Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
completion around

Description

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.

Official Title

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

Details

Keywords

Locally Advanced or Metastatic Malignant Solid Tumors, Squamous NSCLC, Triple negative breast cancer (TNBC), ASG-22CE, non-small cell lung cancer (NSCLC), Hormone receptor-positive/ human epidermal growth factor receptor 2-negative (HR+/HER2-) breast cancer, non-squamous NSCLC, Head and neck cancer, EV-202, Gastric or gastroesophageal junction (GEJ) or esophageal cancer, Neoplasms, Pembrolizumab, enfortumab vedotin, HR+/HER2- breast cancer, Squamous non-small cell lung cancer, Gastric and esophageal adenocarcinoma (EAC) including GEJ adenocarcinoma, Esophageal squamous cell carcinoma (ESCC), Head and neck squamous cell carcinoma (HNSCC)

Eligibility

Locations

  • University of California - San Francisco
    San Francisco California 94158 United States
  • Comprehensive Cancer Centers of Nevada
    Las Vegas Nevada 89169 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Astellas Pharma Global Development, Inc.
ID
NCT04225117
Phase
Phase 2 research study
Study Type
Interventional
Participants
About 329 people participating
Last Updated