Prometheus Laboratories is enrolling patients for Proclivity 01, a multi-center study of Proleukin (High Dose Interleukin-2 (HD IL-2)) combined with vemurafenib therapy in patients with Braf V600 mutation-positive metastatic melanoma (mM).
HD IL-2 therapy is administered in specialized hospitals as inpatient therapy while vemurafenib as an oral outpatient therapy.
Conducted in approximately 25 sites in the US, the Phase IV study is currently open in 12 sites.
Prometheus Oncology Clinical Development and Medical Affairs senior director James Lowder said that the immune-based therapy with the FDA-approved HD IL-2 has shown to produce meaningful and durable responses in a small percentage of patients with metastatic melanoma.
"The recently FDA-approved vemurafinib produces rapid, but temporary, reductions in tumor size in a majority of patients with an activating mutation of the BRAF signaling protein," Lowder added.
The open-label, two-arm study is enrolling mM patients with BRAFV600 oncogene mutations and the patients will initially receive treatment with vemurafenib sequenced with two courses of HD IL-2.
Cohort one involves 135 patients naive to vemurafenib and HD IL-2 therapy and initially the patients will be treated with 6 weeks of vemurafenib alone followed by two courses of HD IL-2 sequenced with continued vemurafenib.
Cohort two, patients will have received 7-18 weeks of vemurafenib prior to adding HD IL-2 and can be enrolled after starting vemurafenib, will explore the effect of more prolonged vemurafenib treatment on adverse events and efficacy.
The primary endpoint of the study is complete response (CR) at 26 weeks (+/-3 weeks) from the start of HD IL-2.
Patient assessment of overall response rate (OSS), progression-free survival (PFS) and overall survival (OS) will be followed in the PROCLAIM registry study.
