Actively Recruiting
MC1R-targeted Alpha-particle Monotherapy and Combination Therapy Trial With Nivolumab in Adults With Advanced Melanoma
Led by Perspective Therapeutics · Updated on 2026-03-11
300
Participants Needed
13
Research Sites
343 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
MC1R-targeted Alpha-particle Monotherapy and Combination Therapy Trial With Nivolumab in Adults With Advanced Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand and provide informed consent, and comply with study procedures
- Age 18 years or older
- Diagnosed with unresectable Stage III or Stage IV metastatic or recurrent melanoma
- Disease progressed on at least one approved systemic therapy for advanced melanoma
- Positive uptake of [68Ga]VMT02 or [203Pb]VMT01 on PET or SPECT imaging in at least one melanoma tumor site
- Underwent required wash-out period from prior therapies before starting treatment
- Measurable disease by RECIST v1.1 within 45 days before first dose
- Ability to lie flat and still for up to two hours for imaging scans
- For females of reproductive potential: agree to use effective contraception and not donate eggs during and for 6 months after treatment
- For males of reproductive potential: agree to use contraception and not donate sperm during and for 6 months after treatment
- Eastern Cooperative Oncology Group performance score less than 2 at screening
- Life expectancy of at least 3 months after starting treatment
- Satisfactory organ function by laboratory tests
You will not qualify if you...
- Active secondary cancer
- Prior systemic treatment with radioactive nuclides (local or imaging use allowed)
- Pregnancy or breastfeeding
- Serious or uncontrolled infection requiring IV antibiotics within 2 weeks before treatment
- Fever within 48 hours before receiving study drugs
- Treatment with another experimental drug within 45 days before starting treatment
- Current abuse of alcohol or illicit drugs
- Medical or social issues that increase risk or interfere with study conduct
- For combination therapy: untreated or actively treated brain metastases
- Active, known, or suspected autoimmune disease
- Need for systemic corticosteroids or immunosuppressive drugs
- Active hepatitis B or C infection or known HIV/AIDS
- Use of complementary medications like herbal supplements
- Abnormal lab values in blood, liver, or kidney function
- Live or attenuated vaccine within 30 days before treatment
- Treatment-related toxicities from prior immune therapy except those unlikely to recur
- Allergy or hypersensitivity to nivolumab or its components
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 13 locations
1
University of California Irvine
Orange, California, United States, 92868
Actively Recruiting
2
Mayo Clinic
Jacksonville, Florida, United States, 32224
Actively Recruiting
3
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
4
Sarasota Memorial Hospital
Sarasota, Florida, United States, 34239
Actively Recruiting
5
University of Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
6
University of Kentucky
Lexington, Kentucky, United States, 40536
Actively Recruiting
7
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
8
Saint Louis University Hospital
St Louis, Missouri, United States, 63110
Actively Recruiting
9
Washington University of St. Louis
St Louis, Missouri, United States, 63110
Actively Recruiting
10
Nebraska Cancer Specialists
Omaha, Nebraska, United States, 68130
Actively Recruiting
11
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Actively Recruiting
12
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
13
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States, 53792
Actively Recruiting
Research Team
C
ClinicalTrials at Perspectivetherapeutics
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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