Study of Nivolumab with Cisplatin and 5-Fluorouracil for Treating EBV-positive Nasopharyngeal Carcinoma in Children and Adults

What this Trial Is About

Researchers are evaluating whether adding the immune checkpoint inhibitor Nivolumab to induction chemotherapy improves the rate of complete response in patients with nasopharyngeal carcinoma, as seen on MRI and PET scans after three cycles of induction therapy. This phase 2 study includes children and adults with EBV-positive nasopharyngeal carcinoma, aiming to assess this combinations effect on tumor response and survival outcomes. Participants will receive Nivolumab at a dose of 4.5 mgkg body weight maximum 360 mg every three weeks combined with standard induction chemotherapy. Children and adults without metastases receive cisplatin and 5-fluorouracil, while adults with metastatic disease receive cisplatin and gemcitabine. Depending on response, Nivolumab may continue during radiochemotherapy, followed by maintenance therapy with recombinant interferon beta-1a for six months in younger patients. During the study, patients undergo a two-week screening period before treatment begins. MRI and PET scans are performed at diagnosis and after induction therapy to evaluate tumor response. Researchers will monitor treatment-related side effects, survival rates over two years, and tumor PD-L1 expression. Patient-reported outcomes will be collected at baseline, before radiochemotherapy, at 100 days, and two years after enrollment. The total study duration includes induction therapy, radiochemotherapy, maintenance, and follow-up assessments.

Nivolumab in Children and Adults With Nasopharyngeal Carcinoma