Doxorubicin Plus Dual Checkpoint Blockade for Soft Tissue Sarcomas
Status:
Recruiting
Trial end date:
2022-11-01
Target enrollment:
Participant gender:
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.