A Study of Amivantamab and mFOLFOX6 or FOLFIRI Versus Cetuximab and mFOLFOX6 or FOLFIRI as First-line Treatment in Participants With KRAS/NRAS and BRAF Wild-type Unresectable or Metastatic Left-sided Colorectal Cancer
OrigAMI-2
A Randomized, Open-label Phase 3 Study of Amivantamab and mFOLFOX6 or FOLFIRI Versus Cetuximab and mFOLFOX6 or FOLFIRI as First-line Treatment in Participants With KRAS/NRAS and BRAF Wild-type Unresectable or Metastatic Left-sided Colorectal Cancer
2 other identifiers
interventional
1,000
22 countries
234
Brief Summary
The purpose of this study is to compare how long the participants are disease-free (progression-free survival) when treated with amivantamab and chemotherapy with 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, oxaliplatin (mFOLFOX6) or 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, and irinotecan hydrochloride (FOLFIRI) versus cetuximab and mFOLFOX6 or FOLFIRI in adult participants with Kirsten rat sarcoma viral oncogene homolog (KRAS)/ Neuroblastoma RAS viral oncogene homolog (NRAS) and v-Raf murine sarcoma viral oncogene homolog B1 (BRAF) wild type (WT) unresectable or metastatic left-sided colorectal cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2024
Longer than P75 for phase_3
234 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
Study Start
First participant enrolled
October 18, 2024
CompletedFirst Submitted
Initial submission to the registry
October 28, 2024
CompletedFirst Posted
Study publicly available on registry
October 29, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 30, 2032
April 13, 2026
April 1, 2026
4.2 years
October 28, 2024
April 8, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR)
PFS is defined as the time from randomization until the date of objective disease progression or death (due to any cause), whichever comes first, as assessed by BICR using response evaluation criteria in solid tumors (RECIST) version (v) 1.1. Participants who have not progressed or have not died at the time of analysis will be censored at their last evaluable RECIST v1.1 assessment date.
Up to 4 years and 2 months
Secondary Outcomes (20)
Overall Survival (OS)
Up to 7 Years 3 Months
Objective Response Rate (ORR) as Assessed by BICR
Up to 7 Years 3 Months
Objective Response Rate (ORR) as Assessed by Investigator
Up to 7 Years 3 Months
Progression Free Survival (PFS) as Assessed by Investigator
Up to 7 Years 3 Months
Duration of Response (DOR) as Assessed by BICR
Up to 7 Years 3 Months
- +15 more secondary outcomes
Study Arms (2)
Arm A: Amivantamab in Combination With Chemotherapy
EXPERIMENTALParticipants will receive amivantamab in combination with chemotherapy (mFOLFOX6 \[chemotherapy consisting of 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, and oxaliplatin\] or FOLFIRI \[chemotherapy consisting of 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, and irinotecan hydrochloride\]) for 28-days treatment cycles and will continue to receive the treatment until radiographic disease progression or other discontinuation criteria are met.
Arm B: Cetuximab in Combination With Chemotherapy
ACTIVE COMPARATORParticipants will receive cetuximab in combination with chemotherapy (mFOLFOX6 or FOLFIRI) for 28-days treatment cycles and will continue to receive the treatment until radiographic disease progression or other discontinuation criteria are met.
Interventions
Cetuximab will be administered.
5-fluorouracil will be administered as chemotherapy regimen.
Leucovorin calcium/Levoleucovorin will be administered as chemotherapy regimen.
Oxaliplatin will be administered as chemotherapy regimen.
Irinotecan hydrochloride will be administered as chemotherapy regimen.
Amivantamab will be administered.
Eligibility Criteria
You may qualify if:
- Have histologically or cytologically confirmed adenocarcinoma of the left-sided colorectal cancer. Participants must have unresectable or metastatic disease
- Determined to have Kirsten rat sarcoma viral oncogene (KRAS), neuroblastoma RAS viral oncogene homolog (NRAS), and v-raf murine sarcoma viral oncogene homolog B (BRAF) wild-type (WT) tumor by local and/or central testing (if available)
- Must agree to the submission of fresh tumor tissue
- Have measurable disease according to RECIST v1.1
- Has not received any prior systemic therapy for unresectable or metastatic colorectal cancer (CRC). Prior adjuvant/neoadjuvant therapy in the non-metastatic disease is permitted. However, the last course of adjuvant or neoadjuvant chemotherapy must have concluded greater than (\>) 12 months prior to CRC recurrence/metastases
- Have an eastern cooperative oncology group (ECOG) performance status (PS) of 0 or 1
You may not qualify if:
- Has medical history of (noninfectious) interstitial lung disease (ILD) /pneumonitis/pulmonary fibrosis or has current ILD/pneumonitis/pulmonary fibrosis, or where suspected ILD/pneumonitis/pulmonary fibrosis cannot be ruled out by imaging at screening
- Has known allergies, hypersensitivity, or intolerance to excipients of any of the following: (a) amivantamab or cetuximab, (b) any component of mFOLFOX6 and, (c) any component of FOLFIRI
- Has a prior or concurrent second malignancy other than the disease under study or one whose natural history or treatment is likely to interfere with any study endpoints of safety or the efficacy of the study treatment(s)
- Participant with known mismatch repair deficiency (dMMR)/ high microsatellite instability (MSI-H) status and human epidermal growth factor receptor 2 (HER2)-positive/amplified tumor
- Has prior exposure to any agents that target epidermal growth factor receptor (EGFR), mesenchymal epithelial transition (MET) or vascular endothelial growth factor (VEGF)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (234)
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234, United States
St. Bernard's Medical Center
Jonesboro, Arkansas, 72401, United States
Highlands Oncology Group
Springdale, Arkansas, 72762, United States
CBCC Global Research
Bakersfield, California, 93309, United States
Los Angeles Cancer Network
Glendale, California, 91204, United States
Cancer and Blood Specialty Clinic
Los Alamitos, California, 90720, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
UCLA
Santa Monica, California, 90404, United States
Providence Medical Foundation
Santa Rosa, California, 95403, United States
Torrance Memorial Physicians Network
Torrance, California, 90505, United States
Rocky Mountain Cancer Centers
Denver, Colorado, 80218, United States
Yale University School Of Medicine
New Haven, Connecticut, 06519, United States
Georgetown Univ Medical Center Lombardi Cancer Center
Washington D.C., District of Columbia, 20007, United States
Florida Cancer Specialists South
Fort Myers, Florida, 33901, United States
AdventHealth Medical Group Oncology and Hematology at Orlando
Orlando, Florida, 32804, United States
Florida Cancer Specialists North Region
St. Petersburg, Florida, 33701-4553, United States
Florida Cancer Specialists East
West Palm Beach, Florida, 33401-3406, United States
Grady Memorial Hospital
Atlanta, Georgia, 30303, United States
Winship Cancer Institute Emory University
Atlanta, Georgia, 30322, United States
Illinois CancerCare
Peoria, Illinois, 61615, United States
Fort Wayne Medical Oncology & Hematology
Fort Wayne, Indiana, 46804, United States
University of Iowa Hospital
Iowa City, Iowa, 52242, United States
Mission Cancer Blood
Waukee, Iowa, 50263, United States
Cancer Center of Kansas
Wichita, Kansas, 67214, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
MedStar Franklin Square Medical Center
Baltimore, Maryland, 21237, United States
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, 48105, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Start Midwest
Grand Rapids, Michigan, 49503, United States
Hattiesburg Clinic
Hattiesburg, Mississippi, 39401, United States
Washington University School Of Medicine
St Louis, Missouri, 63110, United States
Nebraska Cancer Specialists Midwest Cancer Center
Omaha, Nebraska, 68130, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169, United States
Astera Cancer Care
East Brunswick, New Jersey, 08816, United States
Rutgers Cancer Institute
New Brunswick, New Jersey, 08901, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87102, United States
Perlmutter Cancer Center at NYU Long Island
Mineola, New York, 11501, United States
Mount Sinai
New York, New York, 10003, United States
Mount Sinai West
New York, New York, 10009, United States
NYU Langone Medical Center NYU Hematology Associates
New York, New York, 10016, United States
Herbert Irving Comprehensive Cancer Center Columbia University Medical Center
New York, New York, 10032, United States
New York Cancer and Blood Specialists
Shirley, New York, 11967, United States
Montefiore Einstein Comprehensive Cancer Center
The Bronx, New York, 10461, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Gabrail Cancer Center
Canton, Ohio, 44718, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Cleveland Clinic Cancer Center Fairview Hospital Moll Pavilion
Cleveland, Ohio, 44111, United States
Taussig Cancer Insititute Cleveland Clinic
Cleveland, Ohio, 44195, United States
Cleveland Clinic Cancer Center Independence Family Health Center
Independence, Ohio, 44131, United States
Cleveland Clinic Cancer Center Mansfield
Mansfield, Ohio, 44906, United States
Cleveland Clinic Cancer Center Hillcrest Hospital
Mayfield Heights, Ohio, 44124, United States
Cleveland Clinic Cancer Centers Sandusky
Sandusky, Ohio, 44870, United States
Cleveland Clinic Cancer Center Strongsville
Strongsville, Ohio, 44136, United States
Cleveland Clinic Cancer Center South Pointe Hospital
Warrensville Heights, Ohio, 44122, United States
Wooster Milltown Specialty and Surgery Center
Wooster, Ohio, 44691, United States
Oregon Health And Science University
Portland, Oregon, 97239, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
University Of Pittsburgh Medical Center UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232 1301, United States
SCRI Oncology Partners
Nashville, Tennessee, 37203, United States
Texas Oncology West Texas
Abilene, Texas, 79606, United States
Texas Oncology DFW
Dallas, Texas, 75246, United States
UT Southwestern
Dallas, Texas, 75390, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Texas Oncology - San Antonio
San Antonio, Texas, 78240, United States
Baylor Scott and White Health
Temple, Texas, 76508, United States
Virginia Cancer Specialists
Arlington, Virginia, 22201, United States
Inova Schar Cancer Institute Dept of Fairfax Hospital
Fairfax, Virginia, 22031, United States
Richmond VA Medical Center
Richmond, Virginia, 23249, United States
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, 23298, United States
Swedish Cancer Institute Edmonds
Edmonds, Washington, 98026, United States
Swedish Cancer Institute Issaquah
Issaquah, Washington, 98029, United States
Swedish Cancer Institute
Seattle, Washington, 98104, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109, United States
William S. Middleton Memorial VA
Madison, Wisconsin, 53705, United States
Institut Jules Bordet
Anderlecht, 1070, Belgium
Universitair Ziekenhuis Antwerpen
Edegem, 2650, Belgium
AZ Maria Middelares
Ghent, 9000, Belgium
Hopital de Jolimont
Haine Saint Paul La Louviere, 7100, Belgium
Az Groeninge
Kortrijk, 8500, Belgium
Universitair Ziekenhuis Leuven
Leuven, 3000, Belgium
Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman
Liège, 4000, Belgium
Fundacao Pio XII
Barretos, 14780 070, Brazil
Fundacao Universidade de Caxias do Sul
Caxias do Sul, 95070 560, Brazil
Fundacao Doutor Amaral Carvalho
Jaú, 17210 080, Brazil
Hospital Nossa Senhora da Conceicao S A
Porto Alegre, 91350 200, Brazil
Hospital Santa Izabel Santa Casa de Misericordia da Bahia
Salvador, 40050 410, Brazil
Clinica de Hematologia e Oncologia Viver Ltda
Santa Maria, 97015 450, Brazil
Fundacao Faculdade Regional De Medicina S Jose Rio Preto Hospital De Base
São José do Rio Preto, 15090 000, Brazil
Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
São Paulo, 01246 000, Brazil
Fundacao Antonio Prudente A C Camargo Cancer Center
São Paulo, 01509 900, Brazil
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
São Paulo, 05651 900, Brazil
Associacao Feminina de Educacao e Combate ao Cancer Hospital Santa Rita de Cassia
Vitória, 29043 260, Brazil
Arthur J E Child Comprehensive Cancer Centre
Calgary, Alberta, T2N 5G2, Canada
Ottawa Hospital
Ottawa, Ontario, K1H 8L6, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, M5G1X6, Canada
Centre de Recherche du CHUM
Montreal, Quebec, H2X 0C1, Canada
Peking University First Hospital
Beijing, 100034, China
Beijing Friendship Hospital Capital Medical University
Beijing, 100050, China
Beijing Cancer Hospital
Beijing, 100142, China
Peking University Third Hospital
Beijing, 100191, China
The First Bethune Hospital of Jilin University
Changchun, 130021, China
Hunan Cancer hospital
Changsha, 410013, China
Sun Yat Sen University Cancer Center
Guangzhou, 510062, China
The Sixth Affiliated Hospital Sun Yat sen University
Guangzhou, 510655, China
Guangdong Provincial People's Hospital
Guangzhou, 519041, China
The First Affiliated Hospital Zhejiang University College of Medicine
Hangzhou, 310003, China
The Second Affiliated Hospital of Zhejiang University College of Medicine
Hangzhou, 310009, China
Zhejiang Cancer Hospital
Hangzhou, 310022, China
Harbin medical university cancer hospital
Harbin, 150081, China
Huizhou Central People's Hospital
Huizhou, 516001, China
The First Affiliated Hospital of NanChang University
Nanchang, 330006, China
Fudan University Shanghai Cancer Center
Shanghai, 200032, China
Liaoning Cancer Hospital and Institute
Shenyang, 110042, China
Peking University Shenzhen Hospital
Shenzhen, 518036, China
West China Hospital of Sichuan University
Sichuan, 610044, China
First Hospital of Shanxi Medical University
Taiyuan, 030001, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, 300060, China
Hubei Cancer Hospital
Wuhan, 430079, China
Institut Sainte Catherine
Avignon, 84918, France
Hopital Claude Huriez
Lille, 59000, France
Hopital Prive Jean Mermoz
Lyon, 69008, France
Institut du Cancer de Montpellier
Montpellier, 34298, France
CHU Nantes
Nantes, 44000, France
Hopital Saint Antoine
Paris, 75571, France
Hopital Haut Leveque
Pessac, 33604, France
CHU De Poitiers
Poitiers, 86000, France
Gustave Roussy
Villejuif, 94805, France
Charite Universitatsmedizin Berlin Campus Virchow Klinikum
Berlin, 13353, Germany
Universitaetsklinikum Carl Gustav Carus TU Dresden
Dresden, 01307, Germany
Essen University Hospital
Essen, 45147, Germany
Krankenhaus NorthWest
Frankfurt am Main, 60488, Germany
Praxis fur interdisziplinare Onkologie & Hamatologie GbR
Freiburg im Breisgau, 79110, Germany
Asklepios Klinik Altona
Hamburg, 22763, Germany
National Center for Tumor Diseases NCT
Heidelberg, 69120, Germany
Universitatsmedizin der Johannes Gutenberg Universitat Mainz
Mainz, 55131, Germany
Klinikum der Universitaet Muenchen
Munich, 81377, Germany
Universitatsklinikum Ulm
Ulm, 89081, Germany
Semmelweis Egyetem
Budapest, 1082, Hungary
Markhot Ferenc Oktatokorhaz es Rendelointezet
Eger, 3300, Hungary
Pecsi Tudomanyegyetem
Pécs, 7624, Hungary
Szegedi Tudomanyegyetem
Szeged, 6720, Hungary
Rajiv Gandhi Cancer Institute and Research Centre
Delhi, 110085, India
B P Poddar Hospital and Medical research Limited
Kolkata, 700053, India
Tata Memorial Hospital
Mumbai, 400012, India
Deenanath Mangeshkar Hospital and Research Centre
Pune, 411004, India
Mahamana Pandit Madan Mohan Malviya Cancer Centre
Varanasi, 221005, India
Yitzhak Shamir Medical Center
Beer Yaakov, 70300, Israel
Rambam Medical Center
Haifa, 3109601, Israel
Hadassah University Hospita Ein Kerem
Jerusalem, 9112001, Israel
Rabin Medical Center
Petah Tikva, 4941492, Israel
Sheba Medical Center
Ramat Gan, 52621, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906, Israel
Assuta MC
Tel Aviv, 69710, Israel
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola, 47014, Italy
Istituto Dei Tumori Di Milano
Milan, 20133, Italy
Istituto Oncologico Veneto - IRCCS
Padova, 35128, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, 56126, Italy
Istituto Clinico Humanitas
Rozzano, 20089, Italy
Chiba Cancer Center
Chiba, 260 0801, Japan
National Cancer Center Hospital
Chūōku, 104 0045, Japan
National Cancer Center Hospital East
Kashiwa, 277 8577, Japan
Aichi Cancer Center
Nagoya, 464 8681, Japan
National Hospital Organization Osaka National Hospital
Osaka, 540 0006, Japan
Osaka International Cancer Institute
Osaka, 541 8567, Japan
Shizuoka Cancer Center
Shizuoka, 411 8777, Japan
The University of Osaka Hospital
Suita, 565 0871, Japan
The Cancer Institute Hospital of JFCR
Tokyo, 135 8550, Japan
Hospital Canselor Tuanku Muhriz UKM
Cheras, 56000, Malaysia
Hospital Pulau Pinang
George Town, 10450, Malaysia
Hospital Raja Permaisuri Bainun
Ipoh, 30450, Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, 50586, Malaysia
University Malaya Medical Centre
Kuala Lumpur, 59100, Malaysia
Hospital Umum Sarawak
Kuching, 93586, Malaysia
National Cancer Institute
Putrajaya, 62250, Malaysia
Meander Medisch Centrum
Amersfoort, 3813 TZ, Netherlands
Antoni van Leeuwenhoek
Amsterdam, 1066 CX, Netherlands
Radboud University Medical Center
Nijmegen, 6525 GA, Netherlands
Erasmus MC
Rotterdam, 3015 GD, Netherlands
Elisabeth-TweeSteden Ziekenhuis
Tilburg, 5022 GC, Netherlands
UMC Utrecht
Utrecht, 3584 CX, Netherlands
Bialostockie Centrum Onkologii im Marii Sklodowskiej Curie w Bialymstoku
Bialystok, 15 027, Poland
Wojewodzki Szpital Specjalistyczny
Biała Podlaska, 21 500, Poland
Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im Ks B Markiewicza
Brzozów, 36 200, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, 80 214, Poland
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz w Gliwicach
Gliwice, 44 100, Poland
Instytut Centrum Zdrowia Matki Polki
Lodz, 93 339, Poland
Szpital Kliniczny MSWiA z WMCO
Olsztyn, 10 228, Poland
SPZOZ Opolskie Centrum Onkologii im. Prof. Tadeusza Koszarowskiego
Opole, 45 061, Poland
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
Warsaw, 02 781, Poland
Pan American Center for Oncology Trials LLC
Barrio Monacillos, 00935, Puerto Rico
Kyungpook National University Chilgok Hospital
Daegu, 41404, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Severance Hospital Yonsei University Health System
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
The Catholic University of Korea Seoul St Marys Hospital
Seoul, 06591, South Korea
Hosp. de La Santa Creu I Sant Pau
Barcelona, 08025, Spain
Hosp Univ Vall D Hebron
Barcelona, 08035, Spain
Hosp. Gral. Univ. Gregorio Maranon
Madrid, 28007, Spain
Hosp. Univ. Ramon Y Cajal
Madrid, 28034, Spain
Hosp. Univ. 12 de Octubre
Madrid, 28041, Spain
Clinica Univ. de Navarra
Pamplona, 31008, Spain
Hosp. Virgen Del Rocio
Seville, 41013, Spain
Hosp. Clinico Univ. de Valencia
Valencia, 46010, Spain
Sahlgrenska University Hospital
Gothenburg, 413 45, Sweden
Skanes universitetssjukhus
Lund, 222 42, Sweden
Sodersjukhuset
Stockholm, 118 83, Sweden
Karolinska Universitetssjukhuset
Stockholm, 171 76, Sweden
Uppsala University
Uppsala, SE 751 85, Sweden
Kaohsiung Medical University Chung Ho Memorial Hospital
Kaohsiung City, 80756, Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 83301, Taiwan
National Cheng Kung University Hospital
Tainan, 704, Taiwan
National Taiwan University Hospital
Taipei, 10043, Taiwan
Linkou Chang Gung Memorial Hospital
Taoyuan District, 333, Taiwan
Adana City Hospital
Adana, 01060, Turkey (Türkiye)
Gulhane Egitim ve Arastirma Hastanesi
Ankara, 06010, Turkey (Türkiye)
Dr Abdurrahman Yurtaslan Oncology Training and Research Hospital
Ankara, 06200, Turkey (Türkiye)
Gazi Universitesi Hastanesi
Ankara, 06560, Turkey (Türkiye)
Ankara Bilkent Sehir Hastanesi
Ankara, 06800, Turkey (Türkiye)
Bakirkoy Training and Research Hospital
Istanbul, 34147, Turkey (Türkiye)
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi
Istanbul, 34899, Turkey (Türkiye)
Necmettin Erbakan Universitesi Tip Fakultesi Hastanesi
Konya, 42090, Turkey (Türkiye)
Sakarya University Training and Research Hospital
Sakarya, 54290, Turkey (Türkiye)
Birmingham Heartlands Hospital
Birmingham, B9 5ST, United Kingdom
Addenbrooke's Hospital
Cambridge, CB2 0QQ, United Kingdom
Western General Hospital
Edinburgh, EH4 2XU, United Kingdom
Castle Hill Hospital
Hull, HU16 5JQ, United Kingdom
St James University Hospital
Leeds, LS9 7TF, United Kingdom
St Bartholomew's Hospital
London, EC1A 7BE, United Kingdom
University College Hospital
London, NW1 2BU, United Kingdom
Mount Vernon Cancer Centre
Northwood, HA6 2RN, United Kingdom
Royal Marsden Hospital (Sutton)
Sutton, SM2 5PT, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
October 28, 2024
First Posted
October 29, 2024
Study Start
October 18, 2024
Primary Completion (Estimated)
December 15, 2028
Study Completion (Estimated)
January 30, 2032
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
The data sharing policy of Johnson \& Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu