Study Name: NRG-HN011

Recruiting

Head and Neck

NRG-HN011 (REMAIN), A RANDOMIZED PHASE II STUDY OF NIVOLUMAB VERSUS NIVOLUMAB AND BMS-986016 (RELATLIMAB) AS MAINTENANCE TREATMENT AFTER FIRST-LINE TREATMENT WITH PLATINUM-GEMCITABINE-NIVOLUMAB FOR PATIENTS WITH EPSTEIN-BARR VIRUS-ASSOCIATED RECURRENT/METASTATIC NASOPHARYNGEAL CARCINOMA

NCT#02135042

clinicaltrials.gov/show/NCT02135042

There are two study questions we are asking in this randomized phase II/III trial based on a blood biomarker, Epstein Barr virus (EBV) deoxyribonucleic acid (DNA) for locoregionally advanced non-metastatic nasopharyngeal cancer. All patients will first undergo standard concurrent chemotherapy and radiation therapy. When this standard treatment is completed, if there is no detectable EBV DNA in their plasma, then patients are randomized to either standard adjuvant cisplatin and fluorouracil chemotherapy or observation. If there is still detectable levels of plasma EBV DNA, patients will be randomized to standard cisplatin and fluorouracil chemotherapy versus gemcitabine and paclitaxel. Radiation therapy uses high energy x rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, fluorouracil, gemcitabine hydrochloride, and paclitaxel work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving cisplatin and fluorouracil is more effective than gemcitabine hydrochloride and paclitaxel after radiation therapy in treating patients with nasopharyngeal cancer.

Male and Female – 18 years and older

• Pathologic (histologically or cytologically) proven diagnosis of nasopharyngeal carcinoma (NPC) that had recurred locoregionally and/or is present at distant sites. Patients who present with metastatic (de novo) at diagnosis are also eligible. For locoregional recurrence, the disease must not be amenable to potentially curative surgery or re-irradiation
• Tumor showing EBER-positivity OR known history of detectable EBV DNA at any time point since the initial diagnosis of NPC
• No prior treatment for recurrent/metastatic NPC including cytotoxic chemotherapy.
• Prior treatment for non-recurrent and non-metastatic NPC is allowed
• No prior treatment with a PD-1 inhibitor, PD-L! inhibitor, anti-PD-L2 inhibitor, LAG-3 inhibitor, CTLA-4 inhibitor (except if given as adjuvant or neoadjuvant therapy for non- recurrent/non-metastatic NPC), or any other antibody or drug specifically targeting T=cell co- stimulation or immune checkpoint pathways.
• The interval between the last dose of curative-intent treatment, including definitive radiotherapy and/or induction, concurrent, or adjuvant chemotherapy and recurrence must be >6 months
• No prior palliative radiation with 30 days prior to registration

• No history of myocarditis
• No history of or current pneumonitis that required steroids, idiopathic pulmonary fibrosis, organizing pneumonia, or idiopathic pneumonitis
• No conditions requiring systemic treatment with either immunosuppressive doses of corticosteroids or other immunosuppressive medications within 14 days of registration
• No active autoimmune disease requiring systemic treatment