Clinical trial 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?
An investigational intravenous imaging agent being studied for recurrent melanoma (skin). It is designed to bind the melanocortin‑1 receptor (MC1R) on melanoma cells to allow SPECT/CT imaging.
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
- This study aims to find out if the new treatment is safe and how well it works in people with advanced melanoma.
- Who it's for
- The study is looking for adults with melanoma that has spread or cannot be removed by surgery.
- What's involved
- Participants will receive a targeted radiation drug, either by itself or combined with an immune therapy drug called nivolumab.
- Time commitment
- The source text does not specify the total duration or number of visits required.
- 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
- 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
- Untreated central nervous system (CNS) metastasis or metastasis requiring acute therapy of any modality.
- 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 is enrolling
- 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
- Minneapolis, Minnesota, United States
- Rochester, Minnesota, United States
- St Louis, Missouri, United States
- Omaha, Nebraska, United States
- Chapel Hill, North Carolina, United States
- Cleveland, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Pittsburgh, Pennsylvania, 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, but 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?
This study is enrolling now at 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 8 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.