Study of Relatlimab and Nivolumab (Opdualag) in Replication Repair Deficient HGG and DIPG

Sponsor
Nationwide Children's Hospital
Study ID
NCT07644312
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Diffuse Intrinsic Pontine Glioma
  • High Grade Glioma
  • Replication Repair Deficient
  • WHO Grade 3 Glioma
  • WHO Grade 4 Glioma

Eligibility Criteria

Sex
ALL
Age
12 Years - 39 Years
Healthy Volunteers
Not accepted

Interventions

  • Opdualag — DRUG
    Fixed dose combination of relatlimab and nivolumab (Opdualag)

Study Details

The goal of this study is to further evaluate feasibility and tolerability of Opdualag for patients with replication repair deficient HGG, including DIPG.

Key Dates

First listed
Jun 12, 2026
Start date
Mar 1, 2027
Status verified
May 2026
Primary completion
Mar 1, 2033
Completion
Mar 1, 2038

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Opdualag Maintenance Therapy
    Post-RT Opdualag Maintenance Therapy

Primary Outcome Measure

Number of Participants with Adverse Events, Immune Related Adverse Events, and Dose Modifying Toxicities as assessed by CTCAE v6 [ Time Frame: 4 years ]

Central Contacts

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