Clinical Trial 18615

Cancer Type: Malignant Hematology
Interventions:Adcetris (Brentuximab vedotin); BMS-936558 (Nivolumab); Brentuximab vedotin; Nivolumab; SGN-35 (Brentuximab vedotin)

Study Type: Treatment
Phase of Study: Phase I/II
Investigators:

  • Bijal Shah

Overview

Study Title

A Phase I/ II Study to Evaluate the Safety and Preliminary Efficacy of Nivolumab in Combination with Brentuximab Vedotin in Subjects with Relapsed Refractory Non Hodgkin Lymphomas with CD30 Expression CheckMate 436: CHECKpoint pathway and nivolumab clinical Trail Evaluation

Summary

The purpose of this study is to test the effectiveness (how well the drug works), safety, and tolerability of an investigational drug called nivolumab (also known as BMS-936558) in combination with brentuximab vedotin. An investigational drug is one that is not approved by the US Food and Drug Administration (FDA) or any other agency and is being studied and developed. Nivolumab is an antibody (a type of human protein) that is being tested to see if it will allow the body's immune system to work against tumor cells. Brentuximab vedotin is an antibody-drug conjugate (a type of human protein linked to a study drug). The antibody part of the drug binds to CD30 which often occurs on diseased cells but rarely on normal tissues.

Objective

To evaluate the safety and tolerability of the combination of nivolumab and brentuximab in subjects with the diagnosis of relapsed, refractory DLBCL, PTCL (all subtypes excluding ALCL) and CTCL(MF/SS). To assess the clinical benefit of nivolumab and brentuximab vedotin combination regimen in subjects with the diagnosis of relapsed/refractory DLBCL, relapsed/refractory PTCL (excluding ALCL), and relapsed refractory CTCL (MF/SS) (CD30 expression >= 1% by IHC is a prerequisite for all subjects participating in this study), as measured by ORR, defined as the proportion of subjects achieving either a PR or CR. In subjects with relapsed/refractory DLBCL and relapsed/refractory PTCL the response will be assessed according to Lugano Classification 2014. For subjects with relapsed/refractory CTCL, response will be assessed according to onsensus Global Response Score as per the consensus statement of the International Society for Cutaneous Lymphoma.

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.
  • Participants must be 18 years or older.
  • Additional criteria may apply.

  • Exclusion Criteria

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