drugset / Trial / NCT04387084
Short-term Fasting Prior to PD-1/PD-L1 Inhibitor Therapy for of Advanced or Metastatic Skin Malignancy
Phase 1
Active not recruiting
10 enrolled
University of Southern California
National Cancer Institute (NCI) · collab
NaSingle-groupOpen-labelSupportive care
Summary
This trial studies the side effects of short-term fasting in patients with skin malignancy that has spread to other places in the body (advanced or metastatic) treated with a PD-L1 or PD-1 inhibitor. Immunotherapy with monoclonal antibodies, such as pembrolizumab, nivolumab, cemiplimab, avelumab, atezolizumab, or durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Undergoing short-term fasting prior to treatment with one of these PD-L1 or PD-1 inhibitors may potentially reduce the side effects of immunotherapy or even improve the effectiveness of immunotherapy in patients with skin malignancy.
Timeline
- Start
- 2020-08-12
- Primary completion
- 2026-08-12
- Completion
- 2027-08-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Background | Atezolizumab | Monoclonal antibody | — | Intravenous |
| Background | Avelumab | Monoclonal antibody | — | Intravenous |
| Background | Cemiplimab | Monoclonal antibody | — | Intravenous |
| Background | Dostarlimab | Monoclonal antibody | — | Intravenous |
| Background | Durvalumab | Monoclonal antibody | — | Intravenous |
| Background | Nivolumab | Monoclonal antibody | — | Intravenous |
| Background | Pembrolizumab | Monoclonal antibody | — | Intravenous |
| Background | Retifanlimab | Monoclonal antibody | — | Intravenous |
| Background | Tislelizumab | Monoclonal antibody | — | Intravenous |
| Background | Toripalimab | Monoclonal antibody | — | Intravenous |