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

Phase 1

• Conditions: ymphoma. Non-Hodgkin; MedDRA 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-IT
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02-14
• Last Update Posted: 26 February 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• 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 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

Exclusion Criteria

• 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