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

Status
Active
Cancer Type
Trial Phase
Phase I
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT04191421
Protocol IDs
Winship4463-18 (primary)
NCI-2018-01793
IRB00105616
Study Sponsor
Emory University Hospital / Winship Cancer Institute

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 participants 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.

Objectives

PRIMARY OBJECTIVES:
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 OBJECTIVES:
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. Courses 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.

Treatment Sites in Georgia

Emory Saint Joseph's Hospital


5665 Peachtree Dunwoody Road NE
Atlanta, GA 30342
www.emoryhealthcare.org

Emory University Hospital - Midtown


550 Peachtree Street NE
Atlanta, GA 30308
404-686-4411
www.emoryhealthcare.org

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
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