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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02572167
Other study ID # SGN35-025
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date October 31, 2015
Est. completion date October 21, 2021

Study information

Verified date October 2022
Source Seagen Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)


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 information / eligibility

Status Completed
Enrollment 93
Est. completion date October 21, 2021
Est. primary completion date March 1, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
brentuximab vedotin
1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles
nivolumab
3 mg/kg by intravenous (IV) infusion for up to 4 cycles

Locations

Country Name City State
United States Dana Farber Cancer Institute Boston Massachusetts
United States James Cancer Hospital / Ohio State University Columbus Ohio
United States Memorial Sloan Kettering Cancer Center - Commack Commack New York
United States Charles A. Sammons Cancer Center / Baylor University Medical Center Dallas Texas
United States Karmanos Cancer Institute / Wayne State University Detroit Michigan
United States City of Hope National Medical Center Duarte California
United States Duke University Medical Center Durham North Carolina
United States Hackensack University Medical Center Hackensack New Jersey
United States Memorial Sloan Kettering Cancer Center New York New York
United States University of Nebraska Medical Center Omaha Nebraska
United States Mayo Clinic Minnesota Rochester Minnesota
United States Washington University School of Medicine Saint Louis Missouri
United States Stanford Cancer Center Stanford California

Sponsors (2)

Lead Sponsor Collaborator
Seagen Inc. Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

References & Publications (1)

Herrera AF, Moskowitz AJ, Bartlett NL, Vose JM, Ramchandren R, Feldman TA, LaCasce AS, Ansell SM, Moskowitz CH, Fenton K, Ogden CA, Taft D, Zhang Q, Kato K, Campbell M, Advani RH. Interim results of brentuximab vedotin in combination with nivolumab in pat — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Adverse Events (AEs) 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. Up to 28.9 months
Primary Complete Remission Rate Number of patients with complete metabolic response (CMR) at end of treatment Up to 3.42 months
Secondary Objective Response Rate Number of patients with complete metabolic response (CMR) or partial metabolic response (PMR) Up to 3.42 months
Secondary Duration of Complete Response 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. Up to 69.3 months
Secondary Duration of Objective Response 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. Up to 69.3 months
Secondary Progression-free Survival Post-autologous Stem Cell Transplant 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. Up to 67.3 months
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