Esophageal cancer and head and neck squamous cell carcinoma Cancer
Conditions
Interventions
This is a multi-center retrospective non-interventional study designed to examine PD-L1 protein expression among 920 patients diagnosed with advanced EC and HNSCC at seven participating centers in Chi
Sponsors
Merck Sharp and Dohme (China)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: General criteria: 1. Patient must have informed consent form (ICF) signed previously, which gives consent for his/her sample to be used in a future study, unless the patient is under conditions accepted by IRB/ERC to waive ICF. Otherwise, the patient must provide a specific written informed consent for this study 2. Patient is 18 years of age or older at diagnosis Criteria for EC: 1. Patient has histologically or cytologically confirmed diagnosis of adenocarcinoma or squamous cell carcinoma of the esophagus or Siewert type I adenocarcinoma of the EGJ (defined as adenocarcinomas of the lower esophagus with the center located within 1 cm to 5 cm above the anatomic EGJ) 2. Patient has metastatic disease or locally advanced, unresectable disease 3. Patient must have an available FFPE tumor specimen obtained with resection, core needle biopsy or endoscopic biopsy 3.1. Newly-obtained specimen (collected up to 6 weeks prior to the start of PD-L1 IHC test) is preferred to archived one 3.2. Archival tissue block should be no older than 1 year 3.3. Tumor specimen collected from the primary site is preferred to that from the metastatic site Criteria for HNSCC: 1. Patient has histologically or cytologically confirmed diagnosis of recurrent or metastatic HNSCC that is considered incurable by local therapies. The patient may not have a primary tumor site of nasopharynx (any histology) 2. Patient must have an available FFPE tumor specimen obtained with core or excisional biopsy 2.1. Newly-obtained biopsy specimen (within 90 days prior to start of PD-L1 IHC test) is preferred to an archived one 2.2. Archival tissue block should be no older than 2 years 2.3. Tumor specimen collected from the primary site is preferred to that from the metastatic site 2.4. Decalcified bony specimen is not accepted
Exclusion criteria
Exclusion criteria: Patient has only a specimen obtained with fine needle aspirate (FNA) or cytologic specimen
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PD-L1 expression determined using the PD-L1 IHC 22C3 pharmDx kit at baseline; this is a qualitative IHC assay using monoclonal mouse Anti-PD-L1, clone 22C3 intended for detection of PD-L1 protein in FFPE tissues using the EnVision FLEX visualization system on Autostainer Link 48. PD-L1 protein expression is determined by using Combined Positive Score (CPS), which is the number of PD-L1 staining cells (tumor cells, lymphocytes, macrophages) divided by the total number of viable tumor cells, multiplied by 100. CPS is defined as follows: CPS = # PD-L1 staining cells (tumor cells, lymphocytes, macrophages) / Total # of viable tumor cells × 100 | — |
Secondary
| Measure | Time frame |
|---|---|
| Collected at baseline from each center’s electronic medical record (EMR) system or by chart review if no EMR exists: 1. Key demographic characteristics (e.g. age at diagnosis, gender, family history of studied disease, history of tobacco use) 2. Clinicopathological parameters (e.g. primary tumor site, tumor stage, histology and grade, metastatic location and number, site and type of tumor tissue sample) 3. Treatment status (e.g. previous lines of therapy, prior curative treatments) 4. Other available biomarkers (e.g. HER2 for EC and HPV status for HNSCC) | — |
Countries
China
Outcome results
None listed