Nivolumab in combination with cisplatin and 5-fluorouracil as induction therapy in children and adults with EBV-positive nasopharyngeal carcinoma

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-500676-59-00

Acronym

NPC-Nivo

Enrollment

Registered

2022-08-08

Start date

2025-12-18

Completion date

Unknown

Last updated

2025-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

EBV-positive nasopharyngeal carcinoma

Brief summary

Complete remission rate (CRR): defined as the proportion of subjects achieving a complete response on MRI and PET/CT after induction chemotherapy with 5-fluorouracil and cisplatin in combination with Nivolumab according to RECIST 1.1 criteria

Detailed description

Event-free survival (EFS), Overall survival (OS), Safety and tolerability: adverse events (AEs), serious adverse events (SAEs), Efficacy based on PD-L1 expression in tumor tissue

Interventions

DRUGGEMCITABINE

DRUGCARBOPLATIN

DRUGFLUOROURACIL

DRUGINTERFERON BETA-1A

DRUGCISPLATIN

DRUGNIVOLUMAB

Eligibility

Sex/Gender

All

Age

0 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Complete remission rate (CRR): defined as the proportion of subjects achieving a complete response on MRI and PET/CT after induction chemotherapy with 5-fluorouracil and cisplatin in combination with Nivolumab according to RECIST 1.1 criteria	—

Secondary

Measure	Time frame
Event-free survival (EFS), Overall survival (OS), Safety and tolerability: adverse events (AEs), serious adverse events (SAEs), Efficacy based on PD-L1 expression in tumor tissue	—

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026