Phase 2 Study of Dostarlimab in Untreated dMMR/MSI-H Locally Advanced Rectal Cancer
Research type
Research Study
Full title
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
IRAS ID
1006927
Contact name
Juliette Bayle
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Limited
Eudract number
2022-003289-18
Clinicaltrials.gov Identifier
Research summary
This study is looking at the effects of dostarlimab which helps a persons own immune system to fight cancer. The goal of this study is to prevent a person from having to receive chemotherapy and radiation therapy and to delay or possibly prevent surgery, potentially sparing people from life changing effects of surgery and side effects of chemotherapy and radiation therapy.
About 100 people will take part in this study. People who are at least 18 years old and have newly diagnosed early-stage rectal cancer will be included. Each participant will be on the study until they leave the study, or the study ends. Participants are expected to receive nine doses of this study drug every 3 weeks. After treatment participants will be followed-up to document their response to the treatment, any further treatments and their survival information.
This research study aims to answer the following questions:
• Is the drug dostarlimab safe when used in people who have rectal cancer?
• How well will dostarlimab work to treat people with early-stage rectal cancer and how long can it delay their surgery and prevent the use of chemotherapy and radiation therapy?
• How does dostarlimab affect the cancer?REC name
South Central - Oxford B Research Ethics Committee
REC reference
23/SC/0069
Date of REC Opinion
22 Aug 2023
REC opinion
Further Information Favourable Opinion