VENTANA PD-L1 (SP263) - R3767-ONC-2235
Research type
Research Study
Full title
Diagnostic Protocol for Use of VENTANA PD-L1 (SP263) CDx Assay in Regeneron Pharmaceuticals, Inc. Study R3767-ONC-2235
IRAS ID
326984
Contact name
Kathrina Alexander
Contact email
Sponsor organisation
Ventana Medical Systems
Clinicaltrials.gov Identifier
2022-501483-18-00, Regeneron's pharmaceutical study R3767-ONC-2235 EU CTA Number; 163869, Regeneron's pharmaceutical study R3767-ONC-2235 IND
Duration of Study in the UK
2 years, 2 months, 16 days
Research summary
This Dx protocol is being conducted in support of Regeneron Study R3767-ONC-2235 to identify the PD-L1 expression level of tumor specimens for patient selection and stratification. Results of the Regeneron Study R3767-ONC-2235 will serve 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 fianlimab.
As part of a co-development paradigm including both an investigational therapy and an investigational diagnostic, RTD will be responsible for certain aspects of the investigational IVD use within the Regeneron R3767-ONC-2235. As such, this Dx protocol supports the Study R3767-ONC-2235 by describing the procedures for how the patient tumor samples collected as part of Regeneron Study R3767-ONC-2235 should be tested with VENTANA PD-L1 (SP263) CDx Assay at the Dx testing sites.
Clinical efficacy outcome data from Regeneron Study R3767-ONC-2235 will be used to evaluate the clinical performance of VENTANA PD-L1 (SP263) CDx Assay as a companion diagnostic device for cemiplimab in combination with fianlimab therapy in patients with NSCLC.
VENTANA 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 R3767-ONC-2235. PD-L1 expression results from testing that occurred under CDx protocol RD006664 (D191469) for patients with PD-L1 expression ≥ 50% TC may be enrolled in this Regeneron Study R3767-ONC-2235, at the discretion of the patient’s physician if the patient has given the proper informed consent. Additionally, PD-L1 expression results from testing that occurred under this CDx protocol RD006663 (D191752) for patients that were considered and screen failed for Regeneron Study R3767-ONC-2235 can be used for Regeneron study R3767-ONC-2236 (RD006664) if the patient has given the proper informed consent. It is anticipated that tumor specimens from approximately 4400 subjects undergoing screening to participate in Regeneron Study R3767-ONC-2235, will be tested with VENTANA PD-L1 (SP263) CDx Assay at Dx testing sites.
Stained slides from each case submitted for testing will be interpreted by qualified pathologists who will assign a PD-L1 expression level at the ≥ 50% TC threshold. A positive PD-L1 expression level at the ≥ 50% threshold will be one of the factors used to determine eligibility for enrolling patients into Regeneron Study R3767-ONC-2235. Additionally, PD-L1 expression level in TC (≥ 50% to < 75% vs ≥ 75%) will be one of the stratification factors used for randomization of patients into the treatment arms. Specimens determined to have a PD-L1 expression level < 50% are not eligible for participation in Regeneron Study R3767-ONC-2235, but results captured under this CDx study can be used for enrollment purposes into Regeneron Study R3767-ONC-2236. Performance of VENTANA PD-L1 (SP263) CDx Assay will be evaluated per the endpoints and acceptance criteria defined in the Dx protocol.REC name
North of Scotland Research Ethics Committee 1
REC reference
23/NS/0073
Date of REC Opinion
28 Jul 2023
REC opinion
Favourable Opinion