Phase 2 Study of Pemigatinib and Retifanlimab for Advanced Dedifferentiated Liposarcoma Treatment

What this Trial Is About

Dedifferentiated liposarcomas DDLPS are aggressive soft tissue cancers that currently have no effective medical treatments. Researchers are evaluating whether combining two types of drugsa selective FGFR inhibitor called pemigatinib and a PD-1 immune checkpoint inhibitor called retifanlimabcan slow tumor growth in patients with advanced DDLPS who have already undergone first-line treatment. This study is a Phase 2, open-label trial designed to explore this combination therapys potential benefits. Patients in the trial will first receive pemigatinib alone for an induction phase lasting 6 weeks, given daily in a 3-week cycle pattern 2 weeks on treatment followed by 1 week off for two cycles. This initial period helps assess safety and manage side effects before starting the combination treatment. After the induction phase, patients will receive both pemigatinib following the same 3-week cycle and retifanlimab, given intravenously every three weeks Q3W, as combination therapy. During the study, participants will be regularly monitored for tumor response, safety, side effects, and quality of life. Researchers will collect tissue samples before and during treatment to analyze biomarkers related to treatment effects. The trial will run from 2024 through 2028, with clinical benefit being the primary outcome. Secondary outcomes include further evaluation of clinical efficacy, safety, tolerability, quality of life impact, and biomarker analysis.

A Phase 2, Open Label Study of PEmigatinib and REtifanlimab in Advanced Dedifferentiated LIposarcoma (PERELI)