NCT06019130

Nivolumab in Children and Adults With Nasopharyngeal Carcinoma

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 57 (estimated)
• Sponsor: German Society for Pediatric Oncology and Hematology GPOH gGmbH · Academic / Other
• Sex: All
• Age: 3 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Nasopharyngeal Carcinoma
• Nasopharyngeal Cancer
• Nasopharyngeal Neoplasms
• Nasopharynx Cancer

Interventions

Type	Name	Description
DRUG	Nivolumab	Nivolumab during induction chemotherapy in all groups and during radiochemotherapy in patients with SD or PD after induction or metastases
DRUG	Cisplatin	Cisplatin during induction chemotherapy and during radiochemotherapy in all groups
DRUG	5-Fluorouracil	5-Fluoruracil during induction chemotherapy in all groups except of adults \> 25 years with metastatic disease at diagnosis
DRUG	Gemcitabine	Gemcitabine during induction chemotherapy in patients \> 25 years with metastatic disease at diagnosis
RADIATION	Radiotherapy	After induction therapy in all patients
DRUG	Interferon beta-1a	In patients \< 26 years after end of radiochemotherapy for 6 months
PROCEDURE	MRI	At diagnosis and 17 to 22 days after the beginning of cycle 3 of induction therapy
PROCEDURE	PET	At diagnosis and 17 to 22 days after the beginning of cycle 3 of induction therapy, either as PET-CT or PET-MRI
BEHAVIORAL	Patient-Reported Outcomes	For all patients at baseline, before radiochemotherapy, at day 100, and 2 years after enrolment

Timeline

• Start date: 2023-01-10
• Primary completion: 2026-01-09
• Completion: 2028-01-09
• First posted: 2023-08-31
• Last updated: 2024-05-16

Locations

31 sites across 1 country: Germany