Study of Nivolumab in Subjects With Relapsed or Refractory Follicular Lymphoma (FL) (CheckMate 140)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT02038946
First received: January 15, 2014
Last updated: August 11, 2014
Last verified: June 2014
  Purpose

The purpose of this study is to assess the clinical benefit of Nivolumab, as measured by independent radiologic review committee (IRRC)-assessed objective response rate (ORR) in subjects with Follicular Lymphoma (FL) who have failed therapy with both Rituximab and an Alkylating agent.


Condition Intervention Phase
Lymphoma. Non-Hodgkin
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: A Single Arm, Open-Label Phase 2 Study of Nivolumab (BMS-936558) in Subjects With Relapsed or Refractory Follicular Lymphoma (FL)

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Overall response rate (ORR) as determined by IRRC [ Time Frame: Approximately up to 24 months ] [ Designated as safety issue: No ]
    ORR is determined by an IRRC according to the revised International Working Group Criteria for non-Hodgkin Lymphoma. ORR is defined as the number of subjects with a best overall response (BOR) of complete response (CR) or partial response (PR)


Secondary Outcome Measures:
  • The duration of response (DOR) based on IRRC assessments [ Time Frame: Approximately up to 24 months ] [ Designated as safety issue: No ]
    DOR is defined as the time from first remission (CR or PR) to the date of initial objectively documented progression as determined using the revised International Working Group Criteria for non-Hodgkin Lymphoma or death due to any cause, whichever occurs first

  • The complete remission rate (CRR) based on IRRC assessment [ Time Frame: Approximately up to 24 months ] [ Designated as safety issue: No ]
    CRR is defined as the number of subjects with a BOR of CR according to the revised International Working Group Criteria for non-Hodgkin Lymphoma, divided by the number of treated subjects

  • The progression free survival (PFS) based on IRRC assessment [ Time Frame: Approximately up to 24 months ] [ Designated as safety issue: No ]
    PFS is defined as the time from first dosing date to the date of the first documented progression, as determined by an IRRC, or death due to any cause, whichever occurs first

  • Overall response rate based on investigator assessments [ Time Frame: Approximately up to 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: March 2014
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1: Nivolumab
Nivolumab 3 mg/kg injection by Intravenous for every 2 weeks until disease progression or discontinuation due to 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:

  • Grade 1, 2, or 3a FL without pathologic evidence of transformation
  • Male and female, ages 18 and above, with relapsed or refractory FL lymphoma after > or = 2 prior treatment lines; each of the 2 prior treatment lines must include at least Rituximab and/or an Alkylating agent Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1

Exclusion Criteria:

  • Known central nervous system lymphoma
  • History of interstitial lung disease
  • Subjects with active, known or suspected autoimmune disease
  • Prior allogeneic or autologous stem cell transplant
  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: NCT02038946

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 43 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: NCT02038946     History of Changes
Other Study ID Numbers: CA209-140, 2013-003645-42
Study First Received: January 15, 2014
Last Updated: August 11, 2014
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Paul-Ehrlich-Institut
Italy: Ministry of Health
Norway: Norwegian Medicines Agency
Singapore: Health Sciences Authority
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
United Kingdom: Department of Health

Additional relevant MeSH terms:
Lymphoma, Follicular
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on September 18, 2014