Siltuximab and Spartalizumab in Treating Participants with Metastatic Pancreatic Cancer

Active:	No
Cancer Type:	Pancreatic Cancer Unknown Primary	NCT ID:	NCT04191421
Trial Phases:	Phase I Phase II	Protocol IDs:	Winship4463-18 (primary) NCI-2018-01793 IRB00105616
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Emory University Hospital/Winship Cancer Institute
NCI Full Details:	http://clinicaltrials.gov/show/NCT04191421

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.