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: 20.0Level: HLTClassification code 10029606Term: Non-Hodgkin's lymphomas transformed recurrentSystem Organ Class: 100000004851; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-003286-28-IT
• Lead Sponsor: BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-17
• Last Update Posted: 2 August 2021

Recruitment & Eligibility

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

- Location of the NHL in the central nervous system (CNS)
- Positive test for autoimmune disease

Study & Design

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