drugset / Trial / NCT03802071

A Study of Durvalumab in Combination With Doxorubicin for Advanced Soft Tissue Sarcoma

NCT03802071

Phase 1/2 Completed 44 enrolled Yonsei University
NaSingle-groupOpen-labelTreatment

Summary

The yearly incidence of soft-tissue sarcomas (STS) in the USA is roughly 11,280 cases, and metastatic STS have a median overall survival of about 12 months. Sarcomas of the soft tissue are a heterogeneous group of malignant tumors of mesenchymal origin that originate in connective tissue. Local control with wide surgical resection with or without adjuvant radiation has a success rate of close to 90%. However, approximately 40% to 50% of patients with a large (\>5 cm), deep, high-grade soft-tissue sarcoma eventually develop distant metastases, primarily in the lung. Therefore, overall survival of metastatic STS remained still poor, less than 1 year. Therefore, current clinical trials with various targeted agents are ongoing add on the doxorubicin monotherapy. Investigator planned to conduct the phase I/II trial of durvalumab in combination with standard chemotherapy, doxorubicin for metastatic/recurred sofe tissue sarcoma.

Timeline

Start
2019-09-16
Primary completion
2022-08-10
Completion
2022-08-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Durvalumab Monoclonal antibody 1500 mg Intravenous
Background Doxorubicin Other / unclassified 75 mg/m2 Intravenous

Indications