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Phase II study of neoadjuvant Dostarlimab in patients with untreated T3-4N0-2 or Stage III pMMR/MSS Resectable Colon Cancer

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-512499-36-00
Enrollment
10
Registered
2024-12-17
Start date
2025-04-03
Completion date
Unknown
Last updated
2025-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pMMR/MSS resectable Colon Cancer

Brief summary

Data generation through multi-omic exploration of blood and tissue derived products. Correlation of molecular-biological features identified with pathological response.

Detailed description

Safety analysis. Frequency and severity of treatment emergent AEs, SAEs, irAEs. AEs leading to death, discontinuation of trial intervention or resulting in the participant not being suitable for surgery., Proportion of participants with pathological response, determined by local assessment., Survival time defined from Superhero ICF signature to death from any cause. Proportion of survivors at 2 years., Event free survival time (EFS) defined from Superhero ICF signature to recurrence evaluated by local assessment or death.

Interventions

DRUGJEMPERLI 500 mg concentrate for solution for infusion

Sponsors

UZ Leuven
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Data generation through multi-omic exploration of blood and tissue derived products. Correlation of molecular-biological features identified with pathological response.

Secondary

MeasureTime frame
Safety analysis. Frequency and severity of treatment emergent AEs, SAEs, irAEs. AEs leading to death, discontinuation of trial intervention or resulting in the participant not being suitable for surgery., Proportion of participants with pathological response, determined by local assessment., Survival time defined from Superhero ICF signature to death from any cause. Proportion of survivors at 2 years., Event free survival time (EFS) defined from Superhero ICF signature to recurrence evaluated by local assessment or death.

Countries

Belgium

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026