Participants with Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer
Conditions
Brief summary
Event Free Survival (EFS) with recurrence assessed by Blinded Independent Central Review (BICR). Where an event is defined as: Disease recurrence based on radiological assessment by BICR; Disease progression precluding surgery (local assessment); Disease recurrence based on a pathological assessment of new lesions identified after surgery (local assessment); Death due to any cause; Treatment related toxicity that results in the participant not being suitable for surgery.
Detailed description
Pathological response determined by local assessment., OS, defined as time from randomization to death from any cause., EFS with recurrence assessed by local assesment (component events are the same as primary endpoint)., Frequency and severity of treatment emergent AEs, SAEs, irAEs, and AEs leading to death or discontinuation of study intervention., Serum concentrations and relevant PK parameters (C-EoI and Ctrough) for dostarlimab., Incidence of ADA against dostarlimab.
Interventions
DRUGJEMPERLI 500 mg concentrate for solution for infusion
Sponsors
Glaxosmithkline Research & Development Limited
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event Free Survival (EFS) with recurrence assessed by Blinded Independent Central Review (BICR). Where an event is defined as: Disease recurrence based on radiological assessment by BICR; Disease progression precluding surgery (local assessment); Disease recurrence based on a pathological assessment of new lesions identified after surgery (local assessment); Death due to any cause; Treatment related toxicity that results in the participant not being suitable for surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological response determined by local assessment., OS, defined as time from randomization to death from any cause., EFS with recurrence assessed by local assesment (component events are the same as primary endpoint)., Frequency and severity of treatment emergent AEs, SAEs, irAEs, and AEs leading to death or discontinuation of study intervention., Serum concentrations and relevant PK parameters (C-EoI and Ctrough) for dostarlimab., Incidence of ADA against dostarlimab. | — |
Countries
Belgium, Czechia, Estonia, Finland, France, Germany, Greece, Italy, Netherlands, Norway, Poland, Portugal, Spain, Sweden
Outcome results
None listed