INCMGA0012-204 Umbrella protocol for endometrial cancer
Research type
Research Study
Full title
CDx Clinical Protocol. The testing is in support of Incyte study INCMGA 0012-204 ( Cohort A only) titled "An Umbrella Study of INCMGA00012 Alone and in Combination With Other Therapies in Participants With Advanced or Metastatic Endometrial Cancer Who Have Progressed on or After Platinum-Based Chemotherapy (POD1UM-204)
IRAS ID
294432
Contact name
Justyna Fronczek Sokol
Contact email
Sponsor organisation
Incyte Corporation
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
2020-000496-20, EudraCT
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
The OncoMate™ MSI Dx Analysis System is a PCR-based fragment-sizing test used to determine microsatellite instability (MSI) status in DNA purified from human formalin-fixed paraffin-embedded (FFPE) tissue samples derived from solid tumors. “The objective of this investigation is to determine MSI status of patients being tested in a clinical investigation to evaluate the efficacy and safety of retifanlimab (INCMGA00012) in a patient population with MSI-H endometrial cancer tumors as a part on INCMGA 0012-204 Clinical study for Cohort A only.“ INCMGA 0012-204 Cohort A only aim to enroll 100 MSI-H endometrial cancer participants across 62 investigative sites in US, China, Italy, Germany, France, Belgium and Greece.
REC name
North West - Haydock Research Ethics Committee
REC reference
21/NW/0052
Date of REC Opinion
9 Mar 2021
REC opinion
Further Information Favourable Opinion