Phase
Condition
Colorectal Cancer
Colon Cancer
Rectal Cancer
Treatment
Dostarlimab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 centralassessment
Exclusion
Exclusion Criteria:
Participant has distant metastatic disease
Participant has received prior radiation therapy, systemic therapy, or surgery formanagement of rectal cancer
Has a known additional malignancy that progressed or required active treatmentwithin the past 2 years
Has an active autoimmune disease that has required systemic treatment in the past 2years
Has experienced any of the following with prior immunotherapy: any irAE ≥ Grade 3,immune-related severe neurologic events of any-grade (e.g., myasthenicsyndrome/myasthenia gravis, encephalitis, Guillain Barré Syndrome, or transversemyelitis), exfoliative dermatitis of any grade [SJS (Stevens-Johnson Syndrome, TEN (Toxic Epidermal Necrolysis), DRESS (Drug rash with eosinophilia and systemicsymptoms)], or myocarditis of any grade. Non-clinically significant laboratoryabnormalities 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 donorstem 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 itsexcipients
Study Design
Connect with a study center
GSK Investigational Site
Changsha, 410013
ChinaSite Not Available
GSK Investigational Site
Chengdu, 610041
ChinaActive - Recruiting
GSK Investigational Site
Chongqing, 400010
ChinaActive - Recruiting
GSK Investigational Site
Guangzhou, 510060
ChinaActive - Recruiting
GSK Investigational Site
Hangzhou,
ChinaActive - Recruiting
GSK Investigational Site
Harbin, 150000
ChinaSite Not Available
GSK Investigational Site
Jinan, 250117
ChinaActive - Recruiting
GSK Investigational Site
Kunming, 650106
ChinaSite Not Available
GSK Investigational Site
Shanghai, 200032
ChinaActive - Recruiting
GSK Investigational Site
Taiyuan, 030013
ChinaActive - Recruiting
GSK Investigational Site
Zhengzhou, 450052
ChinaSite Not Available
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