NCT04225117

A Study to Evaluate Enfortumab Vedotin in Subjects With Locally Advanced or Metastatic Malignant Solid Tumors (EV-202)

An Open-label, Multicenter, Multicohort, Phase 2 Study to Evaluate Enfortumab Vedotin in Subjects With Locally Advanced or Metastatic Malignant Solid Tumors (EV-202)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 329 (actual)
• Sponsor: Astellas Pharma Global Development, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to determine the antitumor activity of enfortumab vedotin as measured by confirmed objective response rate (ORR) per RECIST v1.1. This study will also assess other measures of antitumor activity; overall survival (OS); as well as the safety and tolerability of enfortumab vedotin for cohorts 1 to 8 and enfortumab vedotin + pembrolizumab in cohort 9.

Detailed description

This study will consist of 3 periods: screening/baseline, treatment and follow-up. Screening/baseline period will take place up to 28 days prior to the first dose of study treatment. In the treatment period, starting at cycle 1, participants in cohorts 1 to 8 will receive enfortumab vedotin on days 1, 8, and 15 every 28-day cycle until one of the treatment discontinuation criteria are met. participants in cohort 9 will receive enfortumab vedotin on days 1, 8, and pembrolizumab on day 1 of every 21-day cycle until one of the treatment discontinuation criteria are met. Disease assessment will be performed at screening/baseline and repeated every 8 weeks (56 days ± 7 days) for cohorts 1 to 8 and first assessment at week 9 and thereafter every 6 weeks (42 days ± 7 days) for cohort 9 from the first dose of study treatment throughout the study until the participant has radiologically confirmed disease progression, initiates a new subsequent anticancer therapy, dies, withdraws consent, is lost to follow-up or the study closes, whichever occurs first. Participants who discontinue study treatment for reasons other than radiologically-confirmed disease progression by RECIST Version 1.1 will enter into a post treatment follow-up period and continue to receive imaging scans every 8 weeks (56 days ± 7 days) for cohorts 1 to 8 and for cohort 9 first scan will be performed at 9 week and thereafter every 6 weeks (42 days ± 7 days) until the subject has radiologically confirmed disease progression (for cohort 9 confirmed progressive disease \[iCPD\] per modified RECIST 1.1 for immune-based therapeutics \[iRECIST\]), initiates a new anticancer therapy, dies, withdraws consent, is lost to follow-up or the study closes, whichever occurs first. After 1 year on study treatment, the frequency of disease assessment will be reduced to every 12 weeks (84 days ± 7 days) for cohorts 1 to 8. After 18 months on study treatment, the frequency of disease assessment will be reduced to every 9 weeks (63 days ± 7 days) for cohort 9. Participants in cohorts 1to 8 who discontinue study treatment for reasons other than radiologically-confirmed disease progression by RECIST Version 1.1 will enter into a post treatment follow-up period and continue to receive imaging scans every 8 weeks (56 days ± 7 days). Participants in cohort 9 who discontinue study treatment for reasons other than radiologically confirmed disease progression per iRECIST will enter into a post treatment follow-up period and have physical exams, ECOG and disease assessments every 6 weeks (± 7 days) up to 18 months after first dose, then every 9 weeks (± 7 days) until the subject has radiologically confirmed disease progression per iRECIST. After radiologically-confirmed disease progression or initiation of subsequent anticancer therapy, whichever occurs first, participants will be contacted every 12 weeks in the long-term follow-up period for survival status until death, withdrawal of consent, lost to follow-up or study closure, whichever occurs first.

Conditions

• Locally Advanced or Metastatic Malignant Solid Tumors

Interventions

Type	Name	Description
DRUG	enfortumab vedotin	intravenous (IV) infusion
DRUG	pembrolizumab	IV infusion

Timeline

• Start date: 2020-03-10
• Primary completion: 2025-02-25
• Completion: 2026-09-30
• First posted: 2020-01-13
• Last updated: 2026-04-13
• Results posted: 2026-04-13

Locations

39 sites across 3 countries: United States, Canada, Japan

Regulatory

• FDA-regulated drug study