Overview

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

Status:
Not yet recruiting

Trial end date:
2025-10-01

Target enrollment:

Participant gender:

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.

Phase:

Phase 2

Details

Lead Sponsor:

Consorzio Oncotech

Treatments:

Pembrolizumab