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
Susan M. Swetter, MD

Professor of Dermatology

Sunil Arani Reddy
Sunil Arani Reddy

Clinical Associate Professor, Medicine - Oncology

Bernice Kwong, MD
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

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