drugset / Trial / NCT04028063
Doxorubicin Plus Dual Checkpoint Blockade for Soft Tissue Sarcomas
Non-randomizedSequentialOpen-labelTreatment
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.
Timeline
- Start
- 2020-01-28
- Primary completion
- 2027-04-07
- Completion
- 2027-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Balstilimab | Monoclonal antibody | 300 mg | — |
| Subject | Balstilimab | Monoclonal antibody | 450 mg | — |
| Subject | Botensilimab | Monoclonal antibody | 75 mg | — |
| Subject | Doxorubicin | Other / unclassified | 60 mg/m2 | — |
| Subject | Doxorubicin | Other / unclassified | 75 mg/m2 | — |
| Subject | Zalifrelimab | Monoclonal antibody | 1 mg/kg | — |