A randomized phase II study of Durvalumab (MEDI4736) and Tremelimumab compared to doxorubicin in patients with advanced or metastatic soft tissue sarcoma. - MEDISARC

AIO-Studien-gGmbH0 sites100 target enrollmentMay 9, 2017

Overview

No summary available.

Registry

who.int

Start Date

May 9, 2017

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\. Written informed consent and any locally\-required authorization (EU Data Privacy Directive in the EU) obtained from the subject prior to performing any protocol\-related procedures, including screening evaluations
•2\. Age \= 18 years at time of study entry
•3\. Body weight \> 30kg at study inclusion
•4\. Histologically confirmed diagnosis of metastatic or advanced soft tissue sarcoma of intermediate or high grade \[according to FNCLCC score; intermediate\=grade 2 score of 4\-5 points, high grade \= grade 3 score of 6\-8 points] with disease progression within 6 months prior to study inclusion:
•Fibrosarcoma
•Pleomorphic high grade sarcoma (malignant fibrous histiocytoma”)
•Leiomyosarcoma
•Liposarcoma (myxoid liposarcoma, dedifferentiated liposarcoma, pleomorphic liposarcoma)
•Malignant glomus tumor
•Rhabdomyosarcoma, alveolar or pleomorphic (excluding embryonal)

•1\. Patients who are suitable for anthracycline\-based combination therapies
•2\. Cardiac events such as arrhythmias, myocardial infarction, CHF, apoplexy, lung embolism within 6 months prior to study treatment
•3\. Mean QT interval corrected for heart rate (QTc) \=470 ms calculated from 3 electrocardiograms (ECGs) using Fredericia’s correction
•4\. Uncontrolled severe hypertension (failure of diastolic blood pressure to fall below 100 mmHg and systolic blood pressure\>160 mmHg)
•5\. Previous malignancy (other than STS) which either progresses or requires active treatment
•Exceptions are: basal cell cancer of the skin, pre\-invasive cancer of the cervix, T1a or T1b prostate carcinoma, or superficial bladder tumor \[Ta, Tis and T1]
•6\. History or clinical evidence of CNS metastases
•Exceptions are: Subjects who have completed local therapy and who meet both of the following criteria:
•a) are asymptomatic and
•b) have no requirement for steroids 6 weeks prior to start of study treament. Screening with CNS imaging (CT or MRI) is required only if clinically indicated or if the subject has a history of CNS metastases