NCT05578664

Efficacy of PErioperative PEmbrolizumab Treatment in Patients With Resectable Metastases From Kidney Cancer

Efficacy of PErioperative PEmbrolizumab Treatment in Patients With Resectable Metastases From Kidney Cancer. (The PE-PE Study).

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 81 (estimated)
• Sponsor: Consorzio Oncotech · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II trial aiming at assessing the efficacy of pembrolizumab to delay tumor progression in patients with oligometastatic clear cell metastatic Renal Cell Carcinoma (mRCC). Eligible patients for this trial should have received previous surgery for primary tumor and have maximum of three metastases considered eligible for radical therapy (surgery or metastases directed radiotherapy). Eligible patients will be randomized 2:1 to receive: * ARM A: pembrolizumab at flat dose of 400 mg every six weeks for a total of 9 cycles (one year of therapy) and metastasis directed treatment (surgery or RT) from day 21 of cycle 1 to day 42 of cycle 1; or * ARM B: local therapy alone within 42 days.

Detailed description

In this study, approximately 81 participants with ccRCC will be enrolled. The RESORT and E2810 clinical trials reported a rate of patients free of relapse of about 50% at 24 months. This study aims to improve this rate from 50% to 70% corresponding to an Hard Ratio of 0.51. Therefore, the sample size required for demonstrating this relapse-free survival (RFS) advantage includes a total of 74 patients that will be randomized 2:1 in the arm A or B respectively. The study will detect a treatment difference with the 80% probability at a one-sided p and 10.0% significance level, if the true hazard ratio is 0.51. This is based on the assumption that the accrual period will be 30 months, the follow up period will be 24 months, and the median RFS is 24 months. Because 10% of dropout has been estimated, the final number of patients is 81.

Conditions

• Oligometastatic Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Pembrolizumab injection plus metastasis directed treatment (surgery or RT)	Pembrolizumab 400 mg will be administered as a 30 minute IV infusion every 6 weeks for a total of 9 cycles (one year of therapy) and metastasis directed treatment (surgery or RT) from day 21 of cycle 1 to day 42 of cycle 1
OTHER	Tumor resection or RT	Tumor resection or RT will be applied within 42 days from randomization.

Timeline

• Start date: 2023-03-14
• Primary completion: 2024-10-01
• Completion: 2025-10-01
• First posted: 2022-10-13
• Last updated: 2023-08-30

Locations

1 site across 1 country: Italy