drugset / Trial / NCT05567588

Pembrolizumab Plus Radiotherapy for Advanced Renal Cancer

NCT05567588 ↗

Phase 2 Unknown 66 enrolled Nanfang Hospital, Southern Medical University
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

EvaluationDrugModalityDoseRoute
Subject Pembrolizumab Monoclonal antibody 100 mg Intravenous
Subject Pembrolizumab Monoclonal antibody 200 mg Intravenous