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

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ClinicalTrials.gov Identifier: NCT02038946
Recruitment Status : Active, not recruiting
First Posted : January 17, 2014
Results First Posted : June 12, 2018
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
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 FL lymphoma who have failed therapy with both CD20 antibody and an alkylating agent.

Condition or disease Intervention/treatment Phase
Lymphoma Drug: Nivolumab Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 116 participants
Intervention Model: Single Group Assignment
Masking: None (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)
Actual Study Start Date : March 6, 2014
Actual Primary Completion Date : May 17, 2017
Estimated Study Completion Date : April 8, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Nivolumab

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Overall Response Rate (ORR) as Determined by IRRC [ Time Frame: From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months) ]

    ORR is determined by an independent radiologic review committee (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) and expressed as a percentage of all treated participants.

    CR=Disappearance of all clinical/radiographic evidence of disease, regression of lymph nodes to normal size, absence of spleen, liver, and bone marrow involvement.

    PR=Regression of measurable disease and no new sites; no increase in size of liver or spleen. >=50% decrease in SPD of up to 6 largest dominant masses (index lesions); no increase in size of other nodes (non-index lesions)



Secondary Outcome Measures :
  1. Duration of Response (DOR) Based on IRRC Assessments [ Time Frame: From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months) ]

    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.

    CR definition includes the complete disappearance of all evidence of disease, the definition of PR includes at least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses, and PD is defined as any new lesion or increase by >50% of previously involved sites from nadir, as described in the IWG response criteria


  2. Complete Remission Rate (CRR) Based on IRRC Assessment [ Time Frame: From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months) ]

    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 participants and expressed as a percentage.

    CR=Disappearance of all clinical/radiographic evidence of disease, regression of lymph nodes to normal size, absence of spleen, liver, and bone marrow involvement.


  3. Partial Remission (PR) Rate Based on IRRC Assessment [ Time Frame: From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months) ]

    PR rate is defined as the number of participants with a best overall response (BOR) of PR according to the 2007 International Working Group (IWG) criteria, based on IRRC assessment, divided by the number of treated participants and expressed as a percentage.

    PR=Regression of measurable disease and no new sites; no increase in size of liver or spleen. >=50% decrease in SPD of up to 6 largest dominant masses (index lesions); no increase in size of other nodes (non-index lesions)


  4. Progression Free Survival (PFS) Based on IRRC Assessment [ Time Frame: From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months) ]
    PFS was summarized descriptively using the Kaplan-Meier (KM) product-limit method. Median values of PFS, along with the two-sided 95% CIs were calculated using a method based on log-log transformation.

  5. Overall Response Rate (ORR) Based on Investigator Assessments [ Time Frame: From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months) ]

    ORR is determined by investigator assessments 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) and is expressed as a percentage of all treated participants.

    CR=Disappearance of all clinical/radiographic evidence of disease, regression of lymph nodes to normal size, absence of spleen, liver, and bone marrow involvement.

    PR=Regression of measurable disease and no new sites; no increase in size of liver or spleen. >=50% decrease in SPD of up to 6 largest dominant masses (index lesions); no increase in size of other nodes (non-index lesions)




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 CD20 antibody 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 stem cell transplant
  • Prior autologous stem cell transplant ≤12 weeks prior to first dose of study drug

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02038946


  Show 43 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  Study Documents (Full-Text)

Documents provided by Bristol-Myers Squibb:
Study Protocol  [PDF] December 6, 2013
Statistical Analysis Plan  [PDF] June 27, 2017


Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02038946     History of Changes
Other Study ID Numbers: CA209-140
2013-003645-42 ( EudraCT Number )
First Posted: January 17, 2014    Key Record Dates
Results First Posted: June 12, 2018
Last Update Posted: November 14, 2018
Last Verified: October 2018

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

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Nivolumab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs