Phase 3 study for people with Colorectal Cancer

Recruiting Phase 3

Sources: ClinicalTrials.gov Checked: 11 October 2026 Not medical advice

This trial at a glance

Status Recruiting

Phase Phase 3

Sponsor Bristol-Myers Squibb

Registry number NCT07221357

Started 31 December 2025 Today 16 October 2026 Estimated completion 2 February 2030

Where this trial is running

Trial sites and the status recorded for each
Site	City	State or country	Status at this site
Local Institution - 0643	Camperdown	NSW	Not yet recruiting
Liverpool Hospital	Liverpool	NSW	Recruiting
GenesisCare St Leonards	St Leonards	NSW	Recruiting
Westmead Hospital	Westmead	NSW	Recruiting
Sunshine Coast University Hospital	Birtinya	QLD	Recruiting
Royal Brisbane and Women's Hospital	Brisbane	QLD	Recruiting
Gallipoli Medical Research Ltd	Brisbane	QLD	Recruiting
Flinders Medical Centre	Adelaide	SA	Recruiting
Lyell McEwin Hospital	Elizabeth Vale	SA	Recruiting
Grampians Health	Ballarat Central	VIC	Recruiting
Northern Hospital	Epping	VIC	Recruiting
Cabrini Hospital - Malvern	Malvern	VIC	Recruiting
Goulburn Valley Health	Shepparton	VIC	Recruiting
Western Health-Sunshine & Footscray Hospitals	St Albans	VIC	Recruiting
St. John of God Murdoch Hospital	Murdoch	WA	Recruiting

voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice

Who can join

Age 18 Years and over

Sex Anyone, regardless of sex

Healthy volunteers Not accepted

Enrolment target 990

The official eligibility criteria

Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.

Inclusion Criteria

* Participant must previously untreated, histologically confirmed recurrent or metastatic colorectal adenocarcinoma, not amenable to curative surgery.

* Participant must have no known presence of mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) colorectal cancer (CRC) per historical results (a validated test should be used).

* Participant must have no known presence of the gene that encodes the protein B-Raf (BRAF) V600E mutation per local testing.

* Participant must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Exclusion Criteria

* Participant must not have any untreated known central nervous system (CNS) metastases including brain, leptomeningeal and/or spinal cord compression.

* Participant must not have any prior malignancy active within the previous 2 years, except for locally curable cancers that have been apparently cured and considered to be of low risk of recurrence.

* Participant must not have significant cardiovascular disease, such as myocardial infarction, unstable angina, arterial thrombosis or cerebrovascular accident within 6 months prior to randomization, uncontrolled hypertension (≥ 160 systolic, and/or ≥ 100 diastolic mm Hg) despite optimal medical management, or congenital long QT syndrome.

* Participant must not have prior systemic treatment with an anti-PD-1, anti-programmed death (ligand)-1 (PD-L1), anti-PD-L2, CD137 agonists, or anti-cytotoxic T-lymphocyte associated protein 4 (CTLA-4) antibody, or any other antibody or drug specifically targeting T cell co-stimulation or checkpoint pathways or chemotherapy.

* Other protocol-defined Inclusion/Exclusion criteria apply.

Dates on the record

Started 31 December 2025

Estimated completion 2 February 2030

Registry last updated 23 September 2026

Checked by Voxsanity 11 October 2026

Results, publications and the official record

No results are posted on the official record yet.
No publications are listed on the official record yet.
Official record and contacts on ClinicalTrials.gov – contact details for each site are kept there, and are not copied onto this page.

Sources and dates

ClinicalTrials.gov – the record this page reformats
ClinicalTrials.gov processing date: 23 September 2026.
This page last checked by Voxsanity: 11 October 2026.

Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.

Not medical advice.

Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.

Letter for your doctor

A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.

Voxsanity

Clinical trials recruiting in Australia, from the public registries · voxsanity.com.au

Date:

To: My Doctor

Re: Clinical trial enquiry

I am writing to enquire about the following clinical trial, which may be relevant to my care:

Trial: NCT07221357

Sponsor: Bristol-Myers Squibb

Phase: Phase 3

Status: Recruiting

Condition: Colorectal Cancer

More information: https://clinicaltrials.gov/study/NCT07221357

Eligibility criteria, as the registry published them

Reproduced exactly, unedited. Written for researchers rather than for patients.

Inclusion Criteria

Participant must previously untreated, histologically confirmed recurrent or metastatic colorectal adenocarcinoma, not amenable to curative surgery.
Participant must have no known presence of mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) colorectal cancer (CRC) per historical results (a validated test should be used).
Participant must have no known presence of the gene that encodes the protein B-Raf (BRAF) V600E mutation per local testing.
Participant must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Exclusion Criteria

Participant must not have any untreated known central nervous system (CNS) metastases including brain, leptomeningeal and/or spinal cord compression.
Participant must not have any prior malignancy active within the previous 2 years, except for locally curable cancers that have been apparently cured and considered to be of low risk of recurrence.
Participant must not have significant cardiovascular disease, such as myocardial infarction, unstable angina, arterial thrombosis or cerebrovascular accident within 6 months prior to randomization, uncontrolled hypertension (≥ 160 systolic, and/or ≥ 100 diastolic mm Hg) despite optimal medical management, or congenital long QT syndrome.
Participant must not have prior systemic treatment with an anti-PD-1, anti-programmed death (ligand)-1 (PD-L1), anti-PD-L2, CD137 agonists, or anti-cytotoxic T-lymphocyte associated protein 4 (CTLA-4) antibody, or any other antibody or drug specifically targeting T cell co-stimulation or checkpoint pathways or chemotherapy.
Other protocol-defined Inclusion/Exclusion criteria apply.

A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a registered health practitioner to access unapproved therapeutic goods for individual patients.

Not medical advice. Voxsanity reformats information published by public registries. It does not give medical advice and is not a substitute for talking to your doctor.