OncRef

Clinical Trial: NCT01896999

Brentuximab Vedotin and Nivolumab With or Without Ipilimumab in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 1

Lead Sponsor:National Cancer Institute (NCI)
Information Provided By:National Cancer Institute (NCI)
Last Update Posted:2026-09-29

Study Overview

Brief Summary

This phase I/II trial studies the side effects and best dose of ipilimumab and nivolumab when given together with brentuximab vedotin, and how well they work in treating patients with Hodgkin lymphoma that has returned after a period of improvement (recurrent) or has not responded to previous treatment (refractory). Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Brentuximab vedotin is a monoclonal antibody, brentuximab, linked to a toxic agent called vedotin. Brentuximab attaches to CD30 positive cancer cells in a targeted way and delivers vedotin to kill them. It is not known whether giving brentuximab vedotin and nivolumab with or without ipilimumab may kill more cancer cells.

Official Title

A Phase I Study With an Expansion Cohort/Randomized Phase II Study of the Combinations of Ipilimumab, Nivolumab and Brentuximab Vedotin in Patients With Relapsed/Refractory Hodgkin Lymphoma

Conditions

Recurrent Classic Hodgkin Lymphoma, Refractory Classic Hodgkin Lymphoma

Intervention / Treatment

  • Procedure: Biopsy Procedure
  • Procedure: Biospecimen Collection
  • Drug: Brentuximab Vedotin
  • Procedure: Computed Tomography
  • Biological: Ipilimumab
  • Biological: Nivolumab
  • Procedure: Positron Emission Tomography

Other Study ID Numbers

  • NCI-2013-01275
  • NCI-2013-01275
  • E4412
  • S14-00011
  • E4412
  • E4412
  • U10CA180820
  • U24CA196172

Start Date (Actual)

2014-03-07

Primary Completion Date (Estimated)

2027-06-30

Study Completion Date (Estimated)

2027-06-30

Enrollment (Estimated)

146

Study Type

Interventional

Phase

Phase 1, Phase 2