NCT05567588

Pembrolizumab Plus Radiotherapy for Advanced Renal Cancer

A Phase II,Single-arm Study to Evaluate the Safety and Efficacy of Pembrolizumab and Stereotactic Radiotherapy (SBRT) in Patients Advanced Metastatic Renal Clear Cell Carcinoma.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: Nanfang Hospital, Southern Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Clear-cell Metastatic Renal Cell Carcinoma

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Drug: Pembrolizumab	200mg(body weight \>75kg) or 100mg(body weight≤75kg) given intravenously over 30 minutes day 1 of every 3 week cycle until progression as per immune related response criteria.

Timeline

• Start date: 2022-10-31
• Primary completion: 2024-10-31
• Completion: 2025-10-31
• First posted: 2022-10-05
• Last updated: 2024-02-01

Locations

2 sites across 1 country: China

Regulatory

• FDA-regulated drug study