Lymphoma. Non-HodgkinPhase 2NCT02038933

Study of Nivolumab in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) That Have Either Failed or Are Not Eligible for Autologous Stem Cell Transplant (CheckMate 139)

A Phase 2 study testing Nivolumab in people with Lymphoma. Non-Hodgkin, run by Bristol-Myers Squibb at 46 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine whether Nivolumab is effective in the treatment of DLBCL in patients that have failed or are ineligible for ASCT Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Lymphoma. Non-Hodgkin
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: 121 participants
Where: 46 sitesin 12 countries
Study dates: 5 Mar 2014to 8 Oct 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

Confirmation of relapsed or refractory DLBCL or transformed lymphoma (TL)
Eastern Cooperative Oncology Group (ECOG) performance status of 0 -1
At least one lesion that measures >1.5 cm
Prior therapy and screening lab criteria must be met
Appropriate contraceptive measures must be taken

Who cannot join

Known central nervous system (CNS) lymphoma
History of interstitial lung disease, prior malignancy, active autoimmune disease, positive test for hepatitis B or hepatitis C virus
Prior allogeneic stem cell transplant (SCT), chest radiation ≤ 24 weeks from study drug, ≥1000 mg of Carmustine Bis-chloroethylnitrosourea (BCNU) as part of pre-transplant conditioning regimen, prior treatment with drug targeting T-cell costimulation or immune checkpoint pathways
Women who are breastfeeding or pregnant

Trial locations and contacts

46 sites in 12 countries.

Country

City, postcode or hospital

46 sites in 12 countries

United States10 sites

Winship Cancer Center
Atlanta, Georgia, 30322
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601
Division Of Hematology & Oncology Ctr. For Health Sciences
Los Angeles, California, 90095
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
Columbia University Medical Center (Cumc)
New York, New York, 10019
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

Other trials in United States

Italy5 sites

Local Institution
Bergamo, 24127
Local Institution
Bologna, 40138
Local Institution
Milan, 20133
Local Institution
Naples, 80131
Local Institution
Roma, 00161

Other trials in Italy

France4 sites

Local Institution
Créteil, 94010
Hopital Saint Eloi
Montpellier, 34295
Local Institution
Pierre-Bénite, 69495
Local Institution
Rennes, 35033

Other trials in France

Germany4 sites

Local Institution
Erlangen, 91054
Local Institution
Essen, 45147
Local Institution
Homburg, 66424
Local Institution
Ulm, 89081

Other trials in Germany

Netherlands4 sites

Local Institution
Amsterdam, 1066 CX
Local Institution
Rotterdam, 3000 CA
Local Institution
Rotterdam, 3075 EA
Local Institution
Utrecht, 3584 CX

Other trials in Netherlands

Spain4 sites

Local Institution
Hospitalet Llobregat- Barcelona, 9908
Local Institution
Madrid, 28009
Hospital Universitario La Paz
Madrid, 28046
Local Institution
Salamanca, 37007

Other trials in Spain

Australia3 sites

Local Institution
Heidelberg, Victoria, 3084
Local Institution
Waratah, New South Wales, NSW 2298
Local Institution
Woodville, South Australia, 5011

Other trials in Australia

Belgium3 sites

Local Institution
B-leuven, 3000
Local Institution
Brussels, 1200
Local Institution
Ghent, 9000

Other trials in Belgium

United Kingdom3 sites

Local Institution
Southampton, Hampshire, SO16 6YD
Local Institution
Sutton, Surrey, SM2 5PT
Local Institution
Withington, Manchester, M20 4BX

Other trials in United Kingdom

Canada2 sites

Local Institution
Montreal, Quebec, H3T 1E2
Local Institution
Montreal, H2X 3E4

Other trials in Canada

Singapore2 sites

Local Institution
Singapore, 119228
Local Institution
Singapore, 169608

Other trials in Singapore

Sweden2 sites

Local Institution
Gothenburg, 413 45
Local Institution
Lund, 221 85

Other trials in Sweden

About this study

Official title: A Single-Arm, Open-Label, Phase 2 Study of Nivolumab (BMS-936558) in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) After Failure of Autologous Stem Cell Transplant (ASCT) or After Failure of At Least Two Prior Multi-Agent Chemotherapy Regimens in Subjects Who Are Not Candidates for ASCT

The purpose of this study is to determine whether Nivolumab is effective in the treatment of DLBCL in patients that have failed or are ineligible for ASCT

Conditions: Lymphoma. Non-Hodgkin
Being tested: Nivolumab
Medical subject headings: Lymphoma, Non-Hodgkin

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 groups in NCT02038933
Study group	Role	What they receive
Nivolumab (3 mg/kg)	Experimental	Nivolumab 3 mg/kg solution intravenously every 2 weeks until progression or unacceptable toxicity Receives: Drug: Nivolumab

What is being measured

The primary outcome is the main question the study is designed to answer.

Objective Response Rate (ORR) Per Independent Radiologic Review Committee (IRRC) Assessment
ORR is defined as the percentage of participants with a Best Overall Response (BOR) of Complete Remission (CR) or Partial Remission (PR), according to the 2007 revised International Working Group (IWG) Criteria for Malignant Lymphoma, , based on IRRC assessment. CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measurable disease and no emergence of new sites
Measured: From first dose until date of documented disease progression or subsequent therapy, whichever occurs first (assesed up to April 2016, approximately 25 months)

Secondary outcomes (7)

Duration of Response (DOR)
DOR is defined as the time from first response (Complete Response (CR) or Partial Response (PR)) to the date of initial objectively documented progression as determined using the 2007 revised IWG Criteria for Malignant Lymphoma, based on Independent Radiology Review Committee (IRRC) assessment, or death due to any cause, whichever occurs first. CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measurable disease and no emergence of new sites.
Measured: From date of first response to the date of documented disease progression or death, whichever occurs first (up to approximately 18 months)
Complete Remission Rate
Complete Remission Rate is defined as the percentage of participants with a Best Overall Response (BOR) of Complete Response (CR) according to the 2007 revised IWG Criteria for Malignant Lymphoma, based on Independent Radiology Review Committee (IRRC) assessment. CR= Disappearance of all evidence of disease, confirmed by PET scan.
Measured: From date of first dose to study completion (up to approximately 78 months)
Duration of Complete Remission
The duration of Complete Remission is defined as the time from first documentation of Complete Response (CR) (which is the date of first negative FDG-PET scan or the date of first documentation of no disease involvement in the bone marrow [if required], whichever occurs later) to the date of initial objectively documented progression as determined using the 2007 IWG criteria, based on Independent Radiology Review Committee (IRRC) assessment, or death due to any cause, whichever occurs first.
CR= Disappearance of all evidence of disease, confirmed by PET scan.
Measured: From time of first documentation of CR to the date of initial documented disease progression or death due to any cause, whichever occurs first (up approximately 14 months)
Partial Remission Rate
Partial Remission rate is defined as the percentage of participants with a Best Overall Response (BOR) of Partial Response (PR) according to the 2007 revised IWG Criteria for Malignant Lymphoma, based on Independent Radiology Review Committee (IRRC) assessment. PR= Regression of measurable disease and no emergence of new sites.
Measured: From date of first dose to study completion (up to approximately 78 months)
Duration of Partial Remission
Duration of Partial Remission is defined as the time from first documentation of Partial Response (PR) to the date of initial objectively documented progression as determined using the 2007 IWG criteria, based on Independent Radiology Review Committee (IRRC) assessment, or death due to any cause, whichever occurs first.
PR= Regression of measurable disease and no emergence of new sites.
Measured: From date of first documentation of PR to date of disease progression or death due to any cause, whichever occurs first (up to approximately 12 months)
Progression Free Survival
Progression Free Survival (PFS) is defined as the time from first dosing date to the date of the first documented progression, as determined by an Independent Radiology Review Committee (IRRC) according to the 2007 revised IWG Criteria for Malignant Lymphoma, or death due to any cause, whichever occurs first.
Measured: From date of first dose to date of documented disease progression or death due to any cause, whichever occurs first (up to approximately 2 months)
Objective Response Rate (ORR) Per Investigator Assessment
ORR is defined as the percentage of participants with a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR), according to investigator assessment.
CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measurable disease and no emergence of new sites.
Measured: From first dose until date of documented disease progression or subsequent therapy, whichever occurs first (up to approximately 30 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Mar 20148 Oct 2020

First posted17 Jan 2014 (estimated)
Study start5 Mar 2014
Primary completion8 Apr 2016
Study completion8 Oct 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 Lymphoma. Non-HodgkinStudies 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: 121 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02038933
Sponsor's protocol ID: CA209-139
Other IDs: 2013-003621-28
Status last verified: Oct 2021
First submitted: 15 Jan 2014
Last updated: 14 Oct 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Ansell SM, Minnema MC, Johnson P, Timmerman JM, Armand P, Shipp MA, Rodig SJ, Ligon AH, Roemer MGM, Reddy N, Cohen JB, Assouline S, Poon M, Sharma M, Kato K, Samakoglu S, Sumbul A, Grigg A. Nivolumab for Relapsed/Refractory Diffuse Large B-Cell Lymphoma in Patients Ineligible for or Having Failed Autologous Transplantation: A Single-Arm, Phase II Study. J Clin Oncol. 2019 Feb 20;37(6):481-489. doi: 10.1200/JCO.18.00766. Epub 2019 Jan 8.
PubMed 30620669

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 14 Oct 2021. 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 Diffuse Large B-Cell Lymphoma (DLBCL) After Failure of Autologous Stem Cell Transplant (ASCT) or After Failure of At Least Two Prior Multi-Agent Chemotherapy Regimens in Subjects Who Are Not Candidates for ASCT
ClinicalTrials.gov ID: NCT02038933
Acronym / sponsor ID: CA209-139
Conditions: Lymphoma. Non-Hodgkin
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 121 participants (actual)
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Study start: 5 Mar 2014 (actual)
Primary completion: 8 Apr 2016 (actual)
Study completion: 8 Oct 2020 (actual)
First posted: 17 Jan 2014 (estimated)
Results: Posted 30 May 2017

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 determine whether Nivolumab is effective in the treatment of DLBCL in patients that have failed or are ineligible for ASCT

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Nivolumab (3 mg/kg)	Experimental	Drug: NivolumabNivolumab 3 mg/kg solution intravenously every 2 weeks until progression or unacceptable toxicity

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Confirmation of relapsed or refractory DLBCL or transformed lymphoma (TL)
Eastern Cooperative Oncology Group (ECOG) performance status of 0 -1
At least one lesion that measures >1.5 cm
Prior therapy and screening lab criteria must be met
Appropriate contraceptive measures must be taken

Key exclusion criteria (4 listed)

Known central nervous system (CNS) lymphoma
History of interstitial lung disease, prior malignancy, active autoimmune disease, positive test for hepatitis B or hepatitis C virus
Prior allogeneic stem cell transplant (SCT), chest radiation ≤ 24 weeks from study drug, ≥1000 mg of Carmustine Bis-chloroethylnitrosourea (BCNU) as part of pre-transplant conditioning regimen, prior treatment with drug targeting T-cell costimulation or immune checkpoint pathways
Women who are breastfeeding or pregnant

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	Nivolumab (3 mg/kg)

Primary outcome

Objective Response Rate (ORR) Per Independent Radiologic Review Committee (IRRC) Assessment
Time frame: From first dose until date of documented disease progression or subsequent therapy, whichever occurs first (assesed up to April 2016, approximately 25 months)
ORR is defined as the percentage of participants with a Best Overall Response (BOR) of Complete Remission (CR) or Partial Remission (PR), according to the 2007 revised International Working Group (IWG) Criteria for Malignant Lymphoma, , based on IRRC assessment. CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measurable disease and no emergence of new sites

7 secondary outcomes

Duration of Response (DOR)
Time frame: From date of first response to the date of documented disease progression or death, whichever occurs first (up to approximately 18 months)
Complete Remission Rate
Time frame: From date of first dose to study completion (up to approximately 78 months)
Duration of Complete Remission
Time frame: From time of first documentation of CR to the date of initial documented disease progression or death due to any cause, whichever occurs first (up approximately 14 months)
Partial Remission Rate
Time frame: From date of first dose to study completion (up to approximately 78 months)
Duration of Partial Remission
Time frame: From date of first documentation of PR to date of disease progression or death due to any cause, whichever occurs first (up to approximately 12 months)
Progression Free Survival
Time frame: From date of first dose to date of documented disease progression or death due to any cause, whichever occurs first (up to approximately 2 months)
Objective Response Rate (ORR) Per Investigator Assessment
Time frame: From first dose until date of documented disease progression or subsequent therapy, whichever occurs first (up to approximately 30 months)

Results and safety

Results posted to the registry on 30 May 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Nivolumab 3mg/kg	121	0

Primary outcome: Objective Response Rate (ORR) Per Independent Radiologic Review Committee (IRRC) Assessment

Time frame: From first dose until date of documented disease progression or subsequent therapy, whichever occurs first (assesed up to April 2016, approximately 25 months). Number (95% Confidence Interval). Unit: Percent of participants

Measure	ASCT-failed n = 87	ASCT-ineligible n = 34
Value	10.3 (4.8 to 18.7)	2.9 (0.1 to 15.3)

Population analysed: All treated participants

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: All-cause mortality was assessed from date of first dose to study completion (up to approximately 79 months). Serious Adverse events and other adverse events were assessed from date of first dose to 100 days following date of last dose (up to approximately 66 months). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
NIVOLUMAB 3 mg/kg	83 of 121 (68.6%)	109 of 121 (90.1%)	98 of 121

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30620669Ansell SM, Minnema MC, Johnson P, Timmerman JM, Armand P, Shipp MA, Rodig SJ, Ligon AH, Roemer MGM, Reddy N, Cohen JB, Assouline S, Poon M, Sharma M, Kato K, Samakoglu S, Sumbul A, Grigg A. Nivolumab for Relapsed/Refractory Diffuse Large B-Cell Lymphoma in Patients Ineligible for or Having Failed Autologous Transplantation: A Single-Arm, Phase II Study. J Clin Oncol. 2019 Feb 20;37(6):481-489. doi: 10.1200/JCO.18.00766. Epub 2019 Jan 8.
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.

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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

46 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. Non-Hodgkin, run by Bristol-Myers Squibb at 46 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 5 inclusion and 4 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 14 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 sites in United States, Italy, France, Germany, Netherlands 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 30 May 2017). 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?

Objective Response Rate (ORR) Per Independent Radiologic Review Committee (IRRC) Assessment (time frame: From first dose until date of documented disease progression or subsequent therapy, whichever occurs first (assesed up to April 2016, approximately 25 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 NCT02038933, 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 14 Oct 2021.