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New treatment option for Recurrent Melanoma (Skin)
Official title MC1R-targeted Alpha-particle Monotherapy and Combination Therapy Trial With Nivolumab in Adults With Advanced Melanoma
ClinicalTrials.gov ID: NCT05655312
What this study is testing
What is [203Pb]VMT01?
[203Pb]VMT01 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for recurrent melanoma (skin).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- In this first-in human, phase I/IIa study, the safety and efficacy of [212Pb]VMT01, an alpha-particle emitting therapeutic agent targeted to melanocortin sub-type 1 receptor (MC1R) is being evaluated as a monotherapy and in combination with nivolumab in subjects with unresectable and metastatic melanoma.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 24 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90
You may be able to join if
- 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...
You likely can't join if
- Active secondary malignancy
- Prior systematic treatment with radioactive nuclides. people who had localized treatment with radioactive nuclides or imaging using radioactive...
- 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; people should...
- Treatment with another investigational drug product (therapeutic IND agents) within the last 45 days before the first dose of [212Pb]VMT01 on C1D1.
See the full eligibility criteria
- 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
- people 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...
- 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...
- 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...
- 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
- Active secondary malignancy
- Prior systematic treatment with radioactive nuclides. people 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; people 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 Additional...
- Untreated central nervous system (CNS) metastasis or metastasis requiring acute therapy of any modality. people must have been either off corticosteroids, or on a stable or decreasing dose of prednisone (or equivalent)...
- people with an active, known, or suspected autoimmune disease
- people 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Orange, California, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Sarasota, Florida, United States
- Iowa City, Iowa, United States
- Lexington, Kentucky, United States
- Rochester, Minnesota, United States
- St Louis, Missouri, United States
- Omaha, Nebraska, United States
- Philadelphia, Pennsylvania, United States
- Pittsburgh, Pennsylvania, United States
- Madison, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 24 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Orange, California, United States; Jacksonville, Florida, United States; Miami, Florida, United States; Sarasota, Florida, United States; Iowa City, Iowa, United States; Lexington, Kentucky, United States and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.