Lymphoma. Non-Hodgkin MedDRA version: 20.0 Level: PT Classification code 10029547 Term: Non-Hodgkin's lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Opdivo (100 mg/10 ml)
Product Name: Nivolumab- 10ml vial-CLINICAL
Product Code: BMS-936558
Pharmaceutical Form: Solution for injection/infus
Sponsors
Bristol-Myers Squibb International Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Grade 1, 2, or 3a FL without pathologic evidence of transformation. •Male and female, ages 18 and above, with relapsed or refractory FL lymphoma after > or = 2 prior treatment lines; each of the 2 prior treatment lines must include at least CD20 antibody and/or an alkylating agent •ECOG PS 0-1 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 86 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 29
Exclusion criteria
Exclusion criteria: •Known central nervous system lymphoma. •History of interstitial lung disease •Subjects with active, known or suspected autoimmune disease. •Prior allogeneic stem cell transplant. •Prior autologous stem cell transplant = 12 weeks prior to first dose of study drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary endpoint is ORR as determined by an IRRC according to the revised International Working Group Criteria for non-Hodgkin Lymphoma.;Timepoint(s) of evaluation of this end point: Assessments (CT/MRI) begin 8 weeks after the start of nivolumab and continue at 8 weeks intervals through Month 8, 12-week intervals Month 9 to 2 years and then every 6 months after 2 years; Main Objective: The purpose of this study is to assess the clinical benefit of nivolumab, as measured by independent radiologic review committee (IRRC)- assessed objective response rate (ORR) in subjects with FL lymphoma who have failed therapy with both CD20 antibody and an alkylating agent. ; Secondary Objective: •To assess the duration of response based on IRRC assessments •To assess the complete remission rate and the duration of complete remission based on IRRC assessment •To assess the partial remission rate and the duration of partial remission based on IRRC assessment •To assess the progression free survival based on IRRC assessment •To assess the ORR, based on investigator assessments. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •To assess the duration of response based on IRRC assessments •To assess the complete remission rate and the duration of complete remission based on IRRC assessment •To assess the partial remission rate and the duration of partial remission based on IRRC assessment •To assess the progression free survival based on IRRC assessment •To assess the ORR, based on investigator assessments. ;Timepoint(s) of evaluation of this end point: Assessed at the same timepoints as the primary endpoint | — |
Countries
Australia, Belgium, Canada, France, Germany, Italy, Norway, Singapore, Spain, Sweden, United Kingdom, United States
Contacts
Public ContactGCT SU
Bristol-Myers Squibb International Corporation
Outcome results
None listed