Actively Recruiting
A Single Arm Pilot of Neoadjuvant and Adjuvant Nivolumab in Children and Young Adults With Recurrent or Progressive High Grade Glioma
Led by Sabine Mueller, MD, PhD · Updated on 2025-05-04
20
Participants Needed
20
Research Sites
156 weeks
Total Duration
On this page
Sponsors
S
Sabine Mueller, MD, PhD
Lead Sponsor
P
Pediatric Neuro-Oncology Consortium
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the side effects and genetic changes caused by the immunotherapy drug nivolumab given before and after surgery in children and young adults with recurrent or progressive high-grade glioma (HGG). This phase I trial aims to understand how this treatment affects tumor growth and the immune system, and to assess safety and tolerability in this patient group. The study also explores survival outcomes, tumor response, immune markers, advanced imaging, quality of life, cognitive function, and patient satisfaction. Participants receive a single infusion of nivolumab approximately 14 days before surgery to remove tumor tissue. After surgery, patients begin adjuvant treatment with nivolumab infusions every two weeks, continuing until disease progression, unacceptable side effects, or withdrawal. Tumor samples from surgery and previous operations are analyzed to study genetic and immune changes. Quality-of-life assessments and questionnaires are completed in person or online. Throughout the study, participants undergo blood tests to monitor immune responses and side effects, as well as imaging scans to evaluate tumor status. Follow-up visits occur 30 days after treatment ends, then every two months for up to five years to monitor survival, disease progression, and long-term safety. The study measures changes in tumor genetics, treatment-related adverse events, overall survival, and progression-free survival over 12 months.
CONDITIONS
Brief Title
Immunotherapy Before and After Surgery for Treatment of Recurrent or Progressive High Grade Glioma in Children and Young Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants with recurrent or progressive high-grade gliomas (WHO grade III or IV) who are candidates for surgical tumor removal
- Age greater than 6 months and less than 25 years at enrollment
- Karnofsky score ≥ 50 for participants older than 16 years, Lansky score ≥ 50 for participants 16 years or younger
- Stable neurological deficits for at least 1 week prior to enrollment with documented neurological exam
- Fully recovered from prior anti-cancer therapy toxic effects and met required time intervals since last treatments
- Willing to avoid other cytotoxic anti-tumor therapies except study treatment during the trial
- Adequate organ function including specific blood count and kidney, liver function limits
- Women of child-bearing potential must agree to use contraception during and for 5 months after study participation
- MRI performed within 28 days prior to registration
You will not qualify if you...
- Current or planned participation in another investigational study
- Diagnosis of immunodeficiency
- Tumor mainly in brainstem or spinal cord
- Presence of diffuse leptomeningeal disease, multifocal, or extracranial disease
- Use of systemic immunosuppressive treatments, except corticosteroids, within 6 months prior to registration
- Need for systemic corticosteroids above 0.25 mg/kg daily prednisone equivalent within 14 days before study start
- Unable to taper steroids below 0.1 mg/kg/day dexamethasone after surgery
- Known active tuberculosis infection
- Other progressing malignancy requiring treatment within 3 years except certain skin or cervical cancers
- Active autoimmune disease requiring systemic treatment in past 2 years
- History or evidence of active non-infectious pneumonitis
- Active infection requiring systemic therapy
- Allergy to study therapy products
- Known HIV/AIDS or positive hepatitis B or C tests
- Prior allogeneic stem cell transplant
- Serious uncontrolled medical disorders increasing risk or interfering with study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 14 ± 5 days
Participants receive a single infusion of nivolumab approximately 14 days before surgery as neoadjuvant treatment.
1 visit for infusion and 1 pre-surgical blood sample visit
Duration - Day of surgery
Participants undergo standard of care surgical tumor removal during which tumor samples are collected for analysis.
1 visit (in-person surgery)
Duration - Ongoing every 2 weeks until progression or unacceptable toxicity
Participants receive adjuvant nivolumab infusions every 2 weeks after recovering from surgery and tapering off steroids, continuing until disease progression, unacceptable toxicity, or withdrawal.
Infusions on Day 1 and Day 15 of each 28-day cycle
Duration - Up to 5 years
After completing study treatment, participants are monitored for safety and outcomes at 30 days post-treatment and then every 2 months for up to 5 years.
Visits every 2 months after 30-day post-treatment visit
Trial Site Locations
Total: 20 locations
1
University of Alabama at Birmingham, Children's of Alabama
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Children's Hospital of Los Angeles
Los Angeles, California, United States, 90027
Actively Recruiting
3
Rady Children's Hospital
San Diego, California, United States, 92123
Actively Recruiting
4
University of California, San Francisco
San Francisco, California, United States, 94115
Actively Recruiting
5
Children's National Hospital
Washington D.C., District of Columbia, United States, 20310
Actively Recruiting
6
University of Florida
Gainesville, Florida, United States, 32611
Actively Recruiting
7
Riley Children's Hospital
Indianapolis, Indiana, United States, 46202
Actively Recruiting
8
Johns Hopkins University
Baltimore, Maryland, United States, 21287
Actively Recruiting
9
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
10
Washington University St. Louis
St Louis, Missouri, United States, 63110
Actively Recruiting
11
Hackensack Meridian Children's Health at Joseph M. Sanzari Children's Hospital
Hackensack, New Jersey, United States, 07601
Actively Recruiting
12
Duke Children's Hospital & Health Center
Durham, North Carolina, United States, 27705
Actively Recruiting
13
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
14
University of Utah
Salt Lake City, Utah, United States, 84113
Actively Recruiting
15
Sydney Children's Hospital
Sydney, New South Wales, Australia, 1291
Actively Recruiting
16
The Children's Hospital at Westmead
Westmead, New South Wales, Australia, 2152
Actively Recruiting
17
Queensland Children's Hospital
South Brisbane, Queensland, Australia, 4101
Actively Recruiting
18
Women's and Children's Hospital
North Adelaide, South Australia, Australia, 5006
Actively Recruiting
19
Royal Children's Hospital
Parkville, Victoria, Australia, 3052
Actively Recruiting
20
Perth Children's' Hospital
Perth, Western Australia, Australia, 6009
Actively Recruiting
Research Team
J
Jannerfer An
S
Sabine Mueller, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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