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

Hodgkin Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02572167
• Other study ID #: SGN35-025
• Status: Completed
• Phase: Phase 1/Phase 2
• 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
• 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)

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin Lymphoma
• Lymphoma

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