Non-Small Cell Lung CancerPhase 2CheckMate 592NCT03001882

An Exploratory Study of the Effects of Nivolumab Combined With Ipilimumab in Patients With Treatment-Naive Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)

A Phase 2 study testing Nivolumab and Ipilimumab in people with Non-Small Cell Lung Cancer, run by Bristol-Myers Squibb at 35 sites in 8 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 explore the possible links between participant characteristics and their cancer, with how effective the combination of nivolumab with ipilimumab is, in participants with Stage IV or recurrent Non-Small Cell Lung Cancer (NSCLC). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Non-Small Cell Lung Cancer
What is being tested?: Nivolumab and Ipilimumab
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 230 participants
Where: 35 sitesin 8 countries
Study dates: 29 Mar 2017to 24 Apr 2023
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

Histologically confirmed, stage IV or recurrent non-small cell lung cancer with no prior systemic anticancer therapy given as primary therapy for advanced or metastatic disease
Measurable disease by CT or MRI
Must have full activity or, if limited, must be able to walk and carry out light activities such as light house work or office work

Who cannot join

Participants with untreated central nervous system metastases
Participants with active, known or suspected autoimmune disease
Prior treatment with any drug that targets T cell co-stimulations pathways (such as checkpoint inhibitors)
Other protocol defined inclusion/exclusion criteria apply

Trial locations and contacts

35 sites in 8 countries.

Country

City, postcode or hospital

35 sites in 8 countries

United States10 sites

Local Institution - 0009
Atlanta, Georgia, 30322
Local Institution - 0002
Cleveland, Ohio, 44195
Local Institution - 0008
Cleveland, Ohio, 44195
Local Institution - 0007
Greenville, South Carolina, 29607
Local Institution - 0005
Jacksonville, Florida, 32256
Local Institution - 0004
Nashville, Tennessee, 37203
Local Institution - 0001
New Haven, Connecticut, 06520
Local Institution - 0006
Springdale, Arkansas, 72762
Local Institution - 0003
St Louis, Missouri, 63110
Local Institution - 0038
The Bronx, New York, 10461

Other trials in United States

Belgium5 sites

Local Institution - 0018
Ghent, 9000
Local Institution - 0028
Ghent, 9000
Local Institution - 0017
La Louvière, Hainaut, 7100
Local Institution - 0027
Liège, 4000
Local Institution - 0016
Sint-Niklaas, 9100

Other trials in Belgium

France4 sites

Local Institution - 0036
Paris, 75248
Local Institution - 0033
Pierre-Bénite, 69495
Local Institution - 0034
Strasbourg, 67091
Local Institution - 0039
Toulon, 83000

Other trials in France

Germany4 sites

Local Institution - 0015
Essen, 45136
Local Institution - 0014
Immenstadt im Allgäu, 87509
Local Institution - 0013
Löwenstein, 74245
Local Institution - 0012
Stuttgart, 70174

Other trials in Germany

Italy4 sites

Local Institution - 0023
Bergamo, 24127
Local Institution - 0025
Catania, 95123
Local Institution - 0026
Parma, 43100
Local Institution - 0024
Perugia, 06129

Other trials in Italy

Spain4 sites

Local Institution - 0031
Barcelona, 08908
Local Institution - 0029
Madrid, 28041
Local Institution - 0030
Madrid, 28046
Local Institution - 0032
Seville, 41009

Other trials in Spain

Netherlands2 sites

Local Institution - 0021
Amsterdam, 1066 CX
Local Institution - 0022
Nijmegen, 6525 GA

Other trials in Netherlands

Romania2 sites

Local Institution - 0011
Cluj-Napoca, Cluj, 400015
Local Institution - 0010
Craiova, 200542

Other trials in Romania

About this study

Official title: An Exploratory Study of the Biologic Effects and Biomarkers of Nivolumab in Combination With Ipilimumab in Subjects With Treatment-Naive Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)

Conditions: Non-Small Cell Lung Cancer
Being tested: Nivolumab, Ipilimumab
Medical subject headings: Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NivolumabBiological
Also called Opdivo, BMS-936558
Specified dose on specified days
IpilimumabBiological
Also called Yervoy, BMS-734016
Specified dose on specified days

Study groups in NCT03001882
Study group	Role	What they receive
Combination therapy	Experimental	Nivolumab + Ipilimumab Receives: Biological: Nivolumab; Biological: Ipilimumab

What is being measured

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

Objective Response Rate (ORR) Per Investigator by Blood TMB (bTMB) Within PD-L1 Subgroup (TMB Cut-point = 16 Mutations/MB)
Objective response rate (ORR) is defined as the percent of treated participants with a best overall response of a complete response (CR) or partial response (PR) assessed by investigator per Response Evaluation Criteria In Solid Tumors (RECIST 1.1).
PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. CR is disappearance of all target lesions and a reduction in pathological lymph node (whether target or non-target) short axis to <10 mm.
Blood tumor mutational burden (bTMB) is the total number of nonsynonymous somatic mutations produced by a tumor that are detected in serum.
CR+PR, confidence interval based on the Clopper and Pearson method.
Measured: From first dose up to the date of objectively documented progression, or the date of initiation of palliative local therapy or the date of initiation of subsequent anticancer therapy (up to approximately 58 months)
Objective Response Rate (ORR) Per Investigator by Blood TMB (bTMB) Within PD-L1 Subgroup (Blood TMB Cut-point = 21-mutations/MB)
Objective response rate (ORR) is defined as the percent of treated participants with a best overall response of a complete response (CR) or partial response (PR) assessed by investigator per Response Evaluation Criteria In Solid Tumors (RECIST 1.1).
PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. CR is disappearance of all target lesions and a reduction in pathological lymph node (whether target or non-target) short axis to <10 mm.
Blood tumor mutational burden (bTMB) is the total number of nonsynonymous somatic mutations produced by a tumor that are detected in serum.
CR+PR, confidence interval based on the Clopper and Pearson method.
Measured: From first dose up to the date of objectively documented progression, or the date of initiation of palliative local therapy or the date of initiation of subsequent anticancer therapy (up to approximately 58 months)
Objective Response Rate (ORR) Per Investigator by Tissue TMB Within PD-L1 Subgroup (Tissue TMB Cut-point = 10-mutations/MB)
Objective response rate (ORR) is defined as the percent of treated participants with a best overall response of a complete response (CR) or partial response (PR) assessed by investigator per Response Evaluation Criteria In Solid Tumors (RECIST 1.1).
PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. CR is disappearance of all target lesions and a reduction in pathological lymph node (whether target or non-target) short axis to <10 mm.
Tissue tumor mutational burden (tTMB) is the total number of nonsynonymous somatic mutations produced by a tumor that are detected in tumor tissue samples.
CR+PR, confidence interval based on the Clopper and Pearson method.
Measured: From first dose up to the date of objectively documented progression, or the date of initiation of palliative local therapy or the date of initiation of subsequent anticancer therapy (up to approximately 58 months)

Secondary outcomes (9)

Objective Response Rate (ORR) for All Treated Participants by Investigator Per RECIST 1.1
Objective response rate (ORR) is defined as the percent of treated participants with a best overall response of a complete response (CR) or partial response (PR) assessed by investigator per Response Evaluation Criteria In Solid Tumors (RECIST 1.1).
Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Complete Response (CR) is disappearance of all target lesions and a reduction in pathological lymph node (whether target or non-target) short axis to <10 mm.
CR+PR, confidence interval based on the Clopper and Pearson method.
Measured: From first dose until the date of objectively documented progression, or the date of initiation of palliative local therapy or the date of initiation of subsequent anticancer therapy, whichever occurs first (Up to approximately 67 months)
Disease Control Rate (DCR) for Part 1
Disease control rate (DCR) is the percent of treated participants with a best overall response of a complete response (CR), partial response (PR), or stable disease (SD), assessed by investigator per Response Evaluation Criteria In Solid Tumors (RECIST 1.1).
PR is at least a 30% decrease in the sum of diameters of target lesions, using the baseline sum diameters as reference. CR is disappearance of all target lesions and a reduction in short axis to <10 mm of any pathological lymph nodes (target or non-target). SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking smallest sum diameters as reference. PD is at least a 20% increase in the sum of diameters of target lesions, taking the smallest sum as reference. The sum must also demonstrate an absolute increase of at least 5 mm. (one or more new lesions is also considered progression). CR+PR, confidence interval based on the Clopper and Pearson method.
Measured: From first dose until the date of objectively documented progression, or the date of initiation of palliative local therapy or the date of initiation of subsequent anticancer therapy, whichever occurs first (Up to approximately 67 months)
Duration of Response (DOR) for Part 1
DOR is the time between first confirmed response (Complete/Partial Response) and first documented tumor progression (per RECIST 1.1) or death due to any cause. Participants who don't progress or die are censored on the date of their last evaluable tumor assessment. Participants who started subsequent anti-cancer therapy without prior reported progression were censored at the last evaluable tumor assessment prior to or on the date of subsequent anti-cancer therapy.
PR is at least 30% decrease in the sum of diameters of target lesions, using baseline sum diameters as reference. CR is disappearance of all target lesions and reduction in short axis to <10 mm of any pathological lymph nodes (target or non-target). Progressive Disease (PD) is at least 20% increase in the sum of diameters of target lesions, taking the smallest sum as reference. The sum must also show an overall increase of > 5 mm. (one or more new lesions is also progression). Median computed using Kaplan-Meier method.
Measured: From first dose to the date of the first documented tumor progression or death due to any cause (Up to approximately 67 months)
Time to Response (TTR) for Part 1
TTR is the time taken from first dosing date to the time the criteria for Complete Response (CR)/Partial Response (PR) are first met.
Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Complete Response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
Measured: From first dose to the time the criteria for Complete Response/Partial Response are first met (Up to approximately 67 months)
Progression Free Survival (PFS)
PFS is defined as the time from first dosing date to the date of the first documented tumor progression (per RECIST 1.1) or death due to any cause.
Participants who neither progress nor die will be censored on the date of their last evaluable tumor assessment. Participants who started any subsequent anti-cancer therapy without a prior reported progression will be censored at the last evaluable tumor assessment prior to or on the date of initiation of subsequent anti-cancer therapy.
Progressive Disease (PD) is at least a 20% increase in the sum of diameters of target lesions, taking the smallest sum on study as reference. The sum must also show an overall increase of > 5 mm. (one or more new lesions is also progression).
Median calculated using Kaplan-Meier estimates.
Measured: From first dose to the date of the first documented tumor progression or death due to any causes (Assessed up to approximately 67 months)
Overall Survival (OS)
OS is defined as the time from first dosing date to the date of death. If a participant didn't die, OS will be censored on the last date the participant was known to be alive.
Median based on Kaplan-Meier estimates.
Measured: From first dose to the date of death (Assessed up to approximately 67 months)
Number of Participants With Adverse Events (AEs) for Study Part 2
An Adverse Event (AE) is any new untoward medical occurrence or worsening preexisting medical condition in a treated participant and that does not necessarily have a causal relationship with treatment.
An AE can be any unfavorable, unintended sign, symptom, or disease temporally associated with the use of treatment, whether or not related to the treatment.
Measured: From first dose to 30 days after last dosing date (assessed up to approximately 27 months)
Number of Participants With Serious Adverse Events (SAEs) for Study Part 2
A Serious Adverse Event (SAE) results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), or requires inpatient hospitalization or causes prolongation of existing hospitalization.
Measured: From first dose to 30 days after last dosing date (assessed up to approximately 27 months)
Number of Participants With Select Adverse Events (AEs) for Study Part 2
An Adverse Event (AE) is any new untoward medical occurrence or worsening preexisting medical condition in a treated participant and that does not necessarily have a causal relationship with treatment.
An AE can be any unfavorable, unintended sign, symptom, or disease temporally associated with the use of treatment, whether or not related to the treatment.
Measured: From first dose to 30 days after last dosing date (up to approximately 27 months)

Timeline

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

29 Mar 201724 Apr 2023

First posted23 Dec 2016 (estimated)
Study start29 Mar 2017
Primary completion17 Feb 2022
Study completion24 Apr 2023

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 Non-Small Cell Lung CancerStudies 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: 230 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03001882
Sponsor's protocol ID: CA209-592
Other IDs: 2018-000462-11, 2018
Acronym: CheckMate 592
Status last verified: Apr 2024
First submitted: 21 Dec 2016
Last updated: 20 May 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Smit J, Borm FJ, Gerards NR, Wiegers SE, Holden D, Leung D, Grootendorst DJ, Windhorst B, Nabulsi N, Cai Z, Huang Y, Carson RE, Gettinger S, Smit EF, Boellaard R, de Langen AJ. PD-L1 PET/CT imaging with 18F-BMS-986,229 and 18F-BMS-986,192 in patients with advanced-stage non-small cell lung cancer. Eur J Nucl Med Mol Imaging. 2026 Sep 29. doi: 10.1007/s00259-026-08188-4. Online ahead of print.
PubMed 42809016

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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All Non-Small Cell Lung Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Exploratory Study of the Biologic Effects and Biomarkers of Nivolumab in Combination With Ipilimumab in Subjects With Treatment-Naive Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)
ClinicalTrials.gov ID: NCT03001882
Acronym / sponsor ID: CheckMate 592 / CA209-592
Conditions: Non-Small Cell Lung Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 230 participants (actual)
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Collaborators: Yale University
Study start: 29 Mar 2017 (actual)
Primary completion: 17 Feb 2022 (actual)
Study completion: 24 Apr 2023 (actual)
First posted: 23 Dec 2016 (estimated)
Results: Posted 6 Jun 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

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

Arm	Type	Receives
Combination therapy	Experimental	Biological: Nivolumab, Biological: IpilimumabNivolumab + Ipilimumab

Who may qualify

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

Key inclusion criteria (3 listed)

Histologically confirmed, stage IV or recurrent non-small cell lung cancer with no prior systemic anticancer therapy given as primary therapy for advanced or metastatic disease
Measurable disease by CT or MRI
Must have full activity or, if limited, must be able to walk and carry out light activities such as light house work or office work

Key exclusion criteria (4 listed)

Participants with untreated central nervous system metastases
Participants with active, known or suspected autoimmune disease
Prior treatment with any drug that targets T cell co-stimulations pathways (such as checkpoint inhibitors)
Other protocol defined inclusion/exclusion criteria apply

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: Opdivo, BMS-936558Specified dose on specified days	Biological	Combination therapy
IpilimumabAlso: Yervoy, BMS-734016Specified dose on specified days	Biological	Combination therapy

Primary outcome

Objective Response Rate (ORR) Per Investigator by Blood TMB (bTMB) Within PD-L1 Subgroup (TMB Cut-point = 16 Mutations/MB)
Time frame: From first dose up to the date of objectively documented progression, or the date of initiation of palliative local therapy or the date of initiation of subsequent anticancer therapy (up to approximately 58 months)
Objective response rate (ORR) is defined as the percent of treated participants with a best overall response of a complete response (CR) or partial response (PR) assessed by investigator per Response Evaluation Criteria In Solid Tumors (RECIST 1.1). PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. CR is disappearance of all target lesions and a reduction in pathological lymph node (whether target or non-target) short axis to <10 mm. Blood tumor mutational burden (bTMB) is the total number of nonsynonymous somatic mutations produced by a tumor that are detected in serum. CR+PR, confidence interval based on the Clopper and Pearson method.
Objective Response Rate (ORR) Per Investigator by Blood TMB (bTMB) Within PD-L1 Subgroup (Blood TMB Cut-point = 21-mutations/MB)
Time frame: From first dose up to the date of objectively documented progression, or the date of initiation of palliative local therapy or the date of initiation of subsequent anticancer therapy (up to approximately 58 months)
Objective response rate (ORR) is defined as the percent of treated participants with a best overall response of a complete response (CR) or partial response (PR) assessed by investigator per Response Evaluation Criteria In Solid Tumors (RECIST 1.1). PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. CR is disappearance of all target lesions and a reduction in pathological lymph node (whether target or non-target) short axis to <10 mm. Blood tumor mutational burden (bTMB) is the total number of nonsynonymous somatic mutations produced by a tumor that are detected in serum. CR+PR, confidence interval based on the Clopper and Pearson method.
Objective Response Rate (ORR) Per Investigator by Tissue TMB Within PD-L1 Subgroup (Tissue TMB Cut-point = 10-mutations/MB)
Time frame: From first dose up to the date of objectively documented progression, or the date of initiation of palliative local therapy or the date of initiation of subsequent anticancer therapy (up to approximately 58 months)
Objective response rate (ORR) is defined as the percent of treated participants with a best overall response of a complete response (CR) or partial response (PR) assessed by investigator per Response Evaluation Criteria In Solid Tumors (RECIST 1.1). PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. CR is disappearance of all target lesions and a reduction in pathological lymph node (whether target or non-target) short axis to <10 mm. Tissue tumor mutational burden (tTMB) is the total number of nonsynonymous somatic mutations produced by a tumor that are detected in tumor tissue samples. CR+PR, confidence interval based on the Clopper and Pearson method.

9 secondary outcomes

Objective Response Rate (ORR) for All Treated Participants by Investigator Per RECIST 1.1
Time frame: From first dose until the date of objectively documented progression, or the date of initiation of palliative local therapy or the date of initiation of subsequent anticancer therapy, whichever occurs first (Up to approximately 67 months)
Disease Control Rate (DCR) for Part 1
Time frame: From first dose until the date of objectively documented progression, or the date of initiation of palliative local therapy or the date of initiation of subsequent anticancer therapy, whichever occurs first (Up to approximately 67 months)
Duration of Response (DOR) for Part 1
Time frame: From first dose to the date of the first documented tumor progression or death due to any cause (Up to approximately 67 months)
Time to Response (TTR) for Part 1
Time frame: From first dose to the time the criteria for Complete Response/Partial Response are first met (Up to approximately 67 months)
Progression Free Survival (PFS)
Time frame: From first dose to the date of the first documented tumor progression or death due to any causes (Assessed up to approximately 67 months)
Overall Survival (OS)
Time frame: From first dose to the date of death (Assessed up to approximately 67 months)
Number of Participants With Adverse Events (AEs) for Study Part 2
Time frame: From first dose to 30 days after last dosing date (assessed up to approximately 27 months)
Number of Participants With Serious Adverse Events (SAEs) for Study Part 2
Time frame: From first dose to 30 days after last dosing date (assessed up to approximately 27 months)
Number of Participants With Select Adverse Events (AEs) for Study Part 2
Time frame: From first dose to 30 days after last dosing date (up to approximately 27 months)

Results and safety

Results posted to the registry on 6 Jun 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PART 1: PD-L1+ Status	31	0
PART 1: PD-L1- Status	28	0
PART 1: Not Evaluable/Indeterminate PD-L1 Status	1	0
PART 2: PD-L1 Status Independent	170	0

Primary outcome: Objective Response Rate (ORR) Per Investigator by Blood TMB (bTMB) Within PD-L1 Subgroup (TMB Cut-point = 16 Mutations/MB)

Time frame: From first dose up to the date of objectively documented progression, or the date of initiation of palliative local therapy or the date of initiation of subsequent anticancer therapy (up to approximately 58 months). Number (95% Confidence Interval). Unit: Percent of Participants

Measure	PART 1: PD-L1 + Status n = 19	PART 1: PD-L1- Status n = 16	PART 1: Not Evaluable/Indeterminate PD-L1 Status n = 0	PART 2: PD-L1+ Status n = 39	PART 2: PD-L1- Status n = 62
bTMB High (Cut-point = 16-mutations)	30 (6.7 to 65.2)	50 (18.7 to 81.3)	–	58.8 (32.9 to 81.6)	30.3 (15.6 to 48.7)
bTMB Low (Cut-point = 16-mutations)	33.3 (7.5 to 70.1)	33.3 (4.3 to 77.7)	–	31.8 (13.9 to 54.9)	24.1 (10.3 to 43.5)

Population analysed: All treated PD-L1 and bTMB evaluable Part 1 and 2 participants (Blood TMB Cut-point = 16 mutations/MB). Non-evaluable PD-L1 status means that PD-L1 status could not be determined, thus the Arm population did not meet this criteria. Participants in Part 2: PD-L1(+/-) Status groups were stratified from the PART 2: PD-L1 Status Independent Arm. Not all participants were bTMB evaluable. To be analyzed participants had to be both PD-L1 evaluable and bTMB evaluable.

Primary outcome: Objective Response Rate (ORR) Per Investigator by Blood TMB (bTMB) Within PD-L1 Subgroup (Blood TMB Cut-point = 21-mutations/MB)

Measure	PART 1: PD-L1+ Status n = 19	PART 1: PD-L1- Status n = 16	PART 1: Not Evaluable/Indeterminate PD-L1 Status n = 0	PART 2: PD-L1 + Status n = 39	PART 2: PD-L1- Status n = 62
bTMB High (Cut-point = 21-mutations)	33.3 (4.3 to 77.7)	66.7 (22.3 to 95.7)	–	64.3 (35.1 to 87.2)	40.9 (20.7 to 63.6)
bTMB Low (Cut-point = 21-mutations)	30.8 (9.1 to 61.4)	30.0 (6.7 to 65.2)	–	32.0 (14.9 to 53.5)	20.0 (9.1 to 35.6)

Population analysed: All treated PD-L1 and bTMB evaluable Part 1 and Part 2 participants (Blood TMB Cut-point = 21-mutations/MB). Non-evaluable PD-L1 status means that PD-L1 status could not be determined, thus the Arm population did not meet this criteria. Participants in Part 2: PD-L1(+/-) Status groups were stratified from the PART 2: PD-L1 Status Independent Arm. Not all participants were bTMB evaluable. To be analyzed participants had to be both PD-L1 evaluable and bTMB evaluable.

Primary outcome: Objective Response Rate (ORR) Per Investigator by Tissue TMB Within PD-L1 Subgroup (Tissue TMB Cut-point = 10-mutations/MB)

Measure	PART 1: PD-L1+ Status n = 19	PART 1: PD-L1- Status n = 16	PART 1: Not Evaluable/Indeterminate PD-L1 Status n = 0	PART 2: PD-L1 + Status n = 31	PART 2: PD-L1- Status n = 57
tTMB High (Cut-point = 10-mutations)	25.0 (3.2 to 65.1)	71.4 (29.0 to 96.3)	–	60.0 (32.3 to 83.7)	46.7 (21.3 to 73.4)
tTMB Low (Cut-point = 10-mutations	27.3 (6.0 to 61.0)	22.2 (2.8 to 60.0)	–	25.0 (7.3 to 52.4)	21.4 (10.3 to 36.8)

Population analysed: All treated PD-L1 and bTMB evaluable Part 1 and Part 2 participants (Blood TMB Cut-point = 10-mutations/MB). Non-evaluable PD-L1 status means that PD-L1 status could not be determined, thus the Arm population did not meet this criteria. Participants in Part 2: PD-L1(+/-) Status groups were stratified from the PART 2: PD-L1 Status Independent Arm. Not all participants were bTMB evaluable. To be analyzed participants had to be both PD-L1 evaluable and bTMB evaluable.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 67 months.) SAEs and Other AEs was assessed from first dose to 100 days post the last dose of study therapy (up to approximately an average of 8 months and a maximum of 29 months).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PART 1: PD-L1+ Status	24 of 31 (77.4%)	31 of 31 (100%)	27 of 31
PART 1: PD-L1- Status	14 of 28 (50%)	27 of 28 (96.4%)	22 of 28
PART 1: Not Evaluable/Indeterminate PD-L1 Status	0 of 1 (0%)	1 of 1 (100%)	1 of 1
PART 2: PD-L1 Status Independent	113 of 170 (66.5%)	161 of 170 (94.7%)	134 of 170

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42809016Smit J, Borm FJ, Gerards NR, Wiegers SE, Holden D, Leung D, Grootendorst DJ, Windhorst B, Nabulsi N, Cai Z, Huang Y, Carson RE, Gettinger S, Smit EF, Boellaard R, de Langen AJ. PD-L1 PET/CT imaging with 18F-BMS-986,229 and 18F-BMS-986,192 in patients with advanced-stage non-small cell lung cancer. Eur J Nucl Med Mol Imaging. 2026 Sep 29. doi: 10.1007/s00259-026-08188-4. Online ahead of print.
BMS Clinical Trial InformationLink provided by the sponsor.
BMS Clinical Trial Patient RecruitingLink 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

35 sites in 8 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nivolumab and Ipilimumab in people with Non-Small Cell Lung Cancer, run by Bristol-Myers Squibb at 35 sites in 8 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 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 20 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in United States, Belgium, France, Germany, Italy and 3 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 6 Jun 2023). 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 Investigator by Blood TMB (bTMB) Within PD-L1 Subgroup (TMB Cut-point = 16 Mutations/MB) (time frame: From first dose up to the date of objectively documented progression, or the date of initiation of palliative local therapy or the date of initiation of subsequent anticancer therapy (up to approximately 58 months)). The study lists 3 primary outcomes in all. 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 NCT03001882, 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 20 May 2024.