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

Sponsor
Lund University Hospital
Study ID
NCT06389799
Phase
PHASE2
Status
Recruiting
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Conditions

  • Dedifferentiated Liposarcoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Pemigatinib — DRUG
    selective fibroblast growth factor receptor (FGFR) inhibitor, oral tablet
  • Retifanlimab — DRUG
    PD-1 inhibitor, Intravenous infusion

Study Details

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.

Key Dates

Start date
Jun 20, 2024
Status verified
Aug 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
33 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pemigatinib + Retifanlimab
    Patients will be treated with pemigatinib monotherapy for an induction phase of 6 weeks. This period is a safety measure to assess and manage adverse events of pemigatinib before start of combination treatment. Pemigatinib will be given daily as a 3-weekly cycle (2 weeks on followed by one week off) for 2 cycles. After 6 weeks, patients will receive combination treatment with retifanlimab (Q3W) and pemigatinib also as a 3-weekly cycle (2 weeks on followed by one week off).

Primary Outcome Measure

To evaluate clinical benefit of retifanlimab and pemigatinib in patients with advanced DDLPS [ Time Frame: 2024-2028 ]

Central Contacts

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