Perspective Therapeutics has entered into a clinical collaboration with Bristol Myers Squibb to investigate the safety and tolerability of its alpha-particle therapy [(212)Pb]VMT01 and Bristol Myers Squibb’s drug, nivolumab, for the treatment of MC1R-positive metastatic melanoma.
As part of the collaboration, Perspective will sponsor and fund the combination study and Bristol Myers Squibb will provide nivolumab for use in the study, a news release said.
“Combination of [212Pb]VMT01 with immune checkpoint inhibitors in a PD-1/CTLA-4-resistant preclinical melanoma model has demonstrated potential to generate a number of complete responses, significantly arresting tumor growth and extending survival1,2. We look forward to expanding the clinical development of our radioligand therapy with standard of care immunotherapy to potentially bring novel solutions to patients suffering from this intractable disease,” said Markus Puhlmann, Chief Medical Officer of Perspective Therapeutics.
The ongoing trial, identified as NCT05655312 on clinicaltrials.gov, is a multi-center, open-label study looking at how to safely increase the dosage of a treatment called [212Pb]VMT01 in patients with melanoma who have an imaging scan showing the presence of a protein called MC1R, according to the release.
In the first part of the study, researchers want to find out the highest safe dosage of
[212Pb]VMT01 that patients can receive at once. Patients with advanced melanoma – either stage IV or inoperable stage III — and who have progressed on at least one approved first-line therapy, will get up to three doses of [212Pb]VMT01, spaced about eight weeks apart.
After determining the highest safe dosage in the first phase, researchers will expand the study to include more patients. These patients may also receive up to three doses of [212Pb]VMT01, also spaced about eight weeks apart, depending on their condition.
Additionally, there’s a smaller part of the study where researchers will look at how the treatment spreads in the body, how much is absorbed into the tumor, and whether there’s a connection between the amount absorbed into the tumor and the treatment’s effectiveness, as well as the patients’ side effects.
