Real World Study Dostar Rectal Cancer CUP patients
Research type
Research Study
Full title
A Real-world Study to Evaluate Clinical Outcomes of dostarlimab in Patients with Previously Untreated Stage II/III dMMR/MSI-H Locally Advanced Rectal Cancer
IRAS ID
344563
Contact name
Amir Montazeri
Contact email
Sponsor organisation
GlaxoSmithKline (GSK)
Duration of Study in the UK
4 years, 0 months, 1 days
Research summary
This is a real-world study to evaluate clinical outcomes of dostarlimab. The study population will consist of patients from Europe, Asia, and South America. Patients should be newly diagnosed with stage II/III dMMR/MSI-H rectal cancer since 01 June 2022 and should have received dostarlimab treatment for rectal cancer as part of the compassionate use program (CUP) or in Wales as part of the One Wales process (OW26).
It is a non-interventional, global, multi-site chart review study. This means that eligible patients will be identified from the medical records and invited for study enrolment by their treating physician/ direct care team. After obtaining informed consent from the patient, data will be collected by the treating physician (or their study team) retrospectively from the medical records, and entered into an EDC system. This data is anonymised to the researchers, meaning the patients are not identifiable to the research team in carrying out the research.
The end of follow-up will be 12 months after completion of dostarlimab treatment for the primary objectives; and up to 3 years for secondary and exploratory objectives.
Relevance: this study will help GSK learn more about the participant's health condition and the challenges faced by patients with rectal cancer in the real-world and assist them in developing new treatments in the future.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
25/SC/0052
Date of REC Opinion
7 Feb 2025
REC opinion
Favourable Opinion