A Study of Etrumadenant and Zimberelimab in People With Dedifferentiated Liposarcoma (NCT05886634) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Study of Etrumadenant and Zimberelimab in People With Dedifferentiated Liposarcoma
United States16 participantsStarted 2023-05-23
Plain-language summary
Participants will have a diagnosis of dedifferentiated liposarcoma (DDLS) that has spread beyond its original location (advanced). In addition, their DDLS either has come back after treatment (recurrent), has spread to different parts of your body (metastatic), or is unable to be removed surgically (unresectable). The purpose of this study is to find out whether the combination of etrumadenant and zimberelimab is an effective treatment for people with advanced DDLS.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Diagnosis of recurrent, unresectable, or metastatic DDLPS
* The definition of recurrent disease is a patient with a primary tumor that has been successfully resected, but has recurred after primary surgery
* Any number of prior systemic therapies will be allowed
* Age ≥ 18 years at the time of informed consent
* Willing and able to provide written informed consent/assent for the trial
* Willing to comply with treatment protocol
* Adequate performance status: Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1/Karnofsky Performance Status (KPS) 70-100%
* Presence of measurable disease per RECIST v1.1
o Target lesions must not be chosen from a previously irradiated field unless there has been radiographically and/or pathologically documented tumor progression
* QTc ≤ 480 msec using Fredericia's QT correction formula
* Adequate organ function determined within 2 weeks of treatment initiation, defined as follows:
* Hemoglobin ≥ 9.0 g/dL
* Absolute neutrophil count ≥ 1,500/mm3 (1.0 x 109/L)
* Platelet count ≥ 75,000/mm3 (50 x 109/L)
* Serum bilirubin ≤ 1.5 x upper limit of normal (ULN) OR direct bilirubin ≤ ULN for a patient with total bilirubin level \> 1.5 x ULN
* Aspartate aminotransferase (AST) ≤ 2.5 x ULN OR ≤ 5 x ULN for patients with liver metastases
* Alanine aminotransferase (ALT) ≤ 2.5 x ULN OR ≤ 5 x ULN for patients with liver metastases
* Alkaline phosphatase \< 5 x ULN
* Serum creatinine ≤ 1.5 x ULN or a …