NCT04191421

Siltuximab and Spartalizumab in Patients With Metastatic Pancreatic Cancer

A Phase Ib/II Trial of Siltuximab and Spartalizumab in Metastatic Pancreatic Cancer

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase Ib/II trial studies the best dose and side effects of siltuximab and how well it works in combination with spartalizumab in treating patients with pancreatic cancer that has spread to other places in the body. Monoclonal antibodies, such as siltuximab and spartalizumab, interfere with the ability of tumors cells to grow and spread.

Detailed description

PRIMARY OBJECTIVE: I. Determine the recommended phase II dose for the combination of spartalizumab and siltuximab. SECONDARY OBJECTIVES: I. Define the toxicity profile of the combination of the recommended phase II dose of spartalizumab and siltuximab. II. Evaluate the activity of the combination of spartalizumab and siltuximab in previously treated patients with pancreatic cancer. EXPLORATORY OBJECTIVE: I. Evaluate the effect of the combination on the immune profile in the serum and in tumor biopsies. OUTLINE: This is a dose-escalation study of siltuximab. Participants receive spartalizumab intravenously (IV) over 30 minutes on day 1 and siltuximab IV over 1 hour on day 1. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, participants are followed up at 30, 60, 90, 120, and 150 days, then every 12 weeks thereafter.

Conditions

• Metastatic Pancreatic Adenocarcinoma
• Stage IV Pancreatic Cancer AJCC v8

Interventions

Type	Name	Description
BIOLOGICAL	Siltuximab	Given IV
BIOLOGICAL	Spartalizumab	Given IV

Timeline

• Start date: 2020-01-17
• Primary completion: 2023-04-05
• Completion: 2023-04-05
• First posted: 2019-12-09
• Last updated: 2025-08-22
• Results posted: 2025-08-22

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study