Phase 3 Colorectal Cancer Trial, Recruiting NCT05855200 Sponsor: GlaxoSmithKline Condition: Colorectal Cancer
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Phase 3 Colorectal Cancer Trial, Recruiting

NCT05855200
Recruiting Phase 3 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have been diagnosed with colon cancer (a specific type called adenocarcinoma) that has not yet been treated
  • People whose colon cancer has been confirmed by a pathology test (laboratory analysis of tissue)
  • People whose cancer is considered removable by surgery, based on how far it has spread locally (classified as T4N0 or Stage III)
  • People whose cancer can be measured or assessed using medical imaging (such as a CT scan)
  • People whose tumor has a specific biological marker — either something called "dMMR" or "MSI-H" — which relates to how the cancer's DNA repair system works (confirm with trial site)

Who may not be able to join:

  • People whose cancer has spread to distant parts of the body (metastatic disease)
  • People who have already received any treatment for their current colon cancer diagnosis, including chemotherapy, immunotherapy, targeted therapy, radiation therapy, or surgery
  • People whose tumor is causing a serious blockage of the bowel that requires urgent surgery — however, people who previously had a bowel blockage that was relieved by a surgical opening in the abdomen (a stoma) may still be considered; people who had a blockage treated with a colon stent are not eligible
  • People who have had a major surgery, open biopsy, or serious physical injury within the 28 days before joining the trial
  • People who have a history of a lung condition involving inflammation or scarring (interstitial lung disease or pneumonitis), or inflammation of the bowel caused by radiation
  • People who have cirrhosis or serious liver or bile duct disease, including conditions such as fluid build-up in the abdomen, confusion caused by liver problems, abnormal blood clotting, low protein levels, swollen veins in the food pipe or stomach, or ongoing yellowing of the skin
  • People who have previously had a stem cell transplant from a donor or an organ transplant
  • People who are currently receiving any other cancer treatment or experimental therapy
  • People who are pregnant, breastfeeding, or planning to become pregnant during the period covered by the study
  • People who have had a severe allergic or anaphylactic reaction to certain types of antibody-based medicines, or who are known to be allergic to the study drugs (dostarlimab, FOLFOX, or CAPEOX) or their ingredients

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 14 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: GSK Clinical Trials, GlaxoSmithKline

Phone: 877-379-3718

Australian sites

GSK Investigational Site, Newcastle, New South Wales
877-379-3718
GSK Investigational Site, St Leonards, New South Wales
GSK Investigational Site, Woolangabba, Queensland
877-379-3718
GSK Investigational Site, Heidelberg, Victoria
877-379-3718
GSK Investigational Site, Melbourne, Victoria

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Registry
ClinicalTrials.gov
Start date
1 August 2023
Est. completion
19 March 2029

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇧🇪 Belgium 🇧🇷 Brazil 🇨🇦 Canada 🇨🇳 China 🇨🇿 Czechia 🇪🇪 Estonia 🇫🇮 Finland 🇫🇷 France 🇩🇪 Germany 🇬🇷 Greece 🇮🇳 India 🇮🇹 Italy 🇯🇵 Japan 🇲🇽 Mexico 🇳🇱 Netherlands 🇳🇴 Norway Panama 🇵🇱 Poland 🇵🇹 Portugal 🇰🇷 South Korea 🇪🇸 Spain 🇸🇪 Sweden 🇹🇼 Taiwan Turkey (Türkiye) 🇬🇧 United Kingdom 🇺🇸 United States

5 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Event-free Survival (EFS) Assessed by Blinded Independent Central Review (BICR)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 14 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov