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

Conditions

• Locally Advanced or Metastatic Malignant Solid Tumors

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• enfortumab vedotin — DRUG
  intravenous (IV) infusion
• pembrolizumab — DRUG
  IV infusion

Study Details

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.

Key Dates

Start date

Mar 10, 2020

Status verified

Jun 2026

Primary completion

Feb 25, 2025

Completion

Sep 30, 2026

Study Design

Enrollment

329 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Cohort 1: HR+/HER2- breast cancer
  Participants will receive enfortumab vedotin as an intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. HR+/HER2- = Hormone receptor-positive/ human epidermal growth factor receptor 2-negative
• Experimental: Cohort 2: Triple negative breast cancer (TNBC)
  Participants will receive enfortumab vedotin as an intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle.
• Experimental: Cohort 3: Squamous non-small cell lung cancer
  Participants will receive enfortumab vedotin as an intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle.
• Experimental: Cohort 4: Non-squamous non-small cell lung cancer
  Participants will receive enfortumab vedotin as an intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle.
• Experimental: Cohort 5: Head and neck cancer
  Participants will receive enfortumab vedotin as an intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle.
• Experimental: Cohort 6: Gastric or GEJ or esophageal cancer
  Participants enrolled into Cohort 6 will be reallocated based on disease type and histology into Cohorts 7 or 8. GEJ= gastroesophageal junction
• Experimental: Cohort 7: Gastric and esophageal adenocarcinoma (EAC) including GEJ adenocarcinoma
  Participants will receive enfortumab vedotin as an intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle.
• Experimental: Cohort 8: Esophageal squamous cell carcinoma (ESCC)
  Participants will receive enfortumab vedotin as an intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle.
• Experimental: Cohort 9: Head and neck squamous cell carcinoma (HNSCC)
  Participants will receive enfortumab vedotin as an IV infusion on days 1 and 8 of each 21-day cycle. Pembrolizumab will be administered as an IV infusion on day 1 of each 21-day cycle.

Primary Outcome Measure

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 [ Time Frame: Up to 20.04 months ]

Locations (29)

Related coverage on Hipa.ai

• Pembrolizumab/Enfortumab Vedotin Combo Shows 39.0% ORR in HNSCC
  Pembrolizumab · Apr 13, 2026 · ClinicalTrials.gov

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