Endometrial cancer Cancer of uterus
Conditions
Interventions
VENTANA B7-H4 (A57.1) RxDx Assay
Sponsors
Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: To be eligible for staining with the VENTANA B7-H4 (A57.1) RxDx Assay in this diagnostic study, a specimen must meet all of the following criteria: It must be archival or fresh FFPE tumor specimens submitted from patients who were pre-screened for enrollment into Study D6900C00003 and processed in accordance with standard practice; It must contain sufficient tumor tissue (at least 100 viable cells) for interpretation at the discretion of the reviewing pathologist; and If an FFPE tissue block is unavailable, a minimum of 3 but preferably 5 unstained FFPE slides can be submitted for testing with VENTANA B7-H4 (A57.1) RxDx Assay.
Exclusion criteria
Exclusion criteria: A specimen will be excluded from staining with the VENTANA B7-H4 (A57.1) RxDx Assay in this diagnostic study based on any of the following: It is known to be fixed in 95% alcohol or other alcohol-based fixative, alcohol-formalin-acetic acid (AFA), or PREFER; It is a fine needle aspirate (FNA), any other cytological specimen; It consists of tissue containing bone that has been decalcified* ; or Cut slides were prepared more than 45 days prior to staining #.*Prior to testing any bone specimen, evidence of decalcification must be obtained. This information may be obtained from the pathology report. If the pathology report is not available or does not specify whether the sample has been decalcified or not, the sample must be held and the submitting site queried as to whether the sample has been decalcified. If the sample has been decalcified, testing cannot proceed. # RTD will periodically provide the laboratories with updated information regarding CSS, in the form of an administrative memo that must be retained in the site electronic trial master file (eTMF).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint:Progression-free survival (PFS), defined as the time from randomization until progression per RECIST 1.1 as assessed by BICR or death due to any cause in all randomized participants.Overall-survival (OS), defined as the time from randomization until the date of death due to any cause in all randomized participants. | — |
Secondary
| Measure | Time frame |
|---|---|
| Key Secondary:Objective Response Rate (ORR), defined as the proportion of participants who have a response of CR or PR, as determined by BICR assessment per RECIST 1.1Duration of Response (DoR), defined as the time from the date of first documented response until the date of documented progression per RECIST 1.1 as assessed by BICR or death due to any causeTime to Second Progression or Death (PFS2), defined as time from randomization to the earliest progression event (following the initial Investigator- assessed progression) after the first subsequent therapy, or death | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Czech Republic, Finland, France, Georgia, Germany, Greece, Hungary, Israel, Italy, Japan, Lithuania, Netherlands, Poland, South Korea, Spain, Taiwan, United Kingdom, United States
Contacts
Public ContactJ. Fox
Ventana Medical Systems, Inc.
Outcome results
None listed