NCT05024318

NeoAdjuvant Pembrolizumab and STEreotactic Radiotherapy Prior to Nephrectomy for Renal Cell Carcinoma

NeoAdjuvant Pembrolizumab and STEreotactic Radiotherapy Prior to Nephrectomy for Renal Cell Carcinoma: Investigating Induced Immune Context Changes

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Peter MacCallum Cancer Centre, Australia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, open label, phase II, randomised, non-comparative clinical trial, evaluating changes in tumour-responsive T-cells following neoadjuvant stereotactic ablative body radiotherapy (SABR) with or without pembrolizumab, prior to nephrectomy, in patients with localised primary clear cell renal cell carcinoma (ccRCC).

Conditions

• Renal Cell Carcinoma, Clear Cell, Somatic

Interventions

Type	Name	Description
DRUG	Pembrolizumab	Pembrolizumab 200 mg tobe administered as a 30 minute IV infusion every 21 days for 3 cycles
RADIATION	Stereotactic Ablative Radiotherapy	42Gy delivered in 3 fractions
PROCEDURE	Nephrectomy	Partial or total nephrectomy performed 9-12 weeks after first dose of Pembrolizumab

Timeline

• Start date: 2022-02-08
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2021-08-27
• Last updated: 2024-05-16

Locations

2 sites across 1 country: Australia