An Investigational Immuno-therapy Study to Determine the Safety of Urelumab Given in Combination With Nivolumab in Solid Tumors and B-cell Non-Hodgkin's Lymphoma

Stopped early · Phase 1/Phase 2

Conditions studied: Advanced Solid Tumors, Advanced B-cell NHL

In brief

The purpose of this study is to determine which doses of Urelumab and Nivolumab are safe and tolerable when they are given together.

Key facts

Study ID

NCT02253992

Run by

Bristol-Myers Squibb

People needed

232

Starts

2014-09-29

Expected to finish

2019-05-24

Last updated by the study team

2020-10-05

Who can join

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

You may qualify if…

• For Dose Escalation:
• Subjects with any previously treated advanced (metastatic or refractory) solid tumor type and B-cell non-Hodgkin lymphoma
• For Cohort Expansion:
• Subjects must have a previously treated advanced solid tumor or B cell non-Hodgkin's lymphoma to be eligible
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• For certain subjects, willing and able to provide pre-treatment and on-treatment fresh tumor biopsy
• Women of child-bearing potential and men must use an acceptable method of contraception during treatment and for 23 weeks after treatment for women and 31 weeks for men

You may not qualify if…

• Known central nervous system metastases or central nervous system as the only source of disease
• Other concomitant malignancies (with some exceptions per protocol)
• Active, known or suspected autoimmune disease
• Uncontrolled or significant cardiovascular disease
• History of hepatitis (B or C)
• History of active or latent tuberculosis

Where it is running

• Stanford University School Of Medicine — Palo Alto, California, United States
• H. Lee Moffitt Cancer Center — Tampa, Florida, United States
• University Of Chicago — Chicago, Illinois, United States
• Johns Hopkins Sidney Kimmel Comprehensive Cancer Center — Lutherville, Maryland, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• NYU Langone Medical Center — New York, New York, United States
• Memorial Sloan Kettering Nassau — New York, New York, United States
• Providence Portland Medical Center — Portland, Oregon, United States
• UPMC Cancer Center — Pittsburgh, Pennsylvania, United States
• Md Anderson — Houston, Texas, United States
• Local Institution — Besançon, France
• Local Institution — Marseille, France
• Local Institution — Rennes, France
• Local Institution — Villejuif, France
• Universitaetsklinikum Essen — Essen, Germany
• Clinica Universidad de Navarra — Pamplona, Spain

Full record on ClinicalTrials.gov

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