Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05655312 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Site details revised at 1 of 13 sitesv15
  2. Study sites: 12 to 13v14
  3. Study sites: 11 to 12v13
  4. Primary endpoints: 4 to 3 Enrollment target: 264 to 300 · Study sites: 10 to 11 · Eligibility criteria shortened, about 20 words · 2 morev12 Show 5 more changesShow less
    • Enrollment target: 264 to 300
    • Study sites: 10 to 11
    • Eligibility criteria shortened, about 20 words
    • Secondary endpoints: 5 to 4
    • Study description shortened, about 63 words

    See this version in full on ClinicalTrials.gov ↗

  5. Study sites: 9 to 10v11
Show 9 earlier versionsHide 9 earlier versions
  1. Primary completion date: Jun 30, 2025 to Dec 31, 2027 Completion date: Jun 30, 2027 to Dec 31, 2029v10 Show 1 more changeShow less
    • Completion date: Jun 30, 2027 to Dec 31, 2029
  2. Re-verified, no change to tracked fieldsv9
  3. Enrollment target: 52 to 264 Primary endpoints revised (4) · Interventions: [203Pb]VMT01 (Drug), [212Pb]VMT01 (Drug), [212Pb]VMT01 (Drug) to Nivolumab (Drug), [203Pb]VMT01 (Drug), [212Pb]VMT01 (Drug) · Eligibility criteria expanded, about 140 words · 4 morev8 Show 7 more changesShow less
    • Primary endpoints revised (4)
    • Interventions: [203Pb]VMT01 (Drug), [212Pb]VMT01 (Drug), [212Pb]VMT01 (Drug) to Nivolumab (Drug), [203Pb]VMT01 (Drug), [212Pb]VMT01 (Drug)
    • Eligibility criteria expanded, about 140 words
    • Secondary endpoints revised (5)
    • Study description expanded, about 62 words
    • Study arms: 2 to 4
    • Study title expanded, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  4. Study sites: 8 to 9v7
  5. Study sites: 7 to 8v6
  6. Study sites: 6 to 7v5
  7. Site details revised at 1 of 6 sitesv4
  8. Trial status: Not Yet Recruiting to Recruiting Site details revised at 6 of 6 sitesv3 Show 1 more changeShow less
    • Site details revised at 6 of 6 sites
  9. Start date: Dec 15, 2022 to Jun 1, 2023 Study sites: 3 to 6 · Interventions: [212Pb]VMT01 (Drug) to [203Pb]VMT01 (Drug), [212Pb]VMT01 (Drug), [212Pb]VMT01 (Drug) · Study arms: 1 to 2v2 Show 3 more changesShow less
    • Study sites: 3 to 6
    • Interventions: [212Pb]VMT01 (Drug) to [203Pb]VMT01 (Drug), [212Pb]VMT01 (Drug), [212Pb]VMT01 (Drug)
    • Study arms: 1 to 2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05655312
Lead Sponsor Perspective Therapeutics
Conditions Recurrent Melanoma (Skin), Metastatic Melanoma, Melanoma Stage IV, Melanoma Stage III
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov