Locally Advanced or Metastatic Urothelial Carcinoma (UC)NCT04136808
An Expanded Access Treatment Protocol of Enfortumab Vedotin in Subjects With Locally Advanced or Metastatic Urothelial Carcinoma
A study testing enfortumab vedotin (EV) in people with Locally Advanced or Metastatic Urothelial Carcinoma (UC), run by Astellas Pharma Global Development, Inc. at 15 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced or Metastatic Urothelial Carcinoma (UC)
- What is being tested?
- enfortumab vedotin (EV)
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- 15 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Community Hospital Anderson
Anderson, Indiana, 46011
Johns Hopkins University
Baltimore, Maryland, 21205
Levine Cancer Institute
Charlotte, North Carolina, 28204
Northwestern University Medical Center
Chicago, Illinois, 60611
University of Chicago
Chicago, Illinois, 60637
Geisinger Medical Center
Danville, Pennsylvania, 17822
Duke University Medical Center
Durham, North Carolina, 27710
Inova Schar Cancer Institute
Fairfax, Virginia, 22031
Holy Cross Hospital
Fort Lauderdale, Florida, 33308
Cancer Specialists of North Florida
Jacksonville, Florida, 32204
UCLA Hematology Oncology
Los Angeles, California, 90095
NYU Langone Health
New York, New York, 10016
John Wayne Cancer Institute
Santa Monica, California, 90404
St. Joseph Heritage Medical Group
Santa Rosa, California, 95403
New England Cancer Specialists
Topsham, Maine, 04086
About this study
Official title: 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.
Read the 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.
- Being tested
- enfortumab vedotin (EV)
- Keywords
- Locally Advanced or Metastatic Urothelial Carcinoma, enfortumab vedotin (EV), ASG-22CE, Expanded Access, EV-901
- Medical subject headings
- Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enfortumab vedotin (EV)Drug
Also called ASG-22CE
Participants will receive an intravenously (IV) administered dose once weekly for the first 3 weeks of every 4-week cycle (i.e., on days 1, 8, and 15)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced or Metastatic Urothelial Carcinoma (UC)Studies of the same condition, open and under way.
- More trials run by Astellas Pharma Global Development, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Seagen Inc.
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Global Development, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04136808
- Sponsor's protocol ID
- 7465-CL-0108
- Status last verified
- Jan 2020
- First submitted
- 21 Oct 2019
- Last updated
- 13 Jan 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Expanded Access Treatment Protocol of Enfortumab Vedotin in Subjects With Locally Advanced or Metastatic Urothelial Carcinoma (EV-901)
- ClinicalTrials.gov ID
- NCT04136808
- Acronym / sponsor ID
- 7465-CL-0108
- Keywords
- Locally Advanced or Metastatic Urothelial Carcinoma, enfortumab vedotin (EV), ASG-22CE, Expanded Access, EV-901
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- Astellas Pharma Global Development, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Seagen Inc.
- First posted
- 23 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- 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.
- 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 has exhausted available standard of care therapies for locally advanced or metastatic UC.
- Subject has the following baseline laboratory data:
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| enfortumab vedotin (EV)Also: ASG-22CEParticipants will receive an intravenously (IV) administered dose once weekly for the first 3 weeks of every 4-week cycle (i.e., on days 1, 8, and 15) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Astellas Pharma Global Development, Inc.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing enfortumab vedotin (EV) in people with Locally Advanced or Metastatic Urothelial Carcinoma (UC), run by Astellas Pharma Global Development, Inc. at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2020.