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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
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