Immunotherapy Before and After Surgery for Treatment of Recurrent or Progressive High Grade Glioma in Children and Young Adults
NCT ID: NCT04323046
Last Updated: 2025-05-04
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
PHASE1
Total Enrollment
20 participants
Study Classification
INTERVENTIONAL
Study Start Date
2020-10-02
Study Completion Date
2029-03-01
Brief Summary
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This phase I trial studies the side effects of nivolumab before and after surgery in treating children and young adults with high grade glioma that has come back (recurrent) or is increasing in scope or severity (progressive). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
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Detailed Description
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PRIMARY OBJECTIVES:
I. To measure the relative changes in cell cycle-related genetic signature of the tumor microenvironment post administration of neoadjuvant nivolumab in children and young adults with recurrent or progressive HGG when compared to a cohort of archived non-treated recurrent pediatric HGG samples.
II. To characterize the safety and tolerability of neoadjuvant nivolumab followed by adjuvant nivolumab in children and young adults with recurrent or progressive HGG.
SECONDARY OBJECTIVES:
I. To determine the 6 month and 12 month overall survival (OS) in children and young adults with recurrent or progressive HGG treated with neoadjuvant nivolumab followed by adjuvant nivolumab.
II. To determine the 6 month and 12 month progression-free survival (PFS) in children and young adults with recurrent or progressive HGG treated with neoadjuvant nivolumab followed by adjuvant nivolumab.
EXPLORATORY OBJECTIVES:
I. To measure relative changes in interferon gamma associated genetic signature within the tumor microenvironment post administration of neoadjuvant nivolumab in children and young adults with recurrent or progressive HGG compared to archived non-treated recurrent pediatric HGG samples.
II. To explore the correlation of interferon-gamma-associated genetic signature, cell cycle-related genetic signature and infiltrating T lymphocyte (TIL) density and clonality with clinical responses.
III. To measure TIL density post administration of neoadjuvant nivolumab in children and young adults with recurrent or progressive HGG.
IV. To estimate the objective response rate (ORR) in children and young adults with recurrent or progressive HGG treated with neoadjuvant nivolumab followed by adjuvant nivolumab.
V. To evaluate the association between advanced MRI parameters (ADC on DWI, rCBV on dynamic susceptibility contrast (DSC) perfusion MRI, pre-contrast T1 shortening on T1-weighed images, and/or MTRasym on pH-Weighted Amine CEST-EPI) and tumor and peripheral blood immune responses.
VI. To measure relative change in peripheral T-cell response and post administration of neo-adjuvant nivolumab in children and young adults with recurrent or progressive HGG.
VII. To measure PD-1 and PDL-1 expression by immunohistochemistry for children and young adults with recurrent or progressive HGG post neoadjuvant nivolumab and evaluate the differences between the treatment cohort and archived non-treated recurrent pediatric HGG samples.
VIII. To explore the correlation of tumor mutational load with clinical response for children and young adults with recurrent or progressive HGG treated with neoadjuvant nivolumab followed by adjuvant nivolumab.
IX. To assess Quality of Life (QOL) and cognitive measures in children and young adults with recurrent or progressive HGG treated with neoadjuvant nivolumab followed by adjuvant nivolumab.
X. To assess patient and/or proxy satisfaction with study participation via patient-reported outcome (PRO) measures in the context of race ethnicity and other health related social risks.
XI. To assess on therapy toxicity in the context of race, ethnicity and other health related social risks.
OUTLINE: Neoadjuvant nivolumab followed by adjuvant nivolumab evaluation.
NEOADJUVANT TREATMENT: Participants will receive a single infusion of nivolumab of 3 mg/kg 14± 5 days prior to surgery. When scheduling, please keep in mind that the two pre-surgical plasma samples (day of neoadjuvant dose and day of surgery) should be drawn greater than 10 days apart.
Tumor samples will be obtained at time of surgery. The tissue from this surgery (fresh, frozen and FFPE) and the archived tissue (FFPE) from the most recent surgery prior to registration revealing HGG will be processed so as to best achieve the primary, secondary and exploratory objectives.
ADJUVANT TREATMENT: Infusion Cycle #1 should begin as soon as participant has recovered from surgery and has been tapered off of steroids. A maximum dexamethasone dose of 0.1 mg/kg/day is allowed, but preferably have been discontinued (inhaled or topical use of steroids is allowed).
Maintenance Cycle 1+ Day 1 \& 15: Participants will receive nivolumab (3mg/kg) IV every 2 weeks until progression or development of unacceptable toxicities or withdrawal. Blood samples will be obtained as pharmacodynamic markers throughout the study (Day 1 of every other cycle). Dose interruptions and symptomatic management will occur based upon preset adverse event determination.
After completion of study treatment, patients are followed up at 30 days and then every 2 months for up to 5 years.
I. To measure the relative changes in cell cycle-related genetic signature of the tumor microenvironment post administration of neoadjuvant nivolumab in children and young adults with recurrent or progressive HGG when compared to a cohort of archived non-treated recurrent pediatric HGG samples.
II. To characterize the safety and tolerability of neoadjuvant nivolumab followed by adjuvant nivolumab in children and young adults with recurrent or progressive HGG.
SECONDARY OBJECTIVES:
I. To determine the 6 month and 12 month overall survival (OS) in children and young adults with recurrent or progressive HGG treated with neoadjuvant nivolumab followed by adjuvant nivolumab.
II. To determine the 6 month and 12 month progression-free survival (PFS) in children and young adults with recurrent or progressive HGG treated with neoadjuvant nivolumab followed by adjuvant nivolumab.
EXPLORATORY OBJECTIVES:
I. To measure relative changes in interferon gamma associated genetic signature within the tumor microenvironment post administration of neoadjuvant nivolumab in children and young adults with recurrent or progressive HGG compared to archived non-treated recurrent pediatric HGG samples.
II. To explore the correlation of interferon-gamma-associated genetic signature, cell cycle-related genetic signature and infiltrating T lymphocyte (TIL) density and clonality with clinical responses.
III. To measure TIL density post administration of neoadjuvant nivolumab in children and young adults with recurrent or progressive HGG.
IV. To estimate the objective response rate (ORR) in children and young adults with recurrent or progressive HGG treated with neoadjuvant nivolumab followed by adjuvant nivolumab.
V. To evaluate the association between advanced MRI parameters (ADC on DWI, rCBV on dynamic susceptibility contrast (DSC) perfusion MRI, pre-contrast T1 shortening on T1-weighed images, and/or MTRasym on pH-Weighted Amine CEST-EPI) and tumor and peripheral blood immune responses.
VI. To measure relative change in peripheral T-cell response and post administration of neo-adjuvant nivolumab in children and young adults with recurrent or progressive HGG.
VII. To measure PD-1 and PDL-1 expression by immunohistochemistry for children and young adults with recurrent or progressive HGG post neoadjuvant nivolumab and evaluate the differences between the treatment cohort and archived non-treated recurrent pediatric HGG samples.
VIII. To explore the correlation of tumor mutational load with clinical response for children and young adults with recurrent or progressive HGG treated with neoadjuvant nivolumab followed by adjuvant nivolumab.
IX. To assess Quality of Life (QOL) and cognitive measures in children and young adults with recurrent or progressive HGG treated with neoadjuvant nivolumab followed by adjuvant nivolumab.
X. To assess patient and/or proxy satisfaction with study participation via patient-reported outcome (PRO) measures in the context of race ethnicity and other health related social risks.
XI. To assess on therapy toxicity in the context of race, ethnicity and other health related social risks.
OUTLINE: Neoadjuvant nivolumab followed by adjuvant nivolumab evaluation.
NEOADJUVANT TREATMENT: Participants will receive a single infusion of nivolumab of 3 mg/kg 14± 5 days prior to surgery. When scheduling, please keep in mind that the two pre-surgical plasma samples (day of neoadjuvant dose and day of surgery) should be drawn greater than 10 days apart.
Tumor samples will be obtained at time of surgery. The tissue from this surgery (fresh, frozen and FFPE) and the archived tissue (FFPE) from the most recent surgery prior to registration revealing HGG will be processed so as to best achieve the primary, secondary and exploratory objectives.
ADJUVANT TREATMENT: Infusion Cycle #1 should begin as soon as participant has recovered from surgery and has been tapered off of steroids. A maximum dexamethasone dose of 0.1 mg/kg/day is allowed, but preferably have been discontinued (inhaled or topical use of steroids is allowed).
Maintenance Cycle 1+ Day 1 \& 15: Participants will receive nivolumab (3mg/kg) IV every 2 weeks until progression or development of unacceptable toxicities or withdrawal. Blood samples will be obtained as pharmacodynamic markers throughout the study (Day 1 of every other cycle). Dose interruptions and symptomatic management will occur based upon preset adverse event determination.
After completion of study treatment, patients are followed up at 30 days and then every 2 months for up to 5 years.
Conditions
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Glioblastoma
Malignant Glioma
Recurrent Glioblastoma
Recurrent Malignant Glioma
Recurrent Grade III Glioma
Grade III Glioma
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Neoadjuvant nivolumab and adjuvant nivolumab
NEOADJUVANT: Patients receive nivolumab IV over 30 minutes 14 days before undergoing standard of care surgical resection.
ADJUVANT MAINTENANCE: After completion of neoadjuvant infusion, patients receive nivolumab IV over 30 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group Type
EXPERIMENTAL
Nivolumab
Intervention Type
BIOLOGICAL
Given IV
Quality-of-Life Assessment
Intervention Type
OTHER
Ancillary studies, given in person or online
Questionnaire Administration
Intervention Type
OTHER
Ancillary studies, given in person or online
Interventions
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Nivolumab
Given IV
Intervention Type
BIOLOGICAL
Quality-of-Life Assessment
Ancillary studies, given in person or online
Intervention Type
OTHER
Questionnaire Administration
Ancillary studies, given in person or online
Intervention Type
OTHER
Other Intervention Names
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BMS-936558
MDX-1106
NIVO
ONO-4538
Opdivo
Quality of Life Assessment
Eligibility Criteria
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Inclusion Criteria
1. Participants with recurrent or progressive high-grade gliomas (HGG) (World Health Organization (WHO) grade III or grade IV) who are candidates for surgical tumor debulking will be enrolled in this trial
2. All assessments are to occur within 14 days of registration except where otherwise noted. The participant and their legal parent/guardian must be thoroughly informed about all aspects of the study, including the study visit schedule and required evaluations and all regulatory requirements for informed consent. The written informed consent must be obtained from the participant and legal parent/guardian prior to enrollment
3. Have a history of previously treated histologically confirmed World Health Organization grade III or IV HGG. Previous first line therapy with radiation and/or chemotherapy
4. Have evidence of recurrence or progression of disease by MRI scan
5. Participants must be adequate medical candidates for surgical resection. The intent of surgical resection is to allow both cytoreduction and tumor debulking as part of standard of care, and also collect a minimum of 100 mg of tumor tissue for the study tissue endpoints
6. A primary goal of surgery must be cytoreduction, and not solely on diagnostic biopsy
7. Age: Participants must be \> 6 months and \< 25 years of age at time of enrollment
8. Karnofsky \>= 50 for participants \> 16 years of age and Lansky \>= 50 for participants =\< 16 years of age. Participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score
9. Patients with neurological deficits should have deficits that are stable for a minimum of 1 week prior to enrollment (on stable or tapering dosing of steroids). A baseline detailed neurological exam should clearly document the neurologic status of the patient at the time of enrollment on the study.
10. Prior Therapy: Participants must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment. If after the required timeframe, the defined eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately
* Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive. At least 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea)
* An interval of at least 12 weeks from the completion of radiation therapy to registration unless there is unequivocal histologic confirmation of tumor progression
* Hematopoietic growth factors: At least 14 days after the last dose of a long-acting growth factor (e.g. pegfilgrastim) or 7 days for short acting growth factor. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events (AEs) are known to occur. The duration of this interval must be discussed with the study chair.
* Had their last dose of biologic (anti-neoplastic agent) ≥7 days prior to study registration, or beyond the time during which AEs are known to occur.
* Anti-cancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or absolute neutrophil count \[ANC\] counts): At least 7 days after the last dose of agent
* Interleukins, interferons and cytokines (other than hematopoietic growth factors): \>= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)
* Antibodies: \>= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =\< 1
* An interval of at least 12 weeks from prior exposure to PD-1 or PD-L1 inhibitors.
* Stem cell infusion (with or without total-body irradiation (TBI)):
* Autologous stem cell infusion including boost infusion: \>= 42 days
11. Participants must be willing to forego cytotoxic anti-tumor therapies except study-defined therapy while being treated on study
12. Organ Function Requirements:
* Peripheral absolute neutrophil count (ANC) \>= 1000/mm\^3
* Platelet count \>= 100,000/mm\^3
* Creatinine clearance or radioisotope glomerular filtration rate (GFR) \>= 70 mL/min/1.73 m\^2 OR a serum creatinine based on age/gender as follows:
* Age: Maximum Serum Creatinine (mg/dL)
* 6 months to \< 3 years: 0.6 (male and female)
* 3 to \< 6 years: 0.8 (male and female)
* 6 to \< 10 years: 1 (male and female)
* 10 to \< 13 years: 1.2 (male and female)
* 13 to \< 16 years: 1.5 (male), 1.4 (female)
* \>= 16 years: 1.7 (male), 1.4 (female)
* Bilirubin (sum of conjugated and unconjugated) =\< 1.5 x upper limit of normal (ULN) for age (except participants with Gilbert syndrome who must have a total bilirubin level of \< 3.0
* Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 3.0 x ULN
* Serum albumin \>= 2
13. Pregnancy: The effects of nivolumab on the developing human fetus are unknown. For this reason women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and 5 months after completion of therapy. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
14. MRI within 28 days prior to registration.
2. All assessments are to occur within 14 days of registration except where otherwise noted. The participant and their legal parent/guardian must be thoroughly informed about all aspects of the study, including the study visit schedule and required evaluations and all regulatory requirements for informed consent. The written informed consent must be obtained from the participant and legal parent/guardian prior to enrollment
3. Have a history of previously treated histologically confirmed World Health Organization grade III or IV HGG. Previous first line therapy with radiation and/or chemotherapy
4. Have evidence of recurrence or progression of disease by MRI scan
5. Participants must be adequate medical candidates for surgical resection. The intent of surgical resection is to allow both cytoreduction and tumor debulking as part of standard of care, and also collect a minimum of 100 mg of tumor tissue for the study tissue endpoints
6. A primary goal of surgery must be cytoreduction, and not solely on diagnostic biopsy
7. Age: Participants must be \> 6 months and \< 25 years of age at time of enrollment
8. Karnofsky \>= 50 for participants \> 16 years of age and Lansky \>= 50 for participants =\< 16 years of age. Participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score
9. Patients with neurological deficits should have deficits that are stable for a minimum of 1 week prior to enrollment (on stable or tapering dosing of steroids). A baseline detailed neurological exam should clearly document the neurologic status of the patient at the time of enrollment on the study.
10. Prior Therapy: Participants must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment. If after the required timeframe, the defined eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately
* Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive. At least 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea)
* An interval of at least 12 weeks from the completion of radiation therapy to registration unless there is unequivocal histologic confirmation of tumor progression
* Hematopoietic growth factors: At least 14 days after the last dose of a long-acting growth factor (e.g. pegfilgrastim) or 7 days for short acting growth factor. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events (AEs) are known to occur. The duration of this interval must be discussed with the study chair.
* Had their last dose of biologic (anti-neoplastic agent) ≥7 days prior to study registration, or beyond the time during which AEs are known to occur.
* Anti-cancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or absolute neutrophil count \[ANC\] counts): At least 7 days after the last dose of agent
* Interleukins, interferons and cytokines (other than hematopoietic growth factors): \>= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)
* Antibodies: \>= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =\< 1
* An interval of at least 12 weeks from prior exposure to PD-1 or PD-L1 inhibitors.
* Stem cell infusion (with or without total-body irradiation (TBI)):
* Autologous stem cell infusion including boost infusion: \>= 42 days
11. Participants must be willing to forego cytotoxic anti-tumor therapies except study-defined therapy while being treated on study
12. Organ Function Requirements:
* Peripheral absolute neutrophil count (ANC) \>= 1000/mm\^3
* Platelet count \>= 100,000/mm\^3
* Creatinine clearance or radioisotope glomerular filtration rate (GFR) \>= 70 mL/min/1.73 m\^2 OR a serum creatinine based on age/gender as follows:
* Age: Maximum Serum Creatinine (mg/dL)
* 6 months to \< 3 years: 0.6 (male and female)
* 3 to \< 6 years: 0.8 (male and female)
* 6 to \< 10 years: 1 (male and female)
* 10 to \< 13 years: 1.2 (male and female)
* 13 to \< 16 years: 1.5 (male), 1.4 (female)
* \>= 16 years: 1.7 (male), 1.4 (female)
* Bilirubin (sum of conjugated and unconjugated) =\< 1.5 x upper limit of normal (ULN) for age (except participants with Gilbert syndrome who must have a total bilirubin level of \< 3.0
* Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 3.0 x ULN
* Serum albumin \>= 2
13. Pregnancy: The effects of nivolumab on the developing human fetus are unknown. For this reason women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and 5 months after completion of therapy. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
14. MRI within 28 days prior to registration.
Exclusion Criteria
1. Current or planned participation in a study of an investigational agent or using an investigational device.
2. Has a diagnosis of immunodeficiency.
3. Has tumor primarily localized to the brainstem or spinal cord.
4. Has presence of diffuse leptomeningeal disease or or disseminated/multi-focal disease, or extracranial disease.
5. Has received systemic immunosuppressive treatments (such as methotrexate, chloroquine, azathioprine, etc.), aside from anti-neoplastic chemotherapy or systemic corticosteroids within six months of registration.
6. Participants with a concurrent condition requiring systemic treatment with either corticosteroids (\> 0.25 mg/kg daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses \> 0.25 mg/kg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
7. Unable to taper steroids due to ongoing mass effect; a maximum dexamethasone dose of 0.1 mg/kg/day is allowed (4mg maximum), but preferably have been discontinued (inhaled or topical use of steroids is allowed).
8. Has a known history of active TB (Bacillus tuberculosis).
9. Has a known additional malignancy that is progressing or requires active treatment within 3 years of registration. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
10. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
11. Has known history of, or any evidence of active non-infectious pneumonitis.
12. Has an active infection requiring systemic therapy.
13. Has a known hypersensitivity to any of the study therapy products.
14. Has a known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
* NOTE: Testing for HIV must be performed at sites where mandated locally
15. Any prior positive test result for hepatitis B virus or hepatitis C virus indicating presence of virus, e.g., hepatitis B surface antigen (HBsAg, Australia antigen) positive, or hepatitis C antibody (anti-HCV) positive (except if HCV-ribonucleic acid (RNA) negative).
16. Participants who have had prior allogenic hematopoietic stem cell transplant (HSCT).
17. Any serious or uncontrolled medical disorder that, in the opinion of the investigator may increase the risk associated with study participation or study drug administration, impair the ability of the participant to receive protocol therapy or interfere with interpretation of study results.
2. Has a diagnosis of immunodeficiency.
3. Has tumor primarily localized to the brainstem or spinal cord.
4. Has presence of diffuse leptomeningeal disease or or disseminated/multi-focal disease, or extracranial disease.
5. Has received systemic immunosuppressive treatments (such as methotrexate, chloroquine, azathioprine, etc.), aside from anti-neoplastic chemotherapy or systemic corticosteroids within six months of registration.
6. Participants with a concurrent condition requiring systemic treatment with either corticosteroids (\> 0.25 mg/kg daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses \> 0.25 mg/kg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
7. Unable to taper steroids due to ongoing mass effect; a maximum dexamethasone dose of 0.1 mg/kg/day is allowed (4mg maximum), but preferably have been discontinued (inhaled or topical use of steroids is allowed).
8. Has a known history of active TB (Bacillus tuberculosis).
9. Has a known additional malignancy that is progressing or requires active treatment within 3 years of registration. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
10. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
11. Has known history of, or any evidence of active non-infectious pneumonitis.
12. Has an active infection requiring systemic therapy.
13. Has a known hypersensitivity to any of the study therapy products.
14. Has a known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
* NOTE: Testing for HIV must be performed at sites where mandated locally
15. Any prior positive test result for hepatitis B virus or hepatitis C virus indicating presence of virus, e.g., hepatitis B surface antigen (HBsAg, Australia antigen) positive, or hepatitis C antibody (anti-HCV) positive (except if HCV-ribonucleic acid (RNA) negative).
16. Participants who have had prior allogenic hematopoietic stem cell transplant (HSCT).
17. Any serious or uncontrolled medical disorder that, in the opinion of the investigator may increase the risk associated with study participation or study drug administration, impair the ability of the participant to receive protocol therapy or interfere with interpretation of study results.
Minimum Eligible Age
6 Months
Maximum Eligible Age
25 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Pediatric Neuro-Oncology Consortium
OTHER
Sponsor Role
collaborator
Sabine Mueller, MD, PhD
OTHER
Sponsor Role
lead
Responsible Party
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Sabine Mueller, MD, PhD
Principal Investigator
Responsibility Role
SPONSOR_INVESTIGATOR
Principal Investigators
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Locations
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University of Alabama at Birmingham, Children's of Alabama
Birmingham, Alabama, United States
Site Status
RECRUITING
Children's Hospital of Los Angeles
Los Angeles, California, United States
Site Status
RECRUITING
Rady Children's Hospital
San Diego, California, United States
Site Status
RECRUITING
University of California, San Francisco
San Francisco, California, United States
Site Status
RECRUITING
Children's National Hospital
Washington D.C., District of Columbia, United States
Site Status
RECRUITING
University of Florida
Gainesville, Florida, United States
Site Status
RECRUITING
Riley Children's Hospital
Indianapolis, Indiana, United States
Site Status
RECRUITING
Johns Hopkins University
Baltimore, Maryland, United States
Site Status
RECRUITING
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Site Status
RECRUITING
Washington University St. Louis
St Louis, Missouri, United States
Site Status
RECRUITING
Hackensack Meridian Children's Health at Joseph M. Sanzari Children's Hospital
Hackensack, New Jersey, United States
Site Status
RECRUITING
Duke Children's Hospital & Health Center
Durham, North Carolina, United States
Site Status
RECRUITING
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Site Status
RECRUITING
University of Utah
Salt Lake City, Utah, United States
Site Status
RECRUITING
Sydney Children's Hospital
Sydney, New South Wales, Australia
Site Status
RECRUITING
The Children's Hospital at Westmead
Westmead, New South Wales, Australia
Site Status
RECRUITING
Queensland Children's Hospital
South Brisbane, Queensland, Australia
Site Status
RECRUITING
Women's and Children's Hospital
North Adelaide, South Australia, Australia
Site Status
RECRUITING
Royal Children's Hospital
Parkville, Victoria, Australia
Site Status
RECRUITING
Perth Children's' Hospital
Perth, Western Australia, Australia
Site Status
RECRUITING
Countries
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United States
Australia
Central Contacts
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Facility Contacts
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Other Identifiers
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NCI-2020-01502
Identifier Type: REGISTRY
Identifier Source: secondary_id
PNOC 019
Identifier Type: OTHER
Identifier Source: secondary_id
190815
Identifier Type: -
Identifier Source: org_study_id
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TERMINATED
PHASE2
Intra-Tumoral Injections of Natural Killer Cells for Recurrent Malignant Pediatric Brain Tumors
NCT05887882
RECRUITING
PHASE1
A Phase IB 2 Dose Trial of IRS-1 HSV C134 (IND 17296) Administered Intratumorally in Patients With Recurrent Malignant Glioma
NCT06614855
ACTIVE_NOT_RECRUITING
PHASE1
Adoptive Cellular Therapy in Pediatric Patients With High-grade Gliomas
NCT03334305
TERMINATED
PHASE1
Efficacy of Nivolumab for Recurrent IDH Mutated High-Grade Gliomas
NCT03925246
COMPLETED
PHASE2
Pembrolizumab in Treating Younger Patients With Recurrent, Progressive, or Refractory High-Grade Gliomas, Diffuse Intrinsic Pontine Gliomas, Hypermutated Brain Tumors, Ependymoma or Medulloblastoma
NCT02359565
ACTIVE_NOT_RECRUITING
PHASE1
Vaccine Therapy in Treating Young Patients Who Are Undergoing Surgery for Malignant Glioma
NCT00107185
COMPLETED
PHASE1
Nivolumab, Ipilimumab, and Short-course Radiotherapy in Adults With Newly Diagnosed, MGMT Unmethylated Glioblastoma
NCT03367715
COMPLETED
PHASE2
Testing the Use of the Immunotherapy Drugs Ipilimumab and Nivolumab Plus Radiation Therapy Compared to the Usual Treatment (Temozolomide and Radiation Therapy) for Newly Diagnosed MGMT Unmethylated Glioblastoma
NCT04396860
ACTIVE_NOT_RECRUITING
PHASE2/PHASE3
Peptide-Pulsed Dendritic Cell Vaccination in Combination With Nivolumab and Ipilimumab for the Treatment of Recurrent and/or Progressive Diffuse Hemispheric Glioma, H3 G34-mutant
NCT05457959
WITHDRAWN
PHASE1
GMCI, Nivolumab, and Radiation Therapy in Treating Patients With Newly Diagnosed High-Grade Gliomas
NCT03576612
COMPLETED
PHASE1
A Phase I Clinical Trial of a mRNA Vaccine for Recurrent or Progressive High-grade Glioma
NCT07306299
RECRUITING
PHASE1
Nivolumab and Radiation Therapy With or Without Ipilimumab in Treating Patients With Brain Metastases From Non-small Cell Lung Cancer
NCT02696993
ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
Cellular Adoptive Immunotherapy in Treating Patients With Glioblastoma Multiforme
NCT00331526
COMPLETED
PHASE2
A Phase I/II Trial of BMS-247550 for Treatment of Patients With Recurrent High-Grade Gliomas
NCT00045708
COMPLETED
PHASE1/PHASE2
A Study of GDC-0084 in Patients With Progressive or Recurrent High-Grade Glioma
NCT01547546
COMPLETED
PHASE1
Targeted Pediatric High-Grade Glioma Therapy
NCT05839379
RECRUITING
A Pilot Study of Glioma Associated Antigen Vaccines in Conjunction with Poly-ICLC in Pediatric Gliomas
NCT01130077
COMPLETED
PHASE1
Immunotoxin Therapy in Treating Patients With Malignant Glioma
NCT00006268
COMPLETED
PHASE1/PHASE2
GDC-0449 in Treating Patients With Recurrent Glioblastoma Multiforme That Can Be Removed by Surgery
NCT00980343
COMPLETED
PHASE2