Phase 2 Melanoma Trial, Recruiting NCT05896839 Sponsor: National Cancer Institute (NCI) Condition: Melanoma
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Phase 2 Melanoma Trial, Recruiting

NCT05896839
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 must be a kidney transplant recipient whose transplanted kidney is currently working and you are not on dialysis
  • You must be 18 years of age or older
  • You must have a confirmed diagnosis of one of these skin cancers: melanoma (not of the eye), basal cell carcinoma, Merkel cell carcinoma, or cutaneous squamous cell carcinoma, and standard surgery, radiation, or non-immune-based treatments would not be enough to treat your cancer
  • You must have cancer that can be measured by scans or physical exam
  • You must be well enough to carry out basic daily activities (a doctor will assess this using a standard scale)
  • Your blood counts must meet minimum levels — including white blood cells, infection-fighting cells (neutrophils), and platelets (confirm specific numbers with trial site)
  • Your liver function test results must be within an acceptable range (confirm with trial site)
  • Your kidney function must be within an acceptable range based on blood tests (confirm with trial site)
  • A specific test measuring DNA fragments in your blood (dd-cfDNA) must be within acceptable limits, suggesting your kidney is not being rejected (confirm with trial site)
  • If you are a woman who could become pregnant, you must have a negative pregnancy test before starting and must use contraception for at least 5 months after your last dose of the study drugs
  • If you are HIV-positive, you must be on an effective treatment with an undetectable level of the virus in your blood
  • If you have or have had hepatitis B or C, the virus must be undetectable or successfully treated
  • You must be willing and able to sign a consent form, or have a legal representative do so on your behalf

Who may not be able to join:

  • You have received a liver, lung, heart, or pancreas transplant, a bone marrow transplant, or a stem cell transplant
  • You are unwilling or unable to receive dialysis if your transplanted kidney were to stop working during the trial
  • You have previously developed certain antibodies (HLA or non-HLA donor-specific antibodies) that could attack your transplanted kidney (confirm with trial site)
  • You have had a rejection episode of your transplanted kidney within the past 3 months
  • You have not yet recovered from significant side effects of your most recent cancer treatment
  • You have received certain immune checkpoint therapy drugs (other than anti-PD-(L)1 treatments) within the past year
  • You are currently taking part in another clinical trial involving experimental treatments
  • You have cancer that has spread to the lining around the brain, have more than 3 untreated brain tumours, have an untreated brain tumour larger than 1 cm, or need high-dose steroids for brain-related symptoms
  • You have had a severe allergic reaction to any monoclonal antibody (a type of targeted drug) in the past
  • You have had allergic reactions to drugs similar to those used in this trial
  • You have a serious uncontrolled illness such as an active infection, heart failure, unstable chest pain, or irregular heartbeat
  • You are currently pregnant or breastfeeding
  • You have certain active autoimmune diseases that affect vital organs, or specific conditions such as Guillain-Barré syndrome, serious blistering skin diseases, Stevens-Johnson syndrome, or toxic epidermal necrolysis
  • You have active diverticulitis, an abdominal abscess, a bowel blockage, or cancer spread throughout the abdominal cavity — these will need to be assessed and possibly treated before you could join
  • You have a history of significant heart disease (such as a prior heart attack or heart rhythm problems) — additional heart tests may be needed before you can join (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 21 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.

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Trial details

Status
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
24 July 2024
Est. completion
31 January 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Disease control without allograft loss

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