drugset / Trial / NCT06389799

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

NCT06389799

Phase 2 Recruiting 33 enrolled Lund University Hospital
Non-randomizedSingle-groupOpen-labelTreatment

Summary

Dedifferentiated liposarcomas (DDLPS) are aggressive soft tissue sarcomas with no effective medical treatment options. Immunotherapy with checkpoint inhibitors, so-called PD-1 inhibitors, have shown some effect in DDLPS in previous studies. Effect of immunotherapy can be improved by combining it with other types of tumor drugs. Medicines that inhibit signaling via the FGF receptor, so-called FGFR inhibitors, have shown a tumor-slowing effect in DDLPS in early studies. FGFR inhibitors can also induce changes that make the tumor more available to treatment with immunotherapy. The study aims to investigate whether the combination of an FGFR inhibitor, pemigatinib, with a PD-1 inhibitor, retifanlimab can provide a tumor-slowing effect in patients with advanced DDLPS who have progressed on first-line treatment.

Timeline

Start
2024-06-20
Primary completion
2027-12-31
Completion
2028-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Pemigatinib Small molecule Oral
Subject Retifanlimab Monoclonal antibody Intravenous