Neoadjuvant dostarlimab before surgery for resectable stage III pMMR/MSS colon cancer
Official title: Early Phase II Exploratory, Open-Label, Non-Randomized Study of Neoadjuvant Dostarlimab Monotherapy in Participants With Untreated T3-4N0-2 or Stage III pMMR/MSS Resectable Colon Cancer
Run by Universitaire Ziekenhuizen KU Leuven · NCT06830239 · Data updated 2026-11-12
This will test whether two pre-surgery infusions of the PD-1 drug dostarlimab help people with resectable stage III pMMR/MSS colon cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 10 (estimated) |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Drugs / interventions | immunotherapy, Dostarlimab |
| Locations | 1 site (Leuven) |
| Status | Recruiting |
| Started | April 3, 2025 |
| Main results expected | December 2027 |
| Study ends | December 2028 |
| Registry record updated | February 12, 2026 |
| Trial ID | NCT06830239 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with resectable primary colon adenocarcinoma staged cT3-4, cN0-2 or stage III that are MMR-proficient/MSS, who have not received prior cancer therapy and are fit for immunotherapy and surgery.
✕Probably not a fit
Patients with metastatic or non-resectable disease, prior cancer treatment, or who have a dMMR/MSI-high tumor profile are not eligible for this approach and are unlikely to benefit from this specific regimen.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults with primary resectable cT3-4 or stage III pMMR/MSS colon adenocarcinoma will receive two 500 mg IV doses of dostarlimab given three weeks apart before planned surgery. Tumor and blood samples will be collected to study molecular changes induced by the immunotherapy. Dostarlimab is approved in Belgium for other indications but not for colon cancer, and its ability to change surgical or long-term outcomes in pMMR/MSS colon cancer is unproven. Standard surgical resection is performed after the neoadjuvant dosing per the treating team.
Why it matters
Potential benefit: If successful, the treatment could shrink tumors before surgery and improve surgical outcomes or long-term control for some patients.
How similar studies have gone: Checkpoint inhibitors have shown clear benefit in dMMR/MSI-high colorectal cancers, but responses in pMMR/MSS colon cancer have been rare, so this approach is largely exploratory for this population.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
UZLeuven
Leuven, Belgium Recruiting
Study contacts
- Principal investigator: Sabine Tejpar, MD — Universitaire Ziekenhuizen KU Leuven
- Study coordinator: Sabine Tejpar, MD
- Email: sabine.tejpar@uzleuven.be
- Phone: +32 16 34 42 25
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Testing a B7‑H3 antibody–drug conjugate alone and with dostarlimab in recurrent/metastatic head and neck squamous cell carcinoma
It tests an antibody–drug conjugate called GSK5764227 by itself or with the immunotherapy dostarlimab in adults with recurrent or metastatic head and neck squamous cell carcinoma who have received prior treatments.
-
Dostarlimab with cisplatin, etoposide, and radiotherapy for small cell neuroendocrine cervical cancer
This trial will test whether adding the immunotherapy drug dostarlimab to cisplatin/etoposide chemotherapy plus radiotherapy helps women with small cell neuroendocrine cervical carcinoma stay progression-free longer.
-
Neoadjuvant dostarlimab for locally advanced dMMR/MSI‑H rectal cancer in routine practice
This project will try neoadjuvant dostarlimab in adults with dMMR/MSI‑H stage II–III rectal cancer to see how well it works and how safe it is in real-world clinical care.
-
Dostarlimab with carboplatin–paclitaxel for advanced or recurrent endometrial cancer in Chinese patients with dMMR/MSI-H
This Phase 2 trial will test whether adding dostarlimab to carboplatin and paclitaxel helps Chinese patients with advanced or recurrent dMMR/MSI‑H endometrial cancer respond to treatment and tolerate the combination.
-
Neoadjuvant immunotherapy and radiotherapy for advanced rectal cancer
This study is testing if combining a new immunotherapy drug with short radiation treatment can help people with advanced rectal cancer avoid surgery and improve their chances of staying cancer-free.
-
Evaluating the effects of dostarlimab and vitamin D3 with mFOLFIRINOX in pancreatic cancer
This study is testing a new combination of a cancer drug, vitamin D3, and chemotherapy to see if it can help people with untreated advanced pancreatic cancer.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.