Phase 3 Melanoma Trial, Recruiting NCT06500455 Sponsor: NRG Oncology Condition: Melanoma
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Phase 3 Melanoma Trial, Recruiting

NCT06500455
Recruiting Phase 3

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 one of these cancers, confirmed by laboratory testing of a tissue or cell sample within the past 5 years: non-small cell lung cancer, melanoma, breast cancer, renal cell carcinoma (a type of kidney cancer), or gastrointestinal cancer. If the original diagnosis was more than 5 years ago, more recent confirmation through testing or imaging may be accepted (confirm with trial site)
  • People who have between 1 and 8 brain tumours (metastases) that have spread from the original cancer, detected on a contrast-enhanced MRI scan taken within 21 days before enrolling
  • People where at least one of those brain tumours measures between 1.0 cm and 3.0 cm across at its widest point
  • People whose brain tumours are located outside of the brainstem, at least 5 mm away from the optic nerves or the optic chiasm (the part of the brain connected to vision), and no larger than 3.0 cm
  • People with a disease-specific prognostic score of 1.5 or higher on a standard cancer assessment scale (confirm with trial site)
  • People who have no more than 2 brain lesions planned for surgical removal, if surgery is needed
  • People with no known spread of cancer to the lining of the brain or spinal cord (a condition called leptomeningeal disease)
  • People aged 18 or older
  • People with a Karnofsky Performance Status score of 60 or above, which is a standard measure of a person's ability to carry out daily activities (confirm with trial site)
  • People who have a negative pregnancy test from a urine or blood sample taken within 14 days before enrolling, if there is any possibility of pregnancy
  • People who have never previously had any form of radiation treatment to the brain
  • People whose heart function meets at least a Class II rating on the New York Heart Association scale, meaning their heart condition, if any, causes only slight limitations during physical activity (confirm with trial site)
  • People who do not currently have an active infection that requires antibiotic treatment given through a drip (intravenously)
  • People who do not have liver disease severe enough to cause yellowing of the skin or eyes (jaundice) or blood clotting problems
  • People who do not have a current flare-up of a chronic lung condition or other breathing illness that would prevent participation in the trial

Who may not be able to join:

  • People whose cancer diagnosis cannot be confirmed within the required timeframe through tissue testing or acceptable imaging
  • People with more than 8 brain metastases, or none at all
  • People whose brain tumours do not include at least one measuring between 1.0 cm and 3.0 cm
  • People with brain tumours located in the brainstem, within 5 mm of the optic nerves or optic chiasm, or larger than 3.0 cm
  • People with a disease-specific prognostic score below 1.5
  • People who have more than 2 brain lesions planned for surgical removal
  • People with known leptomeningeal disease (cancer spread to the lining of the brain or spinal cord)
  • People under 18 years of age
  • People with a Karnofsky Performance Status score below 60
  • People who are or may be pregnant, without a recent negative pregnancy test
  • People who have previously received any radiation treatment to the brain
  • People with a heart function rating of Class III or IV on the New York Heart Association scale, meaning their heart condition causes significant or severe limitations
  • People currently being treated with intravenous antibiotics for an active infection
  • People with liver disease causing jaundice or blood clotting problems
  • People currently experiencing a flare-up of a chronic lung condition or another breathing illness

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 26 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.

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Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
NRG Oncology
Registry
ClinicalTrials.gov
Start date
12 December 2024
Est. completion
30 June 2028

Where this trial is recruiting

🇨🇦 Canada Hong Kong 🇮🇪 Ireland 🇺🇸 United States

Primary endpoints

Time to local failure

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: 26 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