Phase II Study of Neoadjuvant Dostarlimab in Patients With Untreated T3-4N0-2 or Stage III pMMR/MSS Resectable Colon Cancer

Launched by UNIVERSITAIRE ZIEKENHUIZEN KU LEUVEN · Feb 11, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the use of a drug called dostarlimab to see if it can help patients with a specific type of colon cancer before they have surgery. Dostarlimab is an immunotherapy drug that helps your immune system recognize and fight cancer. The trial will involve giving participants two doses of dostarlimab, three weeks apart, before their scheduled surgery. The goal is to understand how the drug affects the cancer and whether it improves the chances of successful treatment after surgery.

To be eligible for this trial, participants need to be at least 18 years old and have colon cancer that can be surgically removed, specifically at stage III or certain earlier stages. They must also have a specific type of tumor that is classified as microsatellite stable (MSS). The trial is not yet recruiting participants, but if someone decides to join, they should be prepared for a treatment duration of about six weeks, followed by surgery. After surgery, the doctors will decide on further treatment based on each patient’s situation. Overall, while the benefits of this treatment are still being studied, some patients may experience significant improvements.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • at least 18 years of age and capable of giving informed consent
• • primary adenocarcinoma colon cancer than can be removed surgically, staged cT3-4, cN0-2, cM0 or stage III
• • tumour expresses an MMR proficient/microsatellite stable called MSS
• • tissue samples from tumour and colon mucosa available for molecular analyses
• • capable of receiving immunotherapy
• • adequate general health status and organ function (blood tests)
• Exclusion Criteria:
• • no prior cancer treatment
• • not pregnant and using effective contraception if applicable