Trial Title:
A Study of Dostarlimab in Participants With Untreated Locally Advanced Rectal Cancer in China
NCT ID:
NCT06640049
Condition:
Neoplasms, Rectal
Conditions: Official terms:
Rectal Neoplasms
Dostarlimab
Conditions: Keywords:
Dostarlimab
GSK4057190A
TSR-042
Rectal cancer
dMMR
MSI-H
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Dostarlimab
Description:
Dostarlimab will be administered.
Arm group label:
Dostarlimab monotherapy
Other name:
GSK4057190A
Other name:
TSR-042
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- Participant has distant metastatic disease
- Participant has received prior radiation therapy, systemic therapy, or surgery for
management of rectal cancer
- Has a known additional malignancy that progressed or required active treatment
within the past 2 years
- Has an active autoimmune disease that has required systemic treatment in the past 2
years
- Has experienced any of the following with prior immunotherapy: any irAE ≥ Grade 3,
immune-related severe neurologic events of any-grade (e.g., myasthenic
syndrome/myasthenia gravis, encephalitis, Guillain Barré Syndrome, or transverse
myelitis), exfoliative dermatitis of any grade [SJS (Stevens-Johnson Syndrome, TEN
(Toxic Epidermal Necrolysis), DRESS (Drug rash with eosinophilia and systemic
symptoms)], or myocarditis of any grade. Non-clinically significant laboratory
abnormalities are not exclusionary
- Has any history of interstitial lung disease or pneumonitis
- Has received or plans to receive an organ or stem cell transplant that uses donor
stem cells (allogeneic stem cell transplant)
- Has a history of severe allergic and/or anaphylactic reactions to chimeric, human,
or humanized antibodies, fusion proteins, or known allergies to dostarlimab, or its
excipients
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
GSK Investigational Site
Address:
City:
Changsha
Zip:
410013
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
US GSK Clinical Trials Call Center
Phone:
877-379-3718
Email:
GSKClinicalSupportHD@gsk.com
Contact backup:
Last name:
EU GSK Clinical Trials Call Centre
Phone:
+44 (0) 20 8990 4466
Email:
GSKClinicalSupportHD@gsk.com
Investigator:
Last name:
Yingbin Hu
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Chengdu
Zip:
610041
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
US GSK Clinical Trials Call Center
Phone:
877-379-3718
Email:
GSKClinicalSupportHD@gsk.com
Contact backup:
Last name:
EU GSK Clinical Trials Call Centre
Phone:
+44 (0) 20 8990 4466
Email:
GSKClinicalSupportHD@gsk.com
Investigator:
Last name:
Meng Qiu
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Chongqing
Zip:
400010
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
US GSK Clinical Trials Call Center
Phone:
877-379-3718
Email:
GSKClinicalSupportHD@gsk.com
Contact backup:
Last name:
EU GSK Clinical Trials Call Centre
Phone:
+44 (0) 20 8990 4466
Email:
GSKClinicalSupportHD@gsk.com
Investigator:
Last name:
Yaxu Wang
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
US GSK Clinical Trials Call Center
Phone:
877-379-3718
Email:
GSKClinicalSupportHD@gsk.com
Contact backup:
Last name:
EU GSK Clinical Trials Call Centre
Phone:
+44 (0) 20 8990 4466
Email:
GSKClinicalSupportHD@gsk.com
Investigator:
Last name:
Ruihua Xu
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Guangzhou
Zip:
510655
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
US GSK Clinical Trials Call Center
Phone:
877-379-3718
Email:
GSKClinicalSupportHD@gsk.com
Contact backup:
Last name:
EU GSK Clinical Trials Call Centre
Phone:
+44 (0) 20 8990 4466
Email:
GSKClinicalSupportHD@gsk.com
Investigator:
Last name:
Yanhong Deng
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Hangzhou
Zip:
310003
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
US GSK Clinical Trials Call Center
Phone:
877-379-3718
Email:
GSKClinicalSupportHD@gsk.com
Contact backup:
Last name:
EU GSK Clinical Trials Call Centre
Phone:
+44 (0) 20 8990 4466
Email:
GSKClinicalSupportHD@gsk.com
Investigator:
Last name:
Guosheng Wu
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Hangzhou
Zip:
310016
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
US GSK Clinical Trials Call Center
Phone:
877-379-3718
Email:
GSKClinicalSupportHD@gsk.com
Contact backup:
Last name:
EU GSK Clinical Trials Call Centre
Phone:
+44 (0) 20 8990 4466
Email:
GSKClinicalSupportHD@gsk.com
Investigator:
Last name:
Zhangfa Song
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Hangzhou
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
US GSK Clinical Trials Call Center
Phone:
877-379-3718
Email:
GSKClinicalSupportHD@gsk.com
Contact backup:
Last name:
EU GSK Clinical Trials Call Centre
Phone:
+44 (0) 20 8990 4466
Email:
GSKClinicalSupportHD@gsk.com
Investigator:
Last name:
Kefeng Ding
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Harbin
Zip:
150000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
US GSK Clinical Trials Call Center
Phone:
877-379-3718
Email:
GSKClinicalSupportHD@gsk.com
Contact backup:
Last name:
EU GSK Clinical Trials Call Centre
Phone:
+44 (0) 20 8990 4466
Email:
GSKClinicalSupportHD@gsk.com
Investigator:
Last name:
Yuxian Bai
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Jinan
Zip:
250117
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
US GSK Clinical Trials Call Center
Phone:
877-379-3718
Email:
GSKClinicalSupportHD@gsk.com
Contact backup:
Last name:
EU GSK Clinical Trials Call Centre
Phone:
+44 (0) 20 8990 4466
Email:
GSKClinicalSupportHD@gsk.com
Investigator:
Last name:
Yanlai Sun
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Kunming
Zip:
650106
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
US GSK Clinical Trials Call Center
Phone:
877-379-3718
Email:
GSKClinicalSupportHD@gsk.com
Contact backup:
Last name:
EU GSK Clinical Trials Call Centre
Phone:
+44 (0) 20 8990 4466
Email:
GSKClinicalSupportHD@gsk.com
Investigator:
Last name:
Jian Dong
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
US GSK Clinical Trials Call Center
Phone:
877-379-3718
Email:
GSKClinicalSupportHD@gsk.com
Contact backup:
Last name:
EU GSK Clinical Trials Call Centre
Phone:
+44 (0) 20 8990 4466
Email:
GSKClinicalSupportHD@gsk.com
Investigator:
Last name:
Junjie Peng
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
US GSK Clinical Trials Call Center
Phone:
877-379-3718
Email:
GSKClinicalSupportHD@gsk.com
Contact backup:
Last name:
EU GSK Clinical Trials Call Centre
Phone:
+44 (0) 20 8990 4466
Email:
GSKClinicalSupportHD@gsk.com
Investigator:
Last name:
Jianmin Xu
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Taiyuan
Zip:
030013
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
US GSK Clinical Trials Call Center
Phone:
877-379-3718
Email:
GSKClinicalSupportHD@gsk.com
Contact backup:
Last name:
EU GSK Clinical Trials Call Centre
Phone:
+44 (0) 20 8990 4466
Email:
GSKClinicalSupportHD@gsk.com
Investigator:
Last name:
Haiyi Liu
Email:
Principal Investigator
Facility:
Name:
GSK Investigational Site
Address:
City:
Zhengzhou
Zip:
450052
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
US GSK Clinical Trials Call Center
Phone:
877-379-3718
Email:
GSKClinicalSupportHD@gsk.com
Contact backup:
Last name:
EU GSK Clinical Trials Call Centre
Phone:
+44 (0) 20 8990 4466
Email:
GSKClinicalSupportHD@gsk.com
Investigator:
Last name:
Xiangbin Wan
Email:
Principal Investigator
Start date:
October 17, 2024
Completion date:
March 31, 2031
Lead sponsor:
Agency:
GlaxoSmithKline
Agency class:
Industry
Source:
GlaxoSmithKline
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06640049
