NCT02572167

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

A Phase 1/2 Study Evaluating Brentuximab Vedotin in Combination With Nivolumab in Patients With Relapsed or Refractory Hodgkin Lymphoma After Failure of Frontline Therapy

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: Seagen Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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)

Detailed 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.

Conditions

• Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	brentuximab vedotin	1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles
DRUG	nivolumab	3 mg/kg by intravenous (IV) infusion for up to 4 cycles

Timeline

• Start date: 2015-10-31
• Primary completion: 2018-03-01
• Completion: 2021-10-21
• First posted: 2015-10-08
• Last updated: 2022-11-08
• Results posted: 2019-03-07

Locations

13 sites across 1 country: United States