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Studies

Observational Recruiting

NCT05290038 on ClinicalTrials.gov

ARON-2 Study-Multicentric International Retrospective Study

  • Sponsor: Matteo Santoni
  • Enrollment: 367 (Estimated)
  • Study start: 2022-02-17 (Actual)
  • Primary completion: 2023-12-31 (Actual)
  • Study completion: 2027-09-30 (Estimated)
  • Allocation: N/a
  • InterventionModel: N/a
  • Masking: None
  • PrimaryPurpose: Other

Brief Summary

The ARON-2 study retrospectively analyze patients treated with pembrolizumab as first-line therapy in patients platinum-unfit or as second-line therapy in patients progressed after previous platinum-based chemotherapy. The amendment has been designed to also analyze patients treated with enfortumab vedotin progressed to previous platinum-based chemotherapy and anti-PD-1/PD-L1 inhibitor.

Conditions

  • Urothelial Carcinoma

Primary Outcome Measures

  • Overall Survival (OS) of patients with metastatic Urothelial Cancer (UC) treated with pembrolizumab or enfortumab vedotin (November 15th, 2023)
  • Progression-Free Survival (PFS) of patients with metastatic Urothelial Cancer (UC) treated with pembrolizumab or enfortumab vedotin (November 15th, 2023)
  • Overall Response Rate (ORR) of patients with metastatic Urothelial Cancer (UC) treated with pembrolizumab or enfortumab vedotin (November 15th, 2023)

Countries

Italy

Locations and Investigators