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 in China
Status: Recruiting
Location: See all (8) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The main goal of this study is to evaluate the effect of dostarlimab monotherapy in Chinese participants with locally advanced Mismatch-repair deficient (dMMR)/ Microsatellite instability-high (MSI-H) rectal cancer who have received no prior treatment.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Participant has histologically confirmed Stage II to III (T3-T4, N0, or T any, N+), locally advanced rectal adenocarcinoma
• Participant has radiologically and endoscopically evaluable disease
• Participant has a tumor which can be categorized as dMMR or MSI-H by central assessment
Locations
Other Locations
China
GSK Investigational Site
RECRUITING
Chengdu
GSK Investigational Site
RECRUITING
Chongqing
GSK Investigational Site
RECRUITING
Guangzhou
GSK Investigational Site
RECRUITING
Guangzhou
GSK Investigational Site
RECRUITING
Hangzhou
GSK Investigational Site
RECRUITING
Jinan
GSK Investigational Site
RECRUITING
Shanghai
GSK Investigational Site
RECRUITING
Taiyuan
Contact Information
Primary
US GSK Clinical Trials Call Center
GSKClinicalSupportHD@gsk.com
877-379-3718
Backup
EU GSK Clinical Trials Call Center
GSKClinicalSupportHD@gsk.com
+44 (0) 20 89904466
Time Frame
Start Date: 2024-10-17
Estimated Completion Date: 2031-04-15
Participants
Target number of participants: 23
Treatments
Experimental: Dostarlimab monotherapy
Participants will receive dostarlimab as monotherapy.
Related Therapeutic Areas
Sponsors
Leads: GlaxoSmithKline