LymphomaPhase 2NCT02038946
Study of Nivolumab in Subjects With Relapsed or Refractory Follicular Lymphoma (FL) (CheckMate 140)
A Phase 2 study testing Nivolumab in people with Lymphoma, run by Bristol-Myers Squibb at 45 sites in 12 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- Nivolumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 45 sitesin 12 countries
- Study dates
- 26 Mar 2014to 28 Dec 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
45 sites in 12 countries.
45 sites in 12 countries
United States12 sites
Winship Cancer Institute.
Atlanta, Georgia, 30322
Beth Israel Deaconess Medical Center (BIDMC)
Boston, Massachusetts, 02215
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Massachusetts General Hospital
Boston, Massachusetts, 02215
Duke University Medical Center
Durham, North Carolina, 27710
MD Anderson Cancer Center
Houston, Texas, 77030
Division Of Hematology & Oncology Ctr. For Health Sciences
Los Angeles, California, 90095
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Weill Cornell Medical College
New York, New York, 10021
Mayo Clinic Arizona
Phoenix, Arizona, 85054
Mayo Clinic
Rochester, Minnesota, 55905
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
Germany5 sites
Universitaetsklinikum Essen
Essen, 45147
Universitaetsklinikum d. Saarlandes
Homburg, 66424
Universitaetsklinikum Des Saarlandes
Homburg, 66424
Local Institution
Regensburg, 93053
Universitaetsklinikum Ulm
Ulm, 89081
Italy5 sites
Local Institution
Bergamo, 24127
Local Institution
Bologna, 40138
Local Institution
Milan, 20133
Local Institution
Naples, 80131
Local Institution
Roma, 00161
France4 sites
Local Institution
Créteil, 94010
Local Institution
Montpellier, 34295
Local Institution
Pierre-Bénite, 69495
Local Institution
Rennes, 35033
Spain4 sites
Hospital Duran I Reynals
Hospitalet Llobregat- Barcelona, 9908
Local Institution
Madrid, 28009
Hospital Universitario La Paz
Madrid, 28046
Local Institution
Salamanca, 37007
Belgium3 sites
Local Institution
B-leuven, 3000
Local Institution
Brussels, 1200
Local Institution
Ghent, 9000
United Kingdom3 sites
Local Institution
Southampton, Hampshire, SO16 6YD
Local Institution
Sutton, Surrey, SM2 5PT
Local Institution
Withington, Manchester, M20 4BX
Australia2 sites
Local Institution
Parkville, Victoria, 3050
Local Institution
Woodville, South Australia, 5011
Canada2 sites
Jewish General Hospital
Montreal, Quebec, H3T 1E2
CISSS du Bas-Saint-Laurent Hopital Regional de Rimouski
Rimouski, Quebec, G5L 5T1
Singapore2 sites
Local Institution
Singapore, 169865
Local Institution
Singapore, 308433
Sweden2 sites
Local Institution
Gothenberg, 413 45
Local Institution
Gothenburg, 413 45
About this study
Official title: A Single Arm, Open-Label Phase 2 Study of Nivolumab (BMS-936558) in Subjects With Relapsed or Refractory Follicular Lymphoma (FL)
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
Also called BMS-936558
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Nivolumab | Experimental | Nivolumab 3 mg/kg injection by Intravenous for every 2 weeks until disease progression or discontinuation due to toxicity Receives: Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR) as Determined by IRRC
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)
Measured: From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months)
Secondary outcomes (5)
Duration of Response (DOR) Based on IRRC Assessments
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
Measured: From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months)
Complete Remission Rate (CRR) Based on IRRC Assessment
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.
Measured: From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months)
Partial Remission (PR) Rate Based on IRRC Assessment
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)
Measured: From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months)
Progression Free Survival (PFS) Based on IRRC Assessment
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.
Measured: From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months)
Overall Response Rate (ORR) Based on Investigator Assessments
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)
Measured: From Week 9 until documented disease progression or study discontinuation (assessed up to June 2017, approximately 38 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2014 (estimated)
- Study start26 Mar 2014
- Primary completion17 May 2017
- Study completion28 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02038946
- Sponsor's protocol ID
- CA209-140
- Other IDs
- 2013-003645-42
- Status last verified
- Dec 2021
- First submitted
- 15 Jan 2014
- Last updated
- 4 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Armand P, Janssens A, Gritti G, Radford J, Timmerman J, Pinto A, Mercadal Vilchez S, Johnson P, Cunningham D, Leonard JP, Rodig SJ, Martin-Regueira P, Sumbul A, Samakoglu S, Tang H, Ansell SM. Efficacy and safety results from CheckMate 140, a phase 2 study of nivolumab for relapsed/refractory follicular lymphoma. Blood. 2021 Feb 4;137(5):637-645. doi: 10.1182/blood.2019004753.
PubMed 32870269
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm, Open-Label Phase 2 Study of Nivolumab (BMS-936558) in Subjects With Relapsed or Refractory Follicular Lymphoma (FL)
- ClinicalTrials.gov ID
- NCT02038946
- Acronym / sponsor ID
- CA209-140
- Conditions
- Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 26 Mar 2014 (actual)
- Primary completion
- 17 May 2017 (actual)
- Study completion
- 28 Dec 2020 (actual)
- First posted
- 17 Jan 2014 (estimated)
- Results
- Posted 12 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Nivolumab | Experimental | Drug: NivolumabNivolumab 3 mg/kg injection by Intravenous for every 2 weeks until disease progression or discontinuation due to toxicity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NivolumabAlso: BMS-936558 | Drug | Arm 1: Nivolumab |
Primary outcome
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)
5 secondary outcomes
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)
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)
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)
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)
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32870269Armand P, Janssens A, Gritti G, Radford J, Timmerman J, Pinto A, Mercadal Vilchez S, Johnson P, Cunningham D, Leonard JP, Rodig SJ, Martin-Regueira P, Sumbul A, Samakoglu S, Tang H, Ansell SM. Efficacy and safety results from CheckMate 140, a phase 2 study of nivolumab for relapsed/refractory follicular lymphoma. Blood. 2021 Feb 4;137(5):637-645. doi: 10.1182/blood.2019004753.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
Related trials for Lymphoma
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
RecruitingPhase 2
Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
Non-hodgkin Lymphoma
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Not yet recruitingPhase 1
Testing the Addition of an Anti-Cancer Drug, Glofitamab, to the Usual Chemotherapy Treatment (Alternating R-CHOP/R-DHAP) for Previously Untreated Mantle Cell Lymphoma
Ann Arbor Stage II Mantle Cell Lymphoma, Ann Arbor Stage III Mantle Cell Lymphoma
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
45 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nivolumab in people with Lymphoma, run by Bristol-Myers Squibb at 45 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in United States, Germany, Italy, France, Spain and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02038946, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2022.