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
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
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.Summary of results: Dx protocol conducted in support of Regeneron Study R3767-ONC-2235 to identify the PD-L1 expression level of tumor specimens for patient selection. FFPE NSCLC tumor specimens from ~ 4400 patients were expected to be tested with VENTANA PD-L1 (SP263) CDx Assay. Protocol Amendment 2 and 3 updated to the use of the on-market VENTANA PD-L1 (SP263) Assay for PD-L1 staining for EU and US geographies. Database updated and PA3 was implemented by site on 15Nov2024. COV delayed at pharma partners request, incase an IUO kit was used in error in the months following transition to on-market kits.
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