An Expanded Access Treatment Protocol of Enfortumab Vedotin in Subjects With Locally Advanced or Metastatic Urothelial Carcinoma

January 9, 2020 updated by: Astellas Pharma Global Development, Inc.

A Multicenter, Open-label, Expanded Access Treatment Protocol of Enfortumab Vedotin in Subjects With Locally Advanced or Metastatic Urothelial Carcinoma (EV-901)

The primary purpose of this expanded access program is to evaluate safety and tolerability of enfortumab vedotin (EV) in participants in the United States with locally advanced or metastatic urothelial carcinoma (UC) who have exhausted standard of care therapies and are not eligible to participate in an ongoing EV clinical study. This program will also evaluate the efficacy of EV.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Approved for marketing

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This treatment protocol is being conducted while a phase 3 enfortumab vedotin (EV) study is ongoing for participants with previously treated locally advanced or metastatic urothelial carcinoma (UC).

This is an expanded access program to provide EV to participants with locally advanced or metastatic UC who have previously been treated with a programmed cell death protein 1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor, and a platinum containing regimen and for whom, in the judgment of the investigator, there is no available standard of care therapy. The participants must not be eligible for an ongoing EV clinical study. Participants who have previously participated in any EV studies or studies that included EV as one of the treatment options are not eligible, even if the participants was not given or assigned EV. To request enrollment, the investigator or designee will submit the candidate participant's relevant medical history and other records in order to support the participant's protocol eligibility.

Safety of EV will be assessed through evaluation of adverse events (AEs), serious adverse events (SAEs), Eastern Cooperative Oncology Group (ECOG) performance status, laboratory measurements, vital signs and physical examinations.

Participants will be provided with study medication until FDA approval and commercial availability of enfortumab vedotin (EV) or termination by the sponsor.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Expanded Access

Expanded Access Type

Expanded Access Type

Describes the category of expanded access under U.S. Food and Drug Administration (FDA) regulations. There are three types of expanded access:
  • Individual Patients: Allows a single patient, with a serious disease or condition who cannot participate in a clinical trial, access to a drug or biological product that has not been approved by the FDA. This category also includes access in an emergency situation.
  • Intermediate-size Population: Allows more than one patient (but generally fewer patients than through a Treatment IND/Protocol) access to a drug or biological product that has not been approved by the FDA. This type of expanded access is used when multiple patients with the same disease or condition seek access to a specific drug or biological product that has not been approved by the FDA.
  • Treatment IND/Protocol: Allows a large, widespread population access to a drug or biological product that has not been approved by the FDA. This type of expanded access can only be provided if the product is already being developed for marketing for the same use as the expanded access use.
  • Treatment IND/Protocol

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • UCLA Hematology Oncology
      • Santa Monica, California, United States, 90404
        • John Wayne Cancer Institute
      • Santa Rosa, California, United States, 95403
        • St. Joseph Heritage Medical Group
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • Holy Cross Hospital
      • Jacksonville, Florida, United States, 32204
        • Cancer Specialists of North Florida
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
      • Chicago, Illinois, United States, 60611
        • Northwestern University Medical Center
    • Indiana
      • Anderson, Indiana, United States, 46011
        • Community Hospital Anderson
    • Maine
      • Topsham, Maine, United States, 04086
        • New England Cancer Specialists
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins University
    • New York
      • New York, New York, United States, 10016
        • NYU Langone Health
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Levine Cancer Institute
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Medical Center
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Inova Schar Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Description

Inclusion Criteria:

  • Subject has locally advanced or metastatic urothelial carcinoma (UC) and has progressed during or after the most recent therapy.

  • Subject has previously received a platinum containing regimen (i.e., cisplatin or carboplatin) in the metastatic/locally advanced or neoadjuvant/adjuvant setting.

    • If the platinum containing regimen was administered in the adjuvant/neoadjuvant setting, progression on or after this treatment must be ≤ 12 months after treatment completion.

  • Subject has previously received treatment with a programmed cell death protein 1 (PD-1) inhibitor or programmed death-ligand 1 (PD-L1) inhibitor (including, but not limited to, atezolizumab, pembrolizumab, durvalumab, avelumab and nivolumab) in the metastatic/locally advanced setting.

    • Subject treated with a PD-1 or PD-L1 inhibitor in the neoadjuvant/adjuvant setting and had recurrent or progressive disease either during therapy or ≤ 3 months of therapy completion may be enrolled.

  • Subject has exhausted available standard of care therapies for locally advanced or metastatic UC.

    • Subject may have had any number of prior lines of therapy for locally advanced or metastatic UC.

  • Subject has the following baseline laboratory data:

    • absolute neutrophil count ≥ 1500/mm3
    • platelet count ≥ 75 x 109/L
    • hemoglobin ≥ 8 g/dL
    • serum bilirubin ≤ 1.5 x upper limit of normal (ULN) or ≤ 3 x ULN for subjects with Gilbert's disease
    • creatinine clearance (CrCl) ≥ 15 mL/min or ≥ 30 mL/min for subjects with Eastern Cooperative Oncology Group (ECOG) performance status of 2 as estimated per institutional standards or as measured by 24 hour urine collection (glomerular filtration rate can also be used instead of CrCl)
    • alanine aminotransferase and aspartate aminotransferase ≤ 2.5 x ULN or ≤ 3 x ULN for subjects with liver metastases
  • Subject has ECOG performance status of 0, 1 or 2.

  • Female subject is not pregnant and at least 1of the following conditions apply:

    • not a woman of childbearing potential (WOCBP), or
    • a WOCBP who agrees to follow the contraceptive guidance from the time of informed consent through at least 6 months after final protocol treatment administration.
  • Female subject must agree not to breastfeed starting at screening and throughout the treatment protocol period and for 6 months after final protocol treatment administration.
  • Female subject must not donate ova starting at first dose of investigational product (IP) and throughout the treatment protocol period and for 6 months after final protocol treatment administration.
  • Male subject with female partner(s) of childbearing potential (including breastfeeding partner) must agree to use contraception throughout the treatment period and for 6 months after final protocol treatment administration.
  • Male subject must not donate sperm during the treatment period and for 6 months after final protocol treatment administration.
  • Male subject with pregnant partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy throughout the treatment protocol period and for 6 months after final protocol treatment administration.
  • Subject agrees not to participate in another interventional study while receiving treatment in the present treatment protocol.

Exclusion Criteria:

  • Subject has ongoing sensory or motor neuropathy grade ≥ 2.
  • Subject has ongoing clinically significant toxicity (grade 2 or higher with the exception of alopecia) associated with prior treatment (including systemic therapy, radiotherapy or surgery). Subject with hypothyroidism or panhypopituitarism related to treatment with PD-1 and PD-L1 inhibitors may be enrolled. Subject on hormone replacement therapy may be enrolled if on a stable dose.
  • Subject has ongoing immunotherapy related myocarditis, colitis, uveitis or pneumonitis or other immunotherapy related toxicities requiring high doses of steroids (> 20 mg/day of prednisone or equivalent).
  • Subject has previously received EV or enrolled in an EV study or a study that included EV as one of the treatment options (even if the subject was not given EV).
  • Subject is a candidate for any ongoing EV clinical studies.
  • Subject has known hypersensitivity to EV or to any excipient contained in the drug formulation of EV.
  • Subject completed radiotherapy, major surgery or prior anticancer therapy ≤ 2 weeks before first EV dose.
  • Subject has history of uncontrolled diabetes mellitus ≤ 3 months of the first EV dose. Uncontrolled diabetes is defined as hemoglobin A1C (HbA1c) ≥ 8% or HbA1c between 7 and < 8% with associated diabetes symptoms (polyuria or polydipsia) that are not otherwise explained.
  • Subject is currently receiving systemic antimicrobial treatment for viral, bacterial or fungal infection at the time of first dose of EV. Routine antimicrobial prophylaxis is permitted.
  • Subject has recent history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction or cardiac symptoms (including congestive heart failure) consistent with New York Heart Association Classes III to IV that is not adequately treated and/or controlled at the time of first EV dose.
  • Subject has other underlying medical condition that would impair the ability of the subject to receive or tolerate EV.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Astellas Pharma Global Development, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Seagen Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Medical Director, Astellas Pharma Global Development, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 21, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 21, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 23, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 13, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 7465-CL-0108

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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