A Study Using Nivolumab, in Combination With Chemotherapy Drugs to Treat Nasopharyngeal Carcinoma (NPC)
A Phase 2 Study Using Chemoimmunotherapy with Gemcitabine, Cisplatin and Nivolumab in Newly Diagnosed Nasopharyngeal Carcinoma (NPC)
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Clinical Trial Information
Trial Contact: Armatti, Julie M; Parker, Melanie; Frankos, Marie; Torrescano, Tanner; Singh, Sarah H; Jones, Jamie
Trial Phone: 321-843-5284 ; 321-843-1036 ; 321-842-8738 ; 321-841-8271 ; 321.841.7561 ; 3218412008
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IRB No: ARAR2221
Protocol Abbrev: ARAR2221
Principal Investigator: Jaime A. Carvajal, MD
Phase: Drug: Phase II
Age Group: Pediatric; Adult
Secondary Protocol No: ARAR2221
Treatment: Procedure: Biopsy, Procedure: Biospecimen Collection, Procedure: Chest Radiography, Drug: Cisplatin, Procedure: Computed Tomography, Procedure: Echocardiography, Other: Electronic Health Record Review, Other: Fluciclovine F18, Drug: Gemcitabine, Procedure: Magnetic Resonance Imaging, Procedure: Multigated Acquisition Scan, Biological: Nivolumab, Procedure: Positron Emission Tomography, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Radiation: Radiation Therapy, Procedure: X-Ray Imaging
Therapies Involved: Chemotherapy
ClinicalTrials.gov ID: NCT06064097
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Objective
To evaluate safety of combining chemotherapy (cisplatin and gemcitabine) with an anti-PD1 immune checkpoint inhibitor (nivolumab) in children, adolescents and young adults with nasopharyngeal carcinoma (NPC) by determining the rate of Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or higher immune related adverse events (irAEs).
