Status:
TERMINATED
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
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Advanced Solid Tumors
Advanced B-cell NHL
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to determine which doses of Urelumab and Nivolumab are safe and tolerable when they are given together.
Eligibility Criteria
Inclusion
- For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
- 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
- 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
Key Trial Info
Start Date :
September 29 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 24 2019
Estimated Enrollment :
232 Patients enrolled
Trial Details
Trial ID
NCT02253992
Start Date
September 29 2014
End Date
May 24 2019
Last Update
October 5 2020
Active Locations (17)
Enter a location and click search to find clinical trials sorted by distance.
1
Stanford University School Of Medicine
Palo Alto, California, United States, 94304
2
H. Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612
3
University Of Chicago
Chicago, Illinois, United States, 60637
4
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Lutherville, Maryland, United States, 21093