Safety of nivolumab in treating Indian patients with non-small-cell lung carcinoma and renal cell carcinoma: A prospective multicenter study

• DOI: 10.4103/crst.crst_78_24
• Publication Date: 2025-03-29T01:06:39Z
• Authors: Kumar Prabhash; Shekar Patil; Prabhat S Malik; Krishna Mohan Mal...; Nalini Kilara; Lakshmaiah Kunteg...; Vanita Noronha; Nandini Menon; Rajshri Somani; H P Shashidara; Sachin Khurana; Senthil J Rajappa; Kartik Doshi; Naresh Somani

ABSTRACT Background: Nivolumab has shown significant therapeutic benefits in treating non-small-cell lung carcinoma (NSCLC) and renal cell (RCC). Objectives: The primary objective of the study was to assess safety tolerability nivolumab Indian patients with advanced NSCLC or RCC. secondary evaluate frequency severity TRAEs. Materials Methods: In this single-arm, open-label, multicenter, prospective Phase IV study, we enrolled 100 (70 locally advanced/metastatic 30 RCC) from seven sites India between April 2018 July 2019. Patients received as a second-line treatment (3 mg/kg intravenous (IV) every 2 weeks for 24 weeks). Safety evaluated based on incidence RCC group, 22 (73.3%) underwent prior cancer-related surgery, 7 (23.3%) radiotherapy. Results: Among [median age 56 (range 26 -74) years, 78% (n = 78) male], 95% 95) experienced adverse events (AEs), 25% 25) reporting Grade 3-4 TRAEs (4%) included hyponatremia, respiratory infections, electrolyte imbalances, pneumonitis. leading discontinuation observed none 4 (5.7%) at least one treatment-related SAE any grade. No SAEs were reported group. Conclusion: This confirms RCC, consistent global trials monotherapy after chemotherapy.