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OncoMatch/Clinical Trials/NCT06389799

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

Is NCT06389799 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Pemigatinib and Retifanlimab for dedifferentiated liposarcoma.

Phase 2RecruitingLund University HospitalNCT06389799Data as of May 2026

Treatment: Pemigatinib · RetifanlimabDedifferentiated 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.

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Extracted eligibility criteria

Cancer type

Sarcoma

Biomarker criteria

Required: MDM2 amplification

MDM2 amplification as demonstrated by fluorescence in situ hybridization, polymerase chain reaction (PCR) or sequencing-based methods must be available.

Required: MDM2 overexpression

positive MDM2 immunohistochemistry

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Min 1 prior line

Must have received: systemic treatment

Disease relapse or radiological progression, as determined by the Investigator, within the last 6 months after at least one line of systemic treatment.

Cannot have received: anti-PD-1 therapy

Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.

Cannot have received: FGFR inhibitor

Has received prior therapy with a selective FGFR inhibitor.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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