Endometrial cancer Cancer of uterus
Conditions
Interventions
VENTANA HER2/neu (4B5) IUO Assay
Sponsors
BioNTech SE
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. It must consist of archival or fresh tumor tissue submitted for patient enrollment screening for Study BNT323-01; 2. It must be fixed in 10% neutral buffered formalin and consist of a FFPE tissue block or as unstained slides with approximately 4-µm thick sections cut from such a block; 3. It must appear to contain sufficient tissue for interpretation, as determined by a site pathologist’s review of a serially adjacent or nearly serially adjacent slide stained with hematoxylin and eosin (H&E); and 4. The sections for staining must have been cut within the currently documented cut-slide stability (CSS) window in effect at the time of staining.
Exclusion criteria
Exclusion criteria: 1. It is a fine needle aspirate (FNA), any other cytological specimen, or a decalcified bone metastasis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Primary: Progression-free survival (PFS) by blinded independent central review (BICR) according to response evaluation criteria in solid tumors (Response Evaluation Criteria in Solid Tumors-RECIST 1.1) in participants with HER2- expressing recurrent endometrial cancer and prior immune checkpoint inhibitor treatment. • Key Secondary: PFS by BICR according to RECIST 1.1 in participants with HER2-expressing recurrent endometrial cancer. | — |
Secondary
| Measure | Time frame |
|---|---|
| • The secondary endpoint for this study is the final overall staining acceptability rate for the VENTANA HER2/neu (4B5) IUO Assay. | — |
Countries
Argentina, Austria, Belgium, Brazil, China, Czech Republic, Finland, France, Germany, Greece, Hungary, Israel, Italy, Netherlands, South Korea, Taiwan, United States
Contacts
Public ContactJ.H. Lee
BioNTech SE
Outcome results
None listed