At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed RCC with clear cell, rhabdoid or sarcomatoid components
- ✓Tumor stage T1b-T3, N0 or N1, M0 or low volume M1 planned for nephrectomy
- ✓Male or female aged 18 years or older
- ✓ECOG performance status 0 or 1
- ✕Prior anti-PD-1, anti-PD-L1, or PD-L2 therapy
- ✕Known or active inflammatory bowel disease involving colon and small bowels
- ✕Previous radiotherapy to upper abdomen with overlap to involved kidney
- ✕Participating in investigational agent study or used investigational device within 4 weeks
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT05024318Phase 2RecruitingUpdate OverdueUpdated 25mo ago · Completion was 6mo agoNeoAdjuvant Pembrolizumab and STEreotactic Radiotherapy Prior to Nephrectomy for Renal Cell Carcinoma: Investigating Induced Immune Context Changes
In Brief
A Phase 2 clinical trial evaluating Pembrolizumab, Stereotactic Ablative Radiotherapy, and 1 other intervention for Renal Cell Carcinoma, Clear Cell, Somatic. Currently recruiting, targeting 20 participants across 2 sites.
Signals
Detailed 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).
Study Details
Timeline
Interventions
Pembrolizumab 200 mg tobe administered as a 30 minute IV infusion every 21 days for 3 cycles
42Gy delivered in 3 fractions
Partial or total nephrectomy performed 9-12 weeks after first dose of Pembrolizumab