Actively Recruiting
Early Phase II Study of Neoadjuvant Dostarlimab Monotherapy in Untreated T3-4N0-2 or Stage III pMMR/MSS Resectable Colon Cancer
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2026-02-12
10
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the use of dostarlimab, a PD-1 inhibitor immunotherapy, in patients with untreated T3-4N0-2 or stage III proficient mismatch repair/microsatellite stable (pMMR/MSS) resectable colon cancer. This investigational drug aims to help the immune system recognize and fight cancer cells. The study explores molecular changes in tumor and blood after dostarlimab treatment before surgery to identify possible improvements in response to conventional treatments for some patients. Participants will receive two doses of dostarlimab 500 mg given by intravenous infusion over 30 minutes, spaced three weeks apart, before undergoing surgery. This neoadjuvant treatment lasts six weeks, which may slightly delay surgery compared to standard care. After surgery, further therapy decisions are left to the treating physician. The study includes an initial treatment period followed by up to two years of follow-up. During the trial, patients will undergo collection of tissue and blood samples for molecular analysis before surgery and throughout follow-up. Researchers will assess safety, pathological response at surgery, and survival outcomes over two years. The total participation duration is up to four months from the first dose of dostarlimab, plus the two-year follow-up period to monitor long-term effects and outcomes.
CONDITIONS
Brief Title
Phase II Study of Neoadjuvant Dostarlimab in Patients With Untreated T3-4N0-2 or Stage III pMMR/MSS Resectable Colon Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years of age and able to give informed consent
- Primary adenocarcinoma colon cancer that can be surgically removed, staged cT3-4, cN0-2, cM0 or stage III
- Tumor expresses mismatch repair proficient (MMR) and microsatellite stable (MSS) status
- Tissue samples from tumor and colon mucosa available for molecular analyses
- Capable of receiving immunotherapy
- Adequate general health and organ function based on blood tests
You will not qualify if you...
- Prior cancer treatment
- Pregnant or not using effective contraception if applicable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 6 weeks
Participants receive dostarlimab by intravenous infusion every 3 weeks for 2 cycles (6 weeks total).
2 infusion visits (in-person) every 3 weeks over 6 weeks
Duration - Within 12 to 15 weeks from baseline
Participants undergo surgery to remove the tumor and assess pathological response.
1 surgical visit (in-person)
Duration - Up to 2 years
Participants are followed for safety, survival, and blood sample collection for up to 2 years after enrollment.
Regular follow-up visits for blood sample collection and safety assessments
Trial Site Locations
Total: 1 location
1
UZLeuven
Leuven, Belgium, 3000
Actively Recruiting
Research Team
S
Sabine Tejpar, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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