NCT05024318: NAPSTER

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

Status unknown Phase 2 Last updated 15 May 2024

What this trial tests

Phase 2 trial testing Pembrolizumab in Renal Cell Carcinoma, Clear Cell, Somatic in 20 participants. Status unknown.

Timeline

8 February 2022

Primary endpoint
1 December 2025

1 December 2025

Quick facts

Lead sponsor	Peter MacCallum Cancer Centre, Australia
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	8 February 2022
Primary completion	1 December 2025
Estimated completion	1 December 2025
Sites	2 locations across Australia

Drugs / interventions tested

• Pembrolizumab (pembrolizumab) — full drug profile →
• Stereotactic Ablative Radiotherapy
• Nephrectomy

Conditions studied

• Renal Cell Carcinoma, Clear Cell, Somatic — all drugs for Renal Cell Carcinoma, Clear Cell, Somatic →

Sponsor

Peter MacCallum Cancer Centre, Australia — full company profile →

Who can join

18 and older, any sex, with Renal Cell Carcinoma, Clear Cell, Somatic. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• mPR post-SABR with or without pembrolizumab
  Time frame: At nephrectomy performed 9-12 weeks after first dose of pembrolizumab
  The mPR rate is defined as \<10% residual tumour at post-nephrectomy specimens
• CD8+ TRM in baseline biopsy and post-nephrectomy specimen, all measured as a continuous variable.
  Time frame: Baseline and at nephrectomy performed 9-12 weeks after first dose of pembrolizumab
  To describe changes in tumour-responsive T-cells, TRM CD8+ T-cells from baseline to post-nephrectomy in patients treated with SABR with or without pembrolizumab treatment followed by nephrectomy
• TCF-1 + tumour infiltrating lymphocytes (TILs) in baseline biopsy and post-nephrectomy specimen, measured as a continuous variable
  Time frame: Baseline and at nephrectomy performed 9-12 weeks after first dose of pembrolizumab
  To describe changes in TCF-1+ T-cells from baseline to post-nephrectomy in patients treated with SABR with or without pembrolizumab treatment followed by nephrectomy

Sponsor's own description

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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Programmed death receptor (PD-)1/PD-ligand (L)1 in urological cancers : the "all-around warrior" in immunotherapy.
   Liu Q, Guan Y, Li S. · · 2024 · cited 50× · PMID 39223527 · DOI 10.1186/s12943-024-02095-8
2. NeoAdjuvant pembrolizumab and STEreotactic radiotherapy prior to nephrectomy for renal cell carcinoma (NAPSTER): A phase II randomised clinical trial.
   Ali M, Wood S, Pryor D, Moon D, et al · · 2023 · cited 9× · PMID 37168818 · DOI 10.1016/j.conctc.2023.101145
3. A Review of Neoadjuvant Therapy for Localized and Locally Advanced Renal Cell Carcinoma.
   Qin Q, Tachibana I, Margulis V, Cadeddu JA, et al · · 2025 · cited 8× · PMID 39858094 · DOI 10.3390/cancers17020312
4. Stereotactic Body Radiation Therapy for Primary Renal Cell Carcinoma: A Case-Based Radiosurgery Society Practice Guide.
   Barbour AB, Upadhyay R, Anderson AC, Kutuk T, et al · · 2025 · cited 6× · PMID 39019209 · DOI 10.1016/j.prro.2024.06.012
5. The Landscape of Stereotactic Ablative Radiotherapy (SABR) for Renal Cell Cancer (RCC).
   Moreno-Olmedo E, Sabharwal A, Das P, Dallas N, et al · · 2024 · cited 5× · PMID 39123406 · DOI 10.3390/cancers16152678
6. Leveraging radiotherapy to improve immunotherapy outcomes: rationale, progress and research priorities.
   Hartley F, Ebert M, Cook AM. · · 2025 · cited 4× · PMID 40206193 · DOI 10.1002/cti2.70030
7. Focal therapy for oligometastatic and oligoprogressive renal cell carcinoma: a narrative review.
   Anderson AC, Ho J, Hall ET, Hannan R, et al · · 2024 · cited 4× · PMID 39258792 · DOI 10.1080/14796694.2024.2389769
8. Role of perioperative immunotherapy in localized renal cell carcinoma.
   Kaur J, Patil G, Geynisman DM, Ghatalia P. · · 2023 · cited 4× · PMID 37529159 · DOI 10.1177/17588359231181497