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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
Not Recruiting
Trial ID: NCT02253992
Purpose
The purpose of this study is to determine which doses of Urelumab and Nivolumab are safe and tolerable when they are given together.
Official Title
A Phase 1/2 Dose Escalation and Cohort Expansion Study of the Safety and Tolerability of Urelumab Administered in Combination With Nivolumab in Advanced/Metastatic Solid Tumors and B-cell Non-Hodgkins Lymphoma
Stanford Investigator(s)
Susan M. Swetter, MD
Professor of Dermatology
Sunil Arani Reddy
Clinical Associate Professor, Medicine - Oncology
Bernice Kwong, MD
Clinical Professor, Dermatology
Eligibility
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Intervention(s):
biological: Urelumab
biological: Nivolumab
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061