Lymphoma. Non-Hodgkin MedDRA version: 17.0 Level: PT Classification code 10029547 Term: Non-Hodgkin's lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Bristol-Myers Squibb International Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Confirmation of relapsed or refractory DLBCL or transformed lymphoma (TL);. ECOG performance status of 0 -1; At least one lesion that measures > 1.5 cm; Prior therapy and screening lab criteria must be met; Appropriate contraceptive measures must be taken Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: Known CNS lymphoma; History of interstitial lung disease, prior malignancy, active autoimmune disease, positive test for hepatitis B or hepatitis C virus; Prior allogeneic SCT, chest radiation < 24 weeks from study drug, = 1000mg of carmustine (BCNU) as part of pre-transplant conditioning regimen, prior treatment with drug targeting t-cell costimulation or immune checkpoint pathways. Women who are breastfeeding or pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of this study is to determine whether nivolumab is effective in the treatment of DLBCL in patients that have failed or are ineligible for ASCT ;Secondary Objective: Duration of response Complete remission rate and duration of complete remission Partial Response rate and duration Progression free survival;Primary end point(s): Evidence of clinical benefit, as demonstrated by a clinically meaningful objective response rate.;Timepoint(s) of evaluation of this end point: Assessments (CT/MRI) begin 8 weeks after the start of nivolumab and continue at 8 week intervals through month 8, 12 week intervals month 9 to 2 years and then every 6 months after 2 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Duration of response Complete remission rate Progression free survival ;Timepoint(s) of evaluation of this end point: Assessed at the same time points as the primary endpoint | — |
Countries
Australia, Belgium, Canada, France, Germany, Italy, Netherlands, Singapore, Spain, Sweden, United Kingdom, United States
Contacts
Public ContactGCT-SU
Bristol-Myers Squibb International Corporation
Outcome results
None listed