Non-small Cell Lung CancerPhase 2NCT04623775
A Study of Relatlimab Plus Nivolumab in Combination With Chemotherapy vs. Nivolumab in Combination With Chemotherapy as First Line Treatment for Participants With Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC)
A Phase 2 study testing Nivolumab, Relatlimab and Carboplatin in people with Non-small Cell Lung Cancer and Recurrent Non-small Cell Lung Cancer, run by Bristol-Myers Squibb at 125 sites in 19 countries.
Trial summary
The purpose of this study is to assess the safety profile of relatlimab plus nivolumab in combination with platinum doublet chemotherapy (PDCT) and to determine if nivolumab plus relatlimab in combination with PDCT improves overall response rate (ORR) when compared to nivolumab plus PDCT in participants with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer, Recurrent Non-small Cell Lung Cancer, Metastatic Non-small Cell Lung Cancer
- What is being tested?
- Nivolumab, Relatlimab and Carboplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 468 participants
- Where
- 125 sitesin 19 countries
- Study dates
- 17 Feb 2021to 6 May 2026
- Phase
- Phase 2
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 metastatic non-small cell lung cancer (NSCLC) of squamous (SQ) or non-squamous (NSQ) histology with Stage IV A/B (as defined by the 8th International Association for the Study of Lung Cancer Classification) or recurrent disease following multi-modal therapy for locally advanced disease.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of less than or equal to 1 at screening and confirmed prior to randomization.
- Measurable disease by computed tomography (CT) or magnetic resonance resources (MRI) per response evaluation criteria in solid tumor version 1.1 (RECIST 1.1) criteria.
- No prior systemic anti-cancer treatment (including epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) inhibitors) given as primary therapy for advanced or metastatic disease.
Who cannot join
- Participants with EGFR, ALK, ROS-1, or known B-rapidly accelerated fibrosarcoma proto-oncogene (BRAF V600E) mutations that are sensitive to available targeted therapy.
- Untreated CNS metastases.
- Leptomeningeal metastases (carcinomatous meningitis).
- Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to randomization (ie, participants with a history of prior malignancy are eligible if treatment was completed at least 2 years before randomization and the participant has no evidence of disease).
- Prior treatment with an anti-programmed cell death protein 1 (PD-1), anti-programmed death-ligand 1 (PD-L1), anti-programmed death-ligand 2 (PD-L2), or anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Trial locations and contacts
125 sites in 19 countries.
125 sites in 19 countries
United States29 sites
Local Institution - 0089
Athens, Georgia, 30607
Local Institution - 0156
Cincinnati, Ohio, 45219
Local Institution - 0155
Cleveland, Ohio, 44109
Local Institution - 0149
Dallas, Texas, 75390-9179
Local Institution - 0160
Duarte, California, 91010
Local Institution - 0117
Durham, North Carolina, 27710
Local Institution - 0083
Greenville, South Carolina, 29607
Local Institution - 0091
Harlingen, Texas, 78550
Local Institution - 0152
Howell Township, New Jersey, 07731
Local Institution - 0153
Jacksonville, Florida, 32204
Local Institution - 0124
Johnson City, New York, 13790
Local Institution - 0084
Lancaster, Pennsylvania, 17604
Local Institution - 0159
Lexington, Kentucky, 40503
Local Institution - 0002
Louisville, Kentucky, 40241
Local Institution - 0162
Mineola, New York, 11501
Local Institution - 0157
Morgantown, West Virginia, 26506
Local Institution - 0139
New Haven, Connecticut, 06520
Local Institution - 0128
New York, New York, 10016
Local Institution - 0165
New York, New York, 10021
Local Institution - 0129
Omaha, Nebraska, 68130
Local Institution - 0081
Orange, California, 92868
Local Institution - 0147
Pittsburgh, Pennsylvania, 15212
Local Institution - 0011
Port Saint Lucie, Florida, 34952
Local Institution - 0148
Providence, Rhode Island, 02903
Local Institution - 0082
Scarborough, Maine, 04074
Local Institution - 0092
Spokane, Washington, 99208
Local Institution - 0097
The Bronx, New York, 10461
Local Institution - 0001
Tyler, Texas, 75701
Local Institution - 0121
Wichita, Kansas, 67214
Spain11 sites
Local Institution - 0051
A Coruña, 15006
Local Institution - 0137
Badalona, Barcelona, 08916
Local Institution - 0024
Barcelona, Catalonia, 08008
Local Institution - 0154
Barcelona, 08025
Local Institution - 0048
Barcelona, 08035
Local Institution - 0061
Las Palmas, 35016
Local Institution - 0074
Madrid, 28041
Local Institution - 0123
Madrid, 28046
Local Institution - 0042
Málaga, 29011
Local Institution - 0075
Seville, Andalusia, 41013
Local Institution - 0043
Valencia, 46026
Australia10 sites
Local Institution - 0057
Adelaide, South Australia, 5087
Local Institution - 0130
Ballarat, Victoria, 3350
Local Institution - 0138
Bendigo, Victoria, 3550
Local Institution - 0141
Box Hill, Victoria, 3128
Local Institution - 0055
Camperdown, New South Wales, 2050
Local Institution - 0109
Frankston, Victoria, 3199
Local Institution - 0086
Gosford, New South Wales, 2250
Local Institution - 0119
Murdoch, Western Australia, 6150
Local Institution - 0085
Nedlands, Western Australia, 6009
Local Institution - 0132
Tamworth, New South Wales, 2340
Brazil9 sites
Local Institution - 0107
Barretos, São Paulo, 14784-400
Local Institution - 0161
Ijuí, Rio Grande do Sul, 98700-000
Local Institution - 0063
Natal, Rio Grande do Norte, 59062 000
Local Institution - 0116
Porto Alegre, Rio Grande do Sul, 90050-170
Local Institution - 0112
Porto Alegre, Rio Grande do Sul, 91350-200
Local Institution - 0072
Rio de Janeiro, 20220-410
Local Institution - 0111
Santo André, São Paulo, 09060-870
Local Institution - 0163
São Paulo, 04014-002
Local Institution - 0120
São Paulo, 08270-120
Germany9 sites
Local Institution - 0103
Berlin, 12351
Local Institution - 0045
Berlin, 13585
Local Institution - 0065
Essen, North Rhine-Westphalia, 45136
Local Institution - 0062
Großhansdorf, 22927
Local Institution - 0058
Homburg, 66421
Local Institution - 0108
Löwenstein, 74245
Local Institution - 0071
Marburg, 35043
Local Institution - 0050
Paderborn, 33098
Local Institution - 0030
Ravensburg, 88212
Argentina8 sites
Local Institution - 0021
Buenos Aires, Distrito Federal, C1426
Local Institution - 0060
Córdoba, 5006
Local Institution - 0038
Córdoba, X5004FHP
Local Institution - 0014
Cuiudad Autonoma de Buenos Aires, Distrito Federal, C1430EGF
Local Institution - 0073
La Rioja, F5300COE
Local Institution - 0037
Río Cuarto, Córdoba Province, 5800
Local Institution - 0029
Rosario, Santa Fe Province, 2000
Local Institution - 0039
Viedma, Río Negro Province, 8500
France7 sites
Local Institution - 0007
Dijon, 21 000
Local Institution - 0144
Le Mans, 72037
Local Institution - 0102
Paris, 75014
Local Institution - 0035
Paris, 75018
Local Institution - 0110
Paris, Île-de-France Region, 75005
Local Institution - 0008
Rennes, Ille-Et-Vilaine, 35000
Local Institution - 0006
Saint-Mandé, 94160
Italy7 sites
Local Institution - 0028
Candiolo, 10060
Local Institution - 0009
Catania, 95125
Local Institution - 0032
Genova, 16149
Local Institution - 0059
Milan, 20141
Local Institution - 0164
Pesaro, 61122
Local Institution - 0106
Rome, RA, 00144
Local Institution - 0019
Siena, 53100
Poland5 sites
Local Institution - 0145
Gdynia, 81-519
Local Institution - 0036
Lublin, 20-090
Local Institution - 0031
Lublin, 20-093
Local Institution - 0080
Olsztyn, 10-357
Local Institution - 0088
Warsaw, 02-781
Romania5 sites
Local Institution - 0099
Cluj-Napoca, Cluj, 400015
Local Institution - 0017
Craiova, Dolj, 200385
Local Institution - 0012
Craiova, Jud. Dolj, 200094
Local Institution - 0052
Craiova, 200347
Local Institution - 0069
Timișoara, Timiș County, 300166
Mexico4 sites
Local Institution - 0070
Mexico City, Mexico City, 14050
Local Institution - 0115
Monterrey, Nuevo León, 64710
Local Institution - 0013
San Pedro Garza García, Nuevo León, 66220
Local Institution - 0020
Toluca, State of Mexico, 50090
United Kingdom4 sites
Local Institution - 0067
Leicester, LE15WW
Local Institution - 0101
London, Greater London, NW1 2PG
Local Institution - 0095
Manchester, Lancashire, M20 4BX
Local Institution - 0135
Middlesbrough, Cleveland, TS4 3BW
Belgium3 sites
Local Institution - 0127
Ghent, 9000
Local Institution - 0131
Ghent, 9000
Local Institution - 0125
Roeselare, 8800
Chile3 sites
Local Institution - 0079
Santiago, Santiago Metropolitan, 0
Local Institution - 0041
Santiago, Santiago Metropolitan, 7500713
Local Institution - 0016
Santiago, Santiago Metropolitan, 7500921
Russia3 sites
Arkhangelsk Clinical Oncological Dispensary
Arkhangelsk, 163045
LLC Eurocityclinic
Saint Petersburg, 197022
FSBI ",Research Institute of Influenza named after A.A. Smorodintsev ",of the MoH of the Rus
Saint Petersburg, 197376
Austria2 sites
Local Institution - 0090
Graz, 8036
Local Institution - 0126
Vienna, 1090
Ireland2 sites
Local Institution - 0023
Dublin, 00009
Local Institution - 0133
Elm Park, Dublin, 4
Netherlands2 sites
Local Institution - 0158
Arnhem, 6815
Local Institution - 0053
Harderwijk, Gelderland, 3844
Switzerland2 sites
Local Institution - 0015
Basel, 4031
Local Institution - 0104
Sankt Gallen, 9007
About this study
Official title: A Phase 2 Randomized Study of Relatlimab Plus Nivolumab in Combination With Chemotherapy vs. Nivolumab in Combination With Chemotherapy as First Line Treatment for Participants With Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC)
The purpose of this study is to assess the safety profile of relatlimab plus nivolumab in combination with platinum doublet chemotherapy (PDCT) and to determine if nivolumab plus relatlimab in combination with PDCT improves overall response rate (ORR) when compared to nivolumab plus PDCT in participants with previously untreated Stage IV or recurrent non-small cell lung cancer (NSCLC).
- Conditions
- Non-small Cell Lung Cancer, Recurrent Non-small Cell Lung Cancer, Metastatic Non-small Cell Lung Cancer
- Being tested
- Nivolumab, Relatlimab, Carboplatin, Cisplatin, Paclitaxel
- Keywords
- Stage IV Non-small Cell Lunch Cancer, Recurrent Non-small Cell Lung Cancer, Metastatic Non-small Cell Lung Cancer, Relatlimab, Nivolumab, Chemotherapy
- 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
Specified dose on specified days
RelatlimabBiological
Specified dose on specified days
CarboplatinDrug
Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.
CisplatinDrug
Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.
PaclitaxelDrug
Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.
Nab-PaclitaxelDrug
Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.
PemetrexedDrug
Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Arm A (Nivolumab + Relatlimab Dose 1 + Platinum Doublet Chemotherapy (PDCT)) | Experimental | Not described Receives: Biological: Nivolumab; Biological: Relatlimab; Drug: Carboplatin; Drug: Cisplatin; Drug: Paclitaxel; Drug: Nab-Paclitaxel; Drug: Pemetrexed |
| Part 1: Arm B (Nivolumab + Relatlimab Dose 2 + PDCT)) | Experimental | Not described Receives: Biological: Nivolumab; Biological: Relatlimab; Drug: Carboplatin; Drug: Cisplatin; Drug: Paclitaxel; Drug: Nab-Paclitaxel; Drug: Pemetrexed |
| Part 2: Arm C (Nivolumab + Relatlimab Dose 2 + PDCT) | Experimental | Not described Receives: Biological: Nivolumab; Biological: Relatlimab; Drug: Carboplatin; Drug: Cisplatin; Drug: Paclitaxel; Drug: Pemetrexed |
| Part 2: Arm D (Nivolumab + PDCT) | Active comparator | Not described Receives: Biological: Nivolumab; Drug: Carboplatin; Drug: Cisplatin; Drug: Paclitaxel; Drug: Pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
TRAEs Leading to Discontinuation Within 12 Weeks of First Dose in Part 1
Percentage of participants with treatment related adverse events (TRAEs) leading to discontinuation within 12 weeks of first dose.
AE is defined as any new untoward medical occurrence or worsenig of a preexising medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
Grading will be determined for severity according to the NCI CTCAE v5.0.
Measured: from first dose to 12 weeks after first dose
ORR Per RECISTS v1.1 by BICR in Part 2
Objective Response Rate (ORR) per RECIST v1.1 by BICR is defined as the number of participants in the randomized population who achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) based on BICR assessments (using RECIST v1.1) divided by the number of participants in the population. BOR is defined as the best response, as determined by the BICR, recorded between the date of randomization and the date of first objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurs first.
Measured: Approximately 14.8 Months
Secondary outcomes (17)
TRAEs Leading to Discontinuation in Part 1
Number of participants with treatment related adverse events (TRAEs) leading to discontinuation based on grade.
AE is defined as any new untoward medical occurrence or worsenig of a preexising medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
Grading will be determined for severity according to the NCI CTCAE v5.0
Measured: From first dose to 30 days post last dose of study therapy (Approximately 32.8 Months)
Number of Participants With a Treatment Related AEs in Part 1
Number of participants with a treatment related AE in part 1.
AE is defined as any new untoward medical occurrence or worsenig of a preexising medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
Grading will be determined for severity according to the NCI CTCAE v5.0
Measured: From first dose to 30 days post last dose of study therapy (Approximately 32.8 Months)
Number of Participants With Treatment Releted SAEs in Part 1
A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose, results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event (defined as a medical event(s) that may not be immediately life-threatening or result in death or hospitalization but, based upon appropriate medical and scientific judgment, may jeopardize the participant or may require intervention [e.g., medical, surgical] to prevent one of the other serious outcomes listed in the definition).
Grading will be determined for severity according to the NCI CTCAE v5.0.
Measured: From first dose to 30 days post last dose of study therapy (Approximately 32.8 Months)
Number of Participants With Treatment Releted Select AEs in Part 1
AE is defined as any new untoward medical occurrence or worsenig of a preexising medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
Select Adverse Events (AEs) will be determined for severity according to the NCI CTCAE v5.0.
Measured: From first dose to 30 days post last dose of study therapy (Approximately 32.8 Months)
ORR by PD-L1 Expression Per RECISTS v1.1 by BICR in Part 2
Objective Response Rate (ORR) per RECIST v1.1 by BICR is defined as the number of participants in the randomized population who achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) based on BICR assessments (using RECIST v1.1) divided by the number of participants in the population. BOR is defined as the best response, as determined by the BICR, recorded between the date of randomization and the date of first objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurs first.
Measured: Approximately 14.8 Months
DoR Per RECISTS v1.1 by BICR in Part 2
Duration of Response (DOR) will be assessed by BICR. It is defined as the time between the date of first documented response (CR or PR) that is subsequently confirmed, to the date of the first objectively documented tumor progression as determined by the BICR (per RECIST v1.1), or death due to any cause, whichever occurs first.
Measured: Approximately up to 13.7 months
Number of Participants With a AE in Part 2
Number of participants with an adverse event (AE).
AE is defined as any new untoward medical occurrence or worsenig of a preexising medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
Grading will be determined for severity according to the NCI CTCAE v5.0.
Measured: From first dose to 30 days post last dose of study therapy (Approximately 14.8 Months)
Number of Participants With a Treatment Related AEs in Part 2
AE is defined as any new untoward medical occurrence or worsenig of a preexising medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
Grading will be determined for severity according to the NCI CTCAE v5.0.
Measured: From first dose to 30 days post last dose of study therapy (Approximately 14.8 Months)
Number of Participants With a Treatment Related SAEs in Part 2
SAE is defined as a 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). SAEs can also result in death. The AE requires inpatient hospitalization or causes prolongation of existing hospitalization. Results in persistent or significant disability/incapacity. Is a congenital anomaly/birth defect. Is an important medical event (defined as a medical event(s) that may not be immediately lifethreatening or result in death or hospitalization but, based upon appropriate medical and scientific judgment, may jeopardize the participant or may require intervention [e.g., medical, surgical] to prevent one of the other serious outcomes listed in the definition above.)
Grading will be determined for severity according to the NCI CTCAE v5.0.
Measured: From first dose to 30 days post last dose of study therapy (Approximately 14.8 Months)
Number of Participants With Endocrine Immune-mediated Adverse Events in Part 2
IMAEs are AEs consistent with an immune-mediated mechanism or immune-mediated component for which non-inflammatory etiologies (eg, infection or tumor progression) have been ruled out. IMAEs can include events with an alternate etiology which were exacerbated by the induction of autoimmunity.
Grading will be determined for severity according to the NCI CTCAE v5.0.
Measured: From first dose to 30 days post last dose of study therapy (Approximately 14.8 Months)
ORR by LAG-3 Expression Per RECISTS v1.1 by BICR in Part 2
Objective Response Rate (ORR) per RECIST v1.1 by BICR is defined as the number of participants in the randomized population who achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) based on BICR assessments (using RECIST v1.1) divided by the number of participants in the population. BOR is defined as the best response, as determined by the BICR, recorded between the date of randomization and the date of first objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurs first.
Measured: On Going
ORR by FG-L1 Expression Per RECISTS v1.1 by BICR in Part 2
Objective Response Rate (ORR) per RECIST v1.1 by BICR is defined as the number of participants in the randomized population who achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) based on BICR assessments (using RECIST v1.1) divided by the number of participants in the population. BOR is defined as the best response, as determined by the BICR, recorded between the date of randomization and the date of first objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurs first.
Measured: Ongoing
PFS Per RECISTS v1.1 by BICR in Part 2
Progression Free Survival is defined as the time between the date of randomization and the first date of documented progression, based on BICR assessments (per RECIST v1.1), or death due to any cause, whichever occurs first.
Measured: Ongoing
PFS by PD-L1 Expression Per RECISTS v1.1 by BICR in Part 2
Progression Free Survival is defined as the time between the date of randomization and the first date of documented progression, based on BICR assessments (per RECIST v1.1), or death due to any cause, whichever occurs first.
Measured: Ongoing
PFS by LAG-3 Expression Per RECISTS v1.1 by BICR in Part 2
Progression Free Survival is defined as the time between the date of randomization and the first date of documented progression, based on BICR assessments (per RECIST v1.1), or death due to any cause, whichever occurs first.
Measured: Ongoing
PFS by FG-L1 Expression Per RECISTS v1.1 by BICR in Part 2
Progression Free Survival is defined as the time between the date of randomization and the first date of documented progression, based on BICR assessments (per RECIST v1.1), or death due to any cause, whichever occurs first.
Measured: Ongoing
Number of Participants With Treatment Releted Select AEs in Part 2
AE is defined as any new untoward medical occurrence or worsenig of a preexising medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
Select Adverse Events (AEs) will be determined for severity according to the NCI CTCAE v5.0.
Measured: Ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start17 Feb 2021
- Primary completion11 Jan 2024
- Study completion6 May 2026
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 468 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
- NCT04623775
- Sponsor's protocol ID
- CA224-104
- Other IDs
- 2020-004026-31, U1111-1256-8115
- Status last verified
- May 2026
- First submitted
- 5 Nov 2020
- Last updated
- 18 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html