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

Phase 1

Conditions: Relapsed Refractory Non Hodgkin Lymphomas with CD30 Expression
MedDRA version: 20.0 Level: HLT Classification code 10029606 Term: Non-Hodgkin's lymphomas transformed recurrent System Organ Class: 100000004851
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2015-003286-28-GB

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: Not specified

Target Recruitment: 170

Inclusion Criteria

• Relapsed/refractory diffuse large B cell lymphoma (DLBCL), relapsed/refractory peripheral T cell lymphoma (PTCL) (all subtypes excluding anaplastic large cell lymphoma), relapsed/refractory Cutaneous T cell lymphoma (CTCL) mycosis fungoides/sezary syndrome (MF/SS), relapsed/refractory primary mediastinal B lymphoma (PMBL), and relapsed/refractory mediastinal gray zone lymphoma (MGZL)
• Expression of CD30
• Subjects must be 18 years or older (= 15 years for PMBL)

Are the trial subjects under 18? yes
Number of subjects for this age range: 5
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 85
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80

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

Name	Time	Method
Main Objective: to assess whether nivolumab in combination with brentuximab vedotin is safe and effective in certain subtypes of non-hodgkin lymphomas;<br> Secondary Objective: - Assess the overall duration of response (DOR)<br> - Assess the complete response rate (CRR) and duration<br> - Progression-Free Survival (PFS)<br> - Overall Survival (OS)<br> ;<br> Primary end point(s): - Safety and tolerability of the combination of nivolumab and brentuximab vedotin in subjects with diagnosis of DLBCL, PTCL, CTCL<br> - Assess the clinical benefit of nivolumab and brentuximab vedotin combination regimen in subjects as measured by Overall Response Rate (ORR)<br> ;<br> Timepoint(s) of evaluation of this end point: - First dose to up to 100 days after the last dose of study treatment<br> - 8 months after the last patient receives their first dose<br>

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): - Assess the overall duration of response (DOR)<br> - Assess the complete response rate (CRR) and duration<br> - Progression-Free Survival (PFS)<br> - Overall Survival (OS)<br> ;<br> Timepoint(s) of evaluation of this end point: - 8 months after the last patient receives their first dose<br> - 8 months after the last patient receives their first dose<br> - 8 months after the last patient receives their first dose<br> - 1 year after the first patient receives their first dose<br>

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