Clinical trial details

A Phase 2, Single-Arm, Open-Label Study With Dostarlimab Monotherapy in Participants With Untreated Stage II/III dMMR/MSI-H Locally Advanced Rectal Cancer

Identifier

219369

Sponsor

GLAXOSMITHKLINE, SA

Principal Investigator

JAUME CAPDEVILA CASTILLON

Service

Oncology


Study details

Tumor type: RECTUM
Stage: Early/Locally advanced
Main Investigational Agent : Immunotherapy
Phase: II
Randomization: Non-randomized

Molecular details

Biomarker: MSI pos
Biomarker criteria: Mandatory
Prescreening: Local/Central
Additional study population requirements: Participant has a tumor which can be categorized as dMMR or MSI-H by local or central assessment

Drug details

Arm A: Dostarlimab

Links

Clinical Trials GOV (NCT identifier): NCT05723562
EU Clinical Trials Register (eudraCT Identifier): 2022-003289-18