A Study of Nivolumab Plus Brentuximab Vedotin Versus Brentuximab Vedotin Alone in Patients With Advanced Stage Classical Hodgkin Lymphoma, Who Are Relapsed/ Refractory or Who Are Not Eligible for Autologous Stem Cell Transplant, (CheckMate 812)

• ClinicalTrials.gov Identifier: NCT03138499
• Recruitment Status: Active, not recruiting
• First Posted: May 3, 2017
• Last Update Posted: October 28, 2019
• Sponsor: Bristol-Myers Squibb
• Collaborators: Seattle Genetics, Inc.; Ono Pharmaceutical Co. Ltd
• Information provided by (Responsible Party): Bristol-Myers Squibb

Tracking Information

• First Submitted Date: May 1, 2017
• First Posted Date: May 3, 2017
• Last Update Posted Date: October 28, 2019
• Actual Study Start Date: May 16, 2017
• Estimated Primary Completion Date: November 29, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 1, 2017)

Progression Free Survival (PFS) [ Time Frame: Up to four years ]

To compare progression free survival of nivolumab + Brentuximab vedotin (BV) versus BV based on Blinded Independent Central Review (BICR) assessments

• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT03138499 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: May 1, 2017)

• Complete Response Rate (CRR) [ Time Frame: Up to four years ]
  To compare the complete response rate of nivolumab + BV versus BV based on BICR assessments
• Objective Response Rate (ORR) [ Time Frame: Up to four years ]
  To assess objective response rate and duration of response based on BICR
• Duration of response (DOR) [ Time Frame: Up to four years ]
  To assess duration of response based on BICR
• Duration of complete response (DOCR) [ Time Frame: Up to four years ]
  To assess duration of complete response based on BICR
• Overall Survival (OS) [ Time Frame: Up to four years ]
  To assess overall survival of participants treated with nivolumab + BV versus BV
• Progression Free Survival (PFS) [ Time Frame: Up to four years ]
  To assess PFS based on investigator assessments

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study of Nivolumab Plus Brentuximab Vedotin Versus Brentuximab Vedotin Alone in Patients With Advanced Stage Classical Hodgkin Lymphoma, Who Are Relapsed/ Refractory or Who Are Not Eligible for Autologous Stem Cell Transplant,
• Official Title: Randomized, Open-label, Phase 3 Trial of Nivolumab Plus Brentuximab Vedotin Versus Brentuximab Vedotin Alone in Participants With Relapsed Refractory or Ineligible for Autologous Stem Cell Transplant (ASCT) Advanced Stage Classical Hodgkin Lymphoma (CheckMate 812: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 812)
• Brief Summary: The purpose of this study is to determine whether an investigational immuno-therapy combination, nivolumab with Brentuximab vedotin compared to Brentuximab vedotin alone is safe and effective in the treatment of relapsed and refractory Classical Hodgkin Lymphoma. The participants of this trial will comprise of patients who have relapsed or did not respond to treatment and are not eligible for stem cell transplant
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Hodgkin's Disease

Intervention

• Biological: Nivolumab
  Specified dose on specified days
  Other Name: Opdivo
• Biological: Brentuximab vedotin
  Specified dose on specified days
  Other Name: Adcetris

Study Arms

• Experimental: Module A
  Nivolumab combined with Brentuximab
  Interventions:

  • Biological: Nivolumab
  • Biological: Brentuximab vedotin
• Experimental: Module B
  Brentuximab alone
  Intervention: Biological: Brentuximab vedotin

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: May 1, 2017): 340
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 27, 2023
• Estimated Primary Completion Date: November 29, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
• Participants must have a pathologic diagnosis of classical Hodgkin lymphoma (cHL) who are relapsed or refractory with one of the following:

I. Autologous stem cell transplant (ASCT) ineligible patients

ii. Patients after failure of ASCT

• Must have at least one lesion that is > 15 mm (1.5 cm) in the longest diameter and avid by Fluoro Deoxy Glucose (FDG) Positron Emission Tomography (PET) scan

Exclusion Criteria:

• Known central nervous system lymphoma
• Participants with nodular lymphocyte-predominant Hodgkin lymphoma (HL)
• Participants with known history of pancreatitis or progressive multifocal leukoencephalopathy (PML)

Other protocol defined inclusion/exclusion criteria could apply

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Japan, Puerto Rico, United States
• Removed Location Countries: Australia, Czechia, Hungary, Italy, Turkey

Administrative Information

• NCT Number: NCT03138499
• Other Study ID Numbers: CA209-812; 2017-000847-41 ( EudraCT Number )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Responsible Party: Bristol-Myers Squibb
• Study Sponsor: Bristol-Myers Squibb

Collaborators

• Seattle Genetics, Inc.
• Ono Pharmaceutical Co. Ltd

Investigators

• Study Director: Bristol-Myers Squibb; Bristol-Myers Squibb

• PRS Account: Bristol-Myers Squibb
• Verification Date: October 2019