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New treatment option for Dedifferentiated Liposarcoma
Official title A Phase 2, Open Label Study of PEmigatinib and REtifanlimab in Advanced Dedifferentiated LIposarcoma (PERELI)
ClinicalTrials.gov ID: NCT06389799
What this study is testing
What is Pemigatinib?
Pemigatinib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for dedifferentiated liposarcoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join if
- Participants will be eligible for the study if all of the following criteria are met:
- Be 18 years of age or above, on day of signing informed consent.
- Must be willing and able to provide written informed consent. Written informed consent must be signed and dated before the start of specific protocol...
- Must be willing and able to conform to and comply with all protocol requirements, including, all scheduled visits, protocol procedures, and the...
- Histologically confirmed DDLPS\ . Written pathology report indicating the diagnosis of DDLPS with positive MDM2 immunohistochemistry or MDM2...
You likely can't join if
- Patient has received anticancer therapy within 28 days of the first administration of study treatment, with the exception of localized radiotherapy...
- Toxicity of prior therapy that has not recovered to ≤ Grade 1 with the exception of
- Alopecia
- Peripheral neuropathy
- Anemia not requiring transfusional support
- Other toxicities may be considered acceptable (not an exclusion criteria) upon discussion with the Sponsor.
See the full eligibility criteria
- Participants will be eligible for the study if all of the following criteria are met:
- Be 18 years of age or above, on day of signing informed consent.
- 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.
- 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.
- 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...
- 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...
- 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...
- 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...
- Have a performance status of 0-2 on the ECOG Performance Scale.
- Patient must have adequate organ function as indicated by laboratory values obtained within 14 days of receiving the first dose of study drug (see study protocol)
- Female patients of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed...
- Female patients of childbearing potential must be willing to use a highly effective method of contraception, for the course of the study through 180 days after the last dose of study medication. Please refer to Section...
- Male patients must agree to use an highly effective method of contraception starting with the first dose of study therapy through 180 days after the last dose of study therapy.
- 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.
- Toxicity of prior therapy that has not recovered to ≤ Grade 1 with the exception of
- Alopecia
- Peripheral neuropathy
- Anemia not requiring transfusional support
- Other toxicities may be considered acceptable (not an exclusion criteria) upon discussion with the Sponsor.
- 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...
- Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
- Hypersensitivity to pemigatinib or retifanlimab or any of its excipients. 6. Patients with a prior or concurrent malignant disease whose natural history or treatment have the potential to interfere with the safety or...
- Physiologic corticosteroid replacement therapy at doses \> 10 mg daily of prednisone or equivalent for adrenal or pituitary insufficiency and in the absence of active autoimmune disease is permitted.
- Participants with a condition that requires intermittent use bronchodilators, inhaled steroids, or local steroid injections may be admitted (eg, asthma or chronic obstructive pulmonary disease exacerbation).
- Participants using topical, ocular, intra-articular, or intranasal steroids (with minimal systemic absorption) may be admitted.
- Brief course of corticosteroids for prophylaxis (eg, contrast dye allergy) or study treatment-related standard premedication is permitted. 10\. Has a history of organ transplant, including allogeneic stem cell...
The study team makes the final eligibility decision.
Where it's taking place
- Oslo, Norway
- Gothenburg, Sweden
- Lund, Sweden
- Stockholm, Sweden
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Oslo, Norway; Gothenburg, Sweden; Lund, Sweden; Stockholm, Sweden. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.