Safety Study of IL-21/Anti-PD-1 Combination in the Treatment of Solid Tumors

Completed · Phase 1

Conditions studied: Neoplasms by Site

In brief

The purpose of this study is to determine whether the combination of the 2 drugs being investigated (IL-21 and anti-PD-1) is safe, and provide preliminary information on the clinical benefits of two different schedules of the combination.

Key facts

Study ID

NCT01629758

Run by

Bristol-Myers Squibb

People needed

33

Starts

2012-06-01

Expected to finish

2014-12-01

Last updated by the study team

2015-03-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All subjects will have locally advanced or metastatic solid tumors
• For Part 2 (Cohort Expansion):
• Tumor types will be restricted to clear cell renal cell carcinoma (ccRCC), non-small cell lung cancer (NSCLC), and melanoma
• At least 1 lesion with measurable disease
• Only subjects with tumor samples that are PD-L1 positive or negative are eligible

You may not qualify if…

• Uncontrolled central nervous system (CNS) or leptomeningeal metastasis
• Inadequate liver or kidney function
• History of autoimmune Disease

Where it is running

• Oncology Research Associates, Pllc D/B/A — Scottsdale, Arizona, United States
• Yale University School Of Medicine — New Haven, Connecticut, United States
• Moffitt Cancer Center — Tampa, Florida, United States
• Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins — Baltimore, Maryland, United States
• Seattle Cancer Care Alliance — Seattle, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.