Ignite Creation Date:
2025-12-24 @ 8:01 PM
Ignite Modification Date:
2026-01-03 @ 6:49 AM
Study NCT ID:
NCT03260504
Status:
TERMINATED
Last Update Posted:
2025-12-08
First Post:
2017-08-21
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Aldesleukin and Pembrolizumab in Treating Patients With Advanced or Metastatic Kidney Cancer
Sponsor:
University of Washington
Organization:
Study Overview
Official Title:
A Phase I Trial of Interleukin-2 (Aldesleukin) and Pembrolizumab Combination Therapy for Patients With Advanced Renal Cell Carcinoma
Status:
TERMINATED
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Insufficient funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: