A Study to Evaluate Enfortumab Vedotin Versus (vs) Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer (EV-301)

Official Title

An Open-Label, Randomized Phase 3 Study to Evaluate Enfortumab Vedotin vs Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer (EV-301)

Summary:

The purpose of this study is to compare the overall survival (OS) of participants with locally advanced or metastatic urothelial cancer treated with enfortumab vedotin (EV) to the OS of participants treated with chemotherapy.

This study will also compare progression-free survival on study therapy (PFS1); the overall response rate (ORR) and the disease control rate (DCR) per Response Evaluation Criteria in Solid Tumours (RECIST) V1.1 of participants treated with EV to participants treated with chemotherapy.

In addition, this study will evaluate the duration of response (DOR) per RECIST V1.1 of EV and chemotherapy and assess the safety and tolerability of EV, as well as, the quality of life (QOL) and Patient Reported Outcomes (PRO) parameters.

Trial Description

Primary Outcome:

• Overall Survival (OS)

Secondary Outcome:

• Progression Free Survival on study therapy (PFS1) per Response Evaluation Criteria In Solid Tumours (RECIST) V1.1
• Overall Response Rate (ORR) (Complete Response (CR) and Partial Response(PR)) per RECIST V1.1
• Disease Control Rate (DCR) (CR + PR + stable disease [SD]) per RECIST V1.1
• Duration of Response (DOR) per RECIST V1.1
• Safety assessed by Adverse Events (AEs)
• Number of participants with laboratory value abnormalities and/or adverse events
• Number of participants with vital signs abnormalities and/or adverse events
• Safety assessed by 12- lead electrocardiogram (ECG)
• Safety assessed by Eastern Cooperative Oncology Group Performance Status (ECOG PS)
• Patient reported outcome assessed by quality of life: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30)
• Patient reported outcome assessed by quality of life: EuroQOL 5-dimensions (EQ-5D -5L) questionnaire

Participants considered an adult according to local regulation at the time of obtaining informed consent may participate in the study.

View this trial on ClinicalTrials.gov