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

Phase 1
Completed
Conditions
Hodgkin Lymphoma
Interventions
Registration Number
NCT02572167
Lead Sponsor
Seagen Inc.
Brief 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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
93
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)

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Brentuximab Vedotin + Nivolumabbrentuximab vedotinBrentuximab vedotin plus nivolumab
Brentuximab Vedotin + NivolumabnivolumabBrentuximab vedotin plus nivolumab
Primary Outcome Measures
NameTimeMethod
Number of Participants With Adverse Events (AEs)Up to 28.9 months

Treatment-emergent adverse events (TEAEs) are presented and defined as newly occurring (not present at baseline) or worsening after first dose of investigational product. The timeframe includes a 6.01 month safety reporting period and additional long-term follow up through 28.9 months.

Complete Remission RateUp to 3.42 months

Number of patients with complete metabolic response (CMR) at end of treatment

Secondary Outcome Measures
NameTimeMethod
Duration of Complete ResponseUp to 69.3 months

The time from start of the first documentation of complete response (CR) to the first documentation of tumor progression (PD) including radiographic evidence of progression and clinical progression per investigator or to death due to any cause, whichever comes first.

Duration of Objective ResponseUp to 69.3 months

The time from start of the first documentation of OR (CR or PR) to the first documentation of PD or to death due to any cause, whichever comes first.

Objective Response RateUp to 3.42 months

Number of patients with complete metabolic response (CMR) or partial metabolic response (PMR)

Progression-free Survival Post-autologous Stem Cell TransplantUp to 67.3 months

For participants who undergo ASCT, the time from ASCT to the first documentation of PD or to death due to any cause, whichever comes first.

Trial Locations

Locations (13)

City of Hope National Medical Center

🇺🇸

Duarte, California, United States

Stanford Cancer Center

🇺🇸

Stanford, California, United States

Dana Farber Cancer Institute

🇺🇸

Boston, Massachusetts, United States

Karmanos Cancer Institute / Wayne State University

🇺🇸

Detroit, Michigan, United States

Mayo Clinic Minnesota

🇺🇸

Rochester, Minnesota, United States

Washington University School of Medicine

🇺🇸

Saint Louis, Missouri, United States

University of Nebraska Medical Center

🇺🇸

Omaha, Nebraska, United States

Hackensack University Medical Center

🇺🇸

Hackensack, New Jersey, United States

Memorial Sloan Kettering Cancer Center - Commack

🇺🇸

Commack, New York, United States

Memorial Sloan Kettering Cancer Center

🇺🇸

New York, New York, United States

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City of Hope National Medical Center
🇺🇸Duarte, California, United States

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