Phase 2 Melanoma Trial, Recruiting
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 aged 18 or older
- People who have been diagnosed with melanoma that cannot be surgically removed and has either spread to other parts of the body or come back after previous treatment (Stage III or Stage IV)
- People whose melanoma continued to grow or spread despite having at least one previous approved treatment for advanced melanoma
- People whose scans (PET or SPECT imaging) show that the study's imaging agents ([68Ga]VMT02 or [203Pb]VMT01) are taken up by at least one melanoma tumour site
- People who have had previous intravenous treatments (such as chemotherapy or immunotherapy) or oral targeted therapies, and who test positive for a specific protein marker (MC1R) during screening — provided a waiting period of 21 days (for intravenous treatments) or 7 days (for oral treatments) has passed before starting the study treatment
- People who have measurable disease confirmed by a standard imaging assessment within 45 days before the first dose of study treatment
- People who are able to lie flat and still for up to two hours for imaging scans (mild sedation may be allowed if needed)
- People whose doctors consider their organs (kidneys, liver, etc.) to be functioning well enough, based on blood tests
- People whose general physical condition is rated as largely functional (an activity score below 2 on a standard medical scale)
- People whose life expectancy is at least 3 months from the start of treatment
- Women who could become pregnant must agree to use highly effective contraception and not donate eggs from screening, throughout treatment, and for at least 6 months after the last dose of study treatment
- Men who could father a child must agree to use condoms or other effective contraception and not donate sperm from screening, throughout treatment, and for at least 6 months after the last dose of study treatment
Who may not be able to join:
- People who currently have another active cancer
- People who have previously received a systemic (whole-body) treatment using radioactive substances (note: people who have had localised radioactive treatment or routine radioactive imaging scans may still be considered)
- People who are pregnant or breastfeeding
- People who have had a serious infection requiring intravenous antibiotics within 2 weeks before the first dose of study treatment
- People who have a fever within 48 hours of any scheduled study treatment or imaging appointment
- People who have taken part in another clinical drug trial within the 45 days before the first dose of study treatment
- People who currently misuse alcohol or illicit drugs
- People with medical or personal circumstances that are likely to interfere with safely following the study's requirements, including radiation safety precautions
Additional reasons that may prevent joining for people receiving the combination treatment with nivolumab:
- People with untreated cancer spread to the brain or spinal cord, or brain/spinal metastases currently requiring active treatment
- People with an active, known, or suspected condition where the immune system attacks the body (autoimmune disease)
- People currently taking steroid medications or other medicines that suppress the immune system
- People with active hepatitis B, hepatitis C, or HIV with AIDS
- People currently using complementary medicines such as herbal supplements or traditional Chinese medicines
- People with abnormal blood test results relating to blood cell counts, liver function, or kidney function
- People who have received a live or weakened live vaccine within 30 days before the first dose of study treatment
- People who still have significant side effects from previous immunotherapy treatment
- People with a known allergy or previous reaction to nivolumab or any of its ingredients
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.
Contact this trial
Phone: 206-676-0900
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
Where this trial is recruiting
Primary endpoints
Number of subjects with dose-limiting toxicities (DLTs) after the first administration of [212Pb]VMT01 as a monotherapy or in combination with nivolumab.; Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1; Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) following administration of [212Pb]VMT01 as a monotherapy or in combination with nivolumab
Can't join this trial?
Data last synced from ClinicalTrials.gov: 14 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.