OncoMatch/Clinical Trials/NCT05655312
MC1R-targeted Alpha-particle Monotherapy and Combination Therapy Trial With Nivolumab in Adults With Advanced Melanoma
Is NCT05655312 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies multiple treatments including [203Pb]VMT01 and [212Pb]VMT01 for recurrent melanoma (skin).
Treatment: [203Pb]VMT01 · [212Pb]VMT01 · Nivolumab — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Other
Cancer type
Melanoma
Biomarker criteria
Required: MC1R positivity by PET or SPECT imaging
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
Disease stage
Required: Stage III, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: systemic therapy — advanced melanoma
Previously progressed (radiological progression) on at least one approved systemic therapy for advanced melanoma
Cannot have received: systemic radioactive nuclide treatment
Exception: localized treatment with radioactive nuclides or imaging using radioactive imaging agents may be enrolled
Prior systematic treatment with radioactive nuclides. Subjects who had localized treatment with radioactive nuclides or imaging using radioactive imaging agents may be enrolled
Lab requirements
Blood counts
Satisfactory organ function determined by laboratory testing
Kidney function
Satisfactory organ function determined by laboratory testing
Liver function
Satisfactory organ function determined by laboratory testing
Satisfactory organ function determined by laboratory testing
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of California Irvine · Orange, California
- Mayo Clinic · Jacksonville, Florida
- University of Miami · Miami, Florida
- Sarasota Memorial Hospital · Sarasota, Florida
- University of Iowa · Iowa City, Iowa
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05655312 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic radioactive nuclide treatment disqualifies patients from enrollment.
Does this trial require MC1R?
Yes, MC1R positivity by PET or SPECT imaging is a required biomarker for enrollment.
What disease stage is eligible?
Stage III or IV is required.
Is there an age limit?
Yes. Patients must be 90 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages