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March 4, 2026Journal of Clinical Oncology

A phase 2 study of gemcitabine plus carboplatin as second-line therapy after prior enfortumab vedotin and pembrolizumab in patients with locally advanced or metastatic urothelial carcinoma.

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Authors

GHGregory HemenwayERE. F. RossCSCandice L. Schwebel

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Overview

Phase 2 study evaluates gemcitabine and carboplatin efficacy in patients with recurrent urothelial carcinoma, suggesting a new therapeutic approach.

Key Points

  • Evaluate the efficacy of gemcitabine plus carboplatin as second-line therapy following progression after enfortumab vedotin and pembrolizumab in urothelial carcinoma.
  • Non-randomized, single-arm, open-label phase 2 trial
  • Simon two-stage design to assess efficacy and safety
  • Eligible patients had advanced or metastatic urothelial carcinoma and prior EVP treatment
  • Gemcitabine and carboplatin administered every 3 weeks for up to 6 cycles
  • Tumor response assessed every 9 weeks per RECIST v1.1
  • Primary outcome is overall response rate; a target of ORR ≥ 0.3
  • If 3 or fewer patients show response in first stage, trial stops for futility
  • Secondary outcomes include progression-free survival and overall survival
  • Geriatric assessments will be correlated with treatment toxicity and outcomes
  • Exploratory objectives include unique aging factors affecting treatment responses

Cite This Study

Hemenway et al. (2026) studied this question.

synapsesocial.com/papers/69a7cd5ed48f933b5eed99cchttps://doi.org/10.1200/jco.2026.44.7_suppl.tps901
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