drugset / Trial / NCT05061134
A Study of Ceralasertib Monotherapy and Ceralasertib Plus Durvalumab in Patients With Melanoma and Resistance to PD-(L)1 Inhibition
RandomizedParallel-groupOpen-labelTreatment
Summary
Main study: This is an open-label, phase 2 study that aims to evaluate the efficacy and safety/tolerability of ceralasertib, when administered as monotherapy and in combination with durvalumab in participants with unresectable or advanced melanoma and primary or secondary resistance to PD-(L)1 inhibition.
Timeline
- Start
- 2022-08-11
- Primary completion
- 2024-04-12
- Completion
- 2026-11-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ceralasertib | Small molecule | 240 mg | Oral |
| Subject | Durvalumab | Monoclonal antibody | 20 mg/kg | Intravenous |
| Subject | Durvalumab | Monoclonal antibody | 1500 mg | Intravenous |