Taking peoplePhase 3
Tests dostarlimab before and after surgery for certain colon cancers
Tests dostarlimab with surgery in adults with resectable colon cancer.
Key facts
- Who runs it
- GlaxoSmithKline
- Where
- Bydgoszcz and Warsaw, PolandSee the 2 sitesAlso in 27 other countries, 221 sites
- Trial code
- Registry title
- Study of Perioperative Dostarlimab in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 892 people, planned
- Started
- 1 Aug 2023
- Expected to end
- 27 Mar 2031
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Dostarlimab
- CAPEOX
- FOLFOX
- Record updated
- 23 January 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with colon cancer that has not been treated yet, can be removed by surgery, and has a specific tumor change (dMMR or MSI-H).
- Age
- 18 years or older
- Sex
- Women and men can join.
- Disease stage
- Colon adenocarcinoma that can be removed by surgery, clinically T4N0 or Stage III, with no distant spread. The disease must be visible on imaging.
- Earlier treatment
- No earlier treatment for this colon cancer: no chemotherapy, immunotherapy, biologic or targeted therapy, radiation or surgery.
- Biomarker or test result
- The tumor must show dMMR (defective mismatch repair) or MSI-H (microsatellite instability high).
Main reasons for not taking part
- Cancer that has spread to distant parts of the body
- A tumor that blocks the bowel or needs urgent surgery
- History of interstitial lung disease, pneumonitis or radiation-induced enteritis
- Cirrhosis or unstable liver or bile duct disease
- Past stem cell or organ transplant
The registry criteria, word for word
Show all 14 criteriaShow less
Who can take part
- Has untreated pathologically confirmed colon adenocarcinoma
- Has resectable colon adenocarcinoma defined as clinically T4N0 or Stage III
- Has radiologically evaluable disease
- Has a tumor demonstrating the presence of either dMMR status or MSI-H
Who cannot take part
- Has received prior medical therapy (chemotherapy, immunotherapy, biologic, or targeted therapy), radiation therapy or surgery for management of the current diagnosis of colon cancer
- Has a tumor that, in the investigator's judgment is causing symptomatic bowel obstruction or otherwise requires urgent/emergent surgery at the time of screening. Participants with a history of colonic obstruction are eligible after obstruction is relieved by a diverting stoma (defunctioning ileostomy or colostomy). Patients with a history of colonic obstruction in the context of current colon cancer diagnosis and treated with colonic stents are not eligible
- Has undergone any major surgical procedure, open biopsy, or experienced significant traumatic injury within 28 days prior to randomization
- Is receiving any other anticancer or experimental therapy. No other experimental therapies (including but not limited to chemotherapy, radiation, hormonal treatment, antibody therapy, immunotherapy, gene therapy, vaccine therapy, or other experimental drugs) of any kind are permitted while the participant is receiving study intervention
- Has distant metastatic disease
- Has any history of interstitial lung disease or pneumonitis and/or history of radiation induced enteritis
- Has cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal/gastric varices, or persistent jaundice
- Has a history of allogenic stem cell transplantation or organ transplantation
- Has a history of severe allergic and/or anaphylactic reactions to chimeric, human or humanized antibodies, fusion proteins, or known allergies to dostarlimab, or its excipients, or any components of FOLFOX or CAPEOX
- Is pregnant, breastfeeding, or expecting to conceive children within the projected duration of the study
Where in Poland
Also in 27 other countries, 221 sites
- In- Vivo Sp. z o. o.Bydgoszcz, PolandNo longer taking part
- Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyWarsaw, PolandNo longer taking part
About the trial
What the trial wants to find out
The primary purpose of this study is to evaluate the efficacy of perioperative dostarlimab compared with standard of care (SOC) in participants with untreated T4N0 or Stage III (resectable), defective mismatch repair/ microsatellite instability high (dMMR/MSI-H) colon cancer.
The 2 groups in the trial
- DostarlimabTreatment being tested
Participants will receive Dostarlimab pre and post surgery
- Standard of Care (SOC)Existing treatment, for comparison
Participants will receive SOC (FOLFOX/CAPEOX) or undergo expectant observation post surgery.
Treatment: CAPEOX and FOLFOX
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- A Phase 3, Open-Label, Randomized Study of Perioperative Dostarlimab Monotherapy Versus Standard of Care in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer
- Plain-language title
- Tests dostarlimab before and after surgery for certain colon cancersGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Publications
- A Phase III study of perioperative dostarlimab in patients with dMMR/MSI-H resectable colon cancer: AZUR-2 study design.Future oncology (London, England), 2026
- Record updated
- 23 January 2026