Un estudio de fase 3 para evaluar el petosemtamab en comparación con la monoterapia elegida por el investigador en pacientes con carcinoma de células escamosas de cabeza y cuello previamente tratados
Un estudio controlado aleatorio, abierto de fase 3 para evaluar la eficacia y seguridad de petosemtamab en comparación con el tratamiento de monoterapia elegido por el investigador en pacientes previamente tratados con carcinoma de células escamosas de cabeza y cuello incurable, metastásico o recurrente
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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
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Berlin, Alemania, 12203
- Site 121
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Dresden, Alemania, 01307
- Site 210
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Essen, Alemania, 45147
- Site 165
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Giessen, Alemania, 35390
- Site 84
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Greifswald, Alemania, 17475
- Site 62
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Hanover, Alemania, 30625
- Site 112
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Leipzig, Alemania, 04103
- Site 116
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München, Alemania, 81675
- Site 168
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Würzburg, Alemania, 97080
- Site 99
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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, Australia, 2010
- Site 3
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Herston, Australia, 4060
- Site 170
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Melbourne, Australia, 3000
- Site 38
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Nedlands, Australia, 6009
- Site 30
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Saint Leonards, Australia, 2065
- Site 11
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Sydney, Australia, 2050
- Site 73
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Brasília, Brasil, 70390-140
- Site 154
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Porto Alegre, Brasil, 90110-270
- Site 145
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Porto Alegre, Brasil, 90610-000
- Site 150
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Recife, Brasil, 50040-000
- Site 146
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Rio de Janeiro, Brasil, 22281-100
- Site 148
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São Paulo, Brasil, 01509-900
- Site 147
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São Paulo, Brasil, 04538-132
- Site 144
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Brussels, Bélgica, 1200
- Site 56
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Ghent, Bélgica, 9000
- Site 92
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Leuven, Bélgica, 3000
- Site 72
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Liège, Bélgica, 4000
- Site 108
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Namur, Bélgica, 5000
- Site 69
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Montreal, Canadá, H2X 0A9
- Site 172
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Toronto, Canadá, M4N 3M5
- Site 196
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Olomouc, Chequia, 779 00
- Site 201
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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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Busan, Corea del Sur, 48108
- Site 161
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Goyang-si, Corea del Sur, 10408
- Site 13
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Hwasun, Corea del Sur, 58128
- Site 29
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Seoul, Corea del Sur, 03080
- Site 137
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Seoul, Corea del Sur, 05505
- Site 36
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Seoul, Corea del Sur, 06351
- Site 47
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Soeul, Corea del Sur, 03722
- Site 33
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Suwon, Corea del Sur, 16499
- Site 164
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Barcelona, España, 08035
- Site 78
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Madrid, España, 28040
- Site 109
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Madrid, España, 28040
- Site 75
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Madrid, España, 28041
- Site 71
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Madrid, España, 28050
- Site 166
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Pamplona, España, 31008
- Site 63
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Pamplona, España, 31008
- Site 64
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Valencia, España, 46009
- Site 74
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Alabama
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Mobile, Alabama, Estados Unidos, 36608
- Site 160
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Arizona
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Prescott, Arizona, Estados Unidos, 86301
- Site 102
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Scottsdale, Arizona, Estados Unidos, 85054
- Site 125
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California
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Duarte, California, Estados Unidos, 91010
- Site 82
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La Jolla, California, Estados Unidos, 92037
- Site 25
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Orange, California, Estados Unidos, 92868
- Site 173
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Palo Alto, California, Estados Unidos, 94304
- Site 28
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Sacramento, California, Estados Unidos, 95817
- Site 127
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San Francisco, California, Estados Unidos, 94158
- Site 46
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Colorado
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Lone Tree, Colorado, Estados Unidos, 80124
- Site 130
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District of Columbia
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Washington D.C., District of Columbia, Estados Unidos, 20010
- Site 104
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Florida
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Fort Myers, Florida, Estados Unidos, 33901
- Site 12
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Jacksonville, Florida, Estados Unidos, 32224
- Site 123
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Orlando, Florida, Estados Unidos, 32827
- Site 9
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Tampa, Florida, Estados Unidos, 33612
- Site 138
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Georgia
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Atlanta, Georgia, Estados Unidos, 30322
- Site 187
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Illinois
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Chicago, Illinois, Estados Unidos, 60607
- Site 152
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Chicago, Illinois, Estados Unidos, 60611
- Site 213
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Chicago, Illinois, Estados Unidos, 60637
- Site 68
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46202
- Site 31
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Kentucky
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Louisville, Kentucky, Estados Unidos, 40202
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Louisiana
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Baton Rouge, Louisiana, Estados Unidos, 70809
- Site 40
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New Orleans, Louisiana, Estados Unidos, 70121
- Site 100
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Maryland
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Columbia, Maryland, Estados Unidos, 21044
- Site 153
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02215
- Site 77
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48109
- Site 103
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Detroit, Michigan, Estados Unidos, 48201
- Site 5
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Minnesota
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Maple Grove, Minnesota, Estados Unidos, 55369
- Site 49
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Rochester, Minnesota, Estados Unidos, 55905
- Site 124
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Missouri
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St Louis, Missouri, Estados Unidos, 63110
- Site 18
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New Jersey
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Hackensack, New Jersey, Estados Unidos, 07601
- Site 86
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New Mexico
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Albuquerque, New Mexico, Estados Unidos, 87131
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New York
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New York, New York, Estados Unidos, 10029
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The Bronx, New York, Estados Unidos, 10461
- Site 214
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North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27514
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Durham, North Carolina, Estados Unidos, 27710
- Site 122
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45219
- Site 23
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Cleveland, Ohio, Estados Unidos, 44106
- Site 218
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Cleveland, Ohio, Estados Unidos, 44195
- Site 87
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Columbus, Ohio, Estados Unidos, 43210
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Oregon
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Portland, Oregon, Estados Unidos, 97213
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Pennsylvania
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Bensalem, Pennsylvania, Estados Unidos, 19020
- Site 151
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Philadelphia, Pennsylvania, Estados Unidos, 19107
- Site 158
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South Carolina
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Charleston, South Carolina, Estados Unidos, 29425
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Tennessee
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Chattanooga, Tennessee, Estados Unidos, 37404
- Site 60
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Memphis, Tennessee, Estados Unidos, 38103
- Site 54
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Nashville, Tennessee, Estados Unidos, 37203
- Site 59
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Nashville, Tennessee, Estados Unidos, 37232
- Site 67
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Texas
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Denison, Texas, Estados Unidos, 75020
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El Paso, Texas, Estados Unidos, 79915
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Houston, Texas, Estados Unidos, 77030
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Houston, Texas, Estados Unidos, 77030
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Pearland, Texas, Estados Unidos, 77584
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Utah
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Salt Lake City, Utah, Estados Unidos, 84112
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Virginia
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Blacksburg, Virginia, Estados Unidos, 24060
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Charlottesville, Virginia, Estados Unidos, 22908
- Site 22
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Winchester, Virginia, Estados Unidos, 22601
- Site 156
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Washington
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Seattle, Washington, Estados Unidos, 98109
- Site 163
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Spokane, Washington, Estados Unidos, 99202
- Site 6
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Wisconsin
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Madison, Wisconsin, Estados Unidos, 53705
- Site 216
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Bordeaux, Francia, 33075
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Brest, Francia, 29200
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Le Mans, Francia, 72000
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Lille, Francia, 59000
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Lyon, Francia, 69373
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Marseille, Francia, 13005
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Montpellier, Francia, 34298
- Site 106
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Nice, Francia, 06189
- Site 169
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Paris, Francia, 75005
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Paris, Francia, 75013
- Site 167
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Poitiers, Francia, 86000
- Site 136
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Rennes, Francia, 35042
- Site 141
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Rouen, Francia, 76038
- Site 107
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Toulouse, Francia, 31059
- Site 119
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Vandœuvre-lès-Nancy, Francia, 54519
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Villejuif, Francia, 94800
- Site 113
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Athens, Grecia, 124 62
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Heraklion, Grecia, 71500
- Site 120
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Thessaloniki, Grecia, 55236
- Site 83
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Nyíregyháza, Hungría, 4400
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Pécs, Hungría, 7624
- Site 195
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Szeged, Hungría, 6725
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Haifa, Israel, 3109601
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Jerusalem, Israel, 9112001
- Site 1
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Ramat Gan, Israel, 5265601
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Tel Aviv, Israel, 6423906
- Site 2
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Brescia, Italia, 25123
- Site 93
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Cuneo, Italia, 12100
- Site 111
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Milan, Italia, 20133
- Site 128
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Milan, Italia, 20141
- Site 81
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Naples, Italia, 80131
- Site 209
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Naples, Italia, 80131
- Site 89
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Roma, Italia, 00161
- Site 203
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Rozzano, Italia, 20089
- Site 85
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Chūōku, Japón, 104-0045
- Site 132
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Fukuoka, Japón, 812-8582
- Site 192
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Kashiwa, Japón, 277-8577
- Site 131
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Miki, Japón, 761-0793
- Site 135
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Nagoya, Japón, 464-8681
- Site 139
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Natori, Japón, 981-1293
- Site 186
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Sendai, Japón, 980-8574
- Site 134
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Ōsaka-sayama, Japón, 589-8511
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Kaunas, Lituania, 50161
- Site 180
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Vilnius, Lituania, 08406
- Site 181
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Amsterdam, Países Bajos, 1066 CX
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Nijmegen, Países Bajos, 6525 GA
- Site 61
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Utrecht, Países Bajos, 3584 CX
- Site 66
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Bydgoszcz, Polonia, 85-796
- Site 190
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Gdansk, Polonia, 80-214
- Site 143
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Gliwice, Polonia, 44-102
- Site 97
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Krakow, Polonia, 31-826
- Site 177
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Lodz, Polonia, 93-513
- Site 200
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Poznan, Polonia, 60-185
- Site 117
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Warsaw, Polonia, 02-781
- Site 179
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Coimbra, Portugal, 3004-561
- Site 182
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Lisbon, Portugal, 1998-018
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Porto, Portugal, 4200-072
- Site 185
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Cambridge, Reino Unido, CB2 0QQ
- Site 65
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Cardiff, Reino Unido, CF14 2TL
- Site 174
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Glasgow, Reino Unido, G12 0YN
- Site 171
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Liverpool, Reino Unido, L7 8YA
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London, Reino Unido, E20 1JQ
- Site 157
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London, Reino Unido, EC1A 7BE
- Site 140
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London, Reino Unido, SE1 9RT
- Site 90
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London, Reino Unido, SW3 6JJ
- Site 42
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Manchester, Reino Unido, M20 4BX
- Site 48
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Middlesex, Reino Unido, HA6 2RN
- Site 70
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Newcastle upon Tyne, Reino Unido, NE7 7DN
- Site 191
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Sutton, Reino Unido, SM2 5PT
- Site 43
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Bellinzona, Suiza, CH-6500
- Site 184
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Geneva, Suiza, 1211
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Lausanne, Suiza, 1011
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Sankt Gallen, Suiza, 9007
- Site 178
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Kaohsiung City, Taiwán, 807
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Kaohsiung City, Taiwán, 833
- Site 95
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Taichung, Taiwán, 40447
- Site 53
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Tainan, Taiwán, 70428
- Site 176
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Taipei, Taiwán, 112
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Taoyuan City, Taiwán, 333
- Site 52
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Elección del investigador
|
Cetuximab Methotrexate Docetaxel |
|
Experimental: MCLA-158
|
MCLA-158 |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Overall Survival (OS)
Periodo de tiempo: Up to approximately 3 years
|
OS was defined as the time from randomization to death due to any cause. |
Up to approximately 3 years
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Up to first 6 cycles
|
Clearance of plasma and central volume of distribution based on population PK model |
Up to first 6 cycles
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Study Official, Genmab
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- MCLA-158-CL02
- 2023-510322-32-00 (Ctis)
- 2023 (Subvención/contrato del NIH de EE. UU.)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .