Study of Nivolumab in subjects with Relapsed or Refractory Follicular Lymphoma (FL)

Phase 1

• Conditions: ymphoma. 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); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-003645-42-GB
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-12-10
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 115

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

•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified