protocolSection identificationModule nctId: NCT06389799, orgStudyIdInfo id: PERELI, secondaryIdInfos id: 2022-501993-21-00, type: CTIS, briefTitle: A Phase 2, Open Label Study of PEmigatinib and REtifanlimab in Advanced Dedifferentiated LIposarcoma (PERELI), acronym: PERELI, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-07, primaryCompletionDateStruct date: 2027-12-31, completionDateStruct date: 2028-12-31, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Lund University Hospital, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Dedifferentiated Liposarcoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 33, type: ESTIMATED, armsInterventionsModule interventions name: Pemigatinib, interventions name: Retifanlimab, outcomesModule primaryOutcomes measure: To evaluate clinical benefit of retifanlimab and pemigatinib in patients with advanced DDLPS, secondaryOutcomes measure: To further evaluate clinical efficacy of retifanlimab and pemigatinib in DDLPS, secondaryOutcomes measure: To evaluate the safety and tolerability of pemigatinib and retifanlimab, secondaryOutcomes measure: To evaluate impact of treatment and disease status on quality of life, secondaryOutcomes measure: To evaluate the relationship between baseline and on-treatment biomarkers and clinical activity, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Oslo University Hospital HF, city: Oslo, country: Norway, contacts name: Kjetil Boye, MD, role: CONTACT, phone: 4722934000, email: kjetil.boye@rr-research.no, geoPoint lat: 59.91273, lon: 10.74609, locations facility: Sahlgrenska University Hospital, city: Göteborg, country: Sweden, contacts name: Lina Hansson, MD, role: CONTACT, phone: 46313427950, email: lina.hansson@vgregion.se, geoPoint lat: 57.70716, lon: 11.96679, locations facility: Lund University Hospital, city: Lund, country: Sweden, contacts name: Helena Nyström, MD, role: CONTACT, contacts role: CONTACT, phone: +4646177520, email: helena.nystrom@skane.se, geoPoint lat: 55.70584, lon: 13.19321, hasResults: False