RecruitingPhase 2NCT06389799

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

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


Sponsor

Lund University Hospital

Enrollment

33 participants

Start Date

Jun 20, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — pemigatinib (a targeted therapy) and retifanlimab (an immunotherapy) — in people with an advanced type of fat cell cancer called dedifferentiated liposarcoma (DDLPS) that has come back or gotten worse after prior treatment. **You may be eligible if...** - You are 18 or older - You have been diagnosed with DDLPS confirmed by a lab test (with specific gene markers) - Your cancer has grown or returned within the last 6 months despite at least one previous treatment - You have at least one measurable tumor that cannot be removed surgically - Your body is functioning well enough to tolerate treatment (ECOG performance score 0–2) **You may NOT be eligible if...** - You have received cancer treatment within the past 4 weeks - You have had serious lung inflammation (pneumonitis) that required steroids in the past - You have active, untreated cancer spreading to the brain - You have an active autoimmune disease requiring high-dose steroids - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPemigatinib

selective fibroblast growth factor receptor (FGFR) inhibitor, oral tablet

DRUGRetifanlimab

PD-1 inhibitor, Intravenous infusion


Locations(4)

Oslo University Hospital HF

Oslo, Norway

Sahlgrenska University Hospital

Gothenburg, Sweden

Skåne University Hospital

Lund, Sweden

Karolinska Universitetssjukhuset

Stockholm, Sweden

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NCT06389799


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