Melanoma Treatment Study: [212Pb]VMT01 with or without Nivolumab
This study is testing a new treatment, [212Pb]VMT01, by itself and with nivolumab, for adults with advanced melanoma that has spread or come back. [212Pb]VMT01 is a targeted therapy that uses radiation to attack melanoma cells that have a specific marker called MC1R. Before treatment, an imaging agent, [203Pb]VMT01, will be used to confirm your melanoma has this marker. The study aims to find the safest dose and see how well these treatments shrink tumors. You may be eligible if you have unresectable Stage III or IV melanoma, are 18-90 years old, and have tried at least one other treatment that didn't work.
- Study design
- This is a multi-center, open-label study planning to enroll up to 300 participants. It will first find the right dose of [212Pb]VMT01 alone and in combination with nivolumab, then expand to further test these doses.
- What's involved
- If you are in the monotherapy group, you may receive up to 3 doses of [212Pb]VMT01, given about 8 weeks apart. If you are in the combination therapy group, you may receive up to 3 doses of [212Pb]VMT01 along with nivolumab, which is given every 4 weeks for up to 24 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will track side effects and how well the treatment works for up to approximately 2 years after you start treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05655312
MC1R-targeted Alpha-particle Monotherapy and Combination Therapy Trial With Nivolumab in Adults With Advanced Melanoma
Recruiting
PHASE1Ages 18–90InterventionalTreatmentPerspective Therapeutics
~300 participants
Updated 2026-06-10 on ClinicalTrials.gov
What's tested:[203Pb]VMT01[212Pb]VMT01Nivolumab
At a glance
Recruiting sites
12 of 13 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of subjects with dose-limiting toxicities (DLTs) after the first administration of [212Pb]VMT01 as a monotherapy or in combination with nivolumab.
Measured over Incidence of DLTs during the first 42 days of study Treatment will be assessed.
+2 more outcomes measured
Conditions
Where it's being run
13 sites across 9 statesFlorida3
Missouri2
Pennsylvania2
California1
Iowa1
Kentucky1
Minnesota1
Nebraska1
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Ability to understand and willingness to provide informed consent, willingness to comply with all study procedures for the duration of the study
Aged ≥ 18 years
Diagnosed with unresectable Stage III or Stage IV metastatic or recurrent melanoma
Previously progressed (radiological progression) on at least one approved systemic therapy for advanced melanoma
Uptake of \[68Ga\]VMT02 or \[203Pb\]VMT01 by PET or SPECT imaging observed in at least one melanoma tumor site using quantitative imaging analysis compared to reference normal tissue
Subjects on prior intravenous therapy (e.g., chemotherapy or checkpoint inhibitors), or prior oral therapy (e.g.,proto-oncogene B-RAF or mitogen-activated extracellular signal-regulated kinase inhibitors) who demonstrate MC1R positivity during screening are eligible for enrollment, provided that they undergo a wash-out period of 21 days, or 7 days, respectively, prior to Cycle 1 Day 1 treatment with \[212Pb\]VMT01.
Presence of measurable disease by RECIST v1.1 assessed within 45 days prior to the first dose of \[212Pb\]VMT01 on Cycle 1 Day 1
Ability to lie flat and still for up to two hours for imaging scans; moderate conscious sedation allowed if indicated
For females of reproductive potential: agree to use of highly effective contraception and refrain from donating eggs (ova, oocytes) for the purpose of reproduction starting from screening, during treatment with \[212Pb\]VMT01 and/or nivolumab, and for at least 6 months after the last dose of \[212Pb\]VMT01 and/or nivolumab, whichever is administered last
For males of reproductive potential: agree to use of condoms or other methods to ensure effective contraception and refrain from donating sperm starting from screening, during treatment with \[212Pb\]VMT01 and/or nivolumab, and for at least 6 months after the last dose of \[212Pb\]VMT01 and/or nivolumab, whichever is administered last
Eastern Cooperative Oncology Group performance score of \< 2 at Screening
Life expectancy of at least 3 months after Cycle 1 Day 1
Satisfactory organ function determined by laboratory testing
Exclusion
Active secondary malignancy
Prior systematic treatment with radioactive nuclides. Subjects who had localized treatment with radioactive nuclides or imaging using radioactive imaging agents may be enrolled
Pregnancy or breastfeeding a child
Any serious/active/uncontrolled infection requiring parenteral antibiotics within 2 weeks before the first administration of \[212Pb\]VMT01
Febrile illness within 48 hours of any scheduled investigational product (\[212Pb\]VMT01, \[203Pb\]VMT01, or \[68Ga\]VMT02) administration; subjects should be rescheduled \> 48 hours after resolution of fever
Treatment with another investigational drug product (therapeutic IND agents) within the last 45 days before the first dose of \[212Pb\]VMT01 on C1D1.
Current abuse of alcohol or illicit drugs
Existence of any medical or social issues likely to interfere with study conductor that may cause increased risk to the subject or to others, e.g., lack of ability to follow radiation safety precautions
Untreated central nervous system (CNS) metastasis or metastasis requiring acute therapy of any modality. Subjects must have been either off corticosteroids, or on a stable or decreasing dose of prednisone (or equivalent) for at least 2 weeks prior to the first dose of \[212Pb\]VMT01
Subjects with an active, known, or suspected autoimmune disease
Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications
Acute or chronic hepatitis B (e.g., Hepatitis B surface antigen reactive), hepatitis C (e.g., HCV RNA \[qualitative\] is detected) or known history of Human Immunodeficiency Virus (HIV) with an acquired immunodeficiency syndrome
Treatment with complementary medications (e.g., herbal supplements or traditional Chinese medicines)
Existence of abnormal laboratory values in hematology, liver, and renal function
Treatment with any live/attenuated vaccine within 30 days prior to the first dose of \[212Pb\]VMT01
Any treatment-related toxicities from prior systemic immune therapy with the exception of those unlikely to re-occur with standard countermeasures
History of allergy or hypersensitivity to nivolumab or its components
What this trial measures
- Number of subjects with dose-limiting toxicities (DLTs) after the first administration of [212Pb]VMT01 as a monotherapy or in combination with nivolumab.Incidence of DLTs during the first 42 days of study Treatment will be assessed.
DLTs describe side effects of a drug that are serious enough to prevent an increase in dose
- Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1Up to approximately 2 years
Percentage of subjects with complete responses (CRs) or partial responses (PRs) to at least 1 administration of \[212Pb\]VMT01 as a monotherapy or in combination with nivolumab
- Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) following administration of [212Pb]VMT01 as a monotherapy or in combination with nivolumabUp to approximately 2 years
Any untoward medical occurrence in a clinical investigational participant administered \[212Pb\]VMT01 as a monotherapy or in combination with nivolumab. Associated AE or SAE is assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0