Phase 3 Colorectal Cancer Trial, Recruiting NCT07221357 Sponsor: Bristol-Myers Squibb Condition: Colorectal Cancer
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Phase 3 Colorectal Cancer Trial, Recruiting

NCT07221357
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 colorectal cancer (a type of bowel cancer) that has come back or spread to other parts of the body, confirmed by a tissue sample, and have not yet received treatment for this advanced stage of the disease.
  • People whose cancer cannot be removed by surgery with the aim of a cure.
  • People whose cancer does not have certain genetic features — specifically, it must not have what is known as a "mismatch repair deficiency" (dMMR) or "high microsatellite instability" (MSI-H), based on prior test results.
  • People whose cancer does not have a specific gene change called the BRAF V600E mutation, based on local testing.
  • People who have at least one area of cancer that can be measured on scans, according to a standard set of measurement rules used in cancer research.

Who may not be able to join:

  • People who have cancer that has spread to the brain, the lining of the brain, or the spinal cord, if that spread has not yet been treated.
  • People who have had another cancer that has been active in the past 2 years — though some exceptions may apply for certain slow-growing or apparently cured cancers considered unlikely to return (confirm with trial site).
  • People who have had serious heart or blood vessel problems — such as a heart attack, unstable chest pain, a stroke, or a blood clot in an artery — within the 6 months before joining the trial, or who have high blood pressure that cannot be controlled with medication, or a specific inherited heart rhythm condition called long QT syndrome.
  • People who have previously received certain types of cancer treatments that work by targeting the immune system — including drugs known as anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or CD137 therapies — or any chemotherapy.
  • There may be additional eligibility requirements set out in the trial's full protocol that are not listed here (confirm with trial site).

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 23 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: Bristol-Myers Squibb, Bristol-Myers Squibb

Phone: 855-907-3286

Australian sites

Local Institution - 0643, Camperdown, New South Wales
Liverpool Hospital, Liverpool, New South Wales
61287389744
GenesisCare St Leonards, St Leonards, New South Wales
61294631172
Westmead Hospital, Westmead, New South Wales
0288905200
Sunshine Coast University Hospital, Birtinya, Queensland
+61752021111
Royal Brisbane and Women's Hospital, Brisbane, Queensland
61736468111
Gallipoli Medical Research Ltd, Brisbane, Queensland
+61 7 3394 7284
Flinders Medical Centre, Adelaide, South Australia
61882048997
Lyell McEwin Hospital, Elizabeth Vale, South Australia
0871177265
Grampians Health, Ballarat Central, Victoria
Northern Hospital, Epping, Victoria
0384058000
Cabrini Hospital - Malvern, Malvern, Victoria
(03)95083434
Goulburn Valley Health, Shepparton, Victoria
0436474996
Western Health-Sunshine & Footscray Hospitals, St Albans, Victoria
(03)95083434
St. John of God Murdoch Hospital, Murdoch, Western Australia
+61894389599

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
Registry
ClinicalTrials.gov
Start date
31 December 2025
Est. completion
2 February 2030

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇦🇹 Austria 🇧🇪 Belgium 🇧🇷 Brazil 🇨🇦 Canada 🇨🇱 Chile 🇨🇳 China 🇨🇿 Czechia 🇫🇷 France 🇩🇪 Germany 🇭🇺 Hungary 🇮🇳 India 🇮🇹 Italy 🇯🇵 Japan 🇲🇽 Mexico 🇳🇱 Netherlands 🇵🇱 Poland 🇷🇴 Romania 🇸🇬 Singapore 🇰🇷 South Korea 🇪🇸 Spain 🇹🇼 Taiwan Turkey (Türkiye) 🇬🇧 United Kingdom 🇺🇸 United States

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

Primary endpoints

Objective Response (OR) (confirmed complete response (CR) or partial response (PR)) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator assessment; Progression Free Survival (PFS) by RECIST v1.1 per blinded independent central review (BICR); Overall Survival (OS)

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: 23 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