NCT03260504

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

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
BIOLOGICAL	Aldesleukin	Given SC or IV
BIOLOGICAL	Pembrolizumab	Given IV

Timeline

• Start date: 2018-08-28
• Primary completion: 2022-07-26
• Completion: 2022-07-26
• First posted: 2017-08-24
• Last updated: 2025-12-08
• Results posted: 2025-12-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study