February 12 2024
NRG-HN011 (the “REMAIN” study): 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 (REMAIN)
The NRG-HN011, also known as the “REMAIN” study activated to patient accrual in January 2024. This Phase II trial will accrue patients with recurrent or metastatic nasopharyngeal cancer. Following step 1-2 registration, all trial participants will receive induction treatment with platinum-based chemotherapy, gemcitabine, and nivolumab. Following step 3 registration, trial participants without progressive disease will be stratified by age (over or under 50) and number of sites of disease involvement prior to the induction treatment. Trial participants will then be randomly assigned to receive either maintenance nivolumab or nivolumab with relatlimab (BMS-986016). The primary aim of this study is to determine whether adding relatlimab (BMS-986016) to maintenance nivolumab will show a signal of improved progression-free survival in patients who do not progress following induction treatment.
“Prior research has indicated that the use of platinum-gemcitabine chemotherapy with the addition of a PD1 inhibitor was a tolerable and effective treatment for this patient population, but recent findings are beginning to show that the benefit of this combination is waning because of emerging drug resistance.” stated Brigette B.Y. Ma, MD, of the Chinese University of Hong Kong and the Principal Investigator of the NRG-HN011 clinical trial. “This highlights the need for a more effective, long-term solution for patients with this disease.”
Several single cell sequencing studies of nasopharyngeal cancer suggest that other immune checkpoint proteins such as LAG3 contribute to T-cell exhaustion. Relatlimab (BMS-986016) is a LAG3-inhibitor which has been shown to be safe and effective when combined with nivolumab in first-line treatment of advanced melanoma. NRG-HN011 will combine relatlimab (BMS-986016) with nivolumab following platinum-gemcitabine chemotherapy and nivolumab in an effort to improve survival outcomes.
In addition to progression-free survival, NRG-HN011 also includes secondary objectives such as determining if the addition of relatlimab (BMS-986016) improves overall survival, objective response, duration of response, and disease control rate, comparing the patterns of failure between treatment arms, evaluating the tolerability of relatlimab (BMS-986016), and evaluating baseline plasma EBV DNA and validating post-induction plasma EBV DNA as prognostic biomarkers. NRG-HN011 will also be utilizing blood and tissue specimens from patients for future translational science studies.
Protocol documents and materials are located on the CTSU website.