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A Phase 2, Open Label Study of PEmigatinib and REtifanlimab in Advanced Dedifferentiated LIposarcoma (PERELI) | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

NCT06389799•Lund University Hospital

View on ClinicalTrials.gov

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

Age

18 - 100 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participants will be eligible for the study if all of the following criteria are met:
•1. Be 18 years of age or above, on day of signing informed consent.
•2. 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.
•3. 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.
•4. 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.
•5. Have the presence of at least 1 measurable lesion by CT per RECIST v1.1 that is considered non amenable to surgery or other curative treatments or procedures. Tumor lesions located in a previously irradiated area or in an area subjected to other loco-regional therapy are considered measurable if progression has been demonstrated in the lesion.
•6. Disease relapse or radiological progression, as determined by the Investigator, within the last 6 months after at least one line of systemic treatment.
•a. Patients considered to be medically unfit for chemotherapy, as assessed by the sarcoma centre in charge of the patient's treatment, can be considered for the trial after discussion with the trial steering committee.
•7. Be willing to provide tissue by core or excisional biopsy of a tumor lesion at the time points specified in the Trial Flow Chart. Archival tumor tissue can be used instead of pre-treatment biopsy. Biopsy will only be performed if the risk of complication is considered acceptable for the patient.
•8. Have a performance status of 0-2 on the ECOG Performance Scale.
+4 more criteria

Exclusion Criteria

•1. 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.
•2. Toxicity of prior therapy that has not recovered to ≤ Grade 1 with the exception of
•1. Alopecia
•2. Peripheral neuropathy
•3. Anemia not requiring transfusional support
•3. Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
•4. Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
•7\. Has known active central nervous system (CNS) metastases and/or sarcomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include sarcomatous meningitis which is excluded regardless of clinical stability.
•8\. Has an active autoimmune disease requiring systemic immunosuppression with corticosteroids (\> 10 mg/day of prednisone or equivalent) or immunosuppressive drugs within 14 days before the first dose of study treatment.
•9\. Receiving chronic systemic corticosteroids (\> 10 mg/day of prednisone or equivalent):
+18 more criteria

Locations (4)

Oslo University Hospital HF

Oslo, Norway

Sahlgrenska University Hospital

Gothenburg, Sweden

Skåne University Hospital

Lund, Sweden

Karolinska Universitetssjukhuset

Stockholm, Sweden

Key Dates

Start Date

June 20, 2024

Primary Completion Date

December 31, 2027

Completion Date

December 31, 2028

Last Updated

August 28, 2025

Enrollment

ESTIMATED participants

Conditions

Dedifferentiated Liposarcoma

Interventions

Pemigatinib

DRUG

Retifanlimab

DRUG

Contacts

Helena Nyström, MD

CONTACT

+46 46 17 75 20 helena.nystrom@skane.se

Liliya Shcherbina, PhD

CONTACT

liliya.shcherbina@skane.se

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 28, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Testing the Addition of Cemiplimab to Palbociclib for the Treatment of Advanced Dedifferentiated Liposarcoma

SARC041: Study of Abemaciclib Versus Placebo in Patients with Advanced Dedifferentiated Liposarcoma

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