NCT04223856 · OUTCOME

Percentage of Participants With Objective Response Rate (ORR) Per RECIST v1.1 by BICR

Enfortumab Vedotin and Pembrolizumab vs. Chemotherapy Alone in Untreated Locally Advanced or Metastatic Urothelial Cancer · Source last updated 2026-05-29

This outcome was registered, but no numerical results were posted in the captured record.

Measure: Not reported
Unit: Not reported
Interval / dispersion: Not reported
Time frame: From first dose till CR/PR or PD or death, whichever occurred first (maximum up to approximately 7.4 years)

What was measured

ORR as per RECIST v1.1 by BICR was defined as the percentage of participants with confirmed complete response (CR) or partial response (PR) CR was defined as disappearance of all lesions including non-target lesions (not just target lesions). Any pathological lymph nodes must have reduction in short axis to\<10 mm. PR was defined as at least 30 percent \[%\] decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. For a response to be considered as confirmed, the subsequent response needs to be at least 4 weeks after the initial response.

Groups in this outcome

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields

anticipated Posting Date: 2027-09
denom Units Selected: Participants
description: ORR as per RECIST v1.1 by BICR was defined as the percentage of participants with confirmed complete response (CR) or partial response (PR) CR was defined as disappearance of all lesions including non-target lesions (not just target lesions). Any pathological lymph nodes must have reduction in short axis to\<10 mm. PR was defined as at least 30 percent \[%\] decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. For a response to be considered as confirmed, the subsequent response needs to be at least 4 weeks after the initial response.
reporting Status: NOT_POSTED
time Frame: From first dose till CR/PR or PD or death, whichever occurred first (maximum up to approximately 7.4 years)
title: Percentage of Participants With Objective Response Rate (ORR) Per RECIST v1.1 by BICR
type: SECONDARY

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Preserved source evidence · Not medical advice