Actively Recruiting
A Phase 2, Open Label Study of PEmigatinib and REtifanlimab in Advanced Dedifferentiated LIposarcoma
Led by Lund University Hospital · Updated on 2025-08-28
33
Participants Needed
4
Research Sites
52 weeks
Total Duration
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AI-Summary
What this Trial Is About
Dedifferentiated liposarcomas (DDLPS) are aggressive soft tissue cancers that currently have no effective medical treatments. Researchers are evaluating whether combining two types of drugs—a selective FGFR inhibitor called pemigatinib and a PD-1 immune checkpoint inhibitor called retifanlimab—can slow tumor growth in patients with advanced DDLPS who have already undergone first-line treatment. This study is a Phase 2, open-label trial designed to explore this combination therapy's potential benefits. Patients in the trial will first receive pemigatinib alone for an induction phase lasting 6 weeks, given daily in a 3-week cycle pattern (2 weeks on treatment followed by 1 week off) for two cycles. This initial period helps assess safety and manage side effects before starting the combination treatment. After the induction phase, patients will receive both pemigatinib (following the same 3-week cycle) and retifanlimab, given intravenously every three weeks (Q3W), as combination therapy. During the study, participants will be regularly monitored for tumor response, safety, side effects, and quality of life. Researchers will collect tissue samples before and during treatment to analyze biomarkers related to treatment effects. The trial will run from 2024 through 2028, with clinical benefit being the primary outcome. Secondary outcomes include further evaluation of clinical efficacy, safety, tolerability, quality of life impact, and biomarker analysis.
CONDITIONS
Brief Title
A Phase 2, Open Label Study of PEmigatinib and REtifanlimab in Advanced Dedifferentiated LIposarcoma (PERELI)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be 18 years of age or above at the time of signing informed consent.
- Able and willing to provide written informed consent.
- Willing and able to comply with all study requirements, including scheduled visits and oral medication intake.
- Histologically confirmed diagnosis of dedifferentiated liposarcoma with positive MDM2 testing.
- Have at least one measurable tumor lesion not suitable for surgery or curative treatment.
- Disease relapse or progression within the last 6 months after at least one systemic treatment.
- Willing to provide tumor tissue samples as specified.
- Have an ECOG performance status of 0 to 2.
- Adequate organ function based on recent lab tests.
- Female patients of childbearing potential must have a negative pregnancy test and agree to use effective contraception during and 180 days after treatment.
- Male patients must agree to use effective contraception during and 180 days after treatment.
You will not qualify if you...
- Received anticancer therapy within 28 days before starting study treatment.
- Have unresolved toxicity from prior therapy greater than Grade 1, except for certain conditions like alopecia or peripheral neuropathy.
- Participating in another investigational study or received investigational therapy within 4 weeks.
- History of pneumonitis requiring steroids or current pneumonitis.
- Allergic to pemigatinib, retifanlimab, or their components.
- Prior or concurrent malignancies that interfere with trial assessments, with some exceptions.
- Active central nervous system metastases or sarcomatous meningitis.
- Active autoimmune disease requiring immunosuppression.
- Receiving chronic systemic corticosteroids above specified doses.
- History of organ transplant.
- Active infection needing systemic treatment within 7 days before study.
- Medical or psychiatric conditions interfering with participation.
- Pregnant, breastfeeding, or planning pregnancy during study and 180 days after.
- Prior therapy with anti-PD-1/PD-L1 agents or FGFR inhibitors.
- Known HIV infection.
- Active Hepatitis B or C infection.
- Received live vaccine within 30 days before study.
- History of calcium or phosphate disorders with systemic mineral imbalance.
- Use of certain CYP3A4 inhibitors/inducers before study.
- Significant corneal or retinal disorders confirmed by eye exam.
- History of severe vitamin D deficiency requiring high-dose treatment.
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants receive pemigatinib monotherapy for safety assessment before combination treatment.
2 cycles of 3-weekly treatment (2 weeks on, 1 week off)
Duration - Until disease progression or discontinuation
Participants receive combination treatment with retifanlimab and pemigatinib in 3-week cycles.
Pemigatinib given in 3-weekly cycles (2 weeks on, 1 week off) with retifanlimab every 3 weeks
Trial Site Locations
Total: 4 locations
1
Oslo University Hospital HF
Oslo, Norway
Actively Recruiting
2
Sahlgrenska University Hospital
Gothenburg, Sweden
Actively Recruiting
3
Skåne University Hospital
Lund, Sweden
Actively Recruiting
4
Karolinska Universitetssjukhuset
Stockholm, Sweden
Actively Recruiting
Research Team
H
Helena Nyström, MD
L
Liliya Shcherbina, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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