A Phase 2 interventional study of Opdualag in High Grade Glioma, Diffuse Intrinsic Pontine Glioma and WHO Grade 3 Glioma, sponsored by Nationwide Children's Hospital. Not yet recruiting. Open to participants aged 12 Years to 39 Years. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Nationwide Children's Hospital · Phase 2, Interventional, and Treatment
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Among 10 studies in Diffuse Intrinsic Pontine Glioma by Nationwide Children's Hospital — 9 open to participants now, 10 under way, none of them phase 3. Diffuse Intrinsic Pontine Glioma · Nationwide Children's Hospital.
Among the 10 studies in Diffuse Intrinsic Pontine Glioma by Nationwide Children's Hospital, this one is one of 2 that started in 2027, is one of 5 in phase 2, and was the 10th registered.
119 studies on the registry are indexed under Diffuse Intrinsic Pontine Glioma; 39 are open to participants now.
Browse Diffuse Intrinsic Pontine Glioma studies →9 of the 10 studies in Diffuse Intrinsic Pontine Glioma by Nationwide Children's Hospital are open now, in 7 countries. Recruiting first, the newest first:
Nationwide Children's Hospital · Sites in United States, Australia, Canada and 3 more countries
Ages 1–21 · Healthy volunteers
Nationwide Children's Hospital · Sites in United States, Australia, Canada and 2 more countries
Ages 12 mo–39 yrs
Nationwide Children's Hospital · Sites in United States, Australia, Canada and 3 more countries
Ages 12 mo–39 yrs
Nationwide Children's Hospital · Sites in United States, Australia, Canada and 4 more countries
Ages 12 mo–39 yrs
Nationwide Children's Hospital · Sites in United States
Ages 3–39
By country, each count listing its studies:
Of the 29 Diffuse Intrinsic Pontine Glioma studies recruiting now, 3 (10%) set no upper age limit and 26 (90%) stop at 75 or younger; 28 take children under 18; 2 take healthy volunteers.
This study: 12 Years to 39 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
10 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 4 · Phase 2 6
First in 2018; this study’s year is marked. 2 started in 2027.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 12 is below the median of 30 across 109 interventional studies indexed under Diffuse Intrinsic Pontine Glioma.
Median enrollment 64 across the 9 interventional studies, 350 across the 1 observational. None of them has completed or been terminated yet.
This tab as a report to print or save as PDF → With an account.
Nationwide Children's Hospital is the lead sponsor of 233 studies on the registry; 43 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 9 (53%) have results posted.
1 of the studies in Diffuse Intrinsic Pontine Glioma by Nationwide Children's Hospital that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04655404Nationwide Children's HospitalA Pilot Study of Larotrectinib for Newly-Diagnosed High-Grade Glioma With NTRK Fusion | 2026-12-01 |
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Among the 10 studies in Diffuse Intrinsic Pontine Glioma by Nationwide Children's Hospital, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The goal of this study is to further evaluate feasibility and tolerability of Opdualag for patients with replication repair deficient HGG, including DIPG.
This is a multicenter, international study of post-radiotherapy (RT) fixed dose combination of nivolumab and relatlimab (Opdualag) to treat adolescent and young adult patients newly diagnosed with replication repair deficient (RRD) HGG and DIPG. The objectives of the study are to further evaluate feasibility and tolerability of Opdualag after RT, and to further characterize the safety and toxicity of Opdualag for patients with RRD HGG. We will also assess the progression free survival and overall survival distribution in patients.
Protocol maintenance therapy of Opdualag must begin no later than 56 days post-completion of RT. The earliest patients can begin protocol treatment is 28 calendar days post-completion of RT. Each cycle will be 28 days in duration and treatment can continue up to a total of 26 cycles. Opdualag will be given intravenously once every 4 weeks.
119 studies on the registry are indexed under Diffuse Intrinsic Pontine Glioma; 39 are open to participants now.
This study's planned enrollment of 12 is below the median of 30 across 109 interventional studies indexed under Diffuse Intrinsic Pontine Glioma.
Browse Diffuse Intrinsic Pontine Glioma studies →Nationwide Children's Hospital is the lead sponsor of 233 studies on the registry; 43 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 9 (53%) have results posted.
Compared within Diffuse Intrinsic Pontine Glioma, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Glioma. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Diagnosis:
Disease Status:
Demonstration of DNA replication repair deficiency (RRD) by fulfilling at least 2 of the following criteria:
Performance Level: ≥ 50 for patients > 16 years of age and Lansky ≥ 50 for patients ≤ 16 years of age
Prior Therapy for HGG:
Organ Function Requirements:
or radioisotope ≥ 70 mL/min/1.73 m2 OR serum creatinine based on age/gender as follows:
10 to \< 13 years: 1.2 mg/dL for males and females 13 to \< 16 years: 1.5 mg/dL for males and 1.4 mg/dL for females
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Post-RT Opdualag Maintenance Therapy
Drug: Opdualag
Fixed dose combination of relatlimab and nivolumab (Opdualag)
This study also gives Nivolumab. No intervention listed here names it: that was found by reading the record.
Number of Participants with Adverse Events, Immune Related Adverse Events, and Dose Modifying Toxicities as assessed by CTCAE v6
Assess the feasibility of fixed dose combination of nivolumab and relatlimab as adjuvant therapy following radiation therapy in patients with newly diagnosed replication repair deficiency HGG. Adverse event data will be summarized in tables which will incorporate grade, attribution, and dose delays.
Time frame: 4 years
Number of participants that complete the first 3 cycles of maintenance therapy without experiencing dose modifying toxicities
Assess the tolerability of fixed dose combination of nivolumab and relatlimab (Opdualag) as adjuvant therapy following radiation therapy in patients with newly diagnosed replication repair deficient HGG by quantifying the number of participants that complete at least the first 3 cycles of maintenance therapy without experiencing dose modifying toxicities that require permanent discontinuation of Opdualag therapy.
Time frame: 4 years
Progression Free Survival in HGG
Estimate PFS distribution for patients with newly diagnosed RRD-HGG who received Opdualag following RT compared to molecularly stratified and matched historical controls
Time frame: Day 1 of treatment until date of Progressive Disease or death due to any cause or date of last follow-up, assessed up to 5 years
Overall Survival in HGG
Estimate overall survival distribution for patients with newly diagnosed RRD-HGG who receive Opdualag following RT compared to molecularly stratified and matched historical controls.
Time frame: Day 1 of treatment until date of death due to any cause or date of last follow-up, assessed up to 5 years
Correlations between genomic tumor alterations with radiographic response
Explore longitudinal associations of genomic, transcriptomic, epigenetic, and/or immunologic alterations of tumor at diagnosis, recurrence, or autopsy with radiographic response and advanced neuro-imaging measures. Incidence of significant genomic/transcriptomic/epigenetic and/or immunologic alterations found by sequencing and proteomics will be correlated with percent of patients that achieve radiographic responses using RAPNO guidelines.
Time frame: Diagnosis until date of death due to any cause or date of last follow-up, assessed up to 5 years
Evaluate health-related quality of life outcomes using PROMIS questionnaire
Using PROMIS questionnaire, evaluate health-related quality of life outcomes of patients newly diagnosed with RRD-HGG from diagnosis through the end of treatment.
Time frame: From diagnosis through the end of treatment with Opdualag, usually 2 years per patient
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Mar 2027; primary completion for Mar 2033, 72 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Nivolumab
Diffuse Intrinsic Pontine Glioma →
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