drugset / Trial / NCT03074318
Avelumab and Trabectedin in Treating Patients With Liposarcoma or Leiomyosarcoma That is Metastatic or Cannot Be Removed by Surgery
Phase 1/2
Terminated
35 enrolled
Fred Hutchinson Cancer Center
EMD Serono · collabNational Cancer Institute (NCI) · collab
Non-randomizedSequentialOpen-labelTreatment
Summary
This phase I/II studies the side effects of avelumab and trabectedin and how well they work in treating patients with leiomyosarcoma or liposarcoma that has spread to other places in the body (metastatic) or cannot be removed by surgery. Immunotherapy with monoclonal antibodies, such as avelumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as trabectedin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving avelumab and trabectedin may work better in treating patients with liposarcoma or leiomyosarcoma.
Timeline
- Start
- 2017-09-28
- Primary completion
- 2020-11-15
- Completion
- 2020-11-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Avelumab | Monoclonal antibody | — | Intravenous |
| Subject | Trabectedin | Small molecule | 1 mg/m2 | Intravenous |
| Subject | Trabectedin | Small molecule | 1.2 mg/m2 | Intravenous |
| Subject | Trabectedin | Small molecule | 1.5 mg/m2 | Intravenous |