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


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
Bernice Kwong, MD

Clinical Professor, Dermatology

Sunil Arani Reddy
Sunil Arani Reddy

Clinical Associate Professor, Medicine - Oncology

Susan M. Swetter, MD
Susan M. Swetter, MD

Professor of Dermatology


For more information regarding BMS clinical trial participation, please visit

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


biological: Nivolumab

biological: Urelumab

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

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