VENTANA PD-L1 (SP263) - R2810-ONC-2045
Research type
Research Study
Full title
Diagnostic Protocol for VENTANA PD-L1 (SP263) CDx Assay in Regeneron Pharmaceuticals, Inc. Study R2810-ONC-2045
IRAS ID
324221
Contact name
Kathrina Alexander
Contact email
Sponsor organisation
VENTANA Medical Systems, Inc. (Roche Tissue Diagnostics; RTD)
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
NCT05557591, Regeneron's pharmaceutical study R2810-ONC-2045 NCT number; 2021-006901-31, Regeneron's pharmaceutical study R2810-ONC-2045 EudraCT number
Duration of Study in the UK
1 years, 8 months, 0 days
Research summary
This Dx protocol is being conducted in support of Regeneron \nPharmaceuticals, Inc. (hereafter Regeneron) Study R2810-ONC-2045 to identify the PD-L1 expression level of tumor specimens for patient enrollment and stratification. Efficacy results for phase 2 of Regeneron Study R2810-ONC-2045 will be used to evaluate the clinical performance of VENTANA PD-L1 (SP263) CDx Assay in terms of its ability to identify NSCLC patients who may benefit from treatment with cemiplimab in combination with BNT116 versus cemiplimab monotherapy. \n\nAs part of a co-development paradigm including both an investigational therapy and an investigational diagnostic, VENTANA, as the in vitro diagnostic (IVD) device manufacturer, will be responsible for certain aspects of the investigational IVD device use within the Regeneron Study R2810-ONC-2045. As such, this Dx protocol supports the Study R2810-ONC-2045 by describing the procedures for how the patient tumor samples collected as part \nof Regeneron Study R2810-ONC-2045 should be tested with VENTANA PD-L1 (SP263) CDx Assay at the Dx testing sites. \n \nVENTANA PD-L1 (SP263) CDx Assay will be used to assess the PD-L1 expression level of NSCLC tumor specimens collected from patients who are being screened to determine eligibility to participate in Regeneron Study R2810-ONC-2045. \n \nStained slides from each case submitted for testing will be interpreted by qualified pathologists who will assign a PD-L1 expression level. A PD-L1 expression level of ≥50% in tumor cells (TC) is required for enrollment into Regeneron Study R2810-ONC-2045. Enrolled patients will be stratified by PD-L1 expression level at the 75% TC threshold (≥50% to <75% and ≥75%). Performance of VENTANA PD-L1 (SP263) CDx Assay will be evaluated per the endpoints and acceptance criteria described in this protocol.
REC name
North of Scotland Research Ethics Committee 1
REC reference
23/NS/0040
Date of REC Opinion
28 Apr 2023
REC opinion
Favourable Opinion