Phase 2 Melanoma Trial, Recruiting NCT05229614 Sponsor: CNAO National Center of Oncological Hadrontherapy Condition: Melanoma
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Phase 2 Melanoma Trial, Recruiting

NCT05229614
Recruiting Phase 2

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 are willing and able to sign a consent form agreeing to take part in the study
  • You have been diagnosed with a cancer that has been confirmed by a tissue sample (biopsy), and you are currently being treated with a single approved immunotherapy drug that works by blocking certain proteins (called PD-1 or PD-L1) — approved for use in Italy
  • Your cancer has been assessed as stable (not growing significantly) based on official monitoring records
  • You have at least 2 areas of cancer in your body that can be measured — one that can be tracked by standard scans, and one that is suitable for the type of radiation therapy used in this trial
  • You are willing and able to attend all scheduled visits, tests, and follow all study requirements
  • You are 18 years of age or older (there is no upper age limit)
  • You are generally well enough to carry out some daily activities — not completely bedridden (this is measured by a standard scale called ECOG, score of 2 or lower)
  • Your cancer can be measured using CT or MRI scans according to standard guidelines

Who may not be able to join:

  • You are receiving chemotherapy combined with immunotherapy
  • You are receiving a combination of two or more immunotherapy drugs at the same time
  • You are receiving immunotherapy as part of another clinical trial
  • You are receiving immunotherapy outside of its official approved use (such as through special access or compassionate use programmes)
  • You have a very large amount of cancer spread in your body — more than 10 areas affected and/or the total size of tumours adds up to more than 19 cm
  • The only area where your cancer has spread is the brain or spinal cord (central nervous system)
  • You have a serious uncontrolled medical condition that the study doctor believes could put you at risk or affect the study results (confirm with trial site)
  • You have an autoimmune disease, such as inflammatory bowel disease or a condition where the immune system attacks the body's own tissues
  • The specific area of cancer chosen for radiation treatment in this trial has been treated with any type of radiation before
  • You have had a severe immune-related side effect (grade 4 on a standard medical scale) at any point before joining the study
  • You have had a serious immune-related side effect (grade 3 or higher) within the 3 weeks before the radiation treatment in this trial is due to start
  • You have metal implants or another condition in your body that would prevent the medical team from taking the detailed scans needed to plan your radiation treatment
  • There is a local condition — such as an active infection — in the area to be treated that would prevent the radiation therapy from being safely delivered (confirm with trial site)
  • You are currently in prison or held in a facility against your will
  • You are currently being detained under a legal order for treatment of a mental health or physical health condition

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 27 July 2026
Phase 2: approximately ~30% 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: Viviana Vitolo, MD, Fondazione CNAO

Phone: +39 0382078407

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 2
Sponsor
CNAO National Center of Oncological Hadrontherapy
Registry
ClinicalTrials.gov
Start date
26 July 2022
Est. completion
1 August 2025

Where this trial is recruiting

🇩🇪 Germany 🇮🇹 Italy

Primary endpoints

Objective response rate assessed by RECIST V1.1

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: 27 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