The goal of this study is to further evaluate feasibility and tolerability of Opdualag for patients with replication repair deficient HGG, including DIPG.
Patients must be ≥12 years and ≤39 years of age at the time of enrollment on TarGeT-SCR.
Within the United States, patients must weight ≥ 40 kg at the time of enrollment. For all other countries, patients must weight ≥ 30 kg at the time of enrollment.
Patients with newly-diagnosed HGG, including DIPG, are eligible. All patients mut have histologic confirmation from diagnostic biopsy or resection. The diagnosis of HGG, including DIPG must have been confirmed through TarGeT-SCR.
All HGGs must be WHO Grade 3 or 4. Note: WHO Grade 2 gliomas with pontine epicenter and diffuse involvement of at least 2/3 of the pons are eligible.
Pregnant or breastfeeding patients are excluded.
Patients with uncontrolled infection.
Patients with bone marrow failure syndrome.
Participants who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.
Single group
Opdualag
DrugFixed dose combination of relatlimab and nivolumab (Opdualag)
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.
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.
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
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.
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.
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.
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Nationwide Children's Hospital
Lead sponsor
The Hospital for Sick Children
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
