Studie fáze 3 k vyhodnocení petosemtamabu ve srovnání s monoterapií podle volby výzkumníka u dříve léčených pacientů s spinocelulárním karcinomem hlavy a krku
Otevřená, randomizovaná kontrolovaná studie fáze 3 k vyhodnocení účinnosti a bezpečnosti petosemtamabu ve srovnání s monoterapií podle volby výzkumníka u dříve léčených pacientů s nevyléčitelným, metastatickým/recidivujícím spinocelulárním karcinomem hlavy a krku
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.
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 3
Kontakty a umístění
Studijní místa
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Caba, Argentina, C1280AEB
- Site 58
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Córdoba, Argentina, X5008HHW
- Site 45
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Rosario, Argentina, S2000KZE
- Site 110
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Viedma, Argentina, 8500
- Site 57
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Darlinghurst, Austrálie, 2010
- Site 3
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Herston, Austrálie, 4060
- Site 170
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Melbourne, Austrálie, 3000
- Site 38
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Nedlands, Austrálie, 6009
- Site 30
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Saint Leonards, Austrálie, 2065
- Site 11
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Sydney, Austrálie, 2050
- Site 73
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Brussels, Belgie, 1200
- Site 56
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Ghent, Belgie, 9000
- Site 92
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Leuven, Belgie, 3000
- Site 72
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Liège, Belgie, 4000
- Site 108
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Namur, Belgie, 5000
- Site 69
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Brasília, Brazílie, 70390-140
- Site 154
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Porto Alegre, Brazílie, 90110-270
- Site 145
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Porto Alegre, Brazílie, 90610-000
- Site 150
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Recife, Brazílie, 50040-000
- Site 146
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Rio de Janeiro, Brazílie, 22281-100
- Site 148
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São Paulo, Brazílie, 01509-900
- Site 147
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São Paulo, Brazílie, 04538-132
- Site 144
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Providencia, Chile, 7500859
- Site 16
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Recoleta, Chile, 8420000
- Site 20
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Santiago, Chile, 7500921
- Site 27
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Santiago, Chile, 7560908
- Site 21
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Bordeaux, Francie, 33075
- Site 105
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Brest, Francie, 29200
- Site 211
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Le Mans, Francie, 72000
- Site 162
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Lille, Francie, 59000
- Site 149
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Lyon, Francie, 69373
- Site 118
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Marseille, Francie, 13005
- Site 115
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Montpellier, Francie, 34298
- Site 106
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Nice, Francie, 06189
- Site 169
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Paris, Francie, 75005
- Site 114
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Paris, Francie, 75013
- Site 167
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Poitiers, Francie, 86000
- Site 136
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Rennes, Francie, 35042
- Site 141
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Rouen, Francie, 76038
- Site 107
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Toulouse, Francie, 31059
- Site 119
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Vandœuvre-lès-Nancy, Francie, 54519
- Site 142
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Villejuif, Francie, 94800
- Site 113
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Amsterdam, Holandsko, 1066 CX
- Site 76
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Nijmegen, Holandsko, 6525 GA
- Site 61
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Utrecht, Holandsko, 3584 CX
- Site 66
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Brescia, Itálie, 25123
- Site 93
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Cuneo, Itálie, 12100
- Site 111
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Milan, Itálie, 20133
- Site 128
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Milan, Itálie, 20141
- Site 81
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Naples, Itálie, 80131
- Site 209
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Naples, Itálie, 80131
- Site 89
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Roma, Itálie, 00161
- Site 203
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Rozzano, Itálie, 20089
- Site 85
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Haifa, Izrael, 3109601
- Site 19
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Jerusalem, Izrael, 9112001
- Site 1
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Ramat Gan, Izrael, 5265601
- Site 14
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Tel Aviv, Izrael, 6423906
- Site 2
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Chūōku, Japonsko, 104-0045
- Site 132
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Fukuoka, Japonsko, 812-8582
- Site 192
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Kashiwa, Japonsko, 277-8577
- Site 131
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Miki, Japonsko, 761-0793
- Site 135
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Nagoya, Japonsko, 464-8681
- Site 139
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Natori, Japonsko, 981-1293
- Site 186
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Sendai, Japonsko, 980-8574
- Site 134
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Ōsaka-sayama, Japonsko, 589-8511
- Site 133
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Busan, Jižní Korea, 48108
- Site 161
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Goyang-si, Jižní Korea, 10408
- Site 13
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Hwasun, Jižní Korea, 58128
- Site 29
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Seoul, Jižní Korea, 03080
- Site 137
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Seoul, Jižní Korea, 05505
- Site 36
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Seoul, Jižní Korea, 06351
- Site 47
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Soeul, Jižní Korea, 03722
- Site 33
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Suwon, Jižní Korea, 16499
- Site 164
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Montreal, Kanada, H2X 0A9
- Site 172
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Toronto, Kanada, M4N 3M5
- Site 196
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Kaunas, Litva, 50161
- Site 180
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Vilnius, Litva, 08406
- Site 181
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Nyíregyháza, Maďarsko, 4400
- Site 204
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Pécs, Maďarsko, 7624
- Site 195
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Szeged, Maďarsko, 6725
- Site 198
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Berlin, Německo, 12203
- Site 121
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Dresden, Německo, 01307
- Site 210
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Essen, Německo, 45147
- Site 165
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Giessen, Německo, 35390
- Site 84
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Greifswald, Německo, 17475
- Site 62
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Hanover, Německo, 30625
- Site 112
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Leipzig, Německo, 04103
- Site 116
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München, Německo, 81675
- Site 168
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Würzburg, Německo, 97080
- Site 99
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Bydgoszcz, Polsko, 85-796
- Site 190
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Gdansk, Polsko, 80-214
- Site 143
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Gliwice, Polsko, 44-102
- Site 97
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Krakow, Polsko, 31-826
- Site 177
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Lodz, Polsko, 93-513
- Site 200
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Poznan, Polsko, 60-185
- Site 117
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Warsaw, Polsko, 02-781
- Site 179
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Coimbra, Portugalsko, 3004-561
- Site 182
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Lisbon, Portugalsko, 1998-018
- Site 183
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Porto, Portugalsko, 4200-072
- Site 185
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Cambridge, Spojené království, CB2 0QQ
- Site 65
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Cardiff, Spojené království, CF14 2TL
- Site 174
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Glasgow, Spojené království, G12 0YN
- Site 171
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Liverpool, Spojené království, L7 8YA
- Site 44
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London, Spojené království, E20 1JQ
- Site 157
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London, Spojené království, EC1A 7BE
- Site 140
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London, Spojené království, SE1 9RT
- Site 90
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London, Spojené království, SW3 6JJ
- Site 42
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Manchester, Spojené království, M20 4BX
- Site 48
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Middlesex, Spojené království, HA6 2RN
- Site 70
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Newcastle upon Tyne, Spojené království, NE7 7DN
- Site 191
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Sutton, Spojené království, SM2 5PT
- Site 43
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Alabama
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Mobile, Alabama, Spojené státy, 36608
- Site 160
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Arizona
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Prescott, Arizona, Spojené státy, 86301
- Site 102
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Scottsdale, Arizona, Spojené státy, 85054
- Site 125
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California
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Duarte, California, Spojené státy, 91010
- Site 82
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La Jolla, California, Spojené státy, 92037
- Site 25
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Orange, California, Spojené státy, 92868
- Site 173
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Palo Alto, California, Spojené státy, 94304
- Site 28
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Sacramento, California, Spojené státy, 95817
- Site 127
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San Francisco, California, Spojené státy, 94158
- Site 46
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Colorado
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Lone Tree, Colorado, Spojené státy, 80124
- Site 130
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District of Columbia
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Washington D.C., District of Columbia, Spojené státy, 20010
- Site 104
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Florida
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Fort Myers, Florida, Spojené státy, 33901
- Site 12
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Jacksonville, Florida, Spojené státy, 32224
- Site 123
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Orlando, Florida, Spojené státy, 32827
- Site 9
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Tampa, Florida, Spojené státy, 33612
- Site 138
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Georgia
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Atlanta, Georgia, Spojené státy, 30322
- Site 187
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Illinois
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Chicago, Illinois, Spojené státy, 60607
- Site 152
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Chicago, Illinois, Spojené státy, 60611
- Site 213
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Chicago, Illinois, Spojené státy, 60637
- Site 68
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Indiana
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Indianapolis, Indiana, Spojené státy, 46202
- Site 31
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Kentucky
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Louisville, Kentucky, Spojené státy, 40202
- Site 8
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Louisiana
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Baton Rouge, Louisiana, Spojené státy, 70809
- Site 40
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New Orleans, Louisiana, Spojené státy, 70121
- Site 100
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Maryland
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Columbia, Maryland, Spojené státy, 21044
- Site 153
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Massachusetts
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Boston, Massachusetts, Spojené státy, 02215
- Site 77
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Michigan
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Ann Arbor, Michigan, Spojené státy, 48109
- Site 103
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Detroit, Michigan, Spojené státy, 48201
- Site 5
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Minnesota
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Maple Grove, Minnesota, Spojené státy, 55369
- Site 49
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Rochester, Minnesota, Spojené státy, 55905
- Site 124
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Missouri
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St Louis, Missouri, Spojené státy, 63110
- Site 18
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New Jersey
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Hackensack, New Jersey, Spojené státy, 07601
- Site 86
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New Mexico
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Albuquerque, New Mexico, Spojené státy, 87131
- Site 15
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New York
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New York, New York, Spojené státy, 10029
- Site 24
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The Bronx, New York, Spojené státy, 10461
- Site 214
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North Carolina
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Chapel Hill, North Carolina, Spojené státy, 27514
- Site 98
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Durham, North Carolina, Spojené státy, 27710
- Site 122
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Ohio
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Cincinnati, Ohio, Spojené státy, 45219
- Site 23
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Cleveland, Ohio, Spojené státy, 44106
- Site 218
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Cleveland, Ohio, Spojené státy, 44195
- Site 87
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Columbus, Ohio, Spojené státy, 43210
- Site 32
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Oregon
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Portland, Oregon, Spojené státy, 97213
- Site 26
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Pennsylvania
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Bensalem, Pennsylvania, Spojené státy, 19020
- Site 151
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Philadelphia, Pennsylvania, Spojené státy, 19107
- Site 158
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South Carolina
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Charleston, South Carolina, Spojené státy, 29425
- Site 50
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Tennessee
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Chattanooga, Tennessee, Spojené státy, 37404
- Site 60
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Memphis, Tennessee, Spojené státy, 38103
- Site 54
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Nashville, Tennessee, Spojené státy, 37203
- Site 59
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Nashville, Tennessee, Spojené státy, 37232
- Site 67
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Texas
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Denison, Texas, Spojené státy, 75020
- Site 55
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El Paso, Texas, Spojené státy, 79915
- Site 34
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Houston, Texas, Spojené státy, 77030
- Site 51
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Houston, Texas, Spojené státy, 77030
- Site 7
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Pearland, Texas, Spojené státy, 77584
- Site 94
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Utah
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Salt Lake City, Utah, Spojené státy, 84112
- Site 4
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Virginia
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Blacksburg, Virginia, Spojené státy, 24060
- Site 10
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Charlottesville, Virginia, Spojené státy, 22908
- Site 22
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Winchester, Virginia, Spojené státy, 22601
- Site 156
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Washington
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Seattle, Washington, Spojené státy, 98109
- Site 163
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Spokane, Washington, Spojené státy, 99202
- Site 6
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Wisconsin
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Madison, Wisconsin, Spojené státy, 53705
- Site 216
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Kaohsiung City, Tchaj-wan, 807
- Site 17
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Kaohsiung City, Tchaj-wan, 833
- Site 95
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Taichung, Tchaj-wan, 40447
- Site 53
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Tainan, Tchaj-wan, 70428
- Site 176
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Taipei, Tchaj-wan, 112
- Site 35
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Taoyuan City, Tchaj-wan, 333
- Site 52
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Olomouc, Česko, 779 00
- Site 201
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Athens, Řecko, 124 62
- Site 91
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Heraklion, Řecko, 71500
- Site 120
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Thessaloniki, Řecko, 55236
- Site 83
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Barcelona, Španělsko, 08035
- Site 78
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Madrid, Španělsko, 28040
- Site 109
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Madrid, Španělsko, 28040
- Site 75
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Madrid, Španělsko, 28041
- Site 71
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Madrid, Španělsko, 28050
- Site 166
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Pamplona, Španělsko, 31008
- Site 63
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Pamplona, Španělsko, 31008
- Site 64
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Valencia, Španělsko, 46009
- Site 74
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Bellinzona, Švýcarsko, CH-6500
- Site 184
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Geneva, Švýcarsko, 1211
- Site 189
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Lausanne, Švýcarsko, 1011
- Site 194
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Sankt Gallen, Švýcarsko, 9007
- Site 178
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Aktivní komparátor: Volba vyšetřovatele
|
Cetuximab Methotrexate Docetaxel |
|
Experimentální: MCLA-158
|
MCLA-158 |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Overall Survival (OS)
Časové okno: Up to approximately 3 years
|
OS was defined as the time from randomization to death due to any cause. |
Up to approximately 3 years
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: Up to first 6 cycles
|
Clearance of plasma and central volume of distribution based on population PK model |
Up to first 6 cycles
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: Study Official, Genmab
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- MCLA-158-CL02
- 2023-510322-32-00 (Ctis)
- 2023 (Grant/smlouva NIH USA)
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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