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

NCT05024318 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-05-16

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Peter MacCallum Cancer Centre, Australia

    lead OTHER

Principal Investigators

  • Shankar Siva, A/Prof · Peter MacCallum Cancer Centre, Australia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-08
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Australia

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05024318 on ClinicalTrials.gov