← Back to The Absolute EffectBladder Cancer · Medical · Platinum-Refractory Metastatic · Immunotherapy · 2026-09-18
CheckMate 275
Can nivolumab produce clinically meaningful responses after platinum therapy in metastatic or unresectable urothelial carcinoma, and are responses restricted to PD-L1-positive tumours?
Population
270 treated patients with metastatic or surgically unresectable urothelial carcinoma progressing after at least one platinum-based regimen; 265 were evaluable for activity.
Intervention
Nivolumab 3 mg/kg IV every 2 weeks until progression/toxicity.
Comparator
Single-arm study; no randomized comparator.
Sample size / primary endpoint
270 treated patients; Confirmed objective response rate
Absolute Effect
Primary efficacy result
ORR 19.6% (95% CI 15.0–24.9%) overall
Median OS follow-up 7.0 months at the primary report.
OS was immature at the primary analysis; the study was not powered for a randomized OS comparison.
No comparative PFS effect can be calculated because this was a single-arm study.
NNT / NNH
NNT: not applicable; single-arm response data do not support a treatment-vs-control NNT.
NNH: not applicable; there is no randomized control risk from which to calculate an NNH.
Treatment burden and toxicity
Grade 3–4 treatment-related adverse events occurred in 18%; three treatment-related deaths were attributed to pneumonitis, acute respiratory failure and cardiovascular failure.
Quality of life: The study was not designed primarily around comparative QoL; treatment discontinuation and immune-related toxicity were clinically important.
Subgroups / clinically important modifiers
ORR was 28.4% with PD-L1 ≥5%, 23.8% with PD-L1 ≥1%, and 16.1% with PD-L1 <1%, demonstrating responses irrespective of PD-L1 expression.
Limitations and maturity
Single-arm phase II design, short initial OS follow-up and absence of a randomized comparator limit causal absolute-effect inference.
Clinical interpretation
CheckMate 275 established that nivolumab can produce durable responses after platinum failure, including in PD-L1-low tumours, but its single-arm design prevents a conventional NNT/NNH treatment-effect calculation.
The trial is best understood as response-evidence that helped establish checkpoint blockade in platinum-refractory urothelial cancer; later randomized trials are required to quantify comparative survival benefit.
Primary / authoritative sources
Current-practice context · reviewed 14 October 2026
CheckMate 275 is single-arm response evidence and should not be used to infer a comparative NNT or to assume nivolumab monotherapy is the preferred treatment after every modern first-line regimen. Subsequent therapy now depends on prior platinum, checkpoint inhibitor and enfortumab vedotin exposure, eligibility, disease tempo and jurisdiction-specific approvals. The trial remains useful for understanding checkpoint-inhibitor activity in platinum-refractory urothelial carcinoma, including responses in PD-L1-low disease.
EAU bladder-cancer guidance ↗ · CheckMate 275 primary report ↗