A Study of Durvalumab in Combination With Doxorubicin for Advanced Soft Tissue Sarcoma
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Sarcoma
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 19 years and 125 years
- Gender
- Both males and females
Description
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 cont...
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 (STS) eventually develop distant metastases, primarily in the lung. Therefore, overall survival (OS) 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. Durvalumab (MEDI4736) is a human monoclonal antibody that inhibits binding of PD-L1. For this orphan tumor, STS, PD-L1 may be a promising strategy and favorable toxicity may warrant further combination. For this orphan tumor, STS, PD-L1 targeting may be a promising strategy and favorable toxicity may warrant further combination. Regarding anti-PD-L1 treatment in STS, in phase I trial with human monoclonal antibody to PD-L1, MPDL3280A, one heavily treated synovial sarcoma patients demonstrated partial responses. In recent phase II study of pembrolizumab, PD-1 inhibitor in advanced STS among the 40 STS cases (17.5%) had responses (1 complete response and 6 partial response). Based on the study, pembrolizumab monotherapy was approved for previously treated STS in Korea. Therefore, various clinical trials are ongoing immune checkpoint inhibitor with PDGFR inhibitors [axitinib for renal cell carcinoma (RCC), pazopanib for RCC and STS, Sorafenib for RCC, and liver cancer, sunitinib for RCC, gastrointestinal stromal tumor, and pancreatic cancer].
Tracking Information
- NCT #
- NCT03802071
- Collaborators
- Not Provided
- Investigators
- Not Provided