Phase 3 Melanoma Trial, Recruiting NCT06519266 Sponsor: Vastra Gotaland Region Condition: Melanoma
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Phase 3 Melanoma Trial, Recruiting

NCT06519266
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:

  • You are 18 years of age or older
  • You have agreed to take part and signed a consent form
  • You are generally well enough to carry out light activity and care for yourself (confirm with trial site if unsure about your activity level)
  • Your uveal melanoma (a type of eye cancer) has spread to the liver, confirmed by a biopsy or cell sample
  • Your cancer can be measured on a CT scan, with at least one affected area visible in the liver
  • You have not previously received treatment for your melanoma that has spread, unless you have tried a specific drug called tebentafusp and your cancer got worse, or you have had surgery or targeted treatments such as radiation or ablation to the liver
  • Your doctors have decided you are a suitable candidate for a liver perfusion procedure (a specialised treatment delivered directly to the liver)
  • If you are a woman who could become pregnant, you have had a negative pregnancy test within 72 hours before starting treatment
  • If you are a woman who could become pregnant, you are willing to use reliable contraception during the study and for 150 days after your last dose
  • If you are a man who could father a child, you are willing to use reliable contraception from your first dose until 150 days after your last dose

Who may not be able to join:

  • Your doctors estimate you have less than 6 months to live
  • More than half of your liver has been taken over by cancer, as seen on a CT scan
  • Your cancer has spread to areas outside the liver, such as the lungs or other parts of the abdomen
  • You have a history of serious heart problems, such as heart failure, unstable chest pain, a recent heart attack, significant abnormal heart rhythms, or severe heart valve disease that would make general anaesthesia unsafe
  • You have serious lung disease, such as severe COPD, that would make general anaesthesia unsafe
  • You are unable to have general anaesthesia for any reason
  • Your kidneys are not working well enough, based on specific blood test results (confirm with trial site)
  • Your liver is not working well enough, based on specific blood or scan results, or you have a history of liver scarring (cirrhosis) or high blood pressure in the liver's blood vessels (confirm with trial site)
  • Your blood counts are too low, including low red blood cells, platelets, or a type of white blood cell called neutrophils (confirm with trial site)
  • You have received a live vaccine within four weeks before or after study treatment
  • You have had a severe allergic reaction to certain medicines used in this trial, including monoclonal antibodies, melphalan, heparin, or iodine-based contrast dye
  • You have HIV, AIDS, hepatitis B, or hepatitis C
  • You have an active autoimmune disease (where your immune system attacks your own body) or a history of one that needed systemic treatment — although some conditions like diabetes, rheumatoid arthritis, psoriasis, eczema, and an underactive thyroid are exceptions
  • You are currently taking high-dose steroid tablets or other medicines that suppress your immune system
  • You are currently receiving any other cancer treatment, immune-suppressing medication, or another experimental drug
  • You have another cancer that is growing or currently being treated
  • You are pregnant, breastfeeding, or planning to become pregnant or father a child during the study period or within 150 days of your last dose
  • Your doctor feels that any other health condition, treatment, or test result makes it not in your best interest to take part (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 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.

Contact this trial

Principal Investigator: Roger Olofsson Bagge, Professor, Sahlgrenska Universitetssjukhuset

Phone: +46313421000

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
Sponsor
Vastra Gotaland Region
Registry
ClinicalTrials.gov
Start date
10 June 2024
Est. completion
31 December 2028

Where this trial is recruiting

🇸🇪 Sweden

Primary endpoints

Progression-free survival (PFS)

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