drugset / Trial / NCT07224971
Impact of Circadian Rhythm on Immunotherapy
RandomizedParallel-groupOpen-labelTreatment
Summary
This study aims to determine whether morning versus afternoon treatment impacts efficacy of (standard of care) immunotherapy in a broad patient population. Patients with any type of advanced/metastatic malignancy are eligible to enroll in this study, as long as first-line anti-PD-1/PD-L1 immunotherapy is on label for their condition. Participants will then be randomized to either the early treatment group (administration must start and conclude by 11:00 AM +1 hour window) or the late treatment group (administration must start after 12:00 PM).
Timeline
- Start
- 2025-12-02
- Primary completion
- 2027-05-01
- Completion
- 2030-05-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atezolizumab | Monoclonal antibody | — | — |
| Subject | Avelumab | Monoclonal antibody | — | — |
| Subject | Cemiplimab | Monoclonal antibody | — | — |
| Subject | Dostarlimab | Monoclonal antibody | — | — |
| Subject | Durvalumab | Monoclonal antibody | — | — |
| Subject | Nivolumab | Monoclonal antibody | — | — |
| Subject | Pembrolizumab | Monoclonal antibody | — | — |