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NCT05655312 · ClinicalTrials.gov registry record · Phase 1
MC1R-targeted Alpha-particle Monotherapy and Combination Therapy Trial With Nivolumab in Adults With Advanced Melanoma
A Phase 1 study of Metastatic Melanoma and Melanoma Stage IV, sponsored by Perspective Therapeutics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 300
- Enrollment target
- 13
- Study locations
NCT05655312: Recruiting Phase 1 study of Metastatic Melanoma and Melanoma Stage IV, sponsored by Perspective Therapeutics.
NCT05655312 is a Phase 1 study of Metastatic Melanoma and Melanoma Stage IV that is actively recruiting participants, run by Perspective Therapeutics. The registered enrollment target is 300 participants, above the 80-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (275% higher). The trial reports 13 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05655312, a Phase 1 study of Metastatic Melanoma and Melanoma Stage IV, is actively recruiting participants, sponsored by Perspective Therapeutics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 300 participants
- Enrollment target
- 13
- Study locations
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.
Primary Outcome
DLTs describe side effects of a drug that are serious enough to prevent an increase in dose
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2023-06-01 |
| Est. Completion | 2029-12-31 |
| Phase | Phase 1 |
What NCT05655312 shows while recruiting
NCT05655312 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, above the 80-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (275% higher).
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.
NCT05655312 lists 13 locations in 9 states (Florida, Missouri, Pennsylvania).
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).
What interventions are being tested in trial NCT05655312?
The interventions under investigation include: Nivolumab (DRUG), [203Pb]VMT01 (DRUG), [212Pb]VMT01 (DRUG).
Who is sponsoring clinical trial NCT05655312?
This trial is sponsored by Perspective Therapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05655312's enrollment target sits among peer trials
300 5th of 91 higher than 87 of 91 other Metastatic Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Melanoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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