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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

Search all trials

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

855-907-3286

Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #. contact

183 sites in 26 countries

China23 sites, 1 recruiting
  • Local Institution - 0204

    Beijing, Beijing Municipality, 100142

    Completed
  • Local Institution - 0336

    Beijing, Beijing Municipality, 101149

    Active, not recruiting
  • Local Institution - 0244

    Changchun, Jilin, 132000

    Active, not recruiting
  • Local Institution - 0216

    Changsha, Hunan, 410013

    Completed
  • 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

    Active, not recruiting
  • Local Institution - 0229

    Linhai, Zhejiang, 317000

    Completed
  • 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

    Active, not recruiting
  • Local Institution - 0235

    Shenyang, Liaoning, 110042

    Site 0235

    Not yet 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

    Active, not recruiting
  • Local Institution - 0335

    Xi'an, Shaanxi, 710126

    Completed
  • Local Institution - 0212

    Xiamen, Fujian, 361003

    Completed

Other trials in China

United States20 sites, 18 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

    Recruiting
  • Local Institution - 0283

    Hot Springs, Arkansas, 71913

    Completed
  • Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital

    Marietta, Georgia, 30060

    Walid Shaib, Site 0013, 770-281-5124

    Recruiting
  • Local Institution - 0037

    Minneapolis, Minnesota, 55407

    Withdrawn
  • 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

    Recruiting

Other trials in United States

Japan18 sites
  • 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

    Active, not recruiting
  • Local Institution - 0324

    Kashihara, Nara, 634-8522

    Completed
  • 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

    Active, not recruiting
  • Local Institution - 0325

    Takatsuki, Osaka, 569-8686

    Completed
  • Local Institution - 0316

    Yokohama, Kanagawa, 236-0051

    Completed

Other trials in Japan

France10 sites
  • Local Institution - 0047

    Créteil, Val-de-Marne, 94010

    Completed
  • Local Institution - 0044

    Gleizé, Rhône, 69400

    Completed
  • Local Institution - 0040

    La Tronche, Isère, 38700

    Active, not recruiting
  • Local Institution - 0052

    Lille, Nord, 59037

    Completed
  • Local Institution - 0043

    Marseille, 13915

    Active, not recruiting
  • Local Institution - 0048

    Montpellier, Hérault, 34090

    Completed
  • 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

    Active, not recruiting

Other trials in France

Spain10 sites
  • Local Institution - 0294

    Barcelona, Catalunya [Cataluña], 08036

    Completed
  • 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

    Active, not recruiting
  • Local Institution - 0295

    Seville, 41013

    Completed
  • Local Institution - 0303

    Valencia, Valenciana, Comunitat, 46014

    Completed

Other trials in Spain

Germany9 sites
  • 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

    Active, not recruiting
  • Local Institution - 0258

    Gauting, 82131

    Completed
  • 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

    Active, not recruiting

Other trials in Germany

Brazil7 sites
  • 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

    Active, not recruiting
  • Local Institution - 0170

    Santa Cruz do Sul, Rio Grande do Sul, 96830-180

    Completed
  • Local Institution - 0111

    São Paulo, São Paulo, 01509-010

    Active, not recruiting

Other trials in Brazil

Italy7 sites
  • 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

    Active, not recruiting
  • Local Institution - 0070

    Peschiera del Garda, Verona, 37019

    Completed
  • Local Institution - 0069

    Rome, Roma, 00144

    Active, not recruiting

Other trials in Italy

Romania7 sites
  • Local Institution - 0133

    Bucharest, Bucharest, 013812

    Completed
  • 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

    Active, not recruiting

Other trials in Romania

South Korea6 sites
  • Local Institution - 0305

    Cheongju-si, Chungcheongbuk-do [Chungbuk], 28644

    Active, not recruiting
  • Local Institution - 0309

    Daegu, Taegu-Kwangyǒkshi, 42601

    Active, not recruiting
  • Local Institution - 0286

    Seongnam, Kyǒnggi-do, 13620

    Completed
  • 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

    Active, not recruiting

Other trials in South Korea

Argentina5 sites
  • Local Institution - 0077

    ABB, Buenos Aires F.D., C1199ABB

    Completed
  • Local Institution - 0100

    Buenos Aires, Buenos Aires F.D., C1417DTB

    Withdrawn
  • Local Institution - 0080

    CABA, Buenos Aires F.D., C1430EGF

    Active, not recruiting
  • Local Institution - 0079

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ANZ

    Completed
  • Local Institution - 0094

    Río Cuarto, Córdoba Province, X5800AEV

    Active, not recruiting

Other trials in Argentina

Australia5 sites
  • Local Institution - 0190

    Ballarat Central, Victoria, 3350

    Completed
  • 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

    Active, not recruiting

Other trials in Australia

Chile5 sites
  • Local Institution - 0086

    Santiago, Santiago Metropolitan, 0

    Active, not recruiting
  • Local Institution - 0085

    Santiago, Santiago Metropolitan, 7500921

    Active, not recruiting
  • Local Institution - 0083

    Santiago, Santiago Metropolitan, 8330032

    Completed
  • Local Institution - 0084

    Santiago, Santiago Metropolitan, 8420383

    Active, not recruiting
  • Local Institution - 0082

    Viña del Mar, Valparaiso, 2520598

    Active, not recruiting

Other trials in Chile

Greece5 sites
  • Local Institution - 0063

    Athens, Attikí, 115 26

    Active, not recruiting
  • Local Institution - 0064

    Athens, Attikí, 115 27

    Active, not recruiting
  • Local Institution - 0059

    Larissa, Thessalía, 41110

    Completed
  • Local Institution - 0062

    Thessaloniki, Kentrikí Makedonía, 540 07

    Completed
  • Local Institution - 0058

    Thessaloniki, Thessaloníki, 570 01

    Active, not recruiting

Other trials in Greece

India5 sites
  • Local Institution - 0274

    Bengaluru, Karnataka, 560017

    Active, not recruiting
  • Local Institution - 0273

    Kolkata, West Bengal, 700094

    Completed
  • Local Institution - 0271

    Madurai, Tamil Nadu, 625107

    Completed
  • Local Institution - 0278

    New Delhi, National Capital Territory of Delhi, 110029

    Withdrawn
  • Local Institution - 0277

    Varanasi, Uttar Pradesh, 221005

    Active, not recruiting

Other trials in India

Poland5 sites
  • 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

    Active, not recruiting

Other trials in Poland

Turkey (Türkiye)5 sites
  • 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

    Active, not recruiting

Other trials in Turkey (Türkiye)

Austria4 sites
  • Local Institution - 0253

    Graz, Styria, 8036

    Active, not recruiting
  • Local Institution - 0252

    Linz, 4021

    Active, not recruiting
  • Local Institution - 0255

    Rankweil, 6830

    Active, not recruiting
  • Local Institution - 0251

    Wels, Upper Austria, 4600

    Completed

Other trials in Austria

Belgium4 sites
  • 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

    Active, not recruiting

Other trials in Belgium

Canada4 sites
  • 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

    Active, not recruiting
  • Local Institution - 0287

    Rimouski, Quebec, G5L 5T1

    Completed

Other trials in Canada

Czechia4 sites
  • 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

    Active, not recruiting

Other trials in Czechia

United Kingdom4 sites
  • Local Institution - 0159

    Aberdeen, AB9 2ZB

    Completed
  • Local Institution - 0183

    Central Middlesbrough, Middlesbrough, TS4 3BW

    Completed
  • Local Institution - 0101

    Manchester, M20 4BX

    Active, not recruiting
  • Local Institution - 0226

    Metropolitan Borough of Wirral, CH63 4JY

    Active, not recruiting

Other trials in United Kingdom

Malaysia3 sites
  • Local Institution - 0310

    Kuala Lumpur, Kuala Lumpur, 50586

    Completed
  • Local Institution - 0312

    Kuala Lumpur, Kuala Lumpur, 50603

    Completed
  • Local Institution - 0311

    Kuching, Sarawak, 93586

    Active, not recruiting

Other trials in Malaysia

Netherlands3 sites
  • Local Institution - 0097

    Amsterdam, North Holland, 1081 HV

    Completed
  • Local Institution - 0099

    Arnhem, 6815 AD

    Active, not recruiting
  • Local Institution - 0098

    Groningen, 9713 GZ

    Active, not recruiting

Other trials in Netherlands

Switzerland3 sites
  • Local Institution - 0248

    Chur, 7000

    Active, not recruiting
  • Local Institution - 0249

    Winterthur, 8401

    Active, not recruiting
  • Local Institution - 0247

    Zurich, 8091

    Active, not recruiting

Other trials in Switzerland

Mexico2 sites
  • Local Institution - 0146

    Guadalajara, Jalisco, 44630

    Active, not recruiting
  • Local Institution - 0145

    Puebla City, 72424

    Completed

Other trials in Mexico

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.

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 groups in NCT06646276
Study groupRoleWhat they receive
Arm AExperimentalNot described
Receives: Biological: BMS-986489 (Atigotatug+Nivolumab); Drug: Carboplatin; Drug: Etoposide
Arm BActive comparatorNot 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.

  1. Overall Survival (OS)

    Measured: Up to 5 years

Secondary outcomes (7)
  1. 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

  2. Number of participants with Adverse Events (AEs)

    Measured: Up to 135 days after last treatment

  3. Number of Participants with Serious Adverse Events (SAEs)

    Measured: Up to 135 days after last treatment

  4. Number of Participants with Adverse Events (AEs) leading to discontinuation and death

    Measured: Up to 135 days after last treatment

  5. Objective Response (OR)

    Measured: Up to 5 years

  6. Duration of Response (DOR)

    Measured: Up to 5 years

  7. 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.

  1. First posted17 Oct 2024
  2. Study start25 Feb 2025
  3. Primary completion17 Aug 2027 (estimated)
  4. Study completion14 Jul 2031 (estimated)

Resources

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)
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

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