A Study to Evaluate the Safety and Efficacy of Pumitamig in Combination With Chemotherapy Versus Bevacizumab in Combination With Chemotherapy in Participants With Previously Untreated, Unresectable, or Metastatic Colorectal Cancer
ROSETTA CRC-203: A Blinded, Randomized Phase 2/3 Study of Pumitamig in Combination With Chemotherapy Versus Bevacizumab in Combination With Chemotherapy in Participants With Previously Untreated, Unresectable, or Metastatic Colorectal Cancer
3 other identifiers
interventional
990
25 countries
274
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of pumitamig in combination with chemotherapy versus bevacizumab in combination with chemotherapy in participants with previously untreated, unresectable, or metastatic colorectal cancer
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2025
Longer than P75 for phase_2
274 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 23, 2025
CompletedFirst Posted
Study publicly available on registry
October 27, 2025
CompletedStudy Start
First participant enrolled
December 31, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 2, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 11, 2034
May 6, 2026
April 1, 2026
4.1 years
October 23, 2025
May 1, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Objective Response (OR) (confirmed complete response (CR) or partial response (PR)) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator assessment
Phase 2
Up to 5 years
Progression Free Survival (PFS) by RECIST v1.1 per blinded independent central review (BICR)
Phase 3
Up to 5 years
Overall Survival (OS)
Phase 3
Up to 5 years
Secondary Outcomes (7)
PFS by RECIST v1.1 per investigator assessment
Up to 5 years
Duration of Response (DOR) (CR or PR) by RECIST v1.1 per investigator assessment
Up to 5 years
Time to Response (TTR) (CR or PR) by RECIST v1.1 per investigator assessment
Up to 5 years
Disease control (Best Overall Response (BOR) of confirmed CR, confirmed PR, or Stable Disease (SD)) by RECIST v1.1 per investigator assessment
Up to 5 years
Recommended dose of Pumitamig for Phase 3
Up to 5 years
- +2 more secondary outcomes
Study Arms (5)
Arm A1
EXPERIMENTALArm A2
EXPERIMENTALArm B
OTHERArm C
EXPERIMENTALArm D
OTHERInterventions
Specified dose on specified days
Eligibility Criteria
You may qualify if:
- Participant must previously untreated, histologically confirmed recurrent or metastatic colorectal adenocarcinoma, not amenable to curative surgery.
- Participant must have no known presence of mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) colorectal cancer (CRC) per historical results (a validated test should be used).
- Participant must have no known presence of the gene that encodes the protein B-Raf (BRAF) V600E mutation per local testing.
- Participant must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
You may not qualify if:
- Participant must not have any untreated known central nervous system (CNS) metastases including brain, leptomeningeal and/or spinal cord compression.
- Participant must not have any prior malignancy active within the previous 2 years, except for locally curable cancers that have been apparently cured and considered to be of low risk of recurrence.
- Participant must not have significant cardiovascular disease, such as myocardial infarction, unstable angina, arterial thrombosis or cerebrovascular accident within 6 months prior to randomization, uncontrolled hypertension (≥ 160 systolic, and/or ≥ 100 diastolic mm Hg) despite optimal medical management, or congenital long QT syndrome.
- Participant must not have prior systemic treatment with an anti-PD-1, anti-programmed death (ligand)-1 (PD-L1), anti-PD-L2, CD137 agonists, 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 or chemotherapy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BioNTech SEcollaborator
- Bristol-Myers Squibblead
Study Sites (279)
Local Institution - 0428
Tucson, Arizona, 85724, United States
Local Institution - 0432
Springdale, Arkansas, 72762, United States
Local Institution - 0447
La Jolla, California, 92037, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
University of California, Irvine (UCI) Health - UC Irvine Medical Center
Orange, California, 92868, United States
Local Institution - 0317
San Francisco, California, 94115, United States
Local Institution - 0330
Santa Monica, California, 90404, United States
Local Institution - 0293
Stanford, California, 94305, United States
Florida Cancer Specialists - East
Cape Coral, Florida, 33990, United States
Florida Cancer Specialists - North
St. Petersburg, Florida, 33705, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Local Institution - 0276
Atlanta, Georgia, 30342, United States
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
Marietta, Georgia, 30060, United States
Local Institution - 0030
Chicago, Illinois, 60611, United States
Local Institution - 0433
Chicago, Illinois, 60637, United States
Local Institution - 0638
Fort Wayne, Indiana, 46805, United States
Local Institution - 0335
Iowa City, Iowa, 52242, United States
Local Institution - 0262
Baltimore, Maryland, 21287, United States
Maryland Oncology Hematology - Silver Spring
Silver Spring, Maryland, 20904, United States
Local Institution - 0471
Boston, Massachusetts, 02114, United States
Local Institution - 0430
Ann Arbor, Michigan, 48109, United States
Local Institution - 0254
Grand Rapids, Michigan, 49546, United States
Minnesota Oncology
Maple Grove, Minnesota, 55369, United States
Local Institution - 0318
Kansas City, Missouri, 64111, United States
Washington University School OF Medicine-Siteman Cancer Center
St Louis, Missouri, 63110, United States
Local Institution - 0334
Omaha, Nebraska, 68198, United States
Northwell Health/ RJ Zuckerberg Cancer Center
Lake Success, New York, 11042, United States
Local Institution - 0270
Mineola, New York, 11501, United States
Local Institution - 0273
New Hyde Park, New York, 11042, United States
Local Institution - 0290
Charlotte, North Carolina, 28207, United States
Local Institution - 0526
Fargo, North Dakota, 58102, United States
Local Institution - 0339
Columbus, Ohio, 43210, United States
Local Institution - 0605
Oklahoma City, Oklahoma, 73104, United States
Lehigh Valley Health Network
Allentown, Pennsylvania, 18103, United States
Local Institution - 0604
Pittsburgh, Pennsylvania, 15232, United States
Sanford Cancer Center
Sioux Falls, South Dakota, 57104, United States
Local Institution - 0333
Nashville, Tennessee, 37203, United States
SCRI Oncology Partners
Nashville, Tennessee, 37203, United States
Texas Oncology Dallas Fort Worth West (DFWW) - Arlington Cancer Center North
Arlington, Texas, 76012, United States
Texas Oncology, PA
Austin, Texas, 78705, United States
Local Institution - 0252
Houston, Texas, 77030, United States
Texas Oncology - San Antonio
San Antonio, Texas, 78240, United States
Local Institution - 0426
Salt Lake City, Utah, 84102, United States
Local Institution - 0278
Fairfax, Virginia, 22031, United States
Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
Local Institution - 0491
Edmonds, Washington, 98026-8032, United States
Local Institution - 0253
Seattle, Washington, 98109, United States
Local Institution - 0629
Spokane, Washington, 99218, United States
Northwest Cancer Specialists, P.C.
Vancouver, Washington, 98684, United States
Hospital Británico de Buenos Aires
CABA, Buenos Aires, CP1280AEB, Argentina
Instituto Alexander Fleming
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ANZ, Argentina
Local Institution - 0071
ABB, Buenos Aires F.D., C1199ABB, Argentina
Local Institution - 0632
San Miguel de Tucumán, Tucumán Province, T4000IHE, Argentina
Local Institution - 0174
Buenos Aires, 1039, Argentina
Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC)
Buenos Aires, C1431FWO, Argentina
Local Institution - 0630
Córdoba, X5000JHQ, Argentina
Local Institution - 0643
Camperdown, New South Wales, 2050, Australia
Local Institution - 0277
Liverpool, New South Wales, 2170, Australia
GenesisCare St Leonards
St Leonards, New South Wales, 2065, Australia
Sunshine Coast University Hospital
Birtinya, Queensland, 4575, Australia
Royal Brisbane and Women's Hospital
Brisbane, Queensland, 4029, Australia
Local Institution - 0191
Woolloongabba, Queensland, 4102, Australia
Local Institution - 0156
Adelaide, South Australia, 5042, Australia
Lyell McEwin Hospital
Elizabeth Vale, South Australia, 5112, Australia
Grampians Health
Ballarat Central, Victoria, 3350, Australia
Local Institution - 0190
Epping, Victoria, 3076, Australia
Goulburn Valley Health
Shepparton, Victoria, 3630, Australia
Local Institution - 0519
St Albans, Victoria, 3021, Australia
St. John of God Murdoch Hospital
Murdoch, Western Australia, 6150, Australia
Local Institution - 0160
Malvern, 3144, Australia
Local Institution - 0159
Wentworthville, NSW2145, Australia
Local Institution - 0164
Feldkirch, 6800, Austria
Krankenhaus Der Barmherzigen Schwestern Linz
Linz, 4010, Austria
Universitaetsklinik Salzburg
Salzburg, 5020, Austria
Local Institution - 0176
Sankt Pölten, 3100, Austria
Local Institution - 0082
Vienna, A-1090, Austria
Local Institution - 0622
Bonheiden, Antwerpen, 2820, Belgium
Local Institution - 0103
Edegem, Antwerpen, 2650, Belgium
Cliniques universitaires Saint-Luc
Brussels, Bruxelles-Capitale, Région de, 1200, Belgium
Local Institution - 0620
Charleroi, Hainaut, 6060, Belgium
UZ Leuven
Leuven, Vlaams-Brabant, 3000, Belgium
AZ Delta vzw
Roeselare, West-Vlaanderen, 8800, Belgium
Local Institution - 0118
Brussels, 1000, Belgium
Local Institution - 0267
Curitiba, Paraná, 81480-580, Brazil
Local Institution - 0331
Natal/RN, Rio Grande do Norte, 59062-000, Brazil
Local Institution - 0375
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
Local Institution - 0342
Porto Alegre, Rio Grande do Sul, 91610-000, Brazil
Local Institution - 0373
Santa Cruz do Sul, Rio Grande do Sul, 96810-110, Brazil
Local Institution - 0444
Chapecó, Santa Catarina, 89812-211, Brazil
Local Institution - 0266
Barretos, São Paulo, 14784400, Brazil
Local Institution - 0264
São José do Rio Preto, 15090-000, Brazil
Local Institution - 0268
São Paulo, 01246-000, Brazil
Local Institution - 0341
São Paulo, 01308-060, Brazil
Local Institution - 0550
Calgary, Alberta, T2N 5G2, Canada
Local Institution - 0260
Halifax, Nova Scotia, B3H 3A7, Canada
Local Institution - 0255
Ottawa, Ontario, K1H 8L6, Canada
Local Institution - 0424
Toronto, Ontario, M4N 3M5, Canada
Local Institution - 0421
Toronto, Ontario, M5G 2M9, Canada
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 3E4, Canada
Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
Local Institution - 0261
Sherbrooke, Quebec, J1H 5N4, Canada
Local Institution - 0171
Recoleta, Santiago Metropolitan, 8420391, Chile
Local Institution - 0463
Santiago, Santiago Metropolitan, 7500921, Chile
Local Institution - 0175
Santiago, Santiago Metropolitan, 7620002, Chile
Local Institution - 0595
Hefei, Anhui, 230601, China
Local Institution - 0499
Chongqing, Chongqing Municipality, 400030, China
Local Institution - 0354
Fuzhou, Fujian, 350014, China
Local Institution - 0388
Fuzhou Fujian, Fujian, 350001, China
Local Institution - 0414
Guangzhou, Guangdong, 510000, China
Local Institution - 0130
Guangzhou, Guangdong, 510555, China
Local Institution - 0390
Tianjin, Hebei, 300060, China
Local Institution - 0353
Harbin, Heilongjiang, 150081, China
Local Institution - 0384
Nanyang, Henan, 473009, China
Local Institution - 0391
Wuhan, Hubei, 430079, China
Local Institution - 0376
Changsha, Hunan, 410013, China
Local Institution - 0411
Changsha, Hunan, 410031, China
Local Institution - 0398
Yangzhou, Jiangsu, 225001, China
Local Institution - 0381
Nanchang, Jiangxi, 330006, China
Local Institution - 0352
Shenyang, Liaoning, 110001, China
Local Institution - 0355
Shenyang, Liaoning, 110042, China
Local Institution - 0382
Jinan, Shandong, 250117, China
Local Institution - 0378
Shanghai, Shanghai Municipality, 200120, China
Local Institution - 0498
Chengdu, Sichuan, 610041, China
Local Institution - 0360
Hangzhou, Zhejiang, 310003, China
Local Institution - 0383
Hangzhou, Zhejiang, 310022, China
Local Institution - 0409
Beijing, 100034, China
Local Institution - 0457
Hangzhou, 310009, China
Local Institution - 0416
Nanjing, Jiangsu, 210009, China
Local Institution - 0356
Shanghai, 200032, China
Local Institution - 0412
Wuhan, 430022, China
Local Institution - 0489
Prague, Praha 10, 10034, Czechia
Local Institution - 0248
Prague, Praha 5, 150 06, Czechia
Local Institution - 0461
Prague, Praha, Hlavní Mesto, 12808, Czechia
Local Institution - 0180
Brno, 656 53, Czechia
Local Institution - 0188
Hradec Králové, 500 05, Czechia
Local Institution - 0467
Olomouc, 77520, Czechia
CHU Bordeaux Haut-Leveque
Pessac, Aquitaine, 33600, France
Local Institution - 0590
Besançon, Doubs, 25000, France
CHU Rangueil
Toulouse, Haute-Garonne, 31059, France
CHU Charles Nicolle
Rouen, Haute-Normandie, 76031, France
Local Institution - 0182
Saint-Herblain, Loire-Atlantique, 44805, France
Local Institution - 0618
Lorient, Morbihan, 56100, France
Local Institution - 0613
Lille, Nord, 59020, France
Local Institution - 0125
Nantes, Pays de la Loire Region, 44093, France
Local Institution - 0121
Marseille, Provence-Alpes-Côte d'Azur Region, 13273, France
Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand
Dijon, 21000, France
Local Institution - 0616
Limoges, 87042, France
Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone
Marseille, 13385, France
Hôpital Saint Antoine
Paris, 75571, France
Local Institution - 0634
Suresnes, 92151, France
Local Institution - 0098
Villejuif, 94805, France
Local Institution - 0591
Erlangen, Bavaria, 91054, Germany
Local Institution - 0607
Hanover, Lower Saxony, 30161, Germany
Universitaetsklinikum Carl Gustav Carus Dresden
Dresden, Saxony, 01307, Germany
Local Institution - 0035
Berlin, 10117, Germany
Local Institution - 0061
Bochum, 44791, Germany
Local Institution - 0588
Chemnitz, 09113, Germany
Marien Hospital Düsseldorf
Düsseldorf, 40479, Germany
Krankenhaus Nordwest GmbH
Frankfurt, 60488, Germany
Universitaetsmedizin Goettingen
Göttingen, 37075, Germany
Facharztzentrum Eppendorf
Hamburg, 20249, Germany
Local Institution - 0594
Hamburg, 22763, Germany
Universitatsklinikum Leipzig
Leipzig, D-04103, Germany
Local Institution - 0060
Mainz, 55131, Germany
Local Institution - 0059
Mannheim, 68167, Germany
Klinikum Neuperlach
München, 81737, Germany
Local Institution - 0037
Ulm, 89081, Germany
Local Institution - 0203
Veszprém, 8200, Hungary
Local Institution - 0010
Nashik, Dādra and Nagar Haveli and Damān and Diu, 422001, India
Local Institution - 0036
Mumbai, Maharashtra, 400012, India
Local Institution - 0552
Mumbai, Maharashtra, 400036, India
Local Institution - 0006
Delhi, 110029, India
Local Institution - 0554
Delhi, 110029, India
Local Institution - 0557
Puducherry, 605006, India
Local Institution - 0038
Pune, 411001, India
Local Institution - 0617
Castellana Grotte, Bari, 70013, Italy
IRCCS Casa Sollievo della Sofferenza
San Giovanni Rotondo, Foggia, 71013, Italy
Local Institution - 0619
Tricase, Lecce, 73039, Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, Milano, 20162, Italy
Local Institution - 0614
Aviano, Pordenone, 33081, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Tuscany, 56126, Italy
Istituto Oncologico Veneto IRCCS
Padova, Veneto, 35128, Italy
Local Institution - 0609
Avellino, 83100, Italy
Local Institution - 0610
Bari, 70124, Italy
Local Institution - 0227
Catania, 95124, Italy
Local Institution - 0615
La Spezia, 19124, Italy
Local Institution - 0111
Milan, 20133, Italy
Ospedale San Raffaele
Milan, 20132, Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale
Naples, 80131, Italy
Local Institution - 0612
Ravenna, 48121, Italy
Local Institution - 0233
Reggio Emilia, 42123, Italy
Local Institution - 0641
Toyoake, Aichi-ken, 470-1192, Japan
Local Institution - 0053
Chiba, Chiba, 260-8717, Japan
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577, Japan
Local Institution - 0045
Matsuyama, Ehime, 791-0280, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, 0608648, Japan
Local Institution - 0047
Kobe, Hyōgo, 6500047, Japan
Local Institution - 0056
Yokohama, Kanagawa, 2418515, Japan
Local Institution - 0476
Kurashiki, Okayama-ken, 710-8602, Japan
The University of Osaka Hospital
Suita, Osaka, 565-0871, Japan
Local Institution - 0521
Takatsuki, Osaka, 569-8686, Japan
Local Institution - 0046
Hidaka, Saitama, 350-1298, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, 104-0045, Japan
The Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, 135-8550, Japan
Local Institution - 0642
Yamagata, Yamagata, 990-9585, Japan
Local Institution - 0473
Chikusa-ku, 464-8681, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, 811-1395, Japan
Local Institution - 0597
Kitaadachi-gun, 362-0806, Japan
Local Institution - 0506
Osaka, 541-8567, Japan
Local Institution - 0067
Sendai, 980-8574, Japan
Local Institution - 0054
Sunto-gun, 411-8777, Japan
Local Institution - 0173
Eindhoven, North Brabant, 5623 EJ, Netherlands
Local Institution - 0112
Amsterdam, North Holland, 1105 AZ, Netherlands
Local Institution - 0170
Groningen, 9713 GZ, Netherlands
Local Institution - 0216
Tilburg, 5022 GC, Netherlands
Local Institution - 0167
Utrecht, 3543 AZ, Netherlands
Local Institution - 0364
Krakow, Lesser Poland Voivodeship, 31-826, Poland
Local Institution - 0452
Jelenia Góra, Lower Silesian Voivodeship, 58-506, Poland
Luxmed Onkologia sp. z o. o.
Warsaw, Masovian Voivodeship, 01-748, Poland
Local Institution - 0525
Warsaw, Masovian Voivodeship, 02-507, Poland
Local Institution - 0359
Warsaw, Masovian Voivodeship, 03-411, Poland
Local Institution - 0365
Brzozów, Podkarpackie Voivodeship, 36-200, Poland
Local Institution - 0626
Gdansk, Pomeranian Voivodeship, 80-219, Poland
Local Institution - 0451
Gliwice, Silesian Voivodeship, 44-101, Poland
Local Institution - 0361
Koszalin, West Pomeranian Voivodeship, 75-581, Poland
Local Institution - 0362
Opole, 45-372, Poland
Fundeni Clinical Institute
Bucharest, Bucharest, 022328, Romania
Institutul Regional de Gastroenterologie și Hepatologie Prof. Dr. Octavian Fodor
Cluj-Napoca, Cluj, 400162, Romania
Centrul de Oncologie "Sfântul Nectarie"
Craiova, Dolj, 200542, Romania
Institutul Oncologic Cluj
Cluj-Napoca, 400015, Romania
Local Institution - 0139
Floresti/ Cluj, 407280, Romania
S.C. Centrul de Oncologie Euroclinic S.R.L.
Iași, 700106, Romania
Institutul Regional de Oncologie
Iași, 700483, Romania
National Cancer Centre Singapore
Singapore, Central Singapore, 168583, Singapore
Local Institution - 0147
Singapore, 119074, Singapore
Local Institution - 0285
Singapore, 308442, Singapore
Local Institution - 0511
Singapore, 329563, Singapore
Seoul National University Bundang Hospital
Seongnam, Gyeonggido, 13620, South Korea
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [Seoul], 03080, South Korea
Asan Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], 05505, South Korea
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], 06351, South Korea
The Catholic Univ. of Korea Seoul St. Mary's Hospital
Seoul, Seoul-teukbyeolsi [Seoul], 06591, South Korea
Local Institution - 0405
Seoul, 120-752, South Korea
Local Institution - 0163
Badalona, Barcelona [Barcelona], 08916, Spain
Local Institution - 0240
Barcelona, Barcelona [Barcelona], 08035, Spain
Local Institution - 0624
Madrid, Madrid, Comunidad de, 28034, Spain
Local Institution - 0229
Madrid, Madrid, Comunidad de, 28041, Spain
Complejo Hospitalario de Navarra
Pamplona, Navarre, 31009, Spain
Local Institution - 0472
Elche (alicante), 03203, Spain
Hospital General Universitario Gregorio Marañon
Madrid, 28007, Spain
H.R.U Málaga - Hospital General
Málaga, 29011, Spain
Local Institution - 0625
Salamanca, 37007, Spain
Local Institution - 0593
Santiago de Compostela, 15706, Spain
Hospital Universitario Virgen Del Rocio
Seville, 41013, Spain
Local Institution - 0074
Stockholm, Stockholm County, 17176, Sweden
Local Institution - 0185
Gothenburg, Västra Götaland County, 41685, Sweden
Local Institution - 0400
Lund, 22184, Sweden
Local Institution - 0301
Kaohsiung Niao Sung Dist, Kaohsiung, 83301, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807, Taiwan
National Cheng Kung University Hospital
Tainan, 704, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Local Institution - 0300
Taipei, 11217, Taiwan
Chang Gung Medical Foundation-Linkou Branch
Taoyuan, 333, Taiwan
Local Institution - 0020
Adana, 1370, Turkey (Türkiye)
Local Institution - 0065
Ankara, 06100, Turkey (Türkiye)
Local Institution - 0018
Erzurum, 25070, Turkey (Türkiye)
Local Institution - 0296
Istanbul, 34214, Turkey (Türkiye)
Local Institution - 0295
Kadiköy/Istanbul, 41380, Turkey (Türkiye)
The Christie NHS Foundation Trust
Manchester, Lancashire, M20 4BX, United Kingdom
Local Institution - 0600
Enfield, London, EN28JL, United Kingdom
Local Institution - 0366
Oxford, Oxfordshire, OX3 7LJ, United Kingdom
Local Institution - 0540
Birmingham, West Midlands, B15 2TT, United Kingdom
Local Institution - 0601
Cardiff, CF14 2TL, United Kingdom
Local Institution - 0602
Dorchester, DT1 2JY, United Kingdom
Local Institution - 0307
Glasgow, G12 0YN, United Kingdom
Royal Marsden Hospital Sutton
London, SM2 5PT, United Kingdom
Royal Marsden Hospital
London, SW3 6JJ, United Kingdom
Maidstone and Tunbridge Wells NHS Trust
Maidstone, ME16 9QQ, United Kingdom
Local Institution - 0310
Newcastle upon Tyne, NE7 7DN, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Central Study Contacts
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACT
First line of the email MUST contain NCT # and Site #.
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 23, 2025
First Posted
October 27, 2025
Study Start
December 31, 2025
Primary Completion (Estimated)
February 2, 2030
Study Completion (Estimated)
March 11, 2034
Last Updated
May 6, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- See Plan Description
- Access Criteria
- See Plan Description
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