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Nivolumab
Source: Bladder Cancer Treatment (PDQ®)–Health Professional Version, National Cancer Institute.
Source updated: May 2, 2025 · Captured 2026-09-09.
Selected source text with whitespace normalised. This Triangle page is not an NCI PDQ summary.
Nivolumab is a fully human immunoglobulin G4 PD-1 immune checkpoint inhibitor antibody that blocks interaction between PD-L1 and PD-L2 with PD-1. There are no published controlled trials and thus no data regarding whether nivolumab results in longer survival or improved quality of life.
Evidence (nivolumab):
A multicenter trial (NCT01928394) included 86 patients with metastatic urothelial carcinoma whose disease progressed after platinum-based chemotherapy. Patients received nivolumab (3 mg/kg IV every 2 weeks).[55][Level of evidence B4]
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A multicenter trial (NCT01928394) included 86 patients with metastatic urothelial carcinoma whose disease progressed after platinum-based chemotherapy. Patients received nivolumab (3 mg/kg IV every 2 weeks).[55][Level of evidence B4]
With a minimum follow-up of 9 months and a median follow-up of 15 months, 24% of patients had an objective response, and 22% had grade 3 or 4 adverse events.
A multicenter trial (NCT01928394) included 86 patients with metastatic urothelial carcinoma whose disease progressed after platinum-based chemotherapy. Patients received nivolumab (3 mg/kg IV every 2 weeks).[55][Level of evidence B4]
The most common adverse events were elevated lipase or amylase, fatigue, rash, dyspnea, lymphopenia, and neutropenia.
Another multicenter study (NCT02387996) of 270 patients with locally advanced or metastatic urothelial carcinoma that had progressed after treatment with platinum-based chemotherapy reported an objective response rate of 20%.[54][Level of evidence B4]
Source links and citations
Another multicenter study (NCT02387996) of 270 patients with locally advanced or metastatic urothelial carcinoma that had progressed after treatment with platinum-based chemotherapy reported an objective response rate of 20%.[54][Level of evidence B4]
When evaluated by PD-L1 expression, the objective response rate was 28% in those with PD-L1 expression of 5% or greater; 24% in those with PD-L1 expression of 1% or greater; and 16% in those with PD-L1 expression of less than 1%.
Another multicenter study (NCT02387996) of 270 patients with locally advanced or metastatic urothelial carcinoma that had progressed after treatment with platinum-based chemotherapy reported an objective response rate of 20%.[54][Level of evidence B4]
Grade 3 to 4 adverse events were reported in 18% of patients.
Another multicenter study (NCT02387996) of 270 patients with locally advanced or metastatic urothelial carcinoma that had progressed after treatment with platinum-based chemotherapy reported an objective response rate of 20%.[54][Level of evidence B4]
There were three treatment-related deaths.
Studies cited in this source section
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Preserved source evidence · Not medical advice