Untreated Stage II/III dMMR/MSI-H Locally Advanced Rectal Cancer Rectal cancer
Conditions
Interventions
dostarlimab
Sponsors
GlaxoSmithKline
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: A new diagnosis of stage II or stage III (T3-T4, N0, or T any, N+) rectal cancer on or after 01 June 2022 Adults age = 18 years at stage II/III rectal cancer diagnosis date, previously untreated Initiated dostarlimab therapy as part of the CUP for treatment of stage II/III rectal cancer following date of stage II/III rectal cancer diagnosis, or those receiving dostarlimab treatment in countries via approved reimbursement pathwayLab results indicating dMMR status or MSI-H phenotype
Exclusion criteria
Exclusion criteria: Evidence of stage IV rectal cancer on or prior to the overall index date Evidence of malignancy other than rectal cancer, superficial skin cancer (i.e., nonmelanoma skin cancer), superficial bladder cancer, or other in situ cancer in the 2 years prior to date of stage II/III rectal cancer diagnosis Evidence of active treatment for malignancy other than rectal cancer, superficial skin cancer (i.e., non-melanoma skin cancer), superficial bladder cancer, or other in situ cancer in the 2 years prior to date of stage II/III rectal cancer diagnosis Evidence of initiation of dostarlimab in a clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Percentage of participants who maintain real-world complete clinical response (rw-cCR) for 12 months.Time frame: Index date (first overall tumor response assessment following end of dostarlimab treatment) up to 12 months2. Percentage of participants who maintain complete clinical and pathological response combined for 12 monthsTime frame: Index date (first overall tumor response assessment following end of dostarlimab treatment) up to 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percentage of participants with real-world best overall response (rwBOR) Time frame: Up to approximately 3 years | — |
Countries
Australia, Belgium, Brazil, France, Guatemala, Ireland, Netherlands, Spain, United Kingdom
Contacts
Public ContactV Blades
GlaxoSmithKline
Outcome results
None listed