NCT02748564

Aldesleukin and Pembrolizumab in Treating Patients With Stage III-IV Melanoma

Trial of Interleukin-2 in Combination With Pembrolizumab for Patients With Unresectable or Metastatic Melanoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Rutgers, The State University of New Jersey · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the safety and tolerability of IL-2 when given in combination with pembrolizumab to patients with advanced melanoma. Aldesleukin may stimulate white blood cells to melanoma cells. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Giving aldesleukin and pembrolizumab may kill more tumor cells. There are two parts to this study: * Phase Ib: To determine the safety and side effects of increasing doses of IL-2 in combination with pembrolizumab * Phase II: Once the maximum tolerated dose of IL-2 is determined, additional patients will be treated to determine if it is effective against the cancer.

Detailed description

PRIMARY OBJECTIVES: I. To determine an optimal tolerated dose (OTD) of aldesleukin (interleukin \[IL\]-2) that is effective and tolerable in combination with pembrolizumab. II. To characterize the efficacy of the OTD of IL-2 in combination with pembrolizumab. SECONDARY OBJECTIVES: I. To characterize the safety of IL-2 in doses ranging up to the Food and Drug Administration (FDA)- approved dose when administered in combination with pembrolizumab. II. To characterize clinical endpoints, including overall survival, progression-free survival, and complete response rate. TERTIARY OBJECTIVES: I. To characterize immune parameters in the blood and tumor microenvironment and cellular and molecular features of the tumor tissue that correlate with response to combination therapy for study as potential predictive biomarkers. OUTLINE: Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1 every 3 weeks and aldesleukin IV every 8 hours for up to 14 doses at weeks 4, 7, 16, 19, 28, and 31 in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months up to 10 years.

Conditions

• Metastatic Melanoma
• Stage III Mucosal Melanoma of the Head and Neck
• Stage IIIA Skin Melanoma
• Stage IIIB Skin Melanoma
• Stage IIIC Skin Melanoma
• Stage IV Skin Melanoma
• Stage IVA Mucosal Melanoma of the Head and Neck
• Stage IVB Mucosal Melanoma of the Head and Neck
• Stage IVC Mucosal Melanoma of the Head and Neck

Interventions

Type	Name	Description
BIOLOGICAL	Aldesleukin	Given IV
OTHER	Laboratory Biomarker Analysis	Correlative studies
BIOLOGICAL	Pembrolizumab	Given IV

Timeline

• Start date: 2017-03-21
• Primary completion: 2018-10-18
• Completion: 2023-06-05
• First posted: 2016-04-22
• Last updated: 2023-08-03
• Results posted: 2023-02-09

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study