A Study of Brentuximab Vedotin Combined With Nivolumab for Relapsed or Refractory Hodgkin Lymphoma
- 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
- 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
- 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
Group Intervention Description Brentuximab Vedotin + Nivolumab brentuximab vedotin Brentuximab vedotin plus nivolumab Brentuximab Vedotin + Nivolumab nivolumab Brentuximab vedotin plus nivolumab
- Primary Outcome Measures
Name Time Method 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 Rate Up to 3.42 months Number of patients with complete metabolic response (CMR) at end of treatment
- Secondary Outcome Measures
Name Time Method Duration of Complete Response Up 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 Response Up 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 Rate Up to 3.42 months Number of patients with complete metabolic response (CMR) or partial metabolic response (PMR)
Progression-free Survival Post-autologous Stem Cell Transplant Up 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
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
James Cancer Hospital / Ohio State University
🇺🇸Columbus, Ohio, United States
Karmanos Cancer Institute / Wayne State University
🇺🇸Detroit, Michigan, United States
Stanford Cancer Center
🇺🇸Stanford, California, United States
Mayo Clinic Minnesota
🇺🇸Rochester, Minnesota, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Charles A. Sammons Cancer Center / Baylor University Medical Center
🇺🇸Dallas, Texas, United States
Memorial Sloan Kettering Cancer Center - Commack
🇺🇸Commack, New York, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States