RecruitingPhase 2NCT05024318

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


Sponsor

Peter MacCallum Cancer Centre, Australia

Enrollment

20 participants

Start Date

Feb 8, 2022

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests giving pembrolizumab (an immunotherapy drug) along with stereotactic body radiation therapy (precisely targeted radiation) before kidney removal surgery in people with renal cell carcinoma (kidney cancer). The goal is to improve outcomes before and after surgery. **You may be eligible if...** - You are 18 or older - You have kidney cancer (renal cell carcinoma) with clear cell, rhabdoid, or sarcomatoid features, confirmed by biopsy - Your tumor stage is T1B to T3, with planned surgery to remove the kidney - You have no or limited spread to distant organs - Your blood counts and organ function meet the required thresholds **You may NOT be eligible if...** - You have widespread distant metastases that make surgery inappropriate - You have had prior immunotherapy or radiation for this cancer - You have active autoimmune disease or are on immunosuppressive therapy - You are pregnant or breastfeeding - You have significant heart, liver, or kidney problems unrelated to your cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPembrolizumab

Pembrolizumab 200 mg tobe administered as a 30 minute IV infusion every 21 days for 3 cycles

RADIATIONStereotactic Ablative Radiotherapy

42Gy delivered in 3 fractions

PROCEDURENephrectomy

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

View Full Details on ClinicalTrials.gov

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NCT05024318


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