Study of Nivolumab in Subjects With Relapsed or Refractory Follicular Lymphoma (FL) (CheckMate 140)
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| ClinicalTrials.gov Identifier: NCT02038946 |
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Recruitment Status :
Completed
First Posted : January 17, 2014
Results First Posted : June 12, 2018
Last Update Posted : January 4, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lymphoma | Drug: Nivolumab | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 116 participants |
| Allocation: | N/A |
| 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 26, 2014 |
| Actual Primary Completion Date : | May 17, 2017 |
| Actual Study Completion Date : | December 28, 2020 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Arm 1: Nivolumab
Nivolumab 3 mg/kg injection by Intravenous for every 2 weeks until disease progression or discontinuation due to toxicity
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Drug: Nivolumab
Other Name: BMS-936558 |
- 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 participants 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)
- 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
- 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.
- 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)
- 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.
- 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)
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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
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| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Documents provided by Bristol-Myers Squibb:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT02038946 |
| 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: | January 4, 2022 |
| Last Verified: | December 2021 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Lymphoma Lymphoma, Follicular Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders |
Immune System Diseases Lymphoma, Non-Hodgkin Nivolumab Antineoplastic Agents, Immunological Antineoplastic Agents Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action |