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

NCT07644312 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: CONNECT TarGeT-F
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  4 years

Secondary Outcomes (4)

• Progression Free Survival in HGG

  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

  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

  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

  From diagnosis through the end of treatment with Opdualag, usually 2 years per patient

Study Arms (1)

Opdualag Maintenance Therapy

EXPERIMENTAL

Post-RT Opdualag Maintenance Therapy

Drug: Opdualag

Interventions

Opdualag DRUG

Fixed dose combination of relatlimab and nivolumab (Opdualag)

Opdualag Maintenance Therapy

Eligibility Criteria

• Age: 12 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• Diagnosis:
• 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.
• Disease Status:
• Patients must be newly diagnosed.
• Measurable disease is not required.
• Patients with primary spinal tumors are eligible.
• Patients should have no evidence of herniation or impending herniation, and no mass effect leading to severe midline shift.
• Patients with prior malignancy are eligible.
• Metastatic disease is excluded.
• Disseminated or multifocal disease: discussion with Study Chairs is required. Patients with multifocal disease who received upfront CSI are not eligible.
• Demonstration of DNA replication repair deficiency (RRD) by fulfilling at least 2 of the following criteria:
• Tumor mutational burden greater than or equal to 5 mutations/megabase (Intermediate and high TMB)

You may not qualify if:

• 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.
• Inflammatory bowel disease
• Moderate to severe pulmonary conditions defined by need for medical intervention and/or limiting activities of daily living or shortness of breath with limited exertion.
• Personal history of pneumonitis.
• Cardiac conditions.
• Patients with a history of severe or life-threatening adverse dermatologic reactions such as SJS or toxic epidermal necrolysis, or other severe reactions that have been associated with prior immune checkpoint inhibitor therapy.
• Active tuberculosis
• Active autoimmune disease requiring systemic treatment in the past 2 years
• Chronic HBV infections with active disease
• Personal known history of HPC who have not completed curative antiviral treatment
• Personal known history of HIV
• Receipt of any organ transplantation

Sponsors & Collaborators

• Nationwide Children's Hospital: lead

MeSH Terms

Conditions

Glioma; Diffuse Intrinsic Pontine Glioma

Interventions

Opdualag

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Brain Stem Neoplasms; Infratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Kelsey Troyer, PhD

CONTACT

6147223284; kelsey.troyer@nationwidechildrens.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Fixed dose combination of relatlimab and nivolumab (Opdualag)

Study Record Dates

• First Submitted: May 29, 2026
• First Posted: June 12, 2026
• Study Start (Estimated): March 1, 2027
• Primary Completion (Estimated): March 1, 2033
• Study Completion (Estimated): March 1, 2038
• Last Updated: June 12, 2026

Record last verified: 2026-05