A Study to Evaluate Enfortumab Vedotin in Subjects With Locally Advanced or Metastatic Malignant Solid Tumors (EV-202)
第2相
実施中（募集終了）
NCT04225117
| 対象疾患 | Locally Advanced or Metastatic Malignant Solid Tumors |
|---|
| 相 | 第2相 |
|---|
| スポンサー | Astellas Pharma Global Development, Inc. |
|---|
| ステータス | 実施中（募集終了） |
|---|
| 参加者数 | 329 名 |
|---|
| 介入（薬剤） | enfortumab vedotin, pembrolizumab |
|---|
| 開始日 | 2020年3月10日 |
|---|
| 完了日 | 2025年2月25日 |
|---|
| 結果公開日 | 2026年4月13日 |
|---|
概要
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.
Cohorts 1-8: Confirmed Overall Response Rate (ORR) (Complete Response [CR] and Partial Response [PR]) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (V)1.1 Per Investigator Assessment
Up to 20.04 months · Percentage of participants
| Cohort 1: HR+/HER2- Breast Cancer | 15.6 Percentage of participants |
|---|
| Cohort 2: TNBC Cancer | 19.0 Percentage of participants |
|---|
| Cohort 3: Squamous NSCLC | 4.3 Percentage of participants |
|---|
| Cohort 4: Non-squamous NSCLC | 16.3 Percentage of participants |
|---|
| Cohort 5: Head and Neck Cancer | 23.9 Percentage of participants |
|---|
| Cohort 7: EAC | 9.5 Percentage of participants |
|---|
Cohort 9: Confirmed ORR (CR and PR) Per RECIST V1.1 Per Investigator Assessment
Up to 12.85 months · Percentage of participants
| Cohort 9: HNSCC | 39.0 Percentage of participants |
|---|
BENITIONS で見る
ClinicalTrials.gov の原文を見る
すべての治験
このページは ClinicalTrials.gov の公開データをまとめたものです。医学的助言ではなく、投資助言でもありません。必ず専門医にご相談ください。