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Completed

NCT Number: NCT02572167

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

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)

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Key information

Conditions

Hodgkin Lymphoma Hemic and Lymphatic Diseases Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Brentuximab Vedotin

Drug

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

Other names: SGN-35, ADCETRIS

Nivolumab

Drug

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

Other names: BMS-936558, OPDIVO

Primary outcomes

  1. Number of Participants With Adverse Events (AEs)

    Time frame: 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.

  2. Complete Remission Rate

    Time frame: Up to 3.42 months

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

Secondary outcomes

  1. Objective Response Rate

    Time frame: Up to 3.42 months

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

  2. Duration of Complete Response

    Time frame: 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.

  3. Duration of Objective Response

    Time frame: 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.

  4. Progression-free Survival Post-autologous Stem Cell Transplant

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Seagen Inc.

Industry

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2018
Study completion
2021
First posted
Oct 8, 2015
Registry last updated
Nov 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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