RecruitingPhase 1/2

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

United States300 participantsStarted 2023-06-01

Plain-language 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.

Who can participate

Age range

18 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion 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 * Subjects 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 MC1R positivity during screening are eligible for enrollment, provided that they undergo a wash-out period of 21 days, or 7 days, respectively, prior to Cycle 1 Day 1 treatment with \[212Pb\]VMT01. * 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 \[212Pb\]VMT01 and/or nivolumab, and for at …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial uses a radioactive substance called [212Pb]VMT01 that targets a protein called MC1R on melanoma cells — how does my doctor think my tumor's MC1R expression might affect whether this approach could even be relevant to my situation?
2Since this is a Phase 1/2 trial that's still figuring out the right dose by looking for dose-limiting toxicities, what does my doctor think the realistic safety risks of an alpha-particle radiation therapy are, especially compared to treatments I might already be eligible for?
3The trial combines [212Pb]VMT01 with nivolumab, which is an immunotherapy I may have already heard of — should I ask whether I'd be in the monotherapy arm or the combination arm, and how would my doctor weigh those two options for my specific case?
4Because this trial is still in early phases and is actively recruiting, there's still a lot being learned about how patients respond — what does my doctor think about the tradeoff between accessing a novel targeted approach now versus waiting for more safety and efficacy data to emerge?
5Given that this trial is enrolling people with Stage III or Stage IV melanoma, including recurrent disease, what standard treatment options should my doctor and I fully explore before deciding whether a Phase 1/2 investigational study like this is the right next step for me?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of subjects with dose-limiting toxicities (DLTs) after the first administration of [212Pb]VMT01 as a monotherapy or in combination with nivolumab.

Timeframe: Incidence of DLTs during the first 42 days of study Treatment will be assessed.

Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

Timeframe: Up to approximately 2 years

Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) following administration of [212Pb]VMT01 as a monotherapy or in combination with nivolumab

Timeframe: Up to approximately 2 years

Trial details

NCT IDNCT05655312

SponsorPerspective Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-12-31

Contact for this trial

ClinicalTrials at Perspectivetherapeutics

206-676-0900 clinicaltrials@perspectivetherapeutics.com

View on ClinicalTrials.gov More Recurrent Melanoma (Skin) trials

Plain-language summary

Who can participate

Age range

18 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of subjects with dose-limiting toxicities (DLTs) after the first administration of [212Pb]VMT01 as a monotherapy or in combination with nivolumab.

Timeframe: Incidence of DLTs during the first 42 days of study Treatment will be assessed.

Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

Timeframe: Up to approximately 2 years

Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) following administration of [212Pb]VMT01 as a monotherapy or in combination with nivolumab

Timeframe: Up to approximately 2 years