drugset / Trial / NCT03618654
Durvalumab With or Without Metformin in Treating Participants With Head and Neck Squamous Cell Carcinoma
Phase 0
Completed
38 enrolled
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
RandomizedParallel-groupOpen-labelTreatment
Summary
This pilot phase I trial studies how well durvalumab given with or without metformin works in treating participants with head and neck squamous cell carcinoma. Monoclonal antibodies, such as durvalumab, may interfere with the ability of tumor cells to grow and spread. Metformin, a drug typically used for the treatment of diabetes, may help to reduce the metabolic activity of cancer cells and of surrounding supportive tissues. It is not yet known whether giving durvalumab with or without metformin may work better in treating participants with head and neck squamous carcinoma.
Timeline
- Start
- 2018-11-01
- Primary completion
- 2021-11-20
- Completion
- 2022-12-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Durvalumab | Monoclonal antibody | 1500 mg | Intravenous |
| Subject | Metformin | Small molecule | 1000 mg | Oral |