Doxorubicin Plus Dual Checkpoint Blockade for Soft Tissue Sarcomas
Trial Parameters
Brief Summary
This is an open-label, non-randomized, single-institution, single arm Phase II study conducted using a Simon two-stage design with an additional safety lead-in. The overall objective is to determine the efficacy of combination doxorubicin with dual checkpoint blockade with anti-CTLA-4 antibody AGEN1884 and anti-PD-1 antibody AGEN2034. The investigators will estimate the progression-free survival rate at 6 months (PFS6mo) of doxorubicin plus AGEN1884/AGEN2034 in comparison to historical PFS6mo with doxorubicin monotherapy, calculated as the mean from two large randomized Phase 3 clinical trials.
Eligibility Criteria
Inclusion Criteria: Part One: 1. Provision to sign and date the consent form. 2. Stated willingness to comply with all study procedures and be available for the duration of the study. 3. Be male or female aged 18-100 years at the time of signing informed consent. 4. Have a histological diagnosis of advanced or metastatic soft tissue sarcoma (STS) (by local pathology review), not curable by surgery, for which treatment with doxorubicin is deemed appropriate by the investigator. 5. Has one of the following histologies: * synovial sarcoma, * malignant peripheral nerve sheath tumors, * dedifferentiated, pleomorphic or myxoid/round cell liposarcoma, * uterine or soft tissue leiomyosarcoma, * malignant phylloides tumor, * high grade undifferentiated pleomorphic sarcomas (HGUPS/MFH), * myxofibrosarcoma, * fibrosarcoma, * angiosarcoma, * spindle cell or undifferentiated sarcoma NOS, * malignant myoepithelioma, * malignant solitary fibrous tumor/hemangiopericytoma, * epithelioid hemangioendothe