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

NCT05578664 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2023-08-30

No results posted yet for this study

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.

Conditions

  • Oligometastatic Renal Cell Carcinoma

Interventions

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.

Sponsors & Collaborators

  • Consorzio Oncotech

    lead OTHER

Principal Investigators

  • Roberto Iacovelli, MD, PhD · Fondazione Policlinico Universitario "A. Gemelli" IRCCS - UOC Oncologia Medica, Rome

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-14
Primary Completion
2024-10-31
Completion
2025-10-31

Countries

  • Italy

Study Locations

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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 NCT05578664 on ClinicalTrials.gov