Extensive-Stage Small Cell Lung CancerPhase 3NCT06646276
A Study to Compare the Efficacy and Safety of BMS-986489 (Atigotatug+ Nivolumab Fixed Dose Combination) in Combination With Carboplatin Plus Etoposide to That of Atezolizumab With Carboplatin Plus Etoposide as First-Line Therapy in Participants With Extensive-Stage Small Cell Lung Cancer (TIGOS).
A Phase 3 study testing BMS-986489 (Atigotatug+Nivolumab), Atezolizumab and Carboplatin in people with Extensive-Stage Small Cell Lung Cancer, run by Bristol-Myers Squibb at 183 sites in 26 countries.
Trial summary
The Purpose of the Study is to Compare the Efficacy and Safety of BMS-986489 (Anti-fucosyl-GM1+ Nivolumab Fixed Dose Combination) in Combination with Carboplatin plus Etoposide to that of Atezolizumab with Carboplatin plus Etoposide as First-Line Therapy in Participants with Extensive-Stage Small Cell Lung Cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extensive-Stage Small Cell Lung Cancer
- What is being tested?
- BMS-986489 (Atigotatug+Nivolumab), Atezolizumab and Carboplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 530 participants
- Where
- 183 sitesin 26 countries
- Study dates
- 25 Feb 2025to 14 Jul 2031
- Phase
- Phase 3
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
- Participants must have diagnosis of Extensive-Stage Small Cell Lung Cancer (ES-SCLC).
- Participants must be Healthy enough to do their normal activities with little or no help based on the ECOG performance scale.
- Participants must have at least one tumor that can be measured using special imaging techniques like a CT scan or MRI at a site other than the brain and nervous system
Who cannot join
- Participants have already received certain types of treatment for extensive stage small cell lung cancer
- Participants have certain health conditions, like spread of small cell lung cancer to the brain that are causing symptoms, certain lung diseases, heart diseases, infections, autoimmune diseases, other cancers, or a type of nerve damage called peripheral sensory neuropathy
- Other protocol-defined Inclusion/Exclusion criteria apply.
Trial locations and contacts
183 sites in 26 countries. Contact the study team or a site near you to ask about taking part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
183 sites in 26 countries
China23 sites, 1 recruiting
- Completed
Local Institution - 0204
Beijing, Beijing Municipality, 100142
- Active, not recruiting
Local Institution - 0336
Beijing, Beijing Municipality, 101149
- Active, not recruiting
Local Institution - 0244
Changchun, Jilin, 132000
- Completed
Local Institution - 0216
Changsha, Hunan, 410013
- Active, not recruiting
Local Institution - 0330
Chengdu, Sichuan, 610041
- Active, not recruiting
Local Institution - 0203
Chongqing, Chongqing Municipality, 400030
- Active, not recruiting
Local Institution - 0308
Fuzhou, Fujian, 350014
- Active, not recruiting
Local Institution - 0236
Hangzhou, Zhejiang, 310016
- Active, not recruiting
Local Institution - 0237
Hangzhou, Zhejiang, 310022
- Active, not recruiting
Local Institution - 0227
Harbin, Heilongjiang, 150081
- Active, not recruiting
Local Institution - 0200
Jinan, Shandong, 250117
- Completed
Local Institution - 0229
Linhai, Zhejiang, 317000
- Active, not recruiting
Local Institution - 0233
Nanchang, Jiangxi, 330006
- Active, not recruiting
Local Institution - 0206
Shanghai, Shanghai Municipality, 200030
- Active, not recruiting
Local Institution - 0210
Shanghai, Shanghai Municipality, 200032
- Active, not recruiting
Local Institution - 0186
Shanghai, Shanghai Municipality, 200120
- Active, not recruiting
Local Institution - 0234
Shantou, Guangdong, 515000
- Not yet recruiting
Local Institution - 0235
Shenyang, Liaoning, 110042
Site 0235
- Active, not recruiting
Local Institution - 0213
Tianjin, Tianjin Municipality, 300060
- Active, not recruiting
Local Institution - 0209
Wuhan, Hubei, 430079
- Active, not recruiting
Local Institution - 0208
Wuhan, Hubei, 430100
- Completed
Local Institution - 0335
Xi'an, Shaanxi, 710126
- Completed
Local Institution - 0212
Xiamen, Fujian, 361003
United States20 sites, 18 recruiting
- Recruiting
University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, 87106
Moises Harari-Turquie, Site 0033, 505-570-5835
- Recruiting
Texas Oncology - Central/South Texas
Austin, Texas, 78705
James Uyeki, Site 0001, 512-427-9400
- Recruiting
Sanford Medical Center
Bismarck, North Dakota, 58501
Thandiwe Gray, Site 0232, 701-323-5741
- Recruiting
Oncology Hematology Care
Cincinnati, Ohio, 45242
Patrick Ward, Site 0284, 513-751-2273
- Recruiting
Southern Cancer Center, PC
Daphne, Alabama, 36526
Michael Meshad, Site 0337, 111-111-1111
- Recruiting
Duke Cancer Institute
Durham, North Carolina, 27710
Neal Ready, Site 0029, 919-684-8239
- Recruiting
Swedish Cancer Institute - Edmonds
Edmonds, Washington, 98026
Siddhartha Devarakonda, Site 0339, 206-386-2457
- Recruiting
Sanford Fargo Medical Center
Fargo, North Dakota, 58102
Mark Gitau, Site 0010, 000-000-0000
- Recruiting
Florida Cancer Specialists - South
Fort Myers, Florida, 33901
Alexander Glick, Site 0245, 239-274-9930
- Completed
Local Institution - 0283
Hot Springs, Arkansas, 71913
- Recruiting
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
Marietta, Georgia, 30060
Walid Shaib, Site 0013, 770-281-5124
- Withdrawn
Local Institution - 0037
Minneapolis, Minnesota, 55407
- Recruiting
SCRI Oncology Partners
Nashville, Tennessee, 37203
Melissa Johnson, Site 0008, 615-329-7274
- Recruiting
Mid Florida Hematology and Oncology Center
Orange City, Florida, 32763
Santosh Nair, Site 0009, 407-353-1915
- Recruiting
Illinois Cancer Care
Peoria, Illinois, 61615
Gary MacVicar, Site 0019, 309-243-3000
- Recruiting
Oncology & Hematology Associates of Southwest Virginia, Inc.
Roanoke, Virginia, 24014
Jerome Goldschmidt, Site 0246, 540-381-5291
- Recruiting
Swedish Medical Center
Seattle, Washington, 98104
Siddhartha Devarakonda, Site 0026, 206-386-2457
- Recruiting
Sanford Cancer Center
Sioux Falls, South Dakota, 57104
Allison Watson, Site 0231, 605-209-4092
- Recruiting
Florida Cancer Specialists - North
St. Petersburg, Florida, 33705
Maen Hussein, Site 0020, 727-216-1143
- Recruiting
Texas Oncology - Northeast Texas
Tyler, Texas, 75702
Sarah Wang, Site 0281, 903-579-9800
Japan18 sites
- Active, not recruiting
Local Institution - 0326
Bunkyo-ku, Tokyo, 1138603
- Active, not recruiting
Local Institution - 0327
Fukushima, 960-1295
- Active, not recruiting
Local Institution - 0322
Hamamatsu, Shizuoka, 431-3192
- Active, not recruiting
Local Institution - 0320
Hidaka, Saitama, 350-1298
- Active, not recruiting
Local Institution - 0317
Hirakata, Osaka, 573-1191
- Active, not recruiting
Local Institution - 0318
Ina-machi, Saitama, 362-0806
- Active, not recruiting
Local Institution - 0321
Kanazawa, Ishikawa-ken, 920-8641
- Completed
Local Institution - 0324
Kashihara, Nara, 634-8522
- Active, not recruiting
Local Institution - 0323
Kobe, Hyōgo, 650-0047
- Active, not recruiting
Local Institution - 0315
Koto, Tokyo, 135-8550
- Active, not recruiting
Local Institution - 0328
Kurashiki, Okayama-ken, 710-8602
- Active, not recruiting
Local Institution - 0292
Kurume, Fukuoka, 830-0011
- Active, not recruiting
Local Institution - 0319
Matsuyama, Ehime, 791-0280
- Active, not recruiting
Local Institution - 0314
Ōsaka-sayama, Osaka, 589-8511
- Active, not recruiting
Local Institution - 0313
Sapporo, Hokkaido, 0608648
- Active, not recruiting
Local Institution - 0291
Sendai, Miyagi, 9810914
- Completed
Local Institution - 0325
Takatsuki, Osaka, 569-8686
- Completed
Local Institution - 0316
Yokohama, Kanagawa, 236-0051
France10 sites
- Completed
Local Institution - 0047
Créteil, Val-de-Marne, 94010
- Completed
Local Institution - 0044
Gleizé, Rhône, 69400
- Active, not recruiting
Local Institution - 0040
La Tronche, Isère, 38700
- Completed
Local Institution - 0052
Lille, Nord, 59037
- Active, not recruiting
Local Institution - 0043
Marseille, 13915
- Completed
Local Institution - 0048
Montpellier, Hérault, 34090
- Active, not recruiting
Local Institution - 0050
Paris, 75248
- Active, not recruiting
Local Institution - 0051
Pierre-Bénite, Rhône, 69310
- Active, not recruiting
Local Institution - 0215
Quimper, 29000
- Active, not recruiting
Local Institution - 0038
Villejuif, Val-de-Marne, 94800
Spain10 sites
- Completed
Local Institution - 0294
Barcelona, Catalunya [Cataluña], 08036
- Active, not recruiting
Local Institution - 0302
Barcelona, Catalunya [Cataluña], 08041
- Active, not recruiting
Local Institution - 0301
Jaén, Jaén, 23007
- Active, not recruiting
Local Institution - 0298
Madrid, Madrid, Comunidad de, 28034
- Active, not recruiting
Local Institution - 0296
Madrid, Madrid, Comunidad de, 28041
- Active, not recruiting
Local Institution - 0297
Majadahonda, Madrid, Comunidad de, 28222
- Active, not recruiting
Local Institution - 0300
Santiago de Compostela, A Coruña [La Coruña], 15706
- Active, not recruiting
Local Institution - 0299
Seville, 41009
- Completed
Local Institution - 0295
Seville, 41013
- Completed
Local Institution - 0303
Valencia, Valenciana, Comunitat, 46014
Germany9 sites
- Active, not recruiting
Local Institution - 0257
Bad Berka, Thuringia, 99437
- Active, not recruiting
Local Institution - 0261
Cologne, North Rhine-Westphalia, 51109
- Active, not recruiting
Local Institution - 0256
Frankfurt am Main, Hesse, 60488
- Completed
Local Institution - 0258
Gauting, 82131
- Active, not recruiting
Local Institution - 0259
Großhansdorf, 22927
- Active, not recruiting
Local Institution - 0265
Halle, Saxony-Anhalt, 06120
- Active, not recruiting
Local Institution - 0260
Heidelberg, 69126
- Active, not recruiting
Local Institution - 0262
Oldenburg, Lower Saxony, 26121
- Active, not recruiting
Local Institution - 0264
Stuttgart, 70736
Brazil7 sites
- Active, not recruiting
Local Institution - 0178
Barretos, São Paulo, 14784400
- Active, not recruiting
Local Institution - 0166
Fortaleza, Ceará, 60135-237
- Active, not recruiting
Local Institution - 0163
Itajaí, Santa Catarina, 88301-220
- Active, not recruiting
Local Institution - 0165
Porto Alegre, Rio Grande do Sul, 90035-903
- Active, not recruiting
Local Institution - 0169
Porto Alegre, Rio Grande do Sul, 90610-000
- Completed
Local Institution - 0170
Santa Cruz do Sul, Rio Grande do Sul, 96830-180
- Active, not recruiting
Local Institution - 0111
São Paulo, São Paulo, 01509-010
Italy7 sites
- Active, not recruiting
Local Institution - 0074
Bologna, 40138
- Active, not recruiting
Local Institution - 0068
Milan, Lombardy, 20133
- Active, not recruiting
Local Institution - 0067
Milan, 20141
- Active, not recruiting
Local Institution - 0072
Naples, Campania, 80131
- Active, not recruiting
Local Institution - 0110
Perugia, Umbria, 06132
- Completed
Local Institution - 0070
Peschiera del Garda, Verona, 37019
- Active, not recruiting
Local Institution - 0069
Rome, Roma, 00144
Romania7 sites
- Completed
Local Institution - 0133
Bucharest, Bucharest, 013812
- Active, not recruiting
Local Institution - 0135
Bucharest, Bucharest, 022328
- Active, not recruiting
Local Institution - 0141
Cluj-Napoca, 400015
- Active, not recruiting
Local Institution - 0140
Craiova, Dolj, 200542
- Active, not recruiting
Local Institution - 0137
Florești, Cluj, 407280
- Active, not recruiting
Local Institution - 0139
Iași, 700106
- Active, not recruiting
Local Institution - 0132
Iași, 700483
South Korea6 sites
- Active, not recruiting
Local Institution - 0305
Cheongju-si, Chungcheongbuk-do [Chungbuk], 28644
- Active, not recruiting
Local Institution - 0309
Daegu, Taegu-Kwangyǒkshi, 42601
- Completed
Local Institution - 0286
Seongnam, Kyǒnggi-do, 13620
- Active, not recruiting
Local Institution - 0285
Seoul, Seoul-teukbyeolsi [Seoul], 03722
- Active, not recruiting
Local Institution - 0293
Seoul, Seoul-teukbyeolsi [Seoul], 05505
- Active, not recruiting
Local Institution - 0304
Suwon, Kyǒnggi-do, 16499
Argentina5 sites
- Completed
Local Institution - 0077
ABB, Buenos Aires F.D., C1199ABB
- Withdrawn
Local Institution - 0100
Buenos Aires, Buenos Aires F.D., C1417DTB
- Active, not recruiting
Local Institution - 0080
CABA, Buenos Aires F.D., C1430EGF
- Completed
Local Institution - 0079
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ANZ
- Active, not recruiting
Local Institution - 0094
Río Cuarto, Córdoba Province, X5800AEV
Australia5 sites
- Completed
Local Institution - 0190
Ballarat Central, Victoria, 3350
- Active, not recruiting
Local Institution - 0105
Brisbane, Queensland, 4120
- Active, not recruiting
Local Institution - 0202
Campbelltown, New South Wales, 2560
- Active, not recruiting
Local Institution - 0175
Murdoch, Western Australia, 6150
- Active, not recruiting
Local Institution - 0106
Penrith, New South Wales, 2750
Chile5 sites
- Active, not recruiting
Local Institution - 0086
Santiago, Santiago Metropolitan, 0
- Active, not recruiting
Local Institution - 0085
Santiago, Santiago Metropolitan, 7500921
- Completed
Local Institution - 0083
Santiago, Santiago Metropolitan, 8330032
- Active, not recruiting
Local Institution - 0084
Santiago, Santiago Metropolitan, 8420383
- Active, not recruiting
Local Institution - 0082
Viña del Mar, Valparaiso, 2520598
Greece5 sites
- Active, not recruiting
Local Institution - 0063
Athens, Attikí, 115 26
- Active, not recruiting
Local Institution - 0064
Athens, Attikí, 115 27
- Completed
Local Institution - 0059
Larissa, Thessalía, 41110
- Completed
Local Institution - 0062
Thessaloniki, Kentrikí Makedonía, 540 07
- Active, not recruiting
Local Institution - 0058
Thessaloniki, Thessaloníki, 570 01
India5 sites
- Active, not recruiting
Local Institution - 0274
Bengaluru, Karnataka, 560017
- Completed
Local Institution - 0273
Kolkata, West Bengal, 700094
- Completed
Local Institution - 0271
Madurai, Tamil Nadu, 625107
- Withdrawn
Local Institution - 0278
New Delhi, National Capital Territory of Delhi, 110029
- Active, not recruiting
Local Institution - 0277
Varanasi, Uttar Pradesh, 221005
Poland5 sites
- Active, not recruiting
Local Institution - 0195
Bydgoszcz, 85796
- Active, not recruiting
Local Institution - 0193
Konin, Greater Poland Voivodeship, 62-500
- Active, not recruiting
Local Institution - 0189
Lodz, Łódź Voivodeship, 93-338
- Active, not recruiting
Local Institution - 0241
Poznan, Greater Poland Voivodeship, 60-192
- Active, not recruiting
Local Institution - 0192
Prabuty, Pomeranian Voivodeship, 82-550
Turkey (Türkiye)5 sites
- Active, not recruiting
Local Institution - 0154
Adana, 01370
- Active, not recruiting
Local Institution - 0157
Ankara, 06010
- Active, not recruiting
Local Institution - 0177
Ankara, 06280
- Active, not recruiting
Local Institution - 0158
Çiğli, İzmir, 35620
- Active, not recruiting
Local Institution - 0153
Istanbul, 34732
Austria4 sites
- Active, not recruiting
Local Institution - 0253
Graz, Styria, 8036
- Active, not recruiting
Local Institution - 0252
Linz, 4021
- Active, not recruiting
Local Institution - 0255
Rankweil, 6830
- Completed
Local Institution - 0251
Wels, Upper Austria, 4600
Belgium4 sites
- Active, not recruiting
Local Institution - 0198
Brussels, Bruxelles-Capitale, Région de, 1200
- Active, not recruiting
Local Institution - 0091
Ghent, Oost-Vlaanderen, 9000
- Active, not recruiting
Local Institution - 0092
Liège, 4000
- Active, not recruiting
Local Institution - 0187
Sint-Niklaas, Oost-Vlaanderen, B-9100
Canada4 sites
- Active, not recruiting
Local Institution - 0290
Chicoutimi, Quebec, G7H 5H6
- Active, not recruiting
Local Institution - 0289
Edmonton, Alberta, T6G 1Z2
- Active, not recruiting
Local Institution - 0288
Québec, Quebec, G1V 4G5
- Completed
Local Institution - 0287
Rimouski, Quebec, G5L 5T1
Czechia4 sites
- Active, not recruiting
Local Institution - 0114
Brno, Brno-město, 656 53
- Active, not recruiting
Local Institution - 0116
Olomouc, 779 00
- Active, not recruiting
Local Institution - 0117
Ostrava, Ostrava Město, 703 00
- Active, not recruiting
Local Institution - 0113
Prague, Praha 4, 14059
United Kingdom4 sites
- Completed
Local Institution - 0159
Aberdeen, AB9 2ZB
- Completed
Local Institution - 0183
Central Middlesbrough, Middlesbrough, TS4 3BW
- Active, not recruiting
Local Institution - 0101
Manchester, M20 4BX
- Active, not recruiting
Local Institution - 0226
Metropolitan Borough of Wirral, CH63 4JY
Malaysia3 sites
- Completed
Local Institution - 0310
Kuala Lumpur, Kuala Lumpur, 50586
- Completed
Local Institution - 0312
Kuala Lumpur, Kuala Lumpur, 50603
- Active, not recruiting
Local Institution - 0311
Kuching, Sarawak, 93586
Netherlands3 sites
- Completed
Local Institution - 0097
Amsterdam, North Holland, 1081 HV
- Active, not recruiting
Local Institution - 0099
Arnhem, 6815 AD
- Active, not recruiting
Local Institution - 0098
Groningen, 9713 GZ
Switzerland3 sites
- Active, not recruiting
Local Institution - 0248
Chur, 7000
- Active, not recruiting
Local Institution - 0249
Winterthur, 8401
- Active, not recruiting
Local Institution - 0247
Zurich, 8091
Mexico2 sites
- Active, not recruiting
Local Institution - 0146
Guadalajara, Jalisco, 44630
- Completed
Local Institution - 0145
Puebla City, 72424
About this study
Official title: A Randomized, Double Blind, Multicenter Phase 3 Trial of BMS-986489 (Atigotatug+Nivolumab Fixed Dose Combination) in Combination With Carboplatin Plus Etoposide vs Atezolizumab in Combination With Carboplatin Plus Etoposide as First-Line Therapy in Participants With Extensive-Stage Small Cell Lung Cancer (TIGOS).
The Purpose of the Study is to Compare the Efficacy and Safety of BMS-986489 (Anti-fucosyl-GM1+ Nivolumab Fixed Dose Combination) in Combination with Carboplatin plus Etoposide to that of Atezolizumab with Carboplatin plus Etoposide as First-Line Therapy in Participants with Extensive-Stage Small Cell Lung Cancer.
- Conditions
- Extensive-Stage Small Cell Lung Cancer
- Being tested
- BMS-986489 (Atigotatug+Nivolumab), Atezolizumab, Carboplatin, Etoposide
- Keywords
- BMS-986489, BMS-986012, Extensive-Stage Small Cell Lung Cancer, Etoposide, Carboplatin, Nivolumab, TIGOS, fucGM1, SCLC, ES-SCLC, atigotatug
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986489 (Atigotatug+Nivolumab)Biological
Specified dose on specified days
AtezolizumabBiological
Specified dose on specified days
CarboplatinDrug
Specified dose on specified days
EtoposideDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Not described Receives: Biological: BMS-986489 (Atigotatug+Nivolumab); Drug: Carboplatin; Drug: Etoposide |
| Arm B | Active comparator | Not described Receives: Biological: Atezolizumab; Drug: Carboplatin; Drug: Etoposide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Measured: Up to 5 years
Secondary outcomes (7)
Time to definitive deterioration (TTDD)based on the LCSS ASBI defined as the time from randomization until a definitive clinically meaningful decline (≥ 10 point increase from baseline in LCSS ASBI score).
Measured: Up to 5 years
Number of participants with Adverse Events (AEs)
Measured: Up to 135 days after last treatment
Number of Participants with Serious Adverse Events (SAEs)
Measured: Up to 135 days after last treatment
Number of Participants with Adverse Events (AEs) leading to discontinuation and death
Measured: Up to 135 days after last treatment
Objective Response (OR)
Measured: Up to 5 years
Duration of Response (DOR)
Measured: Up to 5 years
Progression Free Survival (PFS)
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start25 Feb 2025
- Primary completion17 Aug 2027 (estimated)
- Study completion14 Jul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extensive-Stage 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 530 participants (estimated)
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
- NCT06646276
- Sponsor's protocol ID
- CA245-0001
- Other IDs
- 2024-515740-23, U1111-1308-1151
- Status last verified
- Oct 2026
- First submitted
- 16 Oct 2024
- Last updated
- 13 Oct 2026
- Results posted
- No
- 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