Study of Nivolumab in Subjects With Hodgkin's Lymphoma (Registrational) (CheckMate 205)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2015 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT02181738
First received: July 1, 2014
Last updated: August 19, 2015
Last verified: May 2015
  Purpose

The purpose of this study is to assess the clinical benefit of Nivolumab, as measured by objective response rate (ORR) based on independent radiologic review committee (IRRC) assessment, and defined as proportion of subjects achieving either a partial remission (PR) or complete remission (CR)


Condition Intervention Phase
Hodgkin Disease
Drug: Nivolumab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Non-Comparative, Two-Cohort, Single Arm, Open-Label, Phase 2 Study of Nivolumab (BMS-936558) in Classical Hodgkin Lymphoma (cHL) Subjects After Failure of Autologous Stem Cell Transplant (ASCT)

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Number of subjects with a best overall response (BOR) of CR or PR, according to the 2007 International Working Group (IWG) criteria, based on Independent Radiographic Review Committee assessment, divided by the number of treated subjects [ Time Frame: Up to one year after last patient first treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of response (DOR) [ Time Frame: Up to one year after last patient first treatment ] [ Designated as safety issue: No ]
  • Complete remission (CR) rate and duration [ Time Frame: Up to one year after last patient first treatment ] [ Designated as safety issue: No ]
  • Partial remission (PR) rate and duration [ Time Frame: Up to one year after last patient first treatment ] [ Designated as safety issue: No ]
  • Investigator-assessed Objective Response Rate and Duration of Response [ Time Frame: Up to one year after last patient first treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 240
Study Start Date: July 2014
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nivolumab
Injection Nivolumab 3mg/kg every 2 weeks intravenously until disease progression or toxicity
Drug: Nivolumab
Other Name: BMS-936558

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Must have received prior high-dose conditioning chemotherapy followed by autologous stem cell transplant (ASCT) as a part of salvage therapy for cHL
  • Subjects may be Brentuximab vedotin- naïve, or may have had prior Brentuximab vedotin treatment

Exclusion Criteria:

  • Known central nervous system lymphoma
  • Subjects with nodular lymphocyte-predominant Hodgkin Lymphoma
  • Prior allogeneic stem cell transplantation (SCT)
  • Chest radiation ≤ 24 weeks prior to first dose
  • Carmustine ≥ 600 mg/m² received as part of the pre-transplant conditioning regimen
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02181738

Contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.

  Show 38 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02181738     History of Changes
Other Study ID Numbers: CA209-205, 2014-001509-42
Study First Received: July 1, 2014
Last Updated: August 19, 2015
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Hodgkin Disease
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on August 31, 2015