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
Status: Recruiting
Location: See all (277) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Arkansas
Highlands Oncology Group
RECRUITING
Springdale
Arizona
Local Institution - 0428
NOT_YET_RECRUITING
Tucson
California
Local Institution - 0330
WITHDRAWN
Los Angeles
USC/Norris Comprehensive Cancer Center
RECRUITING
Los Angeles
University of California, Irvine (UCI) Health - UC Irvine Medical Center
RECRUITING
Orange
Local Institution - 0317
NOT_YET_RECRUITING
San Francisco
Florida
Florida Cancer Specialists - East
RECRUITING
Cape Coral
Florida Cancer Specialists - North
RECRUITING
St. Petersburg
Moffitt Cancer Center
RECRUITING
Tampa
Georgia
Local Institution - 0326
NOT_YET_RECRUITING
Atlanta
Northside Hospital
RECRUITING
Atlanta
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
RECRUITING
Marietta
Iowa
Local Institution - 0335
NOT_YET_RECRUITING
Iowa City
Illinois
Local Institution - 0433
NOT_YET_RECRUITING
Chicago
Indiana
Local Institution - 0638
NOT_YET_RECRUITING
Fort Wayne
Massachusetts
Local Institution - 0471
WITHDRAWN
Boston
Maryland
Local Institution - 0262
NOT_YET_RECRUITING
Baltimore
Maryland Oncology Hematology - Silver Spring
RECRUITING
Silver Spring
Michigan
Local Institution - 0430
NOT_YET_RECRUITING
Ann Arbor
Local Institution - 0254
NOT_YET_RECRUITING
Grand Rapids
Minnesota
Minnesota Oncology
RECRUITING
Maple Grove
Missouri
Local Institution - 0318
NOT_YET_RECRUITING
Kansas City
Washington University School OF Medicine-Siteman Cancer Center
RECRUITING
St Louis
North Carolina
Local Institution - 0290
NOT_YET_RECRUITING
Charlotte
North Dakota
Sanford Fargo Medical Center
RECRUITING
Fargo
Nebraska
University Of Nebraska Medical Center
RECRUITING
Omaha
New York
Northwell Health/ RJ Zuckerberg Cancer Center
RECRUITING
Lake Success
Laura and Isaac Perlmutter Cancer Center at NYU Langone
RECRUITING
Mineola
New York Cancer and Blood Specialists
RECRUITING
Shirley
Ohio
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center
RECRUITING
Columbus
Pennsylvania
Lehigh Valley Health Network
RECRUITING
Allentown
Local Institution - 0604
NOT_YET_RECRUITING
Pittsburgh
South Dakota
Sanford Cancer Center
RECRUITING
Sioux Falls
Tennessee
Local Institution - 0333
NOT_YET_RECRUITING
Nashville
SCRI Oncology Partners
RECRUITING
Nashville
Texas
Texas Oncology Dallas Fort Worth West (DFWW) - Arlington Cancer Center North
RECRUITING
Arlington
Texas Oncology, PA
RECRUITING
Austin
Baylor College of Medicine Medical Center
RECRUITING
Houston
Texas Oncology - San Antonio
RECRUITING
San Antonio
Utah
Local Institution - 0426
NOT_YET_RECRUITING
Salt Lake City
Virginia
Local Institution - 0278
NOT_YET_RECRUITING
Fairfax
Virginia Oncology Associates
RECRUITING
Norfolk
Washington
Local Institution - 0491
NOT_YET_RECRUITING
Edmonds
Local Institution - 0253
NOT_YET_RECRUITING
Seattle
Local Institution - 0629
NOT_YET_RECRUITING
Spokane
Northwest Cancer Specialists, P.C.
RECRUITING
Vancouver
Other Locations
Argentina
Hospital Italiano de Buenos Aires
RECRUITING
Abb
Centro de Educación Médica e Investigaciones clínicas Dr. Norberto Quirno (CEMIC)
RECRUITING
Buenos Aires
Hospital Británico de Buenos Aires
RECRUITING
Caba
Centro Médico Fleischer
RECRUITING
Ciudad Autónoma De Buenos Aires
Instituto Alexander Fleming
RECRUITING
Ciudad Autónoma De Buenos Aires
Local Institution - 0630
NOT_YET_RECRUITING
Córdoba
Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L
RECRUITING
San Miguel De Tucumán
Australia
Flinders Medical Centre
RECRUITING
Adelaide
Grampians Health
RECRUITING
Ballarat Central
Sunshine Coast University Hospital
RECRUITING
Birtinya
Gallipoli Medical Research Ltd
RECRUITING
Brisbane
Royal Brisbane and Women's Hospital
RECRUITING
Brisbane
Local Institution - 0643
NOT_YET_RECRUITING
Camperdown
Lyell McEwin Hospital
RECRUITING
Elizabeth Vale
Northern Hospital
RECRUITING
Epping
Liverpool Hospital
RECRUITING
Liverpool
Cabrini Hospital - Malvern
RECRUITING
Malvern
St. John of God Murdoch Hospital
RECRUITING
Murdoch
Goulburn Valley Health
RECRUITING
Shepparton
Western Health-Sunshine & Footscray Hospitals
RECRUITING
St Albans
GenesisCare St Leonards
RECRUITING
St Leonards
Westmead Hospital
RECRUITING
Westmead
Austria
Local Institution - 0164
WITHDRAWN
Feldkirch
Krankenhaus Der Barmherzigen Schwestern Linz
RECRUITING
Linz
Universitaetsklinik Salzburg
RECRUITING
Salzburg
Universitätsklinikum St. Pölten
RECRUITING
Sankt Pölten
Medizinische Universitaet Wien/AKH
RECRUITING
Vienna
Belgium
Local Institution - 0622
NOT_YET_RECRUITING
Bonheiden
Cliniques universitaires Saint-Luc
RECRUITING
Brussels
Local Institution - 0118
NOT_YET_RECRUITING
Brussels
Local Institution - 0620
WITHDRAWN
Charleroi
Antwerp University Hospital
RECRUITING
Edegem
UZ Leuven
RECRUITING
Leuven
AZ Delta vzw
RECRUITING
Roeselare
Brazil
Local Institution - 0266
NOT_YET_RECRUITING
Barretos
Local Institution - 0444
NOT_YET_RECRUITING
Chapecó
Local Institution - 0267
NOT_YET_RECRUITING
Curitiba
Local Institution - 0331
NOT_YET_RECRUITING
Natal/rn
Local Institution - 0342
NOT_YET_RECRUITING
Porto Alegre
Local Institution - 0375
NOT_YET_RECRUITING
Porto Alegre
Local Institution - 0373
NOT_YET_RECRUITING
Santa Cruz Do Sul
Local Institution - 0264
NOT_YET_RECRUITING
São José Do Rio Preto
Local Institution - 0268
NOT_YET_RECRUITING
São Paulo
Local Institution - 0341
NOT_YET_RECRUITING
São Paulo
Canada
Local Institution - 0550
NOT_YET_RECRUITING
Calgary
Local Institution - 0260
NOT_YET_RECRUITING
Halifax
Centre Hospitalier de l'Université de Montréal
RECRUITING
Montreal
Jewish General Hospital
RECRUITING
Montreal
Local Institution - 0255
NOT_YET_RECRUITING
Ottawa
Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (CIUS
RECRUITING
Sherbrooke
Local Institution - 0421
NOT_YET_RECRUITING
Toronto
Local Institution - 0424
WITHDRAWN
Toronto
Chile
Local Institution - 0171
NOT_YET_RECRUITING
Recoleta
Local Institution - 0175
NOT_YET_RECRUITING
Santiago
Local Institution - 0463
NOT_YET_RECRUITING
Santiago
China
Local Institution - 0409
NOT_YET_RECRUITING
Beijing
Local Institution - 0376
NOT_YET_RECRUITING
Changsha
Local Institution - 0411
NOT_YET_RECRUITING
Changsha
Local Institution - 0498
NOT_YET_RECRUITING
Chengdu
Local Institution - 0499
NOT_YET_RECRUITING
Chongqing
Local Institution - 0354
NOT_YET_RECRUITING
Fuzhou
Local Institution - 0388
NOT_YET_RECRUITING
Fuzhou Fujian
Local Institution - 0130
NOT_YET_RECRUITING
Guangzhou
Local Institution - 0414
NOT_YET_RECRUITING
Guangzhou
Local Institution - 0360
NOT_YET_RECRUITING
Hangzhou
Local Institution - 0383
WITHDRAWN
Hangzhou
Local Institution - 0457
NOT_YET_RECRUITING
Hangzhou
Local Institution - 0353
NOT_YET_RECRUITING
Harbin
Local Institution - 0595
NOT_YET_RECRUITING
Hefei
Local Institution - 0382
NOT_YET_RECRUITING
Jinan
Local Institution - 0381
NOT_YET_RECRUITING
Nanchang
Local Institution - 0416
NOT_YET_RECRUITING
Nanjing, Jiangsu
Local Institution - 0384
NOT_YET_RECRUITING
Nanyang
Local Institution - 0356
NOT_YET_RECRUITING
Shanghai
Local Institution - 0378
NOT_YET_RECRUITING
Shanghai
Local Institution - 0352
WITHDRAWN
Shenyang
Local Institution - 0355
NOT_YET_RECRUITING
Shenyang
Local Institution - 0650
NOT_YET_RECRUITING
Shenzhen
Local Institution - 0390
NOT_YET_RECRUITING
Tianjin
Local Institution - 0391
NOT_YET_RECRUITING
Wuhan
Local Institution - 0412
NOT_YET_RECRUITING
Wuhan
Local Institution - 0398
NOT_YET_RECRUITING
Yangzhou
France
Local Institution - 0590
NOT_YET_RECRUITING
Besançon
Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand
RECRUITING
Dijon
Local Institution - 0613
NOT_YET_RECRUITING
Lille
Local Institution - 0616
NOT_YET_RECRUITING
Limoges
Local Institution - 0618
NOT_YET_RECRUITING
Lorient
Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone
RECRUITING
Marseille
Local Institution - 0121
WITHDRAWN
Marseille
Local Institution - 0125
NOT_YET_RECRUITING
Nantes
Hôpital Saint Antoine
RECRUITING
Paris
CHU Bordeaux Haut-Leveque
RECRUITING
Pessac
CHU Charles Nicolle
RECRUITING
Rouen
Local Institution - 0182
NOT_YET_RECRUITING
Saint-herblain
Local Institution - 0634
NOT_YET_RECRUITING
Suresnes
CHU Rangueil
RECRUITING
Toulouse
Local Institution - 0098
NOT_YET_RECRUITING
Villejuif
Germany
Charité - Universitaetsmedizin Berlin - Campus Bejnamin Franklin
RECRUITING
Berlin
St. Josef und St. Elisabeth Hospital gGmbH
RECRUITING
Bochum
Local Institution - 0588
NOT_YET_RECRUITING
Chemnitz
Universitaetsklinikum Carl Gustav Carus Dresden
RECRUITING
Dresden
Marien Hospital Düsseldorf
RECRUITING
Düsseldorf
Universtiy Hospital of Erlangen
RECRUITING
Erlangen
Krankenhaus Nordwest GmbH
RECRUITING
Frankfurt
Universitaetsmedizin Goettingen
RECRUITING
Göttingen
Facharztzentrum Eppendorf
RECRUITING
Hamburg
Local Institution - 0594
NOT_YET_RECRUITING
Hamburg
Praxis Onkologie am Raschplatz
RECRUITING
Hanover
Universitatsklinikum Leipzig
RECRUITING
Leipzig
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
RECRUITING
Mainz
Universitätsmedizin Mannheim
RECRUITING
Mannheim
Klinikum Neuperlach
RECRUITING
München
Local Institution - 0037
NOT_YET_RECRUITING
Ulm
Hungary
Local Institution - 0203
NOT_YET_RECRUITING
Veszprém
India
Local Institution - 0554
NOT_YET_RECRUITING
Delhi
Local Institution - 0036
NOT_YET_RECRUITING
Mumbai
Local Institution - 0552
WITHDRAWN
Mumbai
Local Institution - 0010
NOT_YET_RECRUITING
Nashik
Local Institution - 0557
WITHDRAWN
Puducherry
Local Institution - 0038
NOT_YET_RECRUITING
Pune
Local Institution - 0654
NOT_YET_RECRUITING
Thiruvananthapuram
Italy
Local Institution - 0609
NOT_YET_RECRUITING
Avellino
Local Institution - 0614
NOT_YET_RECRUITING
Aviano
Local Institution - 0610
NOT_YET_RECRUITING
Bari
Local Institution - 0617
NOT_YET_RECRUITING
Castellana Grotte
Azienda Ospedaliera Garibaldi
RECRUITING
Catania
Local Institution - 0615
NOT_YET_RECRUITING
La Spezia
ASST Grande Ospedale Metropolitano Niguarda
RECRUITING
Milan
Local Institution - 0111
NOT_YET_RECRUITING
Milan
Ospedale San Raffaele
RECRUITING
Milan
Istituto Nazionale Tumori IRCCS Fondazione Pascale
RECRUITING
Naples
Istituto Oncologico Veneto IRCCS
RECRUITING
Padova
Azienda Ospedaliero Universitaria Pisana
RECRUITING
Pisa
Local Institution - 0612
NOT_YET_RECRUITING
Ravenna
Arcispedale Santa Maria Nuova
RECRUITING
Reggio Emilia
IRCCS Casa Sollievo della Sofferenza
RECRUITING
San Giovanni Rotondo
Local Institution - 0619
NOT_YET_RECRUITING
Tricase
Japan
Chiba cancer center
RECRUITING
Chiba
Local Institution - 0473
NOT_YET_RECRUITING
Chikusa-ku
National Cancer Center Hospital
RECRUITING
Chuo-ku
National Hospital Organization Kyushu Cancer Center
RECRUITING
Fukuoka
Saitama Medical University International Medical Center
RECRUITING
Hidaka
Saitama Prefectural Cancer Center
RECRUITING
Ina-machi
National Cancer Center Hospital East
RECRUITING
Kashiwa
Kobe City Medical Center General Hospital
RECRUITING
Kobe
The Cancer Institute Hospital of JFCR
RECRUITING
Koto-ku
Kurashiki Central Hospital
RECRUITING
Kurashiki
National Hospital Organization Shikoku Cancer Center
RECRUITING
Matsuyama
Shizuoka Cancer Center
RECRUITING
Nagaizumi-cho,sunto-gun
Osaka International Cancer Institute
RECRUITING
Osaka
Hokkaido University Hospital
RECRUITING
Sapporo
Local Institution - 0067
NOT_YET_RECRUITING
Sendai
The University of Osaka Hospital
RECRUITING
Suita
Osaka Medical and Pharmaceutical University Hospital
RECRUITING
Takatsuki
Fujita Health University
RECRUITING
Toyoake
Local Institution - 0642
NOT_YET_RECRUITING
Yamagata
Kanagawa cancer center
RECRUITING
Yokohama
Mexico
Local Institution - 0653
NOT_YET_RECRUITING
Chihuahua City
Local Institution - 0559
NOT_YET_RECRUITING
Tlalpan
Netherlands
Local Institution - 0112
WITHDRAWN
Amsterdam
Local Institution - 0173
WITHDRAWN
Eindhoven
Local Institution - 0170
WITHDRAWN
Groningen
Local Institution - 0216
WITHDRAWN
Tilburg
Local Institution - 0167
WITHDRAWN
Utrecht
Poland
Local Institution - 0365
NOT_YET_RECRUITING
Brzozów
Local Institution - 0626
NOT_YET_RECRUITING
Gdansk
Local Institution - 0451
WITHDRAWN
Gliwice
Wojewódzkie Centrum Szpitalne Kotliny Jeleniogórskiej
RECRUITING
Jelenia Góra
Local Institution - 0361
NOT_YET_RECRUITING
Koszalin
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie
RECRUITING
Krakow
SP ZOZ Opolskie Centrum Onkologii im. prof. Tadeusza Koszarowskiego w Opolu
RECRUITING
Opole
Luxmed Onkologia sp. z o. o.
RECRUITING
Warsaw
Państwowy Instytut Medyczny MSWiA
RECRUITING
Warsaw
Mazowiecki Szpital Onkologiczny
RECRUITING
Wieliszew
Republic of Korea
Local Institution - 0636
NOT_YET_RECRUITING
Deagu
Local Institution - 0635
NOT_YET_RECRUITING
Goyang-si
Seoul National University Bundang Hospital
RECRUITING
Seongnam
Asan Medical Center
RECRUITING
Seoul
Local Institution - 0637
NOT_YET_RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Severance Hospital, Yonsei University Health System
RECRUITING
Seoul
The Catholic Univ. of Korea Seoul St. Mary's Hospital
RECRUITING
Seoul
Romania
Fundeni Clinical Institute
RECRUITING
Bucharest
Institutul Oncologic Cluj
RECRUITING
Cluj-napoca
Institutul Regional de Gastroenterologie și Hepatologie Prof. Dr. Octavian Fodor
RECRUITING
Cluj-napoca
Centrul de Oncologie Sfântul Nectarie
RECRUITING
Craiova
Local Institution - 0139
NOT_YET_RECRUITING
Floresti/ Cluj
Institutul Regional de Oncologie
RECRUITING
Iași
S.C. Centrul de Oncologie Euroclinic S.R.L.
RECRUITING
Iași
Singapore
Curie Oncology - Farrer
RECRUITING
Singapore
Local Institution - 0285
NOT_YET_RECRUITING
Singapore
National Cancer Centre Singapore
RECRUITING
Singapore
National University Hospital
RECRUITING
Singapore
Spain
Institut Català d'Oncologia (ICO) - Badalona
RECRUITING
Badalona
Hospital Universitari Vall d'Hebron
RECRUITING
Barcelona
Local Institution - 0472
NOT_YET_RECRUITING
Elche (alicante)
Hospital General Universitario Gregorio Marañon
RECRUITING
Madrid
Local Institution - 0229
NOT_YET_RECRUITING
Madrid
Local Institution - 0624
NOT_YET_RECRUITING
Madrid
H.R.U Málaga - Hospital General
RECRUITING
Málaga
Complejo Hospitalario de Navarra
RECRUITING
Pamplona
Local Institution - 0625
NOT_YET_RECRUITING
Salamanca
Local Institution - 0593
WITHDRAWN
Santiago De Compostela
Hospital Universitario Virgen Del Rocio
RECRUITING
Seville
Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
RECRUITING
Kaohsiung City
Local Institution - 0301
NOT_YET_RECRUITING
Kaohsiung Niao Sung Dist
National Cheng Kung University Hospital
RECRUITING
Tainan
National Taiwan University Hospital
RECRUITING
Taipei
Taipei Veterans General Hospital
RECRUITING
Taipei
Chang Gung Medical Foundation-Linkou Branch
RECRUITING
Taoyuan
Turkey
Local Institution - 0020
NOT_YET_RECRUITING
Adana
Local Institution - 0065
NOT_YET_RECRUITING
Ankara
Local Institution - 0018
WITHDRAWN
Erzurum
Local Institution - 0296
NOT_YET_RECRUITING
Istanbul
Local Institution - 0295
WITHDRAWN
Kadiköy/istanbul
United Kingdom
Local Institution - 0540
NOT_YET_RECRUITING
Birmingham
Velindre Cancer Centre
RECRUITING
Cardiff
Local Institution - 0602
NOT_YET_RECRUITING
Dorchester
Local Institution - 0307
NOT_YET_RECRUITING
Glasgow
The Royal Surrey County Hospital NHS Foundation Trust
RECRUITING
Guildford
Royal Free London NHS Foundation Trust
RECRUITING
London
Royal Marsden Hospital
RECRUITING
London
Royal Marsden Hospital Sutton
RECRUITING
London
St. George's Hospital
RECRUITING
London
Maidstone and Tunbridge Wells NHS Trust
RECRUITING
Maidstone
The Christie NHS Foundation Trust
RECRUITING
Manchester
Local Institution - 0599
NOT_YET_RECRUITING
Metropolitan Borough Of Wirral
Freeman Hospital
RECRUITING
Newcastle Upon Tyne
Norfolk and Norwich University Hospitals NHS Foundation Trust
RECRUITING
Norwich
Oxford University Hospitals NHS Trust
RECRUITING
Oxford
Contact Information
Primary
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Clinical.Trials@bms.com
855-907-3286
Backup
First line of the email MUST contain NCT # and Site #.
Time Frame
Start Date: 2025-12-31
Estimated Completion Date: 2034-03-11
Participants
Target number of participants: 990
Treatments
Experimental: Arm A1
Experimental: Arm A2
Other: Arm B
Experimental: Arm C
Other: Arm D
Related Therapeutic Areas
Sponsors
Leads: Bristol-Myers Squibb
Collaborators: BioNTech SE