Hepatic cancer Hepatic cancer
Conditions
Sponsors
Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: To be eligible for inclusion in this Dx study, a specimen must meet all of the following criteria:It must be an FFPE tumor specimen submitted from participants who were screened for enrollment into the ARTEMIDE-HCC01 trial;It must be an FFPE tumor block processed in accordance with standard practice, or sufficient number of unstained slides prepared from such a tumor block, andIt must contain sufficient viable tumor tissue for interpretation at the discretion of the reviewing pathologist.
Exclusion criteria
Exclusion criteria: A specimen will be excluded from the study if any of the following criteria apply:It is fixed in alcohol-formalin-acetic acid (AFA), 95% alcohol or any other alcohol-based fixative, or PREFER (aglyoxal-based fixative); orIt is a cytology specimen (FNA cytology cell block and fluid cytology such as a brushing, washing, or effusion); orIt consists of tissue containing bone that has been decalcified**; orCut slides were prepared from FFPE blocks beyond the cut-slide stability period of 6 months 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint for this diagnostic study will consist of the endpoint defined in the ARTEMIDE-HCC01 study, analyzed by PD-L1 subgroups identified with the VENTANA PD-L1 (SP263) CDx Assay:Overall survival (OS), defined as the time from randomization until the date of death due to any cause. Comparison of OS for Arm A (rilvegostomig in combination with tremelimumab and bevacizumab) relative to Arm C (atezolizumab and bevacizumab) in participants with advanced HCC by PDL1 subgroup, as identified with the VENTANA PD-L1 (SP263) CDx AssayOS, defined as the time from randomization until the date of death due to any cause. Comparison of OS for Arm B (rilvegostomig and bevacizumab) relative to Arm C (atezolizumab and bevacizumab) in participants with advanced HCC by PD-L1 subgroup, as identified with the VENTANA PD-L1 (SP263) CDx Assay.These endpoints will be analyzed by AstraZeneca as described in the protocol and statistical analysis plan for ARTEMIDE-HCC01. | — |
Secondary
| Measure | Time frame |
|---|---|
| Additional Endpoints:Initial and final overall staining acceptability rate Initial and final tissue morphology acceptability rates Initial and final background acceptability rates | — |
Countries
Australia, Brazil, Canada, China, France, Germany, India, Italy, Japan, Netherlands, Poland, South Korea, Spain, Taiwan, Thailand, Turkey, United Kingdom, United States, Vietnam
Contacts
Public ContactB. Blend
Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)
Outcome results
None listed