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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)
Bernice Kwong, MD
Clinical Professor, Dermatology
Sunil Arani Reddy
Clinical Associate Professor, Medicine - Oncology
Susan M. Swetter, MD
Professor of 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: Nivolumab
biological: Urelumab
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061