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RECRUITING Phase 1

MC1R-targeted Alpha-particle Monotherapy and Combination Therapy Trial With Nivolumab in Adults With Advanced Melanoma

NCT05655312 · View on ClinicalTrials.gov ↗

Study Summary

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.

Interventions

  • DRUG Nivolumab
  • DRUG [203Pb]VMT01
  • DRUG [212Pb]VMT01

Study Locations (13)

Florida

  • Mayo Clinic — Jacksonville
  • University of Miami — Miami
  • Sarasota Memorial Hospital — Sarasota

Missouri

  • Saint Louis University Hospital — St Louis
  • Washington University of St. Louis — St Louis

Pennsylvania

  • Fox Chase Cancer Center — Philadelphia
  • UPMC Hillman Cancer Center — Pittsburgh

California

  • University of California Irvine — Orange

Iowa

  • University of Iowa — Iowa City

Kentucky

  • University of Kentucky — Lexington

Minnesota

  • Mayo Clinic Rochester — Rochester

Nebraska

  • Nebraska Cancer Specialists — Omaha

Trial Details

FieldValue
Enrollment Target 300 participants
Start Date 2023-06-01
Est. Completion 2029-12-31
Phase Phase 1

Sponsor

Perspective Therapeutics

34 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05655312

The ClinicalTrials.gov registry entry for NCT05655312 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Perspective Therapeutics, which has 34 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 4 conditions, with Metastatic Melanoma appearing as the primary indexed condition, and to 3 interventions — of which Nivolumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05655312 reports 13 study locations spanning 9 distinct geographic areas — top geographies include Florida, Missouri, Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05655312 about?

NCT05655312 is a clinical study titled "MC1R-targeted Alpha-particle Monotherapy and Combination Therapy Trial With Nivolumab in Adults With Advanced Melanoma". 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 me...

What is the current status of trial NCT05655312?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 300 participants. The study started on 2023-06-01. Estimated completion is 2029-12-31.

What conditions does trial NCT05655312 study?

This clinical trial studies the following conditions: Metastatic Melanoma, Melanoma Stage IV, Melanoma Stage III, Recurrent Melanoma (Skin). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05655312?

The interventions under investigation include: Nivolumab (DRUG), [203Pb]VMT01 (DRUG), [212Pb]VMT01 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05655312?

This trial is sponsored by Perspective Therapeutics, which has 34 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05655312 being conducted?

This trial has 13 study locations across California, Florida, Iowa, Kentucky, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial