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Nivolumab in Children and Adults With Nasopharyngeal Carcinoma — NPC-Nivo  

Nasopharyngeal Carcinoma Clinical Trial

Official title:
Nivolumab in Combination With Cisplatin and 5-Fluorouracil as Induction Therapy in Children and Adults With EBV-positive Nasopharyngeal Carcinoma

Clinical Trial Summary

The purpose of this study is to assess whether the addition of the immune checkpoint inhibitor Nivolumab to induction chemotherapy will increase the percentage of patients with a complete response on MRI and PET after 3 cycles of induction therapy.

Clinical Trial Description

After being informed about the study and potential risks, all patients will undergo a 2-week screening period to determine eligibility for study entry. After informed consent has been obtained, all patients ≤ 25 years and patients > 25 years without metastases will receive Nivolumab (4.5 mg/kg BW (max. 360 mg) q 3 weeks) added to standard induction chemotherapy (3 blocks of cisplatin/5-fluorouracil). In patients not responding to induction chemotherapy, the application of Nivolumab will be extended throughout the period of radiochemotherapy. Patients > 25 years with metastatic disease will receive Nivolumab (4.5 mg/kg BW (max. 360 mg) q 3 weeks) added to induction chemotherapy with 3 blocks of cisplatin/gemcitabine. All patients with metastatic disease will continue to receive Nivolumab during radiochemotherapy. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06019130
Study type Interventional
Source German Society for Pediatric Oncology and Hematology GPOH gGmbH
Contact Helena Kerp, PhD
Phone +49 201 74 94 96 14
Email h.kerp@forschung-paediatrie.de
Status Recruiting
Phase Phase 2
Start date January 10, 2023
Completion date January 9, 2028
View Details
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