Actively Recruiting
A Phase 2, Open Label Study of PEmigatinib and REtifanlimab in Advanced Dedifferentiated LIposarcoma (PERELI)
Led by Lund University Hospital · Updated on 2025-08-28
33
Participants Needed
4
Research Sites
236 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 older on the day of signing informed consent
- Willing and able to provide written informed consent before starting study procedures
- Able to comply with all protocol requirements including scheduled visits and the ability to swallow oral tablets
- Histologically confirmed dedifferentiated liposarcoma with positive MDM2 immunohistochemistry or amplification
- Have at least one measurable lesion by CT scan not suitable for surgery or curative treatments
- Disease relapse or progression within the last 6 months after at least one line of systemic treatment
- Willing to provide tumor tissue by biopsy or use archival tissue if biopsy risk is too high
- ECOG performance status of 0 to 2
- Adequate organ function as shown by lab tests within 14 days before first dose
- Female patients of childbearing potential must have a negative pregnancy test before first dose
- Female patients of childbearing potential must use highly effective contraception during study and for 180 days after last dose
- Male patients must use highly effective contraception from first dose through 180 days after last dose
You will not qualify if you...
- Received anticancer therapy within 28 days before first study treatment except localized radiotherapy to non-measurable lesions
- Toxicity from prior therapy not recovered to Grade 1 except alopecia, peripheral neuropathy, or mild anemia
- Participation in another investigational study or use of investigational agents within 4 weeks before first dose
- History or current pneumonitis requiring steroids
- Hypersensitivity to pemigatinib, retifanlimab, or their excipients
- Prior or concurrent malignant disease interfering with assessment, except certain controlled cancers
- Active central nervous system metastases or sarcomatous meningitis
- Active autoimmune disease requiring systemic immunosuppression within 14 days before first dose
- Chronic corticosteroid use above 10 mg/day prednisone or equivalent, with some exceptions
- History of organ transplant including stem cell transplantation
- Active infection requiring systemic treatment within 7 days before first dose
- Conditions or abnormalities that could interfere with study participation or safety
- Psychiatric or substance abuse disorders interfering with cooperation
- Pregnant, breastfeeding, or planning to conceive/father children during study and 180 days after
- Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2 agents or selective FGFR inhibitors
- Known HIV infection
- Active Hepatitis B or C infection
- Received live vaccine within 30 days before study start (COVID-19 and seasonal flu vaccines allowed)
- History of calcium/phosphate disorders with systemic mineral imbalance except common localized calcifications
- Use of potent CYP3A4 inhibitors/inducers or moderate inducers within 14 days or 5 half-lives before first dose
- Significant corneal or retinal disorders confirmed by eye exam
- History of severe vitamin D deficiency requiring high-dose supplementation
AI-Screening
AI-Powered Screening
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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
CONTACT
L
Liliya Shcherbina, PhD
CONTACT
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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