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

  • Interventional
  • Not Recruiting
  • NCT02253992
Eligibility Details Visit Clinicaltrials.gov

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

The purpose of this study is to determine which doses of Urelumab and Nivolumab are safe and tolerable when they are given together.

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

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
  • Solid Tumors

At a Glance

National Government IDNCT02253992

IRB#IRB15-0835

Lead SponsorBristol-Myers Squibb

Lead PhysicianMark J. Ratain

Collaborator(s)N/A

EligibilityAll
18 Years and up
Not Recruiting