A Phase II Study of Eribulin and Pembrolizumab in Soft Tissue Sarcomas (NCT03899805) | Clinical Trial Compass
CompletedPhase 2
A Phase II Study of Eribulin and Pembrolizumab in Soft Tissue Sarcomas
United States57 participantsStarted 2019-06-04
Plain-language summary
This research study is studying a combination of drugs (chemotherapy + Immunotherapy) as a possible treatment for liposarcoma, leiomyosarcoma, or undifferentiated pleomorphic sarcoma that has spread and has not responded to standard treatment.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Histologically confirmed liposarcoma, leiomyosarcoma, or undifferentiated/unclassified pleomorphic sarcoma by a Dana-Farber Cancer Institute or Massachusetts General Hospital pathologist
* Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT scan, MRI, or calipers by clinical exam. See Section 11 for the evaluation of measurable disease.
* Participants must have received at least one prior line of chemotherapy. No limit on prior lines of therapy.
* Age ≥ 18 years.
* ECOG performance status of 0 or 1 (see Appendix A).
* Participants must have normal organ and marrow function as defined below:
* leukocytes ≥3,000/mcL
* absolute neutrophil count ≥1,500/mcL
* platelets ≥100,000/mcL
* Hemoglobin ≥ 8 g/dL within the first 2 weeks prior to the first dose of study drugs, transfusion is allowed.
* total bilirubin ≤1.5× institutional upper limit of normal (ULN) (except participants with Gilbert Syndrome, who can have total bilirubin \<3.0 mg/dL)
* AST(SGOT)/ALT(SGPT)\<2.5 x ULN in a participant with no documented liver metastases; ALT and AST \<5.0 x ULN in a participant with documented liver metastases
* creatinine ≤1.5× ULN OR
* creatinine clearance ≥50 mL/min/1.73 m2 for participants with creatinine levels above …