Aldesleukin and Pembrolizumab in Treating Patients With Advanced or Metastatic Kidney Cancer

Stage IV Renal Cell Cancer Clinical Trial

Official title: A Phase I Trial of Interleukin-2 (Aldesleukin) and Pembrolizumab Combination Therapy for Patients With Advanced Renal Cell Carcinoma

Status Terminated

Clinical Trial Summary

This phase I trial studies the side effects and best dose of aldesleukin when given together with pembrolizumab in treating patients with kidney cancer that has spread to other parts of the body. Aldesleukin may stimulate white blood cells to kill kidney cancer cells. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to avoid recognition by immune cells. Giving aldesleukin and pembrolizumab may work better in treating patients with kidney cancer.

Clinical Trial Description

OUTLINE: This is a dose-escalation study of aldesleukin.

Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Patients also receive aldesleukin subcutaneously (SC) 5 days per week for 6 weeks; or aldesleukin IV on days 2-6 of pembrolizumab cycles 1 and 2. Pembrolizumab treatment repeats every 3 weeks for 4 cycles per treatment course in the absence of clinical disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up via surveillance scans for every 3 months for up to 1 year or until disease progression. ;

Related Conditions & MeSH terms

• Advanced Clear Cell Renal Cell Carcinoma
• Carcinoma
• Carcinoma, Renal Cell
• Metastatic Clear Cell Renal Cell Carcinoma
• Stage III Renal Cell Cancer
• Stage IV Renal Cell Cancer

• NCT number: NCT03260504
• Study type: Interventional
• Source: University of Washington
• Status: Terminated
• Phase: Phase 1
• Start date: August 28, 2018
• Completion date: July 26, 2022