A Study of Brentuximab Vedotin Combined With Nivolumab for Relapsed or Refractory Hodgkin Lymphoma

Seagen

Status and phase: Completed; Phase 2; Phase 1

Conditions: Hodgkin Lymphoma

Treatments: Drug: brentuximab vedotin; Drug: nivolumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02572167

SGN35-025

Details and patient eligibility

About

The purpose of this study is to assess the safety profile and antitumor activity of brentuximab vedotin administered in combination with nivolumab in patients with relapsed or refractory Hodgkin lymphoma (HL)

Full description

This study will examine the safety profile and antitumor activity when brentuximab vedotin is combined with nivolumab. Patients will be treated for up to four 21-day cycles with brentuximab vedotin 1.8 mg/kg and nivolumab 3 mg/kg.

There will be 3 parts to this study. In Part 1, the safety of combination treatment will be evaluated by a Safety Monitoring Committee (SMC) prior to expansion of enrollment to evaluate treatment effect in Part 2. Part 2 of the study will further characterize the safety and antitumor activity of brentuximab vedotin combined with nivolumab by enrolling patients at the recommended dose schedule determined in Part 1. Part 3 of the study will evaluate the safety and antitumor activity of combination treatment administered at an alternate dosing schedule determined by cumulative safety and activity data from Parts 1 and 2.

Enrollment: 93 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Relapsed or refractory Hodgkin lymphoma following failure of standard frontline chemotherapy for the treatment of classical Hodgkin lymphoma
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion criteria

• Previously treated with brentuximab vedotin, immune-oncology agents, or received an allogeneic or autologous stem cell transplant
• Documented history of a cerebral vascular event
• History of another invasive malignancy that has not been in remission for at least 3 years
• History of progressive multifocal leukoencephalopathy (PML)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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93 participants in 1 patient group

Brentuximab Vedotin + Nivolumab

Experimental group

Description:

Brentuximab vedotin plus nivolumab

Treatment:

Drug: nivolumab

Drug: brentuximab vedotin