NCT05655312 - MC1R-targeted Alpha-particle Monotherapy and Combination Therapy Trial With Nivolumab in Adults With Advanced Melanoma | Biotech Hunter

Enrollment

300

Participants

Timeline

Start Date

June 1, 2023

Primary Completion Date

December 31, 2027

Study Completion Date

December 31, 2029

Conditions

Recurrent Melanoma (Skin)Metastatic MelanomaMelanoma Stage IVMelanoma Stage III

Interventions

DRUG

[203Pb]VMT01

\[203Pb\]VMT01 is administered intravenous (IV) as an imaging agent for SPECT/CT

DRUG

[212Pb]VMT01

Subjects with positive uptake of \[203Pb\]VMT01 will receive a fixed dose of \[212Pb\]VMT01 administered IV every 8 weeks starting at Cycle 1 Day 1.

DRUG

Nivolumab

For all combination-therapy cohorts, 480 mg nivolumab will be administered every 4 weeks as an IV infusion.

Trial Locations (11)

15232

RECRUITING

UPMC Hillman Cancer Center, Pittsburgh

19111

RECRUITING

Fox Chase Cancer Center, Philadelphia

33136

RECRUITING

University of Miami, Miami

34239

RECRUITING

Sarasota Memorial Hospital, Sarasota

40536

RECRUITING

University of Kentucky, Lexington

52242

RECRUITING

University of Iowa, Iowa City

53792

RECRUITING

University of Wisconsin Carbone Cancer Center, Madison

55905

RECRUITING

Mayo Clinic Rochester, Rochester

63110

RECRUITING

Saint Louis University Hospital, St Louis

RECRUITING

Washington University of St. Louis, St Louis

68130

RECRUITING

Nebraska Cancer Specialists, Omaha