Une étude de phase 3 pour évaluer le pétosemtamab par rapport à la monothérapie choisie par l'investigateur chez des patients atteints d'un carcinome épidermoïde de la tête et du cou précédemment traités
Une étude contrôlée randomisée ouverte de phase 3 pour évaluer l'efficacité et l'innocuité du pétosemtamab par rapport au traitement en monothérapie choisi par l'investigateur chez des patients précédemment traités atteints d'un carcinome épidermoïde de la tête et du cou incurable, métastatique/récidivant
This is a phase 3 open-label, randomized, controlled, multicenter study to compare petosemtamab vs investigator's choice monotherapy in HNSCC patients for the second- and third-line treatment of incurable metastatic/recurrent disease.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
This is a phase 3 open-label, randomized, controlled, multicenter study to compare petosemtamab vs investigator's choice monotherapy in HNSCC patients for the second- and third-line treatment of incurable metastatic/recurrent disease. HNSCC patients must have progressive disease (PD) on or after anti-PD-1 therapy and platinum-containing therapy. Patients treated with platinum-containing therapy only in the adjuvant setting, or in the context of multimodal therapy for locally advanced disease, should have PD within 6 months of the last dose of platinum-containing therapy.
Type d'étude
Inscription (Réel)
Phase
- Phase 3
Contacts et emplacements
Lieux d'étude
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Berlin, Allemagne, 12203
- Site 121
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Dresden, Allemagne, 01307
- Site 210
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Essen, Allemagne, 45147
- Site 165
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Giessen, Allemagne, 35390
- Site 84
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Greifswald, Allemagne, 17475
- Site 62
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Hanover, Allemagne, 30625
- Site 112
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Leipzig, Allemagne, 04103
- Site 116
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München, Allemagne, 81675
- Site 168
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Würzburg, Allemagne, 97080
- Site 99
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Caba, Argentine, C1280AEB
- Site 58
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Córdoba, Argentine, X5008HHW
- Site 45
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Rosario, Argentine, S2000KZE
- Site 110
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Viedma, Argentine, 8500
- Site 57
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Darlinghurst, Australie, 2010
- Site 3
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Herston, Australie, 4060
- Site 170
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Melbourne, Australie, 3000
- Site 38
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Nedlands, Australie, 6009
- Site 30
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Saint Leonards, Australie, 2065
- Site 11
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Sydney, Australie, 2050
- Site 73
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Brussels, Belgique, 1200
- Site 56
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Ghent, Belgique, 9000
- Site 92
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Leuven, Belgique, 3000
- Site 72
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Liège, Belgique, 4000
- Site 108
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Namur, Belgique, 5000
- Site 69
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Brasília, Brésil, 70390-140
- Site 154
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Porto Alegre, Brésil, 90110-270
- Site 145
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Porto Alegre, Brésil, 90610-000
- Site 150
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Recife, Brésil, 50040-000
- Site 146
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Rio de Janeiro, Brésil, 22281-100
- Site 148
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São Paulo, Brésil, 01509-900
- Site 147
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São Paulo, Brésil, 04538-132
- Site 144
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Montreal, Canada, H2X 0A9
- Site 172
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Toronto, Canada, M4N 3M5
- Site 196
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Providencia, Chili, 7500859
- Site 16
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Recoleta, Chili, 8420000
- Site 20
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Santiago, Chili, 7500921
- Site 27
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Santiago, Chili, 7560908
- Site 21
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Busan, Corée du Sud, 48108
- Site 161
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Goyang-si, Corée du Sud, 10408
- Site 13
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Hwasun, Corée du Sud, 58128
- Site 29
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Seoul, Corée du Sud, 03080
- Site 137
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Seoul, Corée du Sud, 05505
- Site 36
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Seoul, Corée du Sud, 06351
- Site 47
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Soeul, Corée du Sud, 03722
- Site 33
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Suwon, Corée du Sud, 16499
- Site 164
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Barcelona, Espagne, 08035
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Madrid, Espagne, 28040
- Site 109
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Madrid, Espagne, 28040
- Site 75
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Madrid, Espagne, 28041
- Site 71
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Madrid, Espagne, 28050
- Site 166
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Pamplona, Espagne, 31008
- Site 63
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Pamplona, Espagne, 31008
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Valencia, Espagne, 46009
- Site 74
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Bordeaux, France, 33075
- Site 105
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Brest, France, 29200
- Site 211
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Le Mans, France, 72000
- Site 162
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Lille, France, 59000
- Site 149
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Lyon, France, 69373
- Site 118
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Marseille, France, 13005
- Site 115
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Montpellier, France, 34298
- Site 106
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Nice, France, 06189
- Site 169
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Paris, France, 75005
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Paris, France, 75013
- Site 167
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Poitiers, France, 86000
- Site 136
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Rennes, France, 35042
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Rouen, France, 76038
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Toulouse, France, 31059
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Vandœuvre-lès-Nancy, France, 54519
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Villejuif, France, 94800
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Athens, Grèce, 124 62
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Heraklion, Grèce, 71500
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Thessaloniki, Grèce, 55236
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Nyíregyháza, Hongrie, 4400
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Pécs, Hongrie, 7624
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Szeged, Hongrie, 6725
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Haifa, Israël, 3109601
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Jerusalem, Israël, 9112001
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Ramat Gan, Israël, 5265601
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Tel Aviv, Israël, 6423906
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Brescia, Italie, 25123
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Cuneo, Italie, 12100
- Site 111
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Milan, Italie, 20133
- Site 128
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Milan, Italie, 20141
- Site 81
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Naples, Italie, 80131
- Site 209
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Naples, Italie, 80131
- Site 89
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Roma, Italie, 00161
- Site 203
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Rozzano, Italie, 20089
- Site 85
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Chūōku, Japon, 104-0045
- Site 132
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Fukuoka, Japon, 812-8582
- Site 192
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Kashiwa, Japon, 277-8577
- Site 131
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Miki, Japon, 761-0793
- Site 135
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Nagoya, Japon, 464-8681
- Site 139
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Natori, Japon, 981-1293
- Site 186
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Sendai, Japon, 980-8574
- Site 134
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Ōsaka-sayama, Japon, 589-8511
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Coimbra, Le Portugal, 3004-561
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Lisbon, Le Portugal, 1998-018
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Porto, Le Portugal, 4200-072
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Kaunas, Lituanie, 50161
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Vilnius, Lituanie, 08406
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Amsterdam, Pays-Bas, 1066 CX
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Nijmegen, Pays-Bas, 6525 GA
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Utrecht, Pays-Bas, 3584 CX
- Site 66
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Bydgoszcz, Pologne, 85-796
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Gdansk, Pologne, 80-214
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Gliwice, Pologne, 44-102
- Site 97
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Krakow, Pologne, 31-826
- Site 177
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Lodz, Pologne, 93-513
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Poznan, Pologne, 60-185
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Warsaw, Pologne, 02-781
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Cambridge, Royaume-Uni, CB2 0QQ
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Cardiff, Royaume-Uni, CF14 2TL
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Glasgow, Royaume-Uni, G12 0YN
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Liverpool, Royaume-Uni, L7 8YA
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London, Royaume-Uni, E20 1JQ
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London, Royaume-Uni, EC1A 7BE
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London, Royaume-Uni, SE1 9RT
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London, Royaume-Uni, SW3 6JJ
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Manchester, Royaume-Uni, M20 4BX
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Middlesex, Royaume-Uni, HA6 2RN
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Newcastle upon Tyne, Royaume-Uni, NE7 7DN
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Sutton, Royaume-Uni, SM2 5PT
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Bellinzona, Suisse, CH-6500
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Geneva, Suisse, 1211
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Lausanne, Suisse, 1011
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Sankt Gallen, Suisse, 9007
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Kaohsiung City, Taïwan, 807
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Kaohsiung City, Taïwan, 833
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Taichung, Taïwan, 40447
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Tainan, Taïwan, 70428
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Taipei, Taïwan, 112
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Taoyuan City, Taïwan, 333
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Olomouc, Tchéquie, 779 00
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Alabama
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Mobile, Alabama, États-Unis, 36608
- Site 160
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Arizona
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Prescott, Arizona, États-Unis, 86301
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Scottsdale, Arizona, États-Unis, 85054
- Site 125
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California
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Duarte, California, États-Unis, 91010
- Site 82
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La Jolla, California, États-Unis, 92037
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Orange, California, États-Unis, 92868
- Site 173
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Palo Alto, California, États-Unis, 94304
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Sacramento, California, États-Unis, 95817
- Site 127
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San Francisco, California, États-Unis, 94158
- Site 46
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Colorado
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Lone Tree, Colorado, États-Unis, 80124
- Site 130
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District of Columbia
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Washington D.C., District of Columbia, États-Unis, 20010
- Site 104
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Florida
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Fort Myers, Florida, États-Unis, 33901
- Site 12
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Jacksonville, Florida, États-Unis, 32224
- Site 123
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Orlando, Florida, États-Unis, 32827
- Site 9
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Tampa, Florida, États-Unis, 33612
- Site 138
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Georgia
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Atlanta, Georgia, États-Unis, 30322
- Site 187
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Illinois
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Chicago, Illinois, États-Unis, 60607
- Site 152
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Chicago, Illinois, États-Unis, 60611
- Site 213
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Chicago, Illinois, États-Unis, 60637
- Site 68
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Indiana
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Indianapolis, Indiana, États-Unis, 46202
- Site 31
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Kentucky
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Louisville, Kentucky, États-Unis, 40202
- Site 8
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Louisiana
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Baton Rouge, Louisiana, États-Unis, 70809
- Site 40
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New Orleans, Louisiana, États-Unis, 70121
- Site 100
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Maryland
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Columbia, Maryland, États-Unis, 21044
- Site 153
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Massachusetts
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Boston, Massachusetts, États-Unis, 02215
- Site 77
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Michigan
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Ann Arbor, Michigan, États-Unis, 48109
- Site 103
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Detroit, Michigan, États-Unis, 48201
- Site 5
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Minnesota
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Maple Grove, Minnesota, États-Unis, 55369
- Site 49
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Rochester, Minnesota, États-Unis, 55905
- Site 124
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Missouri
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St Louis, Missouri, États-Unis, 63110
- Site 18
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New Jersey
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Hackensack, New Jersey, États-Unis, 07601
- Site 86
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New Mexico
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Albuquerque, New Mexico, États-Unis, 87131
- Site 15
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New York
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New York, New York, États-Unis, 10029
- Site 24
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The Bronx, New York, États-Unis, 10461
- Site 214
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North Carolina
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Chapel Hill, North Carolina, États-Unis, 27514
- Site 98
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Durham, North Carolina, États-Unis, 27710
- Site 122
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Ohio
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Cincinnati, Ohio, États-Unis, 45219
- Site 23
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Cleveland, Ohio, États-Unis, 44106
- Site 218
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Cleveland, Ohio, États-Unis, 44195
- Site 87
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Columbus, Ohio, États-Unis, 43210
- Site 32
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Oregon
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Portland, Oregon, États-Unis, 97213
- Site 26
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Pennsylvania
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Bensalem, Pennsylvania, États-Unis, 19020
- Site 151
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Philadelphia, Pennsylvania, États-Unis, 19107
- Site 158
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South Carolina
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Charleston, South Carolina, États-Unis, 29425
- Site 50
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Tennessee
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Chattanooga, Tennessee, États-Unis, 37404
- Site 60
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Memphis, Tennessee, États-Unis, 38103
- Site 54
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Nashville, Tennessee, États-Unis, 37203
- Site 59
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Nashville, Tennessee, États-Unis, 37232
- Site 67
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Texas
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Denison, Texas, États-Unis, 75020
- Site 55
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El Paso, Texas, États-Unis, 79915
- Site 34
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Houston, Texas, États-Unis, 77030
- Site 51
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Houston, Texas, États-Unis, 77030
- Site 7
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Pearland, Texas, États-Unis, 77584
- Site 94
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Utah
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Salt Lake City, Utah, États-Unis, 84112
- Site 4
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Virginia
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Blacksburg, Virginia, États-Unis, 24060
- Site 10
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Charlottesville, Virginia, États-Unis, 22908
- Site 22
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Winchester, Virginia, États-Unis, 22601
- Site 156
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Washington
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Seattle, Washington, États-Unis, 98109
- Site 163
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Spokane, Washington, États-Unis, 99202
- Site 6
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Wisconsin
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Madison, Wisconsin, États-Unis, 53705
- Site 216
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Signed ICF before initiation of any study procedures.
- Age ≥ 18 years at signing of ICF.
- Histologically previously confirmed HNSCC with evidence of metastatic or locally advanced disease not amenable to standard therapy with curative intent.
- HNSCC participants progressed on or after anti-PD-1 therapy and platinum-containing therapy.
- The eligible HNSCC primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx.
- A baseline new tumor sample unless the participant has an available tumor sample as an FFPE block with sufficient material.
- Measurable disease as defined by RECIST v1.1 by radiologic methods.
- ECOG PS of 0 or 1
- Life expectancy ≥ 12 weeks, as per investigator
- Adequate organ function (as per protocol)
Exclusion Criteria:
- Central nervous system metastases that are untreated or symptomatic, or require radiation, surgery, or continued steroid therapy to control symptoms within 14 days prior to randomization.
- Known leptomeningeal involvement
- Any systemic anticancer therapy within 4 weeks prior to randomization.
- Major surgery within 3 weeks or palliative radiotherapy within 2 weeks prior to randomization.
- Persistent Grade >1 clinically significant toxicities related to prior antineoplastic therapies
- History of hypersensitivity reaction to any of the excipients of treatment required for this study.
- Unstable angina; history of congestive heart failure of Class II-IV New York Heart Association (NYHA) criteria, or serious cardiac arrhythmia requiring treatment or history of myocardial infarction within 6 months of study entry
- History of prior malignancies with the exception of localized cancer with curative resection (e.g. cervical intraepithelial neoplasia or nonmelanoma skin cancer)
- Current dyspnea at rest of any origin, or other diseases requiring continuous oxygen therapy
- Current serious illness or medical conditions including, but not limited to, uncontrolled active infection, clinically significant pulmonary, metabolic or psychiatric disorders
- Participants with known infectious diseases (as per protocol)
- Pregnant or breastfeeding participants
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Choix de l'enquêteur
|
Cetuximab Methotrexate Docetaxel |
|
Expérimental: MCLA-158
|
MCLA-158 |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Overall Survival (OS)
Délai: Up to approximately 3 years
|
OS was defined as the time from randomization to death due to any cause. |
Up to approximately 3 years
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review
Délai: Up to approximately 2 years
|
ORR was defined as the proportion of participants in the analysis population who had a Complete Response or Partial Response based per RECIST v1.1 with confirmation. |
Up to approximately 2 years
|
|
Progression Free Survival (PFS) as Assessed by Blinded Independent Central Review
Délai: Up to approximately 2 years
|
PFS was defined as the time from randomization to the first documented disease progression per RECIST v1.1 or death due to any cause. |
Up to approximately 2 years
|
|
Duration of Response (DOR) as Assessed by Blinded Independent Central Review
Délai: Up to approximately 2 years
|
For participants with a confirmed CR or PR per RECIST v1.1, DOR was defined as the time from the date of first documented response of CR or PR per RECIST v1.1 to the date of first documented progression or death due to underlying cancer. |
Up to approximately 2 years
|
|
Objective Response Rate (ORR) as Assessed by Investigator Review
Délai: Up to approximately 2 years
|
ORR was defined as the proportion of participants in the analysis population who had a Complete Response or Partial Response based per RECIST v1.1 with confirmation. |
Up to approximately 2 years
|
|
Progression Free Survival (PFS) as Assessed by Investigator Review
Délai: Up to approximately 2 years
|
PFS was defined as the time from randomization to the first documented disease progression per RECIST v1.1 or death due to any cause. |
Up to approximately 2 years
|
|
Duration of Response (DOR) as Assessed by Investigator Review
Délai: Up to approximately 2 years
|
For participants with a confirmed CR or PR per RECIST v1.1, DOR was defined as the time from the date of the first documented response of CR or PR per RECIST v1.1 to the date of first documented progression or death due to underlying cancer. |
Up to approximately 2 years
|
|
Time to Response (TTR) as Assessed by Blinded Independent Central Review
Délai: Up to approximately 2 years
|
For participants with a confirmed CR or PR per RECIST v1.1, TTR was defined as the time from randomization to the first documented response per RECIST v1.1. |
Up to approximately 2 years
|
|
Time to Response (TTR) as Assessed by Investigator Review
Délai: Up to approximately 2 years
|
For participants with a confirmed CR or PR per RECIST v1.1, TTR was defined as the time from randomization to the first documented response per RECIST v1.1. |
Up to approximately 2 years
|
|
Clinical Benefit Rate (CBR) as Assessed by Blinded Independent Central Review
Délai: Up to approximately 2 years
|
CBR was defined as the proportion of participants with a confirmed CR or PR, or SD lasting 16 weeks for longer per RECIST v1.1 |
Up to approximately 2 years
|
|
Clinical Benefit Rate (CBR) as Assessed by Investigator Review
Délai: Up to approximately 2 years
|
CBR was defined as the proportion of participants with a confirmed CR or PR, or SD lasting 16 weeks for longer per RECIST v1.1 |
Up to approximately 2 years
|
|
Number of Participants who Experienced At Least One Treatment Emergent Adverse Event (TEAE)
Délai: Up to 30 days post-last dose
|
An AE means any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. The term TEAE covers any unfavorable and unintended sign, symptom, syndrome, or illness that develops or worsens during the period of observation after the first treatment administration in the clinical study. The number of all participants who experienced at least one TEAE is presented. |
Up to 30 days post-last dose
|
|
Number of Participants who Experienced At Least One Serious TEAE
Délai: Up to 30 days post-last dose
|
An AE means any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. The term TEAE covers any unfavorable and unintended sign, symptom, syndrome, or illness that develops or worsens during the period of observation after the first treatment administration in the clinical study. The number of all participants who experienced at least one serious TEAE is presented. |
Up to 30 days post-last dose
|
|
Number of Participants who Discontinued Study Treatment Due to TEAEs
Délai: Up to 30 days post-last dose
|
An AE means any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. The term TEAE covers any unfavorable and unintended sign, symptom, syndrome, or illness that develops or worsens during the period of observation after the first treatment administration in the clinical study. The number of all participants who discontinued study treatment due to TEAEs is presented. |
Up to 30 days post-last dose
|
|
Number of Participants who had Dose Modification Due to TEAEs
Délai: Up to 30 days post-last dose
|
An AE means any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related. The term TEAE covers any unfavorable and unintended sign, symptom, syndrome, or illness that develops or worsens during the period of observation after the first treatment administration in the clinical study. The number of all participants who had dose modification due to TEAEs is presented. |
Up to 30 days post-last dose
|
|
Pharmacokinetic parameters
Délai: Up to first 6 cycles
|
Clearance of plasma and central volume of distribution based on population PK model |
Up to first 6 cycles
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Study Official, Genmab
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- MCLA-158-CL02
- 2023-510322-32-00 (Ctis)
- 2023 (Subvention/contrat des NIH des États-Unis)
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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