MagnetisMM-32: A Study to Learn About the Study Medicine Called Elranatamab in People With Multiple Myeloma (MM) That Has Come Back After Taking Other Treatments (Including Prior Treatment With an Anti-CD38 Antibody and Lenalidomide)
A PHASE 3, OPEN-LABEL STUDY OF ELRANATAMAB MONOTHERAPY VERSUS ELOTUZUMAB, POMALIDOMIDE, DEXAMETHASONE (EPd) OR POMALIDOMIDE, BORTEZOMIB, DEXAMETHASONE (PVd) OR CARFILZOMIB, DEXAMETHASONE (Kd) IN PARTICIPANTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA WHO RECEIVED PRIOR ANTI-CD38 DIRECTED THERAPY
3 other identifiers
interventional
492
26 countries
273
Brief Summary
The purpose of this study is to learn about the study medicine called elranatamab.This study aims to compare elranatamab to other medicines for the treatment of MM (a type of cancer). This study is seeking participants who:
- Are 18 years of age or older and have MM.
- Have received treatments before for MM.
- Have MM that has returned or not responded to their most recent treatment. Half of the participants will receive elranatamab. The other half of participants will receive a combination therapy selected by the study doctor. The selected combination therapy will include 2 to 3 different medicines commonly used to treat MM. Elranatamab will be given as a shot under the skin at the study clinic about once a week. This may change to a smaller number of shots later in the study. The medicines in the combination therapy will be taken by mouth (at home or at the study clinic) AND will be given either as:
- a shot under the skin at the study clinic
- through a needle in the vein at the study clinic The number of times these medicines will be taken depends on what combination therapy the study doctor selects. Participants may continue to receive elranatamab or a combination therapy until their MM is no longer responding. The study team will see how each participant is doing with the study treatment during regular visits at the study clinic. The study team will continue to follow-up with participants after study treatment with telephone contacts (or visits). The study will compare the experiences of people receiving elranatamab to those people receiving a combination therapy. This will help learn about the safety and how effective elranatamab is.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 multiple-myeloma
Started Feb 2024
273 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
November 17, 2023
CompletedFirst Posted
Study publicly available on registry
November 30, 2023
CompletedStudy Start
First participant enrolled
February 8, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2027
April 16, 2026
April 1, 2026
2.6 years
November 17, 2023
April 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression free survival per International Myeloma Working Group criteria
From date of randomization to date of progressive disease, discontinuation from study, death, or censoring, whichever occurs first
Up to approximately 5 years
Secondary Outcomes (17)
Overall survival
Up to approximately 5 years
Progression free survival on next-line treatment per International Myeloma Working Group criteria
Up to approximately 5 years
Objective response rate per International Myeloma Working Group criteria
Up to approximately 5 years
Duration of response per International Myeloma Working Group criteria
Up to approximately 5 years
Very good partial response or better response rate per International Myeloma Working Group criteria
Up to approximately 5 years
- +12 more secondary outcomes
Study Arms (2)
Elranatamab
EXPERIMENTALParticipants will receive elranatamab monotherapy
Investigator's Choice
ACTIVE COMPARATORParticipants will receive either Elotuzumab, Pomalidomide and Dexamethasone (EPd), or Pomalidomide, Bortezomib and Dexamethasone (PVd), or Carfilzomib and Dexamethasone (Kd)
Interventions
Eligibility Criteria
You may qualify if:
- Prior diagnosis of multiple myeloma as defined by International Myeloma Working Group (IMWG) criteria and previously received 1 to 4 prior lines of therapy including prior anti-cluster of differentiation 38 (CD38) antibody and prior lenalidomide.
- Documented evidence of progressive disease or failure to achieve a response to last line of therapy per IMWG criteria.
- Measurable disease defined as at least 1 of the following: (a) Serum M-protein ≥0.5 g/dL; (b) Urinary M-protein excretion ≥200 mg/24 hours; (c) Serum involved immunoglobulin FLC ≥10 mg/dL AND abnormal serum immunoglobulin kappa to lambda FLC ratio (\<0.26 or \>1.65).
- Have clinical laboratory values within the specified range.
- ECOG (Eastern Cooperative Oncology Group) performance status ≤2.
- Not pregnant or breastfeeding and willing to use contraception.
You may not qualify if:
- Smoldering multiple myeloma.
- Plasma cell leukemia.
- Amyloidosis.
- Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy and skin abnormalities (POEMS) syndrome.
- Known central nervous system (CNS) involvement or clinical signs of myelomatous meningeal involvement.
- Stem cell transplant within 12 weeks prior to enrolment, or active graft versus host disease.
- Any active, uncontrolled bacterial, fungal, or viral infection.
- Any other active malignancy within 3 years prior to enrolment (exceptions include, adequately treated basal cell or squamous cell skin cancer, carcinoma in situ)
- Previous treatment with a B cell maturation antigen (BCMA)-directed therapy or CD3-redirecting therapy.
- Unable to receive investigator's choice therapy.
- Live attenuated vaccine within 4 weeks of the first dose of study intervention.
- Administration with an investigational product (e.g. drug or vaccine) within 30 days preceding the first dose of study intervention used in this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (274)
Infirmary Cancer Care
Mobile, Alabama, 36607, United States
Western Regional Medical Center, Inc. dba. City of Hope Phoenix
Goodyear, Arizona, 85338, United States
Beverly Hills Cancer Center
Beverly Hills, California, 90211, United States
Clovis Community Medical Center
Clovis, California, 93611, United States
Community Cancer Institute
Clovis, California, 93611, United States
Clinical Research Advisors (Encino Satellite Location)
Encino, California, 91316, United States
University of California San Francisco
Fresno, California, 93701, United States
Community Regional Medical Center
Fresno, California, 93721, United States
Hoag Health Center Irvine
Irvine, California, 92618, United States
Hoag Hospital Irvine
Irvine, California, 92618, United States
Clinical Research Advisors (Korea Town Satellite Location)
Los Angeles, California, 90020, United States
Clinical Research Advisors (West Hollywood Satellite Location)
Los Angeles, California, 90048, United States
Valkyrie Clinical Trials
Los Angeles, California, 90067, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663, United States
Mission Community Hospital (Satellite Site)
Panorama City, California, 91402, United States
University of California Davis (UC Davis) Comprehensive Cancer Center
Sacramento, California, 95817, United States
University of California
Sacramento, California, 95817, United States
UCHealth Poudre Valley Hospital
Fort Collins, Colorado, 80524, United States
UCHealth Harmony
Fort Collins, Colorado, 80528, United States
UCHealth Greeley Hospital
Greeley, Colorado, 80634, United States
UCHealth Longs Peak Hospital
Longmont, Colorado, 80504, United States
UCHealth Longs Peak Medical Center
Longmont, Colorado, 80504, United States
UCHealth - Medical Center of the Rockies
Loveland, Colorado, 80538, United States
Sylvester Comprehensive Cancer Center - The Lennar Foundation Medical Center
Coral Gables, Florida, 33146, United States
University of Miami Hospital and Clinics - Deerfield Beach
Deerfield Beach, Florida, 33442, United States
Sylvester Comprehensive Cancer Center- Doral
Doral, Florida, 33166, United States
Sylvester Comprehensive Cancer Center - Hollywood
Hollywood, Florida, 33021, United States
Sylvester Comprehensive Cancer Center
Miami, Florida, 33136, United States
University of Miami Hospital and Clinics - Griffin Cancer Research Building
Miami, Florida, 33136, United States
University of Miami Hospital and Clinics
Miami, Florida, 33136, United States
Baptist Hospital of Miami
Miami, Florida, 33176, United States
Sylvester Comprehensive Cancer Center- Kendall
Miami, Florida, 33176, United States
BRCR Global
Plantation, Florida, 33322, United States
BRCR Global - Tamarac
Tamarac, Florida, 33321, United States
Endeavor Health - Swedish Hospital
Chicago, Illinois, 60625, United States
Endeavor Health - Evanston Hospital
Evanston, Illinois, 60201, United States
Endeavor Health - Glenbrook Hospital Ambulatory Care Center
Glenview, Illinois, 60026, United States
Endeavor Health - Highland Park Hospital Health Center 1
Highland Park, Illinois, 60035, United States
Simmons Cancer Institute at SIU
Springfield, Illinois, 62702, United States
Springfield Clinic Main Campus
Springfield, Illinois, 62703, United States
HSHS St. John's Hospital
Springfield, Illinois, 62769, United States
Springfield Memorial Hospital
Springfield, Illinois, 62781, United States
Midwestern Regional Medical Center, Inc. dba City of Hope Chicago
Zion, Illinois, 60099, United States
Community Health Network, Inc.
Indianapolis, Indiana, 46227, United States
Community Health Network, Inc.
Indianapolis, Indiana, 46250, United States
Community Health Network, Inc.
Indianapolis, Indiana, 46256, United States
American Oncology Partners, P.A. Dba MidAmerica Cancer Care
Kansas City, Kansas, 66112, United States
Ascentist Doctors' Hospital
Leawood, Kansas, 66211, United States
American Oncology Partners, P.A. Dba MidAmerica Cancer Care
Merriam, Kansas, 66204, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
BIDMC Research Pharmacy
Boston, Massachusetts, 02215, United States
American Oncology Partners, P.A. Dba MidAmerica Cancer Care
Belton, Missouri, 64012, United States
MIVA Medical
Independence, Missouri, 64057, United States
Kansas City VA Medical Center
Kansas City, Missouri, 64128, United States
American Oncology Partners, P.A. Dba MidAmerica Cancer Care
Kansas City, Missouri, 64132, United States
Bryan Medical Center
Lincoln, Nebraska, 68506, United States
NHO Revive Research Institute, LLC
Lincoln, Nebraska, 68506, United States
Atlantic Health System Morristown Medical Center
Morristown, New Jersey, 07960, United States
WMCHealth Advanced Physician Services
Hawthorne, New York, 10532, United States
Northwell Health/ RJ Zuckerberg Cancer Center
Lake Success, New York, 11042, United States
North Shore University Hospital
Manhasset, New York, 11030, United States
Long Island Jewish Medical Center
New Hyde Park, New York, 11040, United States
Westchester Medical Center
Valhalla, New York, 10595, United States
Brody school of Medicine at East Carolina University
Greenville, North Carolina, 27834, United States
ECU Health Medical Center
Greenville, North Carolina, 27834, United States
Sanford Fargo Medical Center
Fargo, North Dakota, 58102, United States
Oncology Hematology Care Clinical Trials, LLC
Cincinnati, Ohio, 45211, United States
TriHealth Cancer Institute-Good Samaritan Hospital
Cincinnati, Ohio, 45220, United States
Oncology Hematology Care Clinical Trials, LLC
Cincinnati, Ohio, 45236, United States
The Jewish Hospital
Cincinnati, Ohio, 45236, United States
Oncology Hematology Care Clinical Trials, LLC
Cincinnati, Ohio, 45242, United States
TriHealth Cancer Institute- Thomas Comprehensive Care Center
Cincinnati, Ohio, 45242, United States
Oncology Hematology Care Clinical Trials, LLC
Cincinnati, Ohio, 45245, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
AHN West Penn Hospital
Pittsburgh, Pennsylvania, 15224, United States
Brown University Health Cancer Institute
Providence, Rhode Island, 02903, United States
The Miriam Hospital
Providence, Rhode Island, 02906, United States
St Francis Cancer Center
Greenville, South Carolina, 29607, United States
Ascension St. Thomas Hospital
Nashville, Tennessee, 37203, United States
Tennessee Oncology, PLLC - Investigational Drug Services
Nashville, Tennessee, 37203, United States
Tennessee Oncology, PLLC - Nashville Elliston Place Plaza Center for Blood Cancers
Nashville, Tennessee, 37203, United States
Tennessee Oncology, PLLC - Nashville Elliston Place Plaza DDU
Nashville, Tennessee, 37203, United States
Tennessee Oncology, PLLC - Nashville Elliston Place Plaza Medical Oncology & Hematology
Nashville, Tennessee, 37203, United States
Baylor University Medical Center, Investigational Drug Services, Department of Pharmacy
Dallas, Texas, 75246, United States
Baylor University Medical Center
Dallas, Texas, 75246, United States
Houston Methodist Cancer Center Infusion
Houston, Texas, 77030, United States
Houston Methodist Hospital - Department of Pharmacy
Houston, Texas, 77030, United States
Houston Methodist Hospital Cancer Center
Houston, Texas, 77030, United States
Houston Methodist Willowbrook Hospital
Houston, Texas, 77070, United States
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, 79410, United States
Houston Methodist Sugar Land Hospital
Sugar Land, Texas, 77479, United States
Baylor Scott & White Medical Center - Temple
Temple, Texas, 76508, United States
WVU Cancer Institute
Morgantown, West Virginia, 26506, United States
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison, Wisconsin, 53718, United States
University of Wisconsin Carbone Cancer Center-University Hospital
Madison, Wisconsin, 53792, United States
Instituto Alexander Fleming
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ANZ, Argentina
Hospital Universitario Austral
Pilar, Buenos Aires, 1629, Argentina
Hospital Italiano de Buenos Aires
Ciudad de Buenos Aires, Buenos Aires F.D., C1199ABB, Argentina
Hospital Italiano de La Plata
La Plata, 1900, Argentina
Blacktown Hospital
Blacktown, New South Wales, 2148, Australia
Concord Repatriation General Hospital
Concord, New South Wales, 2139, Australia
Sunshine Coast University Hospital
Birtinya, Queensland, 4575, Australia
Royal Brisbane and Women's Hospital
Brisbane, Queensland, 4029, Australia
St Vincent's Hospital (Melbourne)
Fitzroy, Victoria, 3065, Australia
Barwon Health
Geelong, Victoria, 3220, Australia
Sir Charles Gairdner Hospital, Haematology Clinical Trials
Nedlands, Western Australia, 6009, Australia
Clinique Saint Pierre
Ottignies, Brabant Wallon, 1340, Belgium
UZ Brussel
Brussels, Bruxelles-capitale, Région de, 1090, Belgium
Grand Hôpital de Charleroi
Gilly, Hainaut, 6060, Belgium
Centre Hospitalier Epicura
Hornu, Hainaut, 7301, Belgium
CHR Verviers - La Tourelle
Verviers, Liège, 4800, Belgium
Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godi
Yvoir, Namur, 5530, Belgium
AZ Delta vzw
Roeselare, West-vlaanderen, 8800, Belgium
Instituto D'Or de Pesquisa e Ensino (IDOR) - Filial Salvador
Salvador, Estado de Bahia, 41253-190, Brazil
Instituto Oncomed de Educação e Pesquisa
Niterói, Rio de Janeiro, 24220-300, Brazil
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, 90035-001, Brazil
Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa
Porto Alegre, Rio Grande do Sul, 90110-270, Brazil
Centro de Pesquisa Clínica - Área Administrativa
Porto Alegre, Rio Grande do Sul, 90850-170, Brazil
Hospital Mae de Deus
Porto Alegre, Rio Grande do Sul, 90880-480, Brazil
Hospital Amaral Carvalho
Jaú, São Paulo, 17210-080, Brazil
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (USP)
Ribeirão Preto, São Paulo, 14051-140, Brazil
Instituto D'Or de Pesquisa e Ensino (IDOR)
São Paulo, São Paulo, 04543-000, Brazil
Clínica Médica São Germano LTDA
SP, São Paulo, 04537-080, Brazil
Instituto de Educação, Pesquisa e Gestão em Saúde
Rio de Janeiro, 20775-001, Brazil
Americas Centro de Oncologia Integrado
Rio de Janeiro, 22775001, Brazil
Instituto de Educação, Pesquisa e Gestão em Saúde
Rio de Janeiro, 22793-080, Brazil
ESHO Empresa de Serviços Hospitalares S.A/ Hospital Samaritano de Higienópolis
São Paulo, 01232-010, Brazil
Instituto D'Or de Pesquisa e Ensino (IDOR)
São Paulo, 01401-002, Brazil
Hospital do Coracao
São Paulo, 04004-030, Brazil
HU UNIFESP / SPDM - Hospital São Paulo
São Paulo, 04024-002, Brazil
Universidade Federal de Sao Paulo
São Paulo, 04024-002, Brazil
INSUMA
São Paulo, 04086-011, Brazil
Clínica Médica São Germano S/S Ltda
São Paulo, 04537-080, Brazil
The Moncton Hospital
Moncton, New Brunswick, E1C 6Z8, Canada
Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
Centre intégré universitaire de santé et de services sociaux du Nord-de-l'Île-de-Montréal (CIUSSS NÎ
Montreal, Quebec, H4J 1C5, Canada
FALP
Santiago, Santiago Metropolitan, 7500921, Chile
Clínica Inmunocel
Santiago, Santiago Metropolitan, 7580206, Chile
Clínica Universidad de Los Andes
Santiago, Santiago Metropolitan, 7620157, Chile
Clínica Alemana de Santiago
Santiago, Santiago Metropolitan, 7650568, Chile
Klinicki bolnicki centar Osijek
Osijek, 31000, Croatia
Klinicki bolnicki centar Rijeka
Rijeka, 51000, Croatia
Klinicki bolnicki centar Split
Split, 21 000, Croatia
Sestre milosrdnice University Hospital Center
Zagreb, 10 000, Croatia
University Hospital Center Zagreb
Zagreb, 10 000, Croatia
Klinicka bolnica Dubrava
Zagreb, 10000, Croatia
Klinicka bolnica Merkur
Zagreb, 10000, Croatia
Fakultní nemocnice Brno Bohunice
Brno, Brno-město, 625 00, Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, Praha 10, 100 34, Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, 100 34, Czechia
Aarhus Universitetshospital, Skejby
Aarhus, Central Jutland, 8200, Denmark
Aalborg Universitetshospital, Syd
Aalborg, North Denmark, 9000, Denmark
Rigshospitalet
Copenhagen Ø, DK 2100, Denmark
Turku University Hospital
Turku, Southwest Finland, 20520, Finland
Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus)
Helsinki, Uusimaa, 00029, Finland
Oulun yliopistollinen sairaala
Oulu, 90220, Finland
CHU Bordeaux Haut-Leveque
Pessac, Aquitaine, 33600, France
Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE
Toulouse, Haute-garonne, 31100, France
Centre Hospitalier de Dunkerque
Dunkirk, Hauts-de-France, 59385, France
Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois
Vandœuvre-lès-Nancy, Lorraine, 54511, France
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
Nantes, Pays de la Loire Region, 44000, France
Hôpital NOVO
Cergy-Pontoise, Val-d'oise, 95303, France
Hôpital NOVO
Pontoise, Val-d'oise, 95300, France
Henri Mondor Hospital
Créteil, Val-de-marne, 94010, France
Centre Hospitalier Universitaire de Poitiers
Poitiers, Vienne, 86021, France
Centre Hospitalier de la Côte Basque
Bayonne, 64109, France
CHD Vendee
La Roche-sur-Yon, 85925, France
Centre Hospitalier du Mans
Le Mans, 72037, France
Hôpital Universitaire Necker Enfants Malades
Paris, 75015, France
Hopitaux Universitaires Paris Centre-Hopital Cochin
Paris, 75679, France
Centre Hospitalier de Cornouaille
Quimper, 29107, France
Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau
Tours, 37032, France
Centre Hospitalier Bretagne Atlantique
Vannes, 56000, France
Centre Hospitalier Bretagne Atlantique
Vannes, 56017, France
Universitaetsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
Robert Bosch Krankenhaus GmbH
Stuttgart, Baden-Wurttemberg, 70376, Germany
Universitaetsklinikum Ulm
Ulm, Baden-Wurttemberg, 89081, Germany
Klinikum Nürnberg Nord
Nuremberg, Bavaria, 90419, Germany
Universitätsklinikum Bonn
Bonn, North Rhine-Westphalia, 53127, Germany
Universitätsklinikum Jena
Jena, Thuringia, 07747, Germany
Vivantes Klinikum Am Urban
Berlin, 10249, Germany
Vivantes Klinikum Am Urban
Berlin, 10967, Germany
Medizinische Universität Lausitz - Carl Thiem
Cottbus, 03048, Germany
Asklepios Altona
Hamburg, 22763, Germany
St. Barbara-Klinik Hamm-Heessen
Hamm, 59073, Germany
Diakonissen-Stiftungs-Krankenhaus Speyer
Speyer, 67346, Germany
University General Hospital of Alexandroupoli
Alexandroupoli, Anatolikí Makedonía KAI Thráki, 681 00, Greece
Alexandra General Hospital of Athens
Athens, Attikí, 115 28, Greece
"Theagenio" Cancer Hospital of Thessaloniki
Thessaloniki, Kentrikí Makedonía, 54639, Greece
G. Papanikolaou General Hospital
Thessaloniki, Thessaloníki, 570 10, Greece
University Hospital of Ioannina
Ioannina, Ípeiros, 455 00, Greece
Rabin Medical Center
Petah Tikva, Central District, 4910021, Israel
Sheba Medical Center
Ramat Gan, Central District, 5265601, Israel
Hadassah Medical Center
Jerusalem, Jerusalem, 9112001, Israel
Soroka Medical Center
Beersheba, Southern District, 8410101, Israel
Sourasky Medical Center
Tel Aviv, TELL ABĪB, 6423906, Israel
P.O. San Carlo Borromeo- ASST SANTI PAOLO E CARLO
Milan, Lombardy, 20153, Italy
Azienda Socio Sanitaria Ovest milanese
Legnano, Milano, 20025, Italy
Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino
Turin, Piedmont, 10126, Italy
A.O.U. Policlinico Paolo Giaccone
Palermo, Sicily, 90127, Italy
Azienda Ospedaliero Universitaria delle Marche
Ancona, The Marches, 60126, Italy
Azienda Ospedaliera Universitaria Careggi
Florence, Tuscany, 50134, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Tuscany, 56126, Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
Bologna, 40138, Italy
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"
Meldola (FC), 47014, Italy
Istituto Europeo di Oncologia IRCCS
Milan, 20141, Italy
ASST Santi Paolo e Carlo Ospedale San Paolo
Milan, 20142, Italy
Ospedale Civile dello Spirito Santo
Pescara, 65124, Italy
Nagoya City University Hospital
Nagoya, Aichi-ken, 467-8602, Japan
Toyohashi Municipal Hospital
Toyohashi, Aichi-ken, 441-8570, Japan
Ehime Prefectural Central Hospital
Matsuyama, Ehime, 790-0024, Japan
Ogaki Municipal Hospital
Ōgaki, Gifu, 503-8502, Japan
Gunma University Hospital
Maebashi, Gunma, 371-8511, Japan
National Hospital Organization Shibukawa Medical Center
Shibukawa, Gunma, 377-0280, Japan
Kobe City Medical Center General Hospital
Kobe, Hyōgo, 650-0047, Japan
Iwate Medical University Hospital
Shiwa-gun Yahaba-cho, Iwate, 028-3695, Japan
Shizuoka Cancer Center
Nagaizumi-cho, Shizuoka, 411-8777, Japan
Nippon Medical School Hospital
Bunkyo-ku, Tokyo, 113-8603, Japan
Japanese Foundation for Cancer Research
Koto, Tokyo, 135-8550, Japan
Yamanashi Prefectural Central Hospital
Kofu, Yamanashi, 400-8506, Japan
Kagoshima University Hospital
Kagoshima, 890-8520, Japan
University Hospital,Kyoto Prefectural University of Medicine
Kyoto, 602-8566, Japan
National Hospital Organization Okayama Medical Center
Okayama, 701-1192, Japan
Okayama Rosai Hospital
Okayama, 702-8055, Japan
Yamagata University Hospital
Yamagata, 990-9585, Japan
Maastricht UMC+
Maastricht, Limburg, 6229 HX, Netherlands
Albert Schweitzer Ziekenhuis, locatie Dordwijk
Dordrecht, South Holland, 3318 AT, Netherlands
Erasmus Medisch Centrum
Rotterdam, South Holland, 3015 GD, Netherlands
Akershus Universitetssykehus
Lørenskog, Akershus, 1474, Norway
St. Olavs Hospital
Trondheim, Sør-trøndelag, 7030, Norway
Sykehuset i Vestfold
Tønsberg, Vestfold, 3103, Norway
Oslo Universitetssykehus Ullevål
Oslo, 0450, Norway
Instituto Português de Oncologia de Lisboa Francisco Gentil
Lisbon, Lisbon District, 1099-023, Portugal
2Ca Braga
Braga, 4710-243, Portugal
Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica
Banská Bystrica, Banská Bystrica Region, 97517, Slovakia
Univerzitna Nemocnica L. Pasteura Kosice
Košice, Košice Region, 040 11, Slovakia
Narodny onkologicky ustav
Bratislava, 833 10, Slovakia
Univerzitna nemocnica Bratislava, Nemocnica sv. Cyrila a Metoda
Bratislava, 851 07, Slovakia
University Medical Centre Ljubljana
Ljubljana, 1000, Slovenia
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [seoul], 03080, South Korea
Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi [seoul], 03722, South Korea
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [seoul], 06351, South Korea
Institut Català d'Oncologia (ICO) - Badalona
Badalona, Barcelona [barcelona], 08916, Spain
Hospital Universitari Mutua Terrassa
Terrassa, Barcelona [barcelona], 08221, Spain
OSI Ezkerraldea-Enkarterri-Cruces - Hospital Universitario Cruces
Barakaldo, Basque Country, 48903, Spain
Hospital Clínic de Barcelona
Barcelona, Catalunya [cataluña], 08036, Spain
Hospital General Universitario Morales Meseguer
Murcia, Galicia [galicia], 30008, Spain
Institut Català d'Oncologia (ICO) - Girona
Girona, Girona [gerona], 17007, Spain
ASCIRES ECG Médica S.L
Valencia, Valenciana, Comunitat, 46004, Spain
Hospital General Universitario Gregorio Marañon
Madrid, 28007, Spain
Hospital Universitario HM Sanchinarro
Madrid, 28050, Spain
H.R.U Málaga - Hospital General
Málaga, 29010, Spain
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
Salamanca, 37007, Spain
Hospital Universitari i Politecnic La Fe
Valencia, 46026, Spain
Falu Lasarett
Falun, 791 31, Sweden
Universitetssjukhuset Örebro
Örebro, Örebro LÄN [se-18], 701 85, Sweden
China Medical University Hospital
Taichung, 404332, Taiwan
Taichung Veterans General Hospital
Taichung, 407, Taiwan
Milton Keynes Hospital
Milton Keynes, Buckinghamshire, MK6 5LD, United Kingdom
Glan Clwyd Hospital
Bodelwyddan, Denbighshire [SIR Ddinbych Gb-ddb], LL18 5UJ, United Kingdom
Royal Bournemouth Hospital
Bournemouth, Dorset, BH7 7DW, United Kingdom
Poole Hospital
Poole, Dorset, BH15 2JB, United Kingdom
Eastbourne District General Hospital
Eastbourne, EAST Sussex, BN21 2UD, United Kingdom
Worthing Hospital
Worthing, EAST Sussex, BN11 2DH, United Kingdom
Queen Elizabeth Hospital Birmingham
Birmingham, England, B15 2TH, United Kingdom
Maidstone Hospital
Maidstone, KENT, ME16 9QQ, United Kingdom
St Bartholomew's Hospital
London, London, CITY of, EC1A 7BE, United Kingdom
Guy's & St Thomas' NHS Foundation Trust
London, London, CITY of, SE1 9RT, United Kingdom
King's College Hospital
London, London, CITY of, SE5 9RL, United Kingdom
Churchill Hospital
Oxford, Oxfordshire, OX3 7LE, United Kingdom
Royal Stoke University Hospital
Stoke-on-Trent, Staffordshire, ST4 6QG, United Kingdom
Royal Marsden Hospital (Sutton)
London, Sutton, SM2 5PT, United Kingdom
Kent and Canterbury Hospital
Canterbury, CT1 3NG, United Kingdom
New Cross Hospital
Wolverhampton, WV10 0QP, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
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
November 17, 2023
First Posted
November 30, 2023
Study Start
February 8, 2024
Primary Completion (Estimated)
August 30, 2026
Study Completion (Estimated)
December 30, 2027
Last Updated
April 16, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.