PD-L1 (SP263) ESCC CDx Study for BeiGene Phase II BGB-A317-A1217-

• Research type

  Research Study

• Full title

  Performance of VENTANA PD-L1 (SP263) CDx Assay with OptiView DAB IHC Detection on the BenchMark ULTRA Instrument for Determining the PD-L1 Expression Level in Esophageal Squamous Cell Carcinoma (ESCC) Specimens for BeiGene Phase II Study BGB-A317-A1217-203

• IRAS ID

  294105

• Contact name

  Reena Merard

• Contact email

  reena.merard@q2labsolutions.com

• Sponsor organisation

  Roche Tissue Diagnostics

• Clinicaltrials.gov Identifier

  RD005802, Diagnostic Study

• Duration of Study in the UK

  1 years, 7 months, 2 days

• Research summary

  This diagnostic study (RD005802) together with the corresponding pharmaceutical clinical trial will evaluate the performance of VENTANA PD-L1 (SP263) CDx Assay as a companion diagnostics device for BGB-A1217 plus tislelizumab combination therapy in ESCC patients with PD-L1 visually-estimated combined positive score (vCPS) ≥ 10%.

• REC name

  HSC REC A

• REC reference

  21/NI/0014

• Date of REC Opinion

  2 Feb 2021

• REC opinion

  Further Information Unfavourable Opinion