A Study to Evaluate Change in Disease Activity of Subcutaneous (SC) Epcoritamab Combined With Intravenous and Oral Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine, and Prednisone (R-CHOP) or R-CHOP in Adult Participants With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL)

Sponsor
AbbVie (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05578976
Collaborator
Genmab (Industry)
900
377
2
89
2.4
0

Study Details

Study Description

Brief Summary

B-cell Lymphoma is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). The purpose of this study is to assess the change in disease activity of epcoritamab when combined with intravenous and oral rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (R-CHOP) or R-CHOP in adult participants globally with diffuse large b-cell lymphoma (DLBCL). Change in disease activity will be assessed.

Epcoritamab is an investigational drug being developed for the treatment of DLBCL. Study doctors put the participants in groups called treatment arms. Participants will receive epcoritamab combined with R-CHOP, followed by epcoritamab or R-CHOP followed by rituximab will be explored. Approximately 900 adult participants with with newly diagnosed DLBCL will be enrolled in the study in approximately 315 sites in globally.

In the Arm 1, participants will receive subcutaneous epcoritamab combined with intravenous and oral R-CHOP followed by subcutaneous epcoritamab in 21-day cycles. In the Arm 2, participants will receive intravenous and oral R-CHOP followed by intravenous rituximab in 21-day cycles.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
900 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 3, Randomized, Open-Label Study to Evaluate Safety and Efficacy of Epcoritamab in Combination With R-CHOP Compared to R-CHOP in Subjects With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL)
Actual Study Start Date :
Jan 11, 2023
Anticipated Primary Completion Date :
Jan 31, 2027
Anticipated Study Completion Date :
Jun 11, 2030

Arms and Interventions

Arm Intervention/Treatment
Experimental: Epcoritamab and R-CHOP

Participants will receive subcutaneous epcoritamab combined with intravenous and oral rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (R-CHOP) followed by epcoritamab in 21-day cycles.

Drug: Epcoritamab
Subcutaneous Injection (SC)
Other Names:
  • ABBV-GMAB-3013
  • Drug: Cyclophosphamide
    Intravenous (IV) Injection

    Drug: Rituximab
    IV Infusion

    Drug: Vincristine
    IV Infusion

    Drug: Doxorubicin
    IV Infusion

    Drug: Prednisone
    Oral; Tablet

    Experimental: R-CHOP and Rituximab

    Participants will receive intravenous and oral R-CHOP followed by rituximab in 21-day cycles.

    Drug: Cyclophosphamide
    Intravenous (IV) Injection

    Drug: Rituximab
    IV Infusion

    Drug: Vincristine
    IV Infusion

    Drug: Doxorubicin
    IV Infusion

    Drug: Prednisone
    Oral; Tablet

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants with Progression-Free Survival (PFS) [Up to Approximately 43 Months]

      PFS is defined as the duration from randomization to the date of disease progression as determined by Lugano 2014 criteria as assessed by IRC, or death from any cause.

    Secondary Outcome Measures

    1. Number of Participants with Event-free survival (EFS) [Up to Approximately 43 Months]

      EFS is defined as the duration from randomization to the date of disease progression determined by Lugano 2014 criteria as assessed by IRC, Initiation of any non-protocol-specified new anti-lymphoma therapy for any reason, or death from any cause.

    2. Percentage of Participants with Complete Remission (CR) [Up to Approximately 28 Weeks]

      CR is defined as the absence of lymphoma determined by fluorodeoxyglucose positron emission tomography (FDG-PET),determined by Lugano 2014 criteria as assessed by IRC.

    3. Overall survival (OS) [Up to Approximately 73 Months]

      OS is defined as time from randomization until death due to any causes.

    4. Percentage of Participants with Minimal Residual Disease (MRD) Negativity [Up to Approximately 73 Months]

      The MRD negativity rate is defined as the percentage of participants who achieve MRD negativity prior to the initiation of any non-protocol-specified new anti-lymphoma therapy.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 79 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Planned to receive treatment with 6 cycles of standard rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (R-CHOP) per investigator determination.

    • Must have newly diagnosed, histologically confirmed CD20+ diffuse large b-cell lymphoma [DLBCL] (de novo or histologically transformed from a diagnosis of follicular lymphoma) at most recent representative tumor biopsy based on the pathology report, with a World Health Organization (WHO) 2016 classification and including:

    • DLBCL, Not Otherwise Specified (NOS).

    • High grade B-cell lymphoma with MYC and BCL-2 and/or BCL-6 rearrangement with DLBCL morphology.

    • T-cell/histiocyte-rich large B-cell lymphoma.

    • Epstein Barr virus-positive DLBCL, NOS.

    • Follicular lymphoma Grade 3b.

    Note: The local pathology report must be available at Screening to support CD20+ DLBCL histology.

    Composite/intermediate histology with any of the following components is not allowed: high grade B-cell lymphoma, NOS; Hodgkin's lymphoma; primary mediastinal (thymic) large B-cell lymphoma; Burkitt; plasmablastic lymphoma or any CD20- lymphoma, such as anaplastic lymphoma kinase-positive large B-cell lymphoma, human herpesvirus type 8-positive DLBCL, or primary effusion lymphoma.

    • Availability of archival or freshly collected tumor tissue at Screening. Archival paraffin-embedded tissue must be obtained within 8 weeks prior to Cycle 1 Day 1.

    • Must have an IPI score of 2-5. The number of participants with IPI 2 will be capped at 35% of the overall sample size.

    • Must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2 prior to initiating R-CHOP treatment. Note that participant with an initial ECOG performance status >= 3 may be screened if pre-phase treatment is planned. Participant may be eligible if ECOG performance status were to improve to 0-2 during pre-phase treatment.

    • Has at least one target lesion defined as:

    • = 1 measurable nodal lesion (long axis > 1.5 cm ) or >= 1 measurable extra-nodal lesion (long axis > 1 cm) on computed tomography (CT) scan or MRI. AND

    • Positron emission tomography (PET)-positive on PET-CT scan.

    • Laboratory values meeting the criteria laid out in the protocol.

    • Left ventricular ejection fraction must be >= 50% by multi-gated acquisition or transthoracic echocardiography at Screening.

    Exclusion Criteria:
    • History of prior systemic anti-lymphoma therapy for diagnosed diffuse large b-cell lymphoma (DLBCL) including any definitive radiotherapy with curative intent] other than corticosteroids with or without vincristine during prephase treatment, or non-curative intent palliative radiotherapy with the stipulation that radiated lesions cannot be selected as target lesion for response assessment.

    • Clinically significant cardiovascular disease as per the protocol.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham - Main /ID# 225373 Birmingham Alabama United States 35233
    2 University of Arizona Cancer Center - North Campus /ID# 227463 Tucson Arizona United States 85719-1478
    3 University of Arkansas for Medical Sciences /ID# 225703 Little Rock Arkansas United States 72205
    4 Sutter Health Alta Bates Summit Medical Center /ID# 229427 Berkeley California United States 94705-2067
    5 Orange Coast Medical Center /ID# 229632 Fountain Valley California United States 92708-6728
    6 Marin Cancer Care /ID# 226647 Greenbrae California United States 94904
    7 Saddleback Memorial Medical Center /ID# 229631 Laguna Hills California United States 92653-3689
    8 Long Beach Memorial Medical Ct /ID# 228996 Long Beach California United States 90806-1701
    9 University of Southern California /ID# 225443 Los Angeles California United States 90033
    10 Kaiser Permanente, Waterpark III Institute for Health Research /ID# 228618 Aurora Colorado United States 80014
    11 UCHSC Anschultz Cancer Pavilion /ID# 226040 Aurora Colorado United States 80045-2517
    12 Yale University /ID# 226022 New Haven Connecticut United States 06510
    13 Christiana Care Health Service /ID# 228266 Newark Delaware United States 19713
    14 Holy Cross Hospital /ID# 228539 Fort Lauderdale Florida United States 33308
    15 Baptist MD Anderson Cancer Center - Jacksonville /ID# 227040 Jacksonville Florida United States 32207-8432
    16 Orlando Health /ID# 232626 Orlando Florida United States 32806-2134
    17 Cleveland Clinic Florida /ID# 229377 Weston Florida United States 33331-3609
    18 Emory University /ID# 226052 Atlanta Georgia United States 30322-1013
    19 Augusta University Georgia Cancer Center /ID# 227131 Augusta Georgia United States 30912-0003
    20 Straub Medical Center /ID# 229464 Honolulu Hawaii United States 96813-3097
    21 Rush University Medical Center /ID# 225453 Chicago Illinois United States 60612
    22 Loyola University Medical Ctr /ID# 227029 Maywood Illinois United States 60153
    23 Southern IL Univ School of Med /ID# 228999 Springfield Illinois United States 62702
    24 Midwestern Regional CTC /ID# 229840 Zion Illinois United States 60099
    25 Parkview Cancer Institute /ID# 227026 Fort Wayne Indiana United States 46845-1739
    26 Goshen Center for Cancer Care /ID# 225534 Goshen Indiana United States 46526
    27 Norton Cancer Institute - St Matthews /ID# 225420 Louisville Kentucky United States 40207
    28 Ochsner Clinic Foundation-New Orleans /ID# 226148 New Orleans Louisiana United States 70121
    29 University of Maryland School of Medicine /ID# 225421 Baltimore Maryland United States 21201-1544
    30 Johns Hopkins University /ID# 225369 Baltimore Maryland United States 21287
    31 Walter Reed National Military Medical Center /ID# 231016 Bethesda Maryland United States 20889-0004
    32 Dana-Farber Cancer Institute /ID# 225506 Boston Massachusetts United States 02215
    33 UMass Chan Medical School /ID# 226939 Worcester Massachusetts United States 01655
    34 University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 225462 Ann Arbor Michigan United States 48109
    35 St. Joseph Mercy Hospital /ID# 228206 Ypsilanti Michigan United States 48197-1051
    36 Mmcorc /Id# 226680 Saint Louis Park Minnesota United States 55416
    37 University of Mississippi Medical Center /ID# 228045 Jackson Mississippi United States 39216-4500
    38 Bozeman Health Cancer Center /ID# 229368 Bozeman Montana United States 59715
    39 NJ Hematology Oncology Association /ID# 228058 Brick New Jersey United States 08724
    40 Titan Health Partners LLC, d/b/a Astera Cancer Care /ID# 226654 East Brunswick New Jersey United States 08816
    41 Morristown Medical Center /ID# 239457 Morristown New Jersey United States 07960-6136
    42 Saint Peter's University Hospital /ID# 229471 New Brunswick New Jersey United States 08901-1766
    43 The Valley Hospital /ID# 229331 Paramus New Jersey United States 07652
    44 Roswell Park Comprehensive Cancer Center /ID# 239127 Buffalo New York United States 14263
    45 NYU Langone - Laura and Isaac Perlmutter Cancer Center /ID# 226141 New York New York United States 10016-4744
    46 Icahn School of Medicine at Mount Sinai /ID# 225370 New York New York United States 10029-6504
    47 Memorial Sloan Kettering Cancer Center-Koch Center /ID# 225379 New York New York United States 10065-6007
    48 Novant Health Presbyterian Medical Center /ID# 227753 Charlotte North Carolina United States 28204
    49 East Carolina University Brody School of Medicine /ID# 225992 Greenville North Carolina United States 27834
    50 Novant Health Forsyth Medical Center /ID# 228339 Winston-Salem North Carolina United States 27103
    51 The Christ Hospital /ID# 229334 Cincinnati Ohio United States 45219
    52 University of Cincinnati /ID# 225374 Cincinnati Ohio United States 45267
    53 University of Oklahoma, Stephenson Cancer Center /ID# 225556 Oklahoma City Oklahoma United States 73104-5418
    54 Kaiser Permanente - Northwest /ID# 225488 Portland Oregon United States 97227
    55 Thomas Jefferson University /ID# 225623 Philadelphia Pennsylvania United States 19107-4414
    56 UPMC Hillman Cancer Ctr /ID# 225423 Pittsburgh Pennsylvania United States 15232
    57 Lankenau Medical Center /ID# 228918 Wynnewood Pennsylvania United States 19096
    58 Medical University of South Carolina /ID# 225427 Charleston South Carolina United States 29425
    59 Gibbs Cancer Center & Research /ID# 229372 Spartanburg South Carolina United States 29303-3040
    60 Thompson Cancer Survival Ctr /ID# 227123 Knoxville Tennessee United States 37916
    61 University of Texas Southwestern Medical Center /ID# 225492 Dallas Texas United States 75390-7208
    62 Millennium Research & Clinical Development /ID# 228284 Kingwood Texas United States 77339-6008
    63 Joe Arrington Cancer Research /ID# 227217 Lubbock Texas United States 79410
    64 Intermountain Medical Center /ID# 231184 Murray Utah United States 84107-5701
    65 University of Virginia Cancer Center - West Complex /ID# 225433 Charlottesville Virginia United States 22903-3363
    66 Virginia Commonwealth University Medical Center Main Hospital /ID# 225796 Richmond Virginia United States 23219
    67 Swedish Cancer Institute - Edmonds /ID# 226845 Seattle Washington United States 98104
    68 University of Washington /ID# 225581 Seattle Washington United States 98109
    69 Multicare Institute for Research and Innovation /ID# 225432 Tacoma Washington United States 98405
    70 UW, Cancer Ctr ProHealth Care /ID# 228741 Waukesha Wisconsin United States 53188
    71 Hospital Italiano de Buenos Aires /ID# 228270 Ciudad Autonoma Buenos Aires Ciuadad Autonoma De Buenos Aires Argentina 1199
    72 Instituto Alexander Fleming /ID# 239473 Ciudad Autonoma de Buenos Aire Ciuadad Autonoma De Buenos Aires Argentina 1426
    73 Cemic /Id# 228264 Ciudad Autonoma de Buenos Aire Ciuadad Autonoma De Buenos Aires Argentina 1431
    74 Hospital Privado Univesitario /ID# 228778 Cordoba Argentina 5016
    75 Clinica de Nefrologia, Urologia y Enfermedades Cardiovasculares /ID# 238730 Santa Fe Argentina 3000
    76 Liverpool Hospital /ID# 230072 Liverpool New South Wales Australia 2170
    77 Royal Adelaide Hospital /ID# 225683 Adelaide South Australia Australia 5000
    78 Alfred Health /ID# 225999 Melbourne Victoria Australia 3004
    79 Monash Medical Centre /ID# 225680 Melbourne Victoria Australia 3168
    80 Hollywood Private Hospital /ID# 251837 Nedlands Western Australia Australia 6009
    81 Perth Blood Institute Ltd /ID# 225679 Nedlands Western Australia Australia 6009
    82 Royal Perth Hospital /ID# 226583 Perth Western Australia Australia 6000
    83 Medizinische Universitaet Innsbruck /ID# 228364 Innsbruck Tirol Austria 6020
    84 Medizinische Universitaet Wien /ID# 252095 Vienna Wien Austria 1090
    85 Klinik Ottakring /ID# 243941 Vienna Wien Austria 1160
    86 Landeskrankenhaus Salzburg-Universitätsklinikum der PMU (LKH) /ID# 228360 Salzburg Austria 5020
    87 Uza /Id# 227095 Edegem Antwerpen Belgium 2650
    88 CHU UCL Namur - site Godinne /ID# 225742 Godinne Namur Belgium 5530
    89 UZ Gent /ID# 250031 Gent Oost-Vlaanderen Belgium 9000
    90 Universitair Ziekenhuis Leuven /ID# 225951 Leuven Vlaams-Brabant Belgium 3000
    91 AZ-Delta /ID# 225736 Roeselare West-Vlaanderen Belgium 8800
    92 Institut Jules Bordet /ID# 225954 Anderlecht Belgium 1070
    93 ZNA Middelheim /ID# 225741 Antwerp Belgium 2020
    94 AZ Sint-Jan Brugge /ID# 225735 Brugge Belgium 8000
    95 Pôle Hospitalier Jolimont /ID# 225738 La Louvière Belgium 7100
    96 Centre Hospitalier Universitaire du Sart Tilman CHU de Liege /ID# 225952 Liege Belgium 4000
    97 Vitaz /Id# 226153 Sint-Niklaas Belgium 9100
    98 Hospital de Clinicas da Universidade Federal do Parana /ID# 226027 Curitiba Parana Brazil 80060-900
    99 Hospital Amaral Carvalho - Fundacao Doutor Amaral Carvalho /ID# 226065 Jaú Sao Paulo Brazil 17210-070
    100 Fundacao Antonio Prudente - AC Camargo Cancer Center /ID# 226809 São Paulo Sao Paulo Brazil 01509-900
    101 Instituto Nacional de Câncer José Alencar Gomes da Silva (INCA) /ID# 226026 Rio de Janeiro Brazil 20231-050
    102 Real e Benemérita Associação Portuguesa de Beneficência /ID# 226023 Sao Paulo Brazil 01323-001
    103 Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo /ID# 226048 Sao Paulo Brazil 05403-000
    104 UMHAT Sveti Georgi /ID# 245780 Plovdiv Bulgaria 4002
    105 Acibadem City Clinic Tokuda University Hospital EAD /ID# 244616 Sofia Bulgaria 1407
    106 UMHAT Sveti Ivan Rilski /ID# 244615 Sofia Bulgaria 1431
    107 SHAT Hematologic Diseases /ID# 250102 Sofia Bulgaria 1756
    108 Tom Baker Cancer Centre /ID# 226077 Calgary Alberta Canada T2N 4N2
    109 BC Cancer - Vancouver /ID# 230573 Vancouver British Columbia Canada V5Z 1L3
    110 BC Cancer - Victoria /ID# 250741 Victoria British Columbia Canada V8R 6V5
    111 Saint John Regional Hospital /ID# 233547 Saint John New Brunswick Canada E2L 4L2
    112 William Osler Health System /ID# 250973 Brampton Ontario Canada L6R 3J7
    113 Juravinski Cancer Centre /ID# 226084 Hamilton Ontario Canada L8V 1C3
    114 Victoria Hospital /ID# 226885 London Ontario Canada N6A 4L6
    115 CSSS Alphonse-Desjardins, CHAU de Levis /ID# 229897 Levis Quebec Canada G6V 3Z1
    116 CIUSSS du Nord-de-l'ile-de-Montréal_Hopital du Sacré-Coeur de Montréal /ID# 233509 Montreal Quebec Canada H4J 1C5
    117 CHUQ- Hôpital de l'Enfant-Jesus /ID# 226074 Quebec City Quebec Canada G1J 1Z4
    118 Saskatoon Cancer Centre /ID# 226082 Saskatoon Saskatchewan Canada S7N 4H4
    119 Beijing Cancer Hospital /ID# 229819 Beijing Beijing China 100142
    120 Peking University Third Hospital /ID# 230975 Beijing Beijing China 100191
    121 Fujian Provincial Cancer Hospital /ID# 238430 Fuzhou Fujian China 350014
    122 The First Affiliated Hospital of Xiamen University /ID# 238426 Xiamen Fujian China 361003
    123 Sun Yat-Sen University Cancer Center /ID# 238371 Guangzhou Guangdong China 510060
    124 Guangdong Provincial People's Hospital /ID# 230945 Guangzhou Guangdong China 510080
    125 Nanfang Hospital of Southern Medical University /ID# 238436 Guangzhou Guangdong China 510515
    126 The Fourth Hospital of Hebei Medical University /ID# 238656 Shijiazhuang Hebei China 050011
    127 Harbin Medical University Cancer Hospital /ID# 241755 Harbin Heilongjiang China 150081
    128 Henan Cancer Hospital /ID# 230398 Zhengzhou Henan China 450008
    129 Hunan Cancer Hospital /ID# 232496 Changsha Hunan China 410006
    130 Jiangsu Cancer Hospital /ID# 232469 Nanjing Jiangsu China 210009
    131 The First Affiliated Hospital of Soochow University /ID# 232569 Suzhou Jiangsu China 215006
    132 Duplicate_The Affiliated Hospital of XuZhou Medical University /ID# 233174 Xuzhou Jiangsu China 221000
    133 The First Affiliated Hospital of Nanchang University /ID# 230399 Nanchang Jiangxi China 330006
    134 The First Hospital of Jilin University /ID# 239618 Changchun Jilin China 130021
    135 The First Hospital of China Medical University /ID# 233201 Shenyang Liaoning China 110001
    136 Shandong Cancer Hospital /ID# 233200 Jinan Shandong China 251601
    137 Shanghai East Hospital /ID# 233516 Pudong New District Shanghai China 200136
    138 Fudan University Shanghai Cancer Center /Id# 251516 Shanghai Shanghai China 200032
    139 West China Hospital, Sichuan University /ID# 233173 Chengdu Sichuan China 610041
    140 Tianjin Medical University Cancer Institute and Hospital /ID# 230974 Tianjin Tianjin China 300222
    141 The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 230387 Hangzhou Zhejiang China 310006
    142 The second Affiliated hospital of Zhejiang University school of Medicine /ID# 231249 Hangzhou Zhejiang China 310009
    143 Zhejiang Cancer hospital /ID# 231388 Hangzhou Zhejiang China 310022
    144 The Fifth Medical Center of PLA General Hospital /ID# 230941 Beijing China 100071
    145 Jiangxi Cancer Hospital /ID# 233379 Nanchang China 330029
    146 Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 234152 Wuhan China 420022
    147 Clinical Hospital Dubrava /ID# 251809 Zagreb Grad Zagreb Croatia 10000
    148 Klinicka bolnica Merkur /ID# 252481 Zagreb Grad Zagreb Croatia 10000
    149 Klinicki bolnicki centar Zagreb /ID# 250709 Zagreb Grad Zagreb Croatia 10000
    150 Klinicki bolnicki centar Rijeka /ID# 251811 Rijeka Primorsko-goranska Zupanija Croatia 51000
    151 Klinicki bolnicki centar Split /ID# 250729 Split Splitsko-dalmatinska Zupanija Croatia 21000
    152 Opca bolnica Dr. Josip Bencevic /ID# 251812 Slavonski Brod Croatia 35000
    153 Fakultni Nemocnice Brno /ID# 225953 Brno Czechia 625 00
    154 Fakultni nemocnice Hradec Kralove /ID# 225955 Hradec Kralove Czechia 500 05
    155 Fakultni nemocnice Ostrava /ID# 225957 Ostrava Czechia 708 52
    156 Fakultni nemocnice Kralovske Vinohrady /ID# 225956 Praha Czechia 100 34
    157 Vseobecna fakultni nemocnice v Praze /ID# 225396 Praha Czechia 128 08
    158 Fakultni Nemocnice v Motole /ID# 225958 Praha Czechia 150 06
    159 Rigshospitalet /ID# 226576 Copenhagen Ø Hovedstaden Denmark 2100
    160 Aarhus University Hospital /ID# 226594 Aarhus N Midtjylland Denmark 8200
    161 Odense University Hospital /ID# 226593 Odense C Syddanmark Denmark 5000
    162 Sygehus Lillebælt, Vejle /ID# 226592 Vejle Syddanmark Denmark 7100
    163 Roskilde Hospital /ID# 226597 Roskilde Denmark 4000
    164 Centre Antoine Lacassagne - Nice /ID# 238339 Nice Alpes-Maritimes France 06189
    165 Chu de Nice-Hopital L'Archet Ii /Id# 226127 Nice Alpes-Maritimes France 06200
    166 CHU Clermont-Ferrand /ID# 229283 Clermont Auvergne-Rhone-Alpes France 63100
    167 HCL - Hopital Lyon Sud /ID# 227086 Pierre Benite CEDEX Auvergne-Rhone-Alpes France 69495
    168 Institut Paoli-Calmettes /ID# 226557 Marseille Bouches-du-Rhone France 13009
    169 CHU de Rennes - PONTCHAILLOU /ID# 228207 Rennes Bretagne France 35000
    170 CHU Dijon /ID# 238345 Dijon Cote-d Or France 21000
    171 CHU Limoges - Dupuytren 1 /ID# 234235 Limoges CEDEX 1 Franche-Comte France 87042
    172 CHU Bordeaux - Hopital Haut Leveque /ID# 226130 Pessac Gironde France 33604
    173 CHRU Lille - Hopital Claude Huriez /ID# 226101 Lille Hauts-de-France France 59037
    174 CHU Montpellier - Hôpital Saint Eloi /ID# 228191 Montpellier Cedex 5 Herault France 34295
    175 CHRU Nancy - Hopitaux de Brabois /ID# 226102 Vandoeuvre-les-Nancy Meurthe-et-Moselle France 54500
    176 CHU de Nantes, Hotel Dieu -HME /ID# 226125 Nantes Pays-de-la-Loire France 44000
    177 CHU Poitiers - La milétrie /ID# 226578 Poitiers Poitou-Charentes France 86000
    178 Centre Hospitalier de la Cote Basque /ID# 249143 Bayonne Pyrenees-Atlantiques France 64100
    179 CHU Amiens-Picardie Site Sud /ID# 238347 Amiens CEDEX 1 Somme France 80054
    180 Chu Angers /Id# 245931 Angers France 49933
    181 CHU de CAEN - Hopital de la Cote de Nacre /ID# 226582 Caen France 14033
    182 Hopital Henri Mondor /ID# 226560 Creteil France 94000
    183 CHD Vendée- La Roche-sur-Yon - Les Oudairies /ID# 243899 La Roche Sur Yon France 85000
    184 CHU Grenoble - Hopital Michallon /ID# 226128 La Tronche France 38700
    185 AP-HP - Hopital Saint-Louis /ID# 226126 Paris France 75010
    186 Hopital Pitie Salpetriere /ID# 238343 Paris France 75013
    187 Centre Henri Becquerel /ID# 226103 Rouen France 76038
    188 IUCT Oncopole /ID# 226129 Toulouse Cedex 9 France 31059
    189 Universitaetsklinikum Tuebingen /ID# 229662 Tubingen Baden-Wuerttemberg Germany 72076
    190 Schwarzwald-Baar-Klinikum /ID# 227143 Villingen-Schwenningen Baden-Wuerttemberg Germany 78052
    191 Universitaetsklinikum Giessen /ID# 239181 Gießen Hessen Germany 35392
    192 Universitaetsklinikum des Saarlandes /ID# 227051 Homburg Saarland Germany 66424
    193 Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 227117 Kiel Schleswig-Holstein Germany 24105
    194 Vivantes Klinikum Am Urban /ID# 227118 Berlin Germany 10967
    195 Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 227048 Berlin Germany 12203
    196 Helios Klinikum Berlin-Buch /ID# 227114 Berlin Germany 13125
    197 St. Antonius Hospital /ID# 232429 Eschweiler Germany 52249
    198 Universitaetsmedizin Goettingen /ID# 227120 Goettingen Germany 37075
    199 Klinikum Kassel /ID# 228303 Kassel Germany 34125
    200 Rotkreuzkliniken Munchen /ID# 232430 Munich Germany 80634
    201 Universitaetsklinikum Regensburg /ID# 231231 Regensburg Germany 93042
    202 Klinikum Mutterhaus der Borromäerinnen /ID# 233434 Trier Germany 54290
    203 Universitaetsklinikum Wuerzburg /ID# 227113 Wuerzburg Germany 97080
    204 General Hospital of Athens Laiko /ID# 225399 Athens Attiki Greece 11527
    205 Alexandra General Hospital /ID# 225402 Athens Attiki Greece 11528
    206 University General Hospital Attikon /ID# 225401 Athens Attiki Greece 12462
    207 General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 225416 Athens Greece 10676
    208 University General Hospital of Ioannina /ID# 225400 Ioannina Greece 45500
    209 General University Hospital of Thessaloniki AXEPA /ID# 225398 Thessaloniki Greece 54636
    210 Theageneio Anticancer Hospital /ID# 225516 Thessaloniki Greece 54639
    211 Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 226838 Szeged Csongrad Hungary 6725
    212 Debreceni Egyetem Klinikai Kozpont /ID# 226821 Debrecen Hajdu-Bihar Hungary 4032
    213 Somogy Megyei Kaposi Mor Oktato Korhaz /ID# 245938 Kaposvár Somogy Hungary 7400
    214 Markusovszky Egyetemi Oktatokorhaz /ID# 226846 Szombathely Vas Hungary 9700
    215 Semmelweis Egyetem /ID# 227239 Budapest Hungary 1085
    216 Orszagos Onkologiai Intezet /ID# 227294 Budapest Hungary 1122
    217 Tolna Megyei Balassa Janos Korhaz /ID# 250063 Szekszard Hungary 7100
    218 Assuta Tel Aviv Medical Center /ID# 226066 Tel Aviv HaMerkaz Israel 6971028
    219 The Chaim Sheba Medical Center /ID# 225600 Ramat Gan Tel-Aviv Israel 5265601
    220 Tel Aviv Sourasky Medical Center /ID# 225891 Tel Aviv-Yafo Tel-Aviv Israel 6423906
    221 Rambam Health Care Campus /ID# 225981 Haifa Israel 3109601
    222 Hadassah /ID# 225614 Jerusalem Israel 91120
    223 Meir Medical Center /ID# 225612 Kfar Saba Israel 4428164
    224 Rabin Medical Center /ID# 225862 Petakh Tikva Israel 4941492
    225 Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 225554 San Giovanni Rotondo Foggia Italy 71013
    226 Ospedale San Raffaele IRCCS /ID# 225555 Milan Milano Italy 20132
    227 IEO -Istituto Europeo di Oncologia /ID# 225545 Milan Milano Italy 20141
    228 Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino /ID# 225775 Torino Piemonte Italy 10126
    229 Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo /ID# 225542 Alessandria Italy 15121
    230 Centro di Riferimento Oncologico /ID# 225553 Aviano Italy 33081
    231 I.R.C.C.S Istituto Tumori Giovanni Paolo II /ID# 225548 Bari Italy 70124
    232 IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 225551 Bologna Italy 40138
    233 ASST Spedali civili di Brescia /ID# 225549 Brescia Italy 25123
    234 Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRCCS /ID# 252192 Meldola Italy 47014
    235 Azienda Ospedaliera Universitaria Federico II /ID# 225543 Napoli Italy 80131
    236 Azienda Ospedaliero Universitaria Maggiore della Carita di Novara /ID# 225773 Novara Italy 28100
    237 A.O. Ospedali Riuniti Villa Sofia - Cervello /ID# 225541 Palermo Italy 90146
    238 Azienda Ospedaliero Universitaria Pisana-Stabilimento di Santa Chiara /ID# 225575 Pisa Italy 56126
    239 Ospedale Santa Maria Croci /ID# 225571 Ravenna Italy 48121
    240 NHO Nagoya Medical Center /ID# 230677 Nagoya-shi Aichi Japan 460-0001
    241 Aichi Cancer Center Hospital /ID# 226090 Nagoya-shi Aichi Japan 464-8681
    242 National Cancer Center Hospital East /ID# 250151 Kashiwa-shi Chiba Japan 277-8577
    243 Matsuyama Red Cross Hospital /ID# 251068 Matsuyama-shi Ehime Japan 790-8524
    244 National Hospital Organization Kyushu Cancer Center /ID# 251622 Fukuoka-shi Fukuoka Japan 811-1395
    245 Kyushu University Hospital /ID# 226091 Fukuoka-shi Fukuoka Japan 812-8582
    246 Fukushima Medical University Hospital /ID# 250869 Fukushima-shi Fukushima Japan 960-1295
    247 Hokkaido University Hospital /ID# 250149 Sapporo-shi Hokkaido Japan 060-8648
    248 Kobe City Medical Center General Hospital /ID# 250597 Kobe-shi Hyogo Japan 650-0047
    249 University of Tsukuba Hospital /ID# 251282 Tsukuba-shi Ibaraki Japan 305-8576
    250 Kanazawa University Hospital /ID# 251770 Kanazawa-shi Ishikawa Japan 920-8641
    251 Kagoshima University Hospital /ID# 250163 Kagoshima-shi Kagoshima Japan 890-8520
    252 Tokai University Hospital /ID# 251281 Isehara-shi Kanagawa Japan 259-1193
    253 Tohoku University Hospital /ID# 250150 Sendai-shi Miyagi Japan 9808574
    254 Okayama University Hospital /ID# 250161 Okayama-shi Okayama Japan 700-8558
    255 Kindai University Hospital /ID# 250160 Osakasayama-shi Osaka Japan 589-8511
    256 Osaka University Hospital /ID# 251283 Suita-shi Osaka Japan 565-0871
    257 National Cancer Center Hospital /ID# 226089 Chuo-ku Tokyo Japan 104-0045
    258 The Cancer Institute Hospital Of JFCR /ID# 230269 Koto-ku Tokyo Japan 135-8550
    259 Yamagata University Hospital /ID# 230003 Yamagata-shi Yamagata Japan 990-9585
    260 Seoul National University Bundang Hospital /ID# 225763 Seongnam Gyeonggido Korea, Republic of 13620
    261 Inje University Busan Paik Hospital /ID# 232262 Busan Korea, Republic of 47392
    262 Dong-A University Hospital /ID# 228451 Busan Korea, Republic of 49201
    263 Keimyung University Dongsan Medical Center /ID# 232264 Daegu Korea, Republic of 41931
    264 Jeonbuk National University Hospital /ID# 232263 Jeonju Korea, Republic of 54907
    265 Seoul National University Hospital /ID# 225760 Seoul Korea, Republic of 03080
    266 Asan Medical Center /ID# 225758 Seoul Korea, Republic of 05505
    267 Samsung Medical Center /ID# 225759 Seoul Korea, Republic of 06351
    268 The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 225761 Seoul Korea, Republic of 06591
    269 Ulsan University Hospital /ID# 226971 Ulsan Korea, Republic of 44033
    270 Centro de Investigacion Clínica Chapultepec SA de CV /ID# 228292 Morelia Michoacan Mexico 58260
    271 Hospital Universitario Dr. Jose Eleuterio Gonzalez /ID# 228752 Monterrey Nuevo Leon Mexico 64460
    272 Centro de Investigacion Clínica Chapultepec S.A. de C.V. /ID# 228613 Ciudad de Mexico Mexico 04100
    273 Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran /ID# 228756 Ciudad de Mexico Mexico 14080
    274 Flevoziekenhuis /ID# 229606 Almere Flevoland Netherlands 1315 RA
    275 Gelre Ziekenhuizen /ID# 229762 Apeldoorn Gelderland Netherlands 7334 DZ
    276 Tergooi /ID# 229772 Hilversum Noord-Holland Netherlands 1213 XZ
    277 Dijklander Ziekenhuis /ID# 229900 Hoorn Nh Noord-Holland Netherlands 1624 NP
    278 Zaans Medisch Centrum /ID# 230614 Zaandam Noord-Holland Netherlands 1502 DV
    279 Albert Schweitzer Ziekenhuis /ID# 229560 Dordrecht Zuid-Holland Netherlands 3318 AT
    280 Noordwest Ziekenhuisgroep /ID# 230613 Alkmaar Netherlands 1815 JD
    281 Meander Medisch Centrum /ID# 229608 Amersfoort Netherlands 3813 TZ
    282 Vrije Universiteit Medisch Centrum /ID# 225608 Amsterdam Netherlands 1081 HV
    283 Onze Lieve Vrouwe Gasthuis /ID# 229761 Amsterdam Netherlands 1091 AC
    284 Amphia Ziekenhuis /ID# 229550 Breda Netherlands 4818 CK
    285 Haaglanden Medisch Centrum /ID# 229686 Den Haag Netherlands 2512 VA
    286 Deventer Ziekenhuis /ID# 229937 Deventer Netherlands 7416 SE
    287 Catharina Ziekenhuis /ID# 230465 Eindhoven Netherlands 5623 EJ
    288 Maxima Medisch Centrum /ID# 225603 Eindhoven Netherlands 5631 BM
    289 Medisch Spectrum Twente /ID# 225610 Enschede Netherlands 7512 KZ
    290 Universitair Medisch Centrum Groningen /ID# 225602 Groningen Netherlands 9713 GZ
    291 Spaarne Gasthuis /ID# 229621 Haarlem Netherlands 2035 RC
    292 Medisch Centrum Leeuwarden /ID# 225605 Leeuwarden Netherlands 8934 AD
    293 Leids Universitair Medisch Centrum /ID# 225606 Leiden Netherlands 2333 ZA
    294 Maastricht Universitair Medisch Centrum /ID# 225607 Maastricht Netherlands 6229 HX
    295 St. Antonius Ziekenhuis /ID# 229901 Nieuwegein Netherlands 3435 CM
    296 Canisius-Wilhelmina Ziekenhuis /ID# 231291 Nijmegen Netherlands 6532 SZ
    297 Jeroen Bosch Ziekenhuis /ID# 229765 S Hertogenbosch Netherlands 5223 GZ
    298 Elisabeth Tweesteden Ziekenhuis /ID# 229773 Tilburg Netherlands 5022 GC
    299 Diakonessenhuis /ID# 251793 Utrecht Netherlands 3582 KE
    300 North Shore Hospital /ID# 250992 Takapuna Auckland New Zealand 0622
    301 Christchurch Hospital /ID# 250993 Christchurch Canterbury New Zealand 8011
    302 Szpital Wojewodzki w Opolu sp. z o.o. /ID# 229669 Opole Dolnoslaskie Poland 45-372
    303 Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka /ID# 228723 Slupsk Pomorskie Poland 76-200
    304 Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej /ID# 225986 Kielce Swietokrzyskie Poland 25-734
    305 SP ZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii /ID# 225985 Olsztyn Warminsko-mazurskie Poland 10-228
    306 ARS-MEDICAL Sp. z o.o. /ID# 225848 Pila Wielkopolskie Poland 64-920
    307 Centrum Medyczne Pratia Poznan /ID# 227236 Skorzewo Wielkopolskie Poland 60-185
    308 CCA Braga - Hospital de Braga /ID# 249112 Braga Portugal 4710-243
    309 IPO Lisboa FG, EPE /ID# 249109 Lisboa Portugal 1099-023
    310 Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 249111 Lisboa Portugal 1649-035
    311 Unidade Local de Saúde de Matosinhos, EPE /ID# 249113 Matosinhos Portugal 4464-513
    312 Hematology and Oncology Institute /ID# 230054 Manati Puerto Rico 00674
    313 Pan American Center for Oncology Trials, LLC /ID# 230052 Rio Piedras Puerto Rico 00935
    314 VA Caribbean Healthcare System /ID# 230053 San Juan Puerto Rico 00921-3201
    315 Narodny Onkologicky ustav /ID# 238847 Bratislava Slovakia 831 01
    316 Univerzitna nemocnica L. Pasteura Kosice /ID# 240174 Kosice Slovakia 040 01
    317 Univerzitna nemocnica Martin /ID# 240828 Martin Slovakia 036 01
    318 Wits Clinical Research Site /ID# 227799 Johannesburg Gauteng South Africa 2193
    319 Wits Clinical Research Site /ID# 227803 Johannesburg Gauteng South Africa 2193
    320 Albert Alberts Stem Cell Transplant Centre /ID# 227798 Pretoria Gauteng South Africa 0044
    321 University of Cape Town /ID# 227802 Cape Town Western Cape South Africa 7925
    322 Haemalife Inc. Netcare Kuilsrivier Hospital /ID# 243391 Kuilsrivier Western Cape South Africa 7580
    323 Instituto Catalan de Oncologia (ICO) Badalona /ID# 228063 Badalona Barcelona Spain 08916
    324 Instituto Catalan de Oncologia (ICO) L'Hospitalet /ID# 227393 Hospitalet de Llobregat Barcelona Spain 08908
    325 CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 225809 Pamplona Navarra Spain 31008
    326 Hospital Parc de Salut del Mar /ID# 225810 Barcelona Spain 08003
    327 Hospital Universitario Vall d'Hebron /ID# 225811 Barcelona Spain 08035
    328 Hospital Clinic de Barcelona /ID# 226651 Barcelona Spain 08036
    329 Hospital Santa Creu i Sant Pau /ID# 225813 Barcelona Spain 08041
    330 Hospital Universitario Reina Sofia /ID# 225806 Cordoba Spain 14004
    331 Hospital General Universitario Gregorio Maranon /ID# 239768 Madrid Spain 28007
    332 CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 228228 Madrid Spain 28027
    333 Hospital Universitario Infanta Leonor /ID# 225816 Madrid Spain 28031
    334 MD Anderson Madrid /ID# 225817 Madrid Spain 28033
    335 Hospital Universitario Ramon y Cajal /ID# 241750 Madrid Spain 28034
    336 Hospital Universitario Fundacion Jimenez Diaz /ID# 225804 Madrid Spain 28040
    337 Hospital Universitario 12 de Octubre /ID# 225815 Madrid Spain 28041
    338 Hospital Clinico Universitario de Valencia /ID# 225818 Valencia Spain 46010
    339 Skane University Hospital Lund /ID# 227285 Lund Skane Lan Sweden SE 221 41
    340 Sodra Alvsborgs sjukhus /ID# 228885 Boras Vastra Gotalands Lan Sweden 501 82
    341 Linkoping University Hospital /ID# 233521 Linkoping Sweden 581 85
    342 Kantonsspital Aarau AG /ID# 229112 Aarau Aargau Switzerland 5001
    343 Spital Thun /ID# 229499 Thun Bern Switzerland 3600
    344 KSW Kantonsspital Winterthur /ID# 241631 Winterthur Zuerich Switzerland 8400
    345 Universitatsspital Zurich /ID# 228916 Zurich Zuerich Switzerland 8091
    346 Kaohsiung Chang Gung Memorial Hospital /ID# 226670 Kaohsiung City Kaohsiung Taiwan 833
    347 China Medical University Hospital /ID# 226188 Taichung City Taiwan 40447
    348 Taichung Veterans General Hospital /ID# 226674 Taichung Taiwan 40705
    349 National Cheng Kung University Hospital /ID# 226671 Tainan Taiwan 704
    350 Gazi University Medical Faculty /ID# 226571 Ankara Turkey 06560
    351 Ankara Universitesi Fakultesi /ID# 227331 Ankara Turkey 06620
    352 Anadolu Saglik Merkezi /ID# 225777 Dilovası Turkey 41455
    353 Koc Universitesi Hastanesi Translasyonel Tip Arastirma Merkezi /ID# 228950 Istanbul Turkey 34010
    354 Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty /ID# 225920 Istanbul Turkey 34098
    355 Bagcilar Medipol Mega Universite Hastanesi /ID# 226726 Istanbul Turkey 34214
    356 Dokuz Eylul University Medical Faculty /ID# 225782 Izmir Turkey 35340
    357 Inonu University Medical Faculty /ID# 226572 Malatya Turkey 44280
    358 Ondokuz Mayis Universitesi Tip /ID# 251247 Samsun Turkey 55139
    359 Karadeniz University /ID# 226573 Trabzon Turkey 61000
    360 Baskent Universitesi Adana Uyg. ve Arast. Merkezi Yuregir Baskent Hastanesi /ID# 225921 Yuregir Turkey 01240
    361 University Hospital of Derby and Burton NHS Foundation Trust /ID# 229066 Derby Derbyshire United Kingdom DE22 3NE
    362 Gloucestershire Hospitals NHS Foundation Trust /ID# 229067 Cheltenham Gloucestershire United Kingdom GL53 7AN
    363 University Hospital Southampton NHS Foundation Trust /ID# 226598 Southampton Hampshire United Kingdom SO16 6YD
    364 Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 226692 Norwich Norfolk United Kingdom NR4 7UY
    365 Oxford University Hospitals NHS Foundation Trust /ID# 226687 Oxford Oxfordshire United Kingdom OX3 9DU
    366 NHS Greater Glasgow and Clyde /ID# 229463 Glasgow Scotland United Kingdom G12 0XH
    367 University Hospitals of North Midlands NHS Trust /ID# 229202 Stoke-on-Trent Staffordshire United Kingdom ST4 6QG
    368 University Hospitals Birmingham NHS Foundation Trust /ID# 229197 Birmingham United Kingdom B15 2TH
    369 East Suffolk and North Essex NHS Foundation Trust /ID# 229056 Colchester United Kingdom CO4 5JL
    370 NHS Lothian /ID# 229055 Edinburgh United Kingdom EH3 9HE
    371 Leeds Teaching Hospitals NHS Trust /ID# 229360 Leeds United Kingdom LS9 7TF
    372 Imperial College Healthcare NHS Trust /ID# 242215 London United Kingdom W2 1NY
    373 The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 226690 Newcastle upon Tyne United Kingdom NE7 7DN
    374 University Hospital Plymouth NHS Trust /ID# 226689 Plymouth United Kingdom PL6 5FP
    375 Portsmouth Hospitals University NHS Trust /ID# 233400 Portsmouth United Kingdom PO6 3LY
    376 South Tyneside and Sunderland NHS Foundation Trust /ID# 229458 South Shields United Kingdom NE34 0PL
    377 Royal Cornwall Hospitals NHS Trust /ID# 229827 Truro United Kingdom TR1 3LJ

    Sponsors and Collaborators

    • AbbVie
    • Genmab

    Investigators

    • Study Director: ABBVIE INC., AbbVie

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AbbVie
    ClinicalTrials.gov Identifier:
    NCT05578976
    Other Study ID Numbers:
    • M20-621
    • 2021-000168-31
    First Posted:
    Oct 13, 2022
    Last Update Posted:
    Jan 31, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by AbbVie
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 31, 2023