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

Seagen Inc.93 enrolled

Overview

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)

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hodgkin Lymphoma

Interventions

brentuximab vedotinDRUG

1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles

nivolumabDRUG

3 mg/kg by intravenous (IV) infusion for up to 4 cycles

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (13)

City of Hope National Medical Center

Duarte, California, United States

Stanford Cancer Center

Stanford, California, United States

Dana Farber Cancer Institute

Outcomes

Primary Outcomes

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.

Time frame: Up to 28.9 months

Complete Remission Rate

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

Time frame: Up to 3.42 months

Secondary Outcomes

Objective Response Rate

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

Time frame: Up to 3.42 months

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.

Time frame: Up to 69.3 months

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.

Time frame: Up to 69.3 months

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.

Time frame: Up to 67.3 months

Data from ClinicalTrials.gov

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