TriangleHEALTH PROFESSIONAL · SOURCE READING
Chemotherapy plus immunotherapy
Source: Bladder Cancer Treatment (PDQ®)–Health Professional Version, National Cancer Institute.
Source updated: May 2, 2025 · Captured 2026-09-09.
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For many years, cisplatin-based chemotherapy was the standard-of-care first-line systemic treatment for patients with stage IV urothelial carcinoma who were eligible to receive cisplatin. A randomized, controlled, phase III trial reported longer OS when cisplatin-based chemotherapy was given with nivolumab, compared with chemotherapy alone.[5]
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Evidence (chemotherapy plus immunotherapy):
A phase III, randomized controlled trial (CheckMate901 [NCT03036098]) included 608 patients (304 to each arm). Patients were randomly assigned to receive either nivolumab plus gemcitabine and cisplatin or gemcitabine and cisplatin alone. Patients received up to six cycles of chemotherapy and up to 2 years of nivolumab. The median follow-up was 33.6 months.[5]
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A phase III, randomized controlled trial (CheckMate901 [NCT03036098]) included 608 patients (304 to each arm). Patients were randomly assigned to receive either nivolumab plus gemcitabine and cisplatin or gemcitabine and cisplatin alone. Patients received up to six cycles of chemotherapy and up to 2 years of nivolumab. The median follow-up was 33.6 months.[5]
The median OS was 21.7 months for patients who received nivolumab and 18.9 months for patients who received chemotherapy alone (HRdeath, 0.78; 95% CI, 0.63–0.96; P = .02).[5][Level of evidence A1]
Source links and citations
A phase III, randomized controlled trial (CheckMate901 [NCT03036098]) included 608 patients (304 to each arm). Patients were randomly assigned to receive either nivolumab plus gemcitabine and cisplatin or gemcitabine and cisplatin alone. Patients received up to six cycles of chemotherapy and up to 2 years of nivolumab. The median follow-up was 33.6 months.[5]
The median PFS was 7.9 months for patients who received nivolumab and 7.6 months for patients who received chemotherapy alone (HRprogression or death, 0.72; 95% CI, 0.59–0.88; P = .001).
A phase III, randomized controlled trial (CheckMate901 [NCT03036098]) included 608 patients (304 to each arm). Patients were randomly assigned to receive either nivolumab plus gemcitabine and cisplatin or gemcitabine and cisplatin alone. Patients received up to six cycles of chemotherapy and up to 2 years of nivolumab. The median follow-up was 33.6 months.[5]
At 1 year, the PFS rate was 34.2% in the nivolumab arm and 21.8% in the chemotherapy-alone arm.
A phase III, randomized controlled trial (CheckMate901 [NCT03036098]) included 608 patients (304 to each arm). Patients were randomly assigned to receive either nivolumab plus gemcitabine and cisplatin or gemcitabine and cisplatin alone. Patients received up to six cycles of chemotherapy and up to 2 years of nivolumab. The median follow-up was 33.6 months.[5]
The overall response rate was 57.6% in the nivolumab arm and 21.7% in the chemotherapy-alone arm. The complete response rate was 21.7% in the nivolumab arm and 11.8% in the chemotherapy-alone arm.
A phase III, randomized controlled trial (CheckMate901 [NCT03036098]) included 608 patients (304 to each arm). Patients were randomly assigned to receive either nivolumab plus gemcitabine and cisplatin or gemcitabine and cisplatin alone. Patients received up to six cycles of chemotherapy and up to 2 years of nivolumab. The median follow-up was 33.6 months.[5]
The duration of complete response was 37.1 months in the nivolumab arm and 13.2 months in the chemotherapy-alone arm.
A phase III, randomized controlled trial (CheckMate901 [NCT03036098]) included 608 patients (304 to each arm). Patients were randomly assigned to receive either nivolumab plus gemcitabine and cisplatin or gemcitabine and cisplatin alone. Patients received up to six cycles of chemotherapy and up to 2 years of nivolumab. The median follow-up was 33.6 months.[5]
Grade 3 or higher adverse events occurred in 61.8% of patients in the nivolumab arm and 51.7% of patients in the chemotherapy-alone arm.
Studies cited in this source section
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Preserved source evidence · Not medical advice