Phase 3 Melanoma Trial, Terminated (NCT05002569)

Phase 3 Melanoma Trial, Terminated NCT05002569 Sponsor: Bristol-Myers Squibb Condition: Melanoma

Printed from Voxsanity (voxsanity.com.au) — NCT05002569 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.

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Trial results

AI generated results 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

According to the results reported on ClinicalTrials.gov, this trial (NCT05002569) enrolled 1,093 people with melanoma — 547 in Treatment 1 and 546 in Treatment 2. Participants were randomly assigned to one of the two treatment groups. The trial's main goal was to measure "Recurrence Free Survival" (RFS) — that is, how long people went without their cancer coming back or dying from any cause. It also tracked overall survival, how long people lived without the cancer spreading to distant parts of the body, and how participants fared on any follow-up treatment after the trial. The reported data shows that for the primary measure of Recurrence Free Survival, a result was only reported for Treatment 2, recorded as a median (middle value) of 33.84 months — meaning half of that group reached that point without a recurrence or death. No figure was reported for Treatment 1. For the remaining outcome measures — overall survival, spread of cancer to distant sites, and outcomes on follow-up treatment — the data was not reported for either group. Regarding safety-related events (unintended medical occurrences tracked during the trial), the reported data shows that 522 people in Treatment 1 and 520 in Treatment 2 experienced at least one such event; 483 in Treatment 1 and 438 in Treatment 2 had a serious event; 132 in Treatment 1 and 78 in Treatment 2 had an event that led to stopping treatment; 102 in Treatment 1 and 65 in Treatment 2 had an event considered related to the study drug; and 83 in Treatment 1 and 76 in Treatment 2 died. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 41109920) ↗

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

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:

You have been diagnosed with Stage 3A (with more than 1mm of cancer in the lymph node), 3B, 3C, 3D, or Stage 4 melanoma, confirmed by a tissue biopsy.
Your melanoma has been completely removed by surgery, with no cancer cells found at the edges of the removed tissue.
Your surgery was completed within the last 90 days before joining the trial.
If you are 18 or older, your general health and ability to carry out daily activities must meet a certain minimum level (confirm with trial site).
If you are between 12 and 17 years old, your general health and functioning must also meet a certain minimum level (confirm with trial site).
You must have had a full physical examination within the last 14 days, and imaging scans within the last 35 days, showing no signs of remaining disease.
You must be willing to provide a tumor tissue sample for research testing.

Who may not be able to join:

You have a history of melanoma that started in the eye.
You have cancer that has spread to the brain or spinal fluid and has not been treated or removed.
You have an active autoimmune disease (where your immune system attacks your own body).
You have a serious or uncontrolled medical condition.
You have previously received immunotherapy treatment for any type of cancer.
You have had a COVID-19 infection within the 4 weeks before screening.
You have ever had inflammation of the heart muscle (myocarditis), for any reason.

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 21 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

Australian sites

Local Institution - 0030, Waratah, New South Wales

Local Institution - 0252, Westmead, New South Wales

Local Institution - 0032, Wollstonecraft, New South Wales

Local Institution - 0254, Tiwi, Northern Territory

Local Institution - 0028, Brisbane, Queensland

Local Institution - 0027, Southport, Queensland

Local Institution - 0250, Woodville, South Australia

Local Institution - 0035, Ballarat, Victoria

Local Institution - 0253, Heidelberg, Victoria

Local Institution - 0031, Melbourne, Victoria

Local Institution - 0251, Murdoch, Western Australia

Local Institution - 0029, Perth, Western Australia

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.

Voxsanity

Clinical trials and treatments, explained plainly · voxsanity.com.au

Date:

To: My Doctor

Re: Clinical trial enquiry

I found the following past clinical trial relevant to my condition, and wanted to raise it with you. It is no longer recruiting, but I wanted to ask whether similar active trials exist, or whether its results are relevant to my care:

Trial: NCT05002569

Sponsor: Bristol-Myers Squibb

Phase: Phase 3

Status: Terminated

Condition: Melanoma

More information: https://clinicaltrials.gov/study/NCT05002569

Eligibility summary (AI generated)

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

You have been diagnosed with Stage 3A (with more than 1mm of cancer in the lymph node), 3B, 3C, 3D, or Stage 4 melanoma, confirmed by a tissue biopsy.
Your melanoma has been completely removed by surgery, with no cancer cells found at the edges of the removed tissue.
Your surgery was completed within the last 90 days before joining the trial.
If you are 18 or older, your general health and ability to carry out daily activities must meet a certain minimum level (confirm with trial site).
If you are between 12 and 17 years old, your general health and functioning must also meet a certain minimum level (confirm with trial site).
You must have had a full physical examination within the last 14 days, and imaging scans within the last 35 days, showing no signs of remaining disease.
You must be willing to provide a tumor tissue sample for research testing.

Who may not be able to join:

You have a history of melanoma that started in the eye.
You have cancer that has spread to the brain or spinal fluid and has not been treated or removed.
You have an active autoimmune disease (where your immune system attacks your own body).
You have a serious or uncontrolled medical condition.
You have previously received immunotherapy treatment for any type of cancer.
You have had a COVID-19 infection within the 4 weeks before screening.
You have ever had inflammation of the heart muscle (myocarditis), for any reason.

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

Access in Australia: 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 doctor to access unapproved therapeutic goods for individual patients. See voxsanity.com.au/sas-navigator/ for a plain English explainer.

This information was sourced from ClinicalTrials.gov via Voxsanity (data last synced 21 July 2026). It is not medical advice. Please verify the trial's current status directly with the trial site before acting.

Trial details

Status

Terminated

Phase

Phase 3

Sponsor

Bristol-Myers Squibb

Registry

ClinicalTrials.gov

Start date

19 October 2021

Est. completion

16 December 2024

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇦🇹 Austria 🇧🇪 Belgium 🇧🇷 Brazil 🇨🇦 Canada 🇨🇱 Chile 🇨🇳 China 🇨🇿 Czechia 🇩🇰 Denmark 🇫🇮 Finland 🇫🇷 France 🇩🇪 Germany 🇬🇷 Greece 🇮🇱 Israel 🇮🇹 Italy 🇲🇽 Mexico 🇳🇴 Norway 🇵🇹 Portugal 🇷🇴 Romania 🇪🇸 Spain 🇸🇪 Sweden 🇨🇭 Switzerland 🇬🇧 United Kingdom 🇺🇸 United States

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

Primary endpoints

Recurrence Free Survival (RFS)

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: 21 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