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.
Be 18 years of age or above, on day of signing informed consent.
Must be willing and able to provide written informed consent. Written informed consent must be signed and dated before the start of specific protocol procedures.
Must be willing and able to conform to and comply with all protocol requirements, including, all scheduled visits, protocol procedures, and the ability to swallow oral tablets.
Histologically confirmed DDLPS*. Written pathology report indicating the diagnosis of DDLPS with positive MDM2 immunohistochemistry or MDM2 amplification as demonstrated by fluorescence in situ hybridization, polymerase chain reaction (PCR) or sequencing-based methods must be available.
Patient has received anticancer therapy within 28 days of the first administration of study treatment, with the exception of localized radiotherapy given to a lesion not considered for RECIST measurements.
Toxicity of prior therapy that has not recovered to ≤ Grade 1 with the exception of
Alopecia
Peripheral neuropathy
Single group
Pemigatinib
Drugselective fibroblast growth factor receptor (FGFR) inhibitor, oral tablet
Retifanlimab
DrugPD-1 inhibitor, Intravenous infusion
To evaluate clinical benefit of retifanlimab and pemigatinib in patients with advanced DDLPS
evaluate clinical benefit of retifanlimab and pemigatinib in patients with advanced DDLPS
To further evaluate clinical efficacy of retifanlimab and pemigatinib in DDLPS
To evaluate the safety and tolerability of pemigatinib and retifanlimab
To evaluate impact of treatment and disease status on quality of life
To evaluate the relationship between baseline and on-treatment biomarkers and clinical activity
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