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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02572167
Recruitment Status : Active, not recruiting
First Posted : October 8, 2015
Results First Posted : March 7, 2019
Last Update Posted : May 1, 2019
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Seattle Genetics, Inc.

Tracking Information
First Submitted Date  ICMJE October 7, 2015
First Posted Date  ICMJE October 8, 2015
Results First Submitted Date  ICMJE February 13, 2019
Results First Posted Date  ICMJE March 7, 2019
Last Update Posted Date May 1, 2019
Actual Study Start Date  ICMJE October 2015
Actual Primary Completion Date March 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 18, 2019)
  • 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 safety reporting period and additional long-term follow up through 28.9 months.
  • Complete Remission Rate [ Time Frame: Up to 3.42 months ]
    Number of patients with complete metabolic response (CMR) at end of treatment
Original Primary Outcome Measures  ICMJE
 (submitted: October 7, 2015)
  • Incidence of adverse events [ Time Frame: Up to 7 months ]
  • Complete response rate [ Time Frame: Up to 5 months ]
Change History Complete list of historical versions of study NCT02572167 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 13, 2019)
  • Objective Response Rate [ Time Frame: Up to 3.42 months ]
    Number of patients with complete metabolic response (CMR) or partial metabolic response (PMR)
  • Duration of Complete Response [ Time Frame: Up to approximately 3 years ]
  • Duration of Objective Response [ Time Frame: Up to approximately 3 years ]
  • Progression-free Survival Post-autologous Stem Cell Transplant [ Time Frame: Up to approximately 3 years ]
    PFS is defined as the time from the start of study treatment to the first documentation of disease progression or to death, whichever comes first.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 7, 2015)
  • Objective Response Rate [ Time Frame: Up to 5 months ]
  • Duration of Complete Response [ Time Frame: Up to approximately 3 years ]
  • Duration of Objective Response [ Time Frame: Up to approximately 3 years ]
  • Progression-free Survival Post-autologous Stem Cell Transplant [ Time Frame: Up to approximately 3 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Brentuximab Vedotin Combined With Nivolumab for Relapsed or Refractory Hodgkin Lymphoma
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hodgkin Lymphoma
Intervention  ICMJE
  • Drug: brentuximab vedotin
    1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles
    Other Name: SGN-35, ADCETRIS
  • Drug: nivolumab
    3 mg/kg by intravenous (IV) infusion for up to 4 cycles
    Other Name: BMS-936558, OPDIVO
Study Arms  ICMJE Experimental: Brentuximab Vedotin + Nivolumab
Brentuximab vedotin plus nivolumab
Interventions:
  • Drug: brentuximab vedotin
  • Drug: nivolumab
Publications * 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 patients with relapsed or refractory Hodgkin lymphoma. Blood. 2018 Mar 15;131(11):1183-1194. doi: 10.1182/blood-2017-10-811224. Epub 2017 Dec 11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: September 28, 2017)
93
Original Estimated Enrollment  ICMJE
 (submitted: October 7, 2015)
60
Estimated Study Completion Date  ICMJE December 2020
Actual Primary Completion Date March 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02572167
Other Study ID Numbers  ICMJE SGN35-025
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Seattle Genetics, Inc.
Study Sponsor  ICMJE Seattle Genetics, Inc.
Collaborators  ICMJE Bristol-Myers Squibb
Investigators  ICMJE
Study Director: Faith Galderisi, DO Seattle Genetics, Inc.
PRS Account Seattle Genetics, Inc.
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP