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RECRUITING
NCT05024318
PHASE2

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

Sponsor: Peter MacCallum Cancer Centre, Australia

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2022-02-08

Completion Date

2025-12

Last Updated

2024-05-16

Healthy Volunteers

No

Interventions

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

Locations (2)

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia