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A Safety and Efficacy Study of Nivolumab in Combination with Brentuximab Vedotin to Treat Non-Hodgkin Lymphomas

Conditions
Relapsed Refractory Non Hodgkin Lymphomas with CD30 Expression
MedDRA version: 19.0Level: HLTClassification code 10029606Term: Non-Hodgkin's lymphomas transformed recurrentSystem Organ Class: 100000004851
Therapeutic area: Diseases [C] - Cancer [C04]
Registration Number
EUCTR2015-003286-28-FR
Lead Sponsor
Bristol-Myers Squibb International Corporation
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Authorised-recruitment may be ongoing or finished
Sex
All
Target Recruitment
120
Inclusion Criteria

Relapsed/refractory Diffuse Large B
Cell Lymphoma (DLBCL),
relapsed/refractory Peripheral T
Cell Lymphoma (PTCL) (all subtypes
excluding Anaplastic Large Cell
Lymphoma) and relapsed/refractory
Cutaneous T Cell Lymphoma (CTCL)
Mycosis Fungoides/Sezary Syndrome (MF/SS)
Expression of CD30
Subjects must be 18 years or older
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 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

Known central nervous system (CNS)
lymphomas; Active
cerebral/meningeal disease related
to the underlying malignancy
Active, known, or suspected autoimmune disease

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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