Durvalumab and Olaparib in Metastatic or recurrent Endometrial Cancer

eiden University Medical Center0 个研究点目标入组 55 人开始时间: 待定最近更新: 2024年2月28日

适应症

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•To be included into the DOMEC-trial, patients must be (1) at least 18 years old, (2) have a WHO performance score of 0-1, (3) weight more than 30kg and (4) have histologically confirmed diagnosis of EC or carcinosarcoma of the uterus. There must be (5) a documented progressive disease (metastatic or locally advanced) according to RECIST 1.1 criteria. (6) Disease must be not amendable to local therapy, chemotherapy and hormonal therapy (or patient is not able/willing to get chemotherapy). (7) Organ system function should be adequate, defined as adequate bone marrow function (Haemoglobin = 10.0 g/dL, Absolute neutrophil count (ANC) = 1.5 x 10^9 /L, Platelet count = 100 x 10^9 /L), liver function (Total bilirubin = 1.5 x institutional upper limit of normal (ULN), Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) = 2.5 x ULN (in case of lever metastases = 5x ULN) and kidney function (creatinine clearance =51 mL/min calculated according to Cockcroft-Gault or 24 hour urine clearance). (8) Life expectancy must be at least 16 weeks.

•Patients with (1) history of leptomeningeal carcinomatosis, symptomatic brain metastases (uncontrolled despite of corticosteroids) or spinal cord compression are not eligible. Other exclusion criteria are (2) severe concomitant diseases; (3) active or prior documented autoimmune or inflammatory disorders; (4) active primary immunodeficiency; (5) active infections including tuberculosis, HIV, hepatitis B or C or (6) other malignant disease (except adequately treated non-melanoma skin cancer, lentigo maligna or carcinoma in situ without evidence of disease). (7) Prior treatment with PARP, PD1 or PD-L1 inhibitor; (8) QTc interval or family history of long QT syndrome; (9) severe psychiatric illness; (10) irreversible grade =2 toxicity from previous anti-cancer therapy; (11) major surgery in the last 2 weeks; (12) prior allogeneic bone marrow transplantation or double umbilical cord blood transplantation; (13) inability to swallow oral medication; (14) concurrent treatment with another investigational agent during the conduct of the trial or (15) expected or known intolerance to olaparib or durvalumab will prohibit inclusion; as well as (16) pregnancy or breast feeding.

发起方

eiden University Medical Center