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NCT04267146COMPLETEDanonymous

Phase I-II Study of Nivolumab in Combination With Temozolomide and Radiotherapy in Children and Adolescents With Newly Diagnosed High-grade Glioma

Sponsor

Source record

Gustave Roussy, Cancer Campus, Grand Paris

Phase

Source record

Phase 1/2

Modality

AI-normalized

small molecule

Target

AI-normalized

PD-1 receptor (programmed cell death protein 1)

Indication / condition

AI-normalized

High Grade Glioma

Intervention

Source record

Nivolumab, Temozolomide, Radiotherapy

Source & freshness

Source record

NCT ID

NCT04267146

Original source

ClinicalTrials.gov

Source last updated

Dec 02, 2024

Ingested at

Jun 19, 2026

Internal sync

Jun 19, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

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NCT ID

NCT04267146

Title

Phase I-II Study of Nivolumab in Combination With Temozolomide and Radiotherapy in Children and Adolescents With Newly Diagnosed High-grade Glioma

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Status

COMPLETED

Phase

Phase 1/2

Condition raw

High Grade Glioma

Condition normalized

High Grade Glioma

Modality raw

small molecule

Modality normalized

small molecule

Target raw

PD-1 receptor (programmed cell death protein 1)

Target normalized

PD-1 receptor (programmed cell death protein 1)

Interventions

Nivolumab, Temozolomide, Radiotherapy

Public preview

Source record

The trial investigates the combination of nivolumab, a PD-1 inhibitor, with temozolomide and radiotherapy in pediatric patients with newly diagnosed high-grade gliomas (HGG). Given the limited treatment options for HGG in children, successful outcomes could position this combination as a new standard of care, potentially capturing significant market share in the pediatric oncology space. The trial's completion and subsequent results will be critical for assessing the commercial viability and potential partnerships or licensing opportunities. Competitors in the pediatric oncology market may include other immunotherapies and novel agents targeting HGG, necessitating thorough competitive analysis and diligence on emerging therapies.

AI-generated analysis supports research triage only. Verify source records, publications, sponsor disclosures and IP databases before making diligence decisions. Model: trialsignal-ai-v1.

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