Urothelial CarcinomaPREVAILNCT03788746
Prevalence of PD-L1 Expression in Patients With Advanced Urothelial Carcinoma
An observational study of Urothelial Carcinoma, run by AstraZeneca at 58 sites in United States.
Trial summary
The purpose of this study is to assess the prevalence of pre-treatment tumor tissue PD-L1 expression in patients diagnosed with advanced urothelial carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Urothelial Carcinoma
- How many people
- 181 participants
- Where
- 58 sitesUnited States
- Study dates
- 17 Jan 2019to 25 May 2023
- Phase
- Observational
- 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 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient population with care managed in a community setting in the United States
Who may be able to join
- Provision of written informed consent
- Age ≥18 years old
- Patient must have advanced UC confirmed by their HCP; histologically- confirmed diagnosis of UC an dHCP-confirmed advanced UC.
- Patient must be either currently receiving 1L systemic treatment for their advanced UC or will be starting 1L systemic treatment (i.e. "newly diagnosed" advanced UC; 1L therapy is defined as the first systemic therapy given for advanced UC).
- Patient remains eligible for the study if they received neoadjuvant or adjuvant platinum-based chemotherapy if their recurrence was more than 12 months after their last chemotherapy dose.
- Radio-sensitizing chemotherapy as part of chemoradiation is NOT counted as neoadjuvant or adjuvant chemotherapy; thus, the 12-month interval mention above does not apply, and the patient would be eligible
- Patients with available tumor tissue sample (fresh or archival - up to 3 years old) that was collected as part of SoC any time prior to 1L treatment for advanced UC with a target of 18 slides (7 minimum) available for biomarker testing (PD-L1 and tTMB). Already prepared slides must have been cut within 6 months prior to PD-L1 testing.
Who cannot join
- Patients concurrently enrolled in other clinical trials that prohibit their participation in a non-interventional study
- Patient has resectable localized UC and has refused surgery
- Patients with history of non-urothelial active malignancy that completed therapy within 2 years from study enrollment except:
- Any resected in situ carcinoma or non-melanoma skin cancer
- Localized (early stage) cancer treated with curative intent (without evidence of recurrence and intent for further therapy) and in which no systemic therapy was indicated
Trial locations and contacts
58 sites in 1 country.
58 sites in 1 country
United States58 sites
Research Site
Albany, New York, 12206
Research Site
Augusta, Georgia, 30912
Research Site
Baton Rouge, Louisiana, 70809
Research Site
Berkeley Heights, New Jersey, 07922
Research Site
Boca Raton, Florida, 33486
Research Site
Brewer, Maine, 04412
Research Site
Bridgeton, Missouri, 63044
Research Site
Cedar Rapids, Iowa, 52403
Research Site
Cincinnati, Ohio, 45267
Research Site
Denver, Colorado, 80211
Research Site
Duluth, Minnesota, 55805
Research Site
East Brunswick, New Jersey, 08816
Research Site
Englewood, Colorado, 80113
Research Site
Englewood, New Jersey, 07631
Research Site
Freehold, New Jersey, 07728
Research Site
Geneva, Illinois, 60134
Research Site
Glendale, California, 91204
Research Site
Grand Rapids, Michigan, 49503-2563
Research Site
Greenville, North Carolina, 27834
Research Site
Greenwood, Indiana, 46143
Research Site
Hartford, Connecticut, 06106
Research Site
Harvey, Illinois, 60426
Research Site
Hialeah, Florida, 33016-1815
Research Site
Jacksonville, Florida, 32256
Research Site
Johnson City, New York, 13790
Research Site
Kansas City, Kansas, 66160
Research Site
Kettering, Ohio, 45429
Research Site
Knoxville, Tennessee, 37920
Research Site
Lafayette, Indiana, 47904
Research Site
Lake Barrington, Illinois, 60010
Research Site
Las Vegas, Nevada, 89106
Research Site
Lewiston, Maine, 04240
Research Site
Little Rock, Arkansas, 72211
Research Site
Little Silver, New Jersey, 07739
Research Site
Los Angeles, California, 90048
Research Site
Los Angeles, California, 90067
Research Site
Monterey, California, 93940
Research Site
Mount Laurel, New Jersey, 08054
Research Site
Muncie, Indiana, 47303
Research Site
Myrtle Beach, South Carolina, 29572
Research Site
Naperville, Illinois, 60540
Research Site
Nashville, Tennessee, 37209
Research Site
Olympia, Washington, 98502
Research Site
Port Jefferson Station, New York, 11776
Research Site
Renton, Washington, 98055
Research Site
Roswell, Georgia, 30076
Research Site
Saint Cloud, Minnesota, 56303
Research Site
Santa Rosa, California, 95403
Research Site
Seattle, Washington, 98101
Research Site
Shreveport, Louisiana, 71106
Research Site
Stamford, Connecticut, 06904
Research Site
Tacoma, Washington, 98405
Research Site
Temple, Texas, 76508
Research Site
The Woodlands, Texas, 77380
Research Site
Virginia Beach, Virginia, 23462
Research Site
Waterloo, Iowa, 50703
Research Site
Wenatchee, Washington, 98801
Research Site
Wichita, Kansas, 67226
About this study
Official title: A Prospective, Non-Interventional Study to Assess the Prevalence of PD-L1 Expression in the First-Line Setting of Locally Advanced/Unresectable or Metastatic Urothelial Carcinoma
The purpose of this study is to assess the prevalence of pre-treatment tumor tissue PD-L1 expression in patients diagnosed with advanced urothelial carcinoma.
Read the detailed description
Advanced urothelial carcinoma (UC) (locally advanced/unresectable or metastatic UC) is a fatal disease with 5-year survival rate of 5%. The most frequently studied diagnostic for advanced UC is the programmed death-ligand 1 (PD-L1) protein expression in tumor tissue. A better understanding of PD-L1 expression in a "real world" setting could help understand its clinical utility in the management and decision making in advanced UC and clinical trial design
- Conditions
- Urothelial Carcinoma
- Keywords
- Urothelial Carcinoma, Registry
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Patients diagnosed with advanced urothelial carcinoma | Patients with a confirmed diagnosis of advanced urothelial carcinoma, prior to or during first line therapy, who have available tumor tissue samples collected as part of standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Categorization of PD-L1 results (dichotomous, high vs. low) based on pre-treatment tissue samples.
The proportion of advanced UC patients with biomarker PD-L1 high results will be calculated.
Measured: 24 months
Secondary outcomes (3)
To assess the association of pre-treatment tumor tissue PD-L1 expression with pre-treatment tumor tissue TMB (tTMB) based on the chosen assay
Assay results for pre-treatment tTMB will be assessed by pre-treatment tumor tissue PD-L1 expression status.
Measured: 24 months
To describe the objective response rate (ORR), progression-free survival (PFS) and overall survival (OS) as well as treatment patterns in the 1L setting of advanced UC
1L advanced UC treatment patterns (such as regimen/agents used, start (first dose) and stop (last dose) dates, reasons for cis/carboplatin ineligibility) will be collected.
Objective Response: complete or partial response based on healthcare provider (HCP) assessment; Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria highly recommended Progression: evidence malignancy has become worse or spreads in the body (based on HCP assessment).
Objective response and survival endpoints (overall, stratified by PD-L1 expression [high vs. low] including the following: ORR: The proportion of patients with a complete or partial response based on HCP assessment; PFS: The time from the start of 1L advanced UC treatment until progression or death (any cause); and OS: The time from start of 1L advanced UC treatment until death (any cause)
Measured: 54 months
To assess the association between pre-treatment tumor tissue PD-L1 expression with objective response, PFS, and OS among treated patients (anti PD-L1/PD-1, chemotherapy, other)
Objective response, PFS, and OS (defined above) will be stratified by pre-treatment tumor tissue PD-L1 expression, and among patients treated with anti-PD-L1/PD-1 or chemotherapy or other.
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2018
- Study start17 Jan 2019
- Primary completion12 Jan 2022
- Study completion25 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urothelial CarcinomaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Petros Grivas, MD, Study chair, University of WashingtonJoshua Meeks, Study chair, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03788746
- Sponsor's protocol ID
- D419BR00008
- Acronym
- PREVAIL
- Status last verified
- Feb 2024
- First submitted
- 27 Nov 2018
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Non-Interventional Study to Assess the Prevalence of PD-L1 Expression in the First-Line Setting of Locally Advanced/Unresectable or Metastatic Urothelial Carcinoma
- ClinicalTrials.gov ID
- NCT03788746
- Acronym / sponsor ID
- PREVAIL / D419BR00008
- Conditions
- Urothelial Carcinoma
- Keywords
- Urothelial Carcinoma, Registry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 17 Jan 2019 (actual)
- Primary completion
- 12 Jan 2022 (actual)
- Study completion
- 25 May 2023 (actual)
- First posted
- 28 Dec 2018 (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 purpose of this study is to assess the prevalence of pre-treatment tumor tissue PD-L1 expression in patients diagnosed with advanced urothelial carcinoma.
Detailed description
Advanced urothelial carcinoma (UC) (locally advanced/unresectable or metastatic UC) is a fatal disease with 5-year survival rate of 5%. The most frequently studied diagnostic for advanced UC is the programmed death-ligand 1 (PD-L1) protein expression in tumor tissue. A better understanding of PD-L1 expression in a "real world" setting could help understand its clinical utility in the management and decision making in advanced UC and clinical trial design
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients diagnosed with advanced urothelial carcinoma | – | –Patients with a confirmed diagnosis of advanced urothelial carcinoma, prior to or during first line therapy, who have available tumor tissue samples collected as part of standard of care |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient population with care managed in a community setting in the United States
Key inclusion criteria (7 listed)
- Provision of written informed consent
- Age ≥18 years old
- Patient must have advanced UC confirmed by their HCP; histologically- confirmed diagnosis of UC an dHCP-confirmed advanced UC.
- Patient must be either currently receiving 1L systemic treatment for their advanced UC or will be starting 1L systemic treatment (i.e. "newly diagnosed" advanced UC; 1L therapy is defined as the first systemic therapy given for advanced UC).
- Patient remains eligible for the study if they received neoadjuvant or adjuvant platinum-based chemotherapy if their recurrence was more than 12 months after their last chemotherapy dose.
Key exclusion criteria (5 listed)
- Patients concurrently enrolled in other clinical trials that prohibit their participation in a non-interventional study
- Patient has resectable localized UC and has refused surgery
- Patients with history of non-urothelial active malignancy that completed therapy within 2 years from study enrollment except:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Categorization of PD-L1 results (dichotomous, high vs. low) based on pre-treatment tissue samples.
Time frame: 24 months
The proportion of advanced UC patients with biomarker PD-L1 high results will be calculated.
3 secondary outcomes
To assess the association of pre-treatment tumor tissue PD-L1 expression with pre-treatment tumor tissue TMB (tTMB) based on the chosen assay
Time frame: 24 months
To describe the objective response rate (ORR), progression-free survival (PFS) and overall survival (OS) as well as treatment patterns in the 1L setting of advanced UC
Time frame: 54 months
To assess the association between pre-treatment tumor tissue PD-L1 expression with objective response, PFS, and OS among treated patients (anti PD-L1/PD-1, chemotherapy, other)
Time frame: 60 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
- Redacted CSR synopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared
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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.
Petros Grivas, MD study chair
University of Washington
Joshua Meeks study chair
Northwestern University
58 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urothelial Carcinoma, run by AstraZeneca at 58 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 7 inclusion and 5 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: finished, as of the sponsor's last update on 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 58 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Categorization of PD-L1 results (dichotomous, high vs. low) based on pre-treatment tissue samples. (time frame: 24 months). It is what the study was designed to measure, not a finding.
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 22 Feb 2024.