Description for experts
Primary study objective
The aim of the study is to increase the percentage of patients without metastases who achieve a complete remission on imaging (MRI and PET) after induction therapy. As a result, the radiation dose can be reduced from 59.4 Gy to 54 Gy in patients under 26 years of age with complete remission.
Secondary study objectives
To evaluate whether nivolumab can be safely used in combination with standard chemotherapy with cisplatin and 5-fluorouracil in children and adults with NPC.
To evaluate whether nivolumab can be safely used in combination with radiochemotherapy in patients who have not responded to induction therapy or have metastases.
Description for laymen
JSON Data
{
"short_title": "Nivolumab-NPC",
"data_mode": "900",
"data_mode_number": "000002468",
"official_title": "Nivolumab in combination with cisplatin and 5-flurouracil as induction therapy in children and adults with EBV-positive nasopharyngeal carcinoma",
"accrual_state": "running",
"therapeutic_value": "therapeutic",
"therapieansatz_value": "kurativ",
"therapieintervention_value": null,
"therapielinie_value": "first",
"ctgov_number": null,
"eudract_number": "2021-006477-32",
"general_contact_email": "Kik-dokuteam-hs65@ukdd.de",
"general_contact_phone": "+49 351-4585035",
"hauptpruefer_dd_name": "Prof. Dr. med. Ralf Kn\u00f6fler",
"description_laie_de": "Prim\u00e4ree Studienziel\r\nDas Ziel der Studie ist es, bei Patienten ohne Metastasen den prozentualen Anteil derer zu erh\u00f6hen, die eine komplette Remission in der Bildgebung (MRT und PET) nach der Induktionstherapie erreichen. In der Folge kann die Strahlendosis bei Patienten unter 26 Jahren mit kompletter Remission von 59,4 Gy auf 54 Gy gesenkt werden.\r\n\r\nSekund\u00e4re Studienziele\r\nEvaluierung, ob Nivolumab in Kombination mit der Standardchemotherapie mit Cisplatin und 5-Fluorouracil sicher bei Kindern und Erwachsenen mit einem NPC angewendet werden kann.\r\nEvaluierung, ob Nivolumab in Kombination mit Radiochemotherapie bei Patienten, die nicht auf die Induktionstherapie angesprochen haben oder Metastasen haben, sicher angewendet werden kann.",
"description_laie_en": null,
"description_expert_de": null,
"description_expert_en": "Primary study objective\r\nThe aim of the study is to increase the percentage of patients without metastases who achieve a complete remission on imaging (MRI and PET) after induction therapy. As a result, the radiation dose can be reduced from 59.4 Gy to 54 Gy in patients under 26 years of age with complete remission.\r\n\r\nSecondary study objectives\r\nTo evaluate whether nivolumab can be safely used in combination with standard chemotherapy with cisplatin and 5-fluorouracil in children and adults with NPC.\r\nTo evaluate whether nivolumab can be safely used in combination with radiochemotherapy in patients who have not responded to induction therapy or have metastases.",
"rechtsgrundlage_value": "AMG",
"phase_amg_value": "II",
"main_cat_id": 14,
"sub_cat_id": 63
}
