drugset / Trial / NCT05567588
Pembrolizumab Plus Radiotherapy for Advanced Renal Cancer
NaSingle-groupOpen-labelTreatment
Summary
This study is designed as a phase-II proof of clinical trial to investigate if a treatment strategy where stereotactic body radiation therapy (SBRT) is given with pembrolizumab is sufficiently active to warrant further investigation in randomized phase II or III studies. Metastatic renal cell cancer (mRCC) patients with PD-1 expressing immune cells are more likely to have larger more aggressive tumours and reduced survival. Pembrolizumab is designed to directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. SBRT will be given to the 1-5 most clinically significant lesions after the 1nd course of pembrolizumab treatment in an effort to improve the activity of pembrolizumab.
Timeline
- Start
- 2022-10-31
- Primary completion
- 2024-10-31
- Completion
- 2025-10-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pembrolizumab | Monoclonal antibody | 100 mg | Intravenous |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |