Sarcoma Alliance for Research through Collaboration
This is a multi-center, open label, phase II study of tebentafusp in patients with unresectable or metastatic clear cell sarcoma (CCS).
This will be a multi-center, open label, phase II study of tebentafusp in patients with unresectable or metastatic CCS. Patients who screen positive for HLA-A\*02:01 and meet the eligibility requirements will be treated with weekly tebentafusp. Radiographic assessment via CT or MR (where CT is not feasible or per the investigator's discretion) will occur at baseline and every subsequent 6 weeks through 48 weeks, and then every 9 weeks thereafter. Patients will be treated until progression of disease or unacceptable toxicity. All patients treated with tebentafusp will undergo mandatory research…
Inclusion Criteria * Age 18 years * Histologically confirmed diagnosis of HMB-45+ clear cell sarcoma which is unresectable and/or metastatic * HLA-A\*02:01 positive * ECOG Performance Status of £ 2 at screening * At least one site of measurable disease on CT/MRI scan as defined by RECIST v 1.1 criteria. Baseline imaging must be performed within 28 days of Cycle 1 Day 1 of study. * Adequate organ function within 28 days of Day 1 of study defined as: * Absolute Neutrophil Count (ANC) ≥ 1.5 * Platelets ≥ 75 * ALT and AST ≤ 2.5 x institutional upper limit of normal (ULN) or ≤ 5.0 x institutional…
Patients who are HLA-A\*02:01-negative and ineligible to receive tebentafusp will be prospectively enrolled onto a separate study arm and treated with physicians' choice of treatment. They will also be radiographically assessed at the same schedule as patients treated with tebentafusp, if feasible, and kept on this treatment arm until progression of disease or unacceptable toxicity on the physicians' choice regimen.
Patients who screen positive for HLA-A\*02:01 and meet the eligibility requirements will be treated with weekly tebentafusp
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