm in the longest dimesion.
- Tumor with any evidence of uncal herniation or mass effect leading to severe midline shift
- Tumor that in the opinion of the local investigator, shows significant mass effect
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
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, 12 months to 25 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. 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.