Study on Enfortumab Vedotin for Advanced or Metastatic Solid Tumors (EV-202)

Sponsor: Astellas Pharma Global Development, Inc.

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04225117

Provider View

This clinical trial is testing the effectiveness and safety of a drug called enfortumab vedotin, alone or with pembrolizumab, in treating advanced or metastatic solid tumors. The study aims to see how well the treatment works in shrinking tumors and improving survival rates.

Patient Parameters

Program Overview

The main goal of this study is to see if enfortumab vedotin can help shrink tumors in people with advanced or metastatic solid tumors. Researchers will also look at how long patients live and how safe the treatment is. The study includes different groups of patients, some receiving enfortumab vedotin alone and others receiving it with pembrolizumab.

Description

The study is divided into three parts: screening, treatment, and follow-up.

During the screening phase, which happens up to 28 days before treatment starts, doctors will check if participants meet the study requirements.

In the treatment phase, participants in groups 1 to 8 will receive enfortumab vedotin on specific days of a 28-day cycle. Participants in group 9 will receive enfortumab vedotin and pembrolizumab on specific days of a 21-day cycle. The treatment continues until certain conditions are met, such as disease progression or withdrawal from the study.

Participants will have regular scans to check the status of their cancer. If the cancer progresses or if they start a new cancer treatment, they will stop the study treatment. If they stop treatment for other reasons, they will continue to have scans every few weeks to monitor their condition.

After one year of treatment, the frequency of scans will decrease for groups 1 to 8. For group 9, the frequency of scans will decrease after 18 months.

Participants will be contacted every 12 weeks to check on their health status until they pass away, withdraw from the study, or the study ends.

Eligibility Criteria

Inclusion Criteria

  • Must be an adult according to local laws.
  • Must have a measurable tumor.
  • Must provide a tumor sample for testing.
  • Must have a good performance status (ECOG 0 or 1).
  • Must have certain blood test results within normal ranges.
  • Must agree not to join another study while participating in this one.
  • Must have advanced or metastatic cancer that cannot be cured with current treatments.

Specific criteria for different cancer types:

  • Breast Cancer (HR+/HER2-): Must have progressed after certain treatments and not be eligible for more hormonal therapy.
  • Triple Negative Breast Cancer (TNBC): Must have progressed after certain treatments and have specific tumor characteristics.
  • Squamous Non-Small Cell Lung Cancer (NSCLC): Must have progressed after certain treatments and not have specific genetic mutations.
  • Non-Squamous NSCLC: Must have progressed after certain treatments and not have specific genetic mutations.
  • Head and Neck Cancer: Must have progressed after certain treatments and have specific tumor characteristics.
  • Gastric, GEJ, or Esophageal Cancer: Must have progressed after certain treatments and have specific tumor characteristics.
  • Head and Neck Squamous Cell Carcinoma (HNSCC): Must have specific tumor characteristics and not have received certain prior treatments.

Exclusion Criteria

  • Have severe nerve damage.
  • Have active cancer spread to the brain unless stable for 6 weeks.
  • Have significant side effects from previous treatments.
  • Have uncontrolled diabetes.
  • Have had previous treatment with enfortumab vedotin.
  • Have another active cancer within the last 3 years.
  • Have active infections or certain viral infections.
  • Have severe heart problems or recent major surgery.
  • Have allergies to study drugs.
  • Have certain eye conditions.

Specific exclusions for group 9 (HNSCC):

  • Have had disease progression within 6 months of previous treatment.
  • Have had an organ transplant.
  • Have severe lung disease.
  • Have a life expectancy of less than 3 months.
  • Have active autoimmune disease requiring treatment.
  • Have received a live vaccine recently.
  • Have active tuberculosis.

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