An Investigational Immuno-therapy Safety and Effectiveness Study of Nivolumab in Combination With Brentuximab Vedotin to Treat Non-Hodgkin Lymphomas
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- Bristol-Myers Squibb
- Study ID
- NCT02581631
- Phase
- PHASE1/PHASE2
- Status
- Completed
Conditions
- Non-Hodgkin's Disease
Eligibility Criteria
- Sex
- ALL
- Age
- 15 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Nivolumab — BIOLOGICAL
- Brentuximab Vedotin — DRUG
Study Details
The purpose of this study is to determine whether Nivolumab, in combination with brentuximab vedotin, is safe and effective in patients with certain subtypes of non-Hodgkin's lymphomas with CD30 expression that have not responded to treatment or have come back. The subtypes we are studying are Diffuse Large B-Cell Lymphoma (DLBCL), Peripheral T-Cell Lymphoma (PTCL), Cutaneous T-Cell Lymphoma (CTCL), Primary Mediastinal Large B-Cell Lymphoma (PMBL) and Mediastinal Gray Zone Lymphoma (MGZL).
Key Dates
- Start date
- Feb 11, 2016
- Status verified
- Feb 2023
- Primary completion
- Jan 16, 2020
- Completion
- Feb 7, 2022
Study Design
- Enrollment
- 145 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Nivolumab+Brentuximab VedotinNivolumab+Brentuximab Vedotin dose as specified
Primary Outcome Measure
Safety Analysis - Number of Participants With Dose Limiting Toxicities (DLT) in the DLT Evaluation Phase [ Time Frame: From first dose of treatment to 6 weeks after first dose ]
Locations (16)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Local Institution - 0017 | Birmingham | Alabama | 35294-3300 | - |
| University Of Miami Sylvester Comprehensive Cancer Center | Miami | Florida | 33136 | - |
| Local Institution - 0012 | Tampa | Florida | 33612 | - |
| Winship Cancer Institute. | Atlanta | Georgia | 30322 | - |
| University Of Chicago | Chicago | Illinois | 60637 | - |
| Mayo Clinic | Rochester | Minnesota | 55905 | - |
| Washington University School Of Medicine | St Louis | Missouri | 63110 | - |
| Local Institution - 0003 | New York | New York | 10021 | - |
| Local Institution - 0010 | New York | New York | 10029 | - |
| University Of Rochester | Rochester | New York | 14642 | - |
| Levine Cancer Institute | Charlotte | North Carolina | 28204 | - |
| The Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | - |
| Stephenson Cancer Center | Oklahoma City | Oklahoma | 73104 | - |
| Providence Portland Medical Center | Portland | Oregon | 97213 | - |
| Bon Secours-St Francis Hosp | Greenville | South Carolina | 29607 | - |
| University of Washington - Seattle Cancer Care Alliance | Seattle | Washington | 98109-1023 | - |