Study of Nivolumab in subjects with Relapsed or Refractory Follicular Lymphoma (FL)
- Conditions
- ymphoma. Non-HodgkinMedDRA version: 16.1Level: PTClassification code 10029547Term: Non-Hodgkin's lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2013-003645-42-ES
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 115
? 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 rituximab 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
? Known central nervous system lymphoma.
? History of interstitial lung disease
? Subjects with active, known or suspected autoimmune disease.
? Prior allogeneic or autologous stem cell transplant.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 rituximab and an alkylating agent.;Secondary Objective: ? To assess the duration of response based on IRRC assessments<br>? To assess the complete remission rate based on IRRC assessment<br>? To assess the progression free survival based on IRRC assessment<br>? To assess the ORR, based on investigator assessments.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): ? To assess the duration of response based on IRRC assessments<br>? To assess the complete remission rate based on IRRC assessment<br>? To assess the progression free survival based on IRRC assessment<br>? 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