Um estudo de fase 3 para avaliar petosemtamabe em comparação com a monoterapia de escolha do investigador em pacientes com carcinoma espinocelular de cabeça e pescoço previamente tratados
Um estudo de fase 3, aberto, randomizado e controlado para avaliar a eficácia e segurança do petosemtamabe em comparação com o tratamento de monoterapia de escolha do investigador em pacientes previamente tratados com carcinoma de células escamosas de cabeça e pescoço incurável, metastático/recorrente
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.
Visão geral do estudo
Status
Descrição detalhada
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 estudo
Inscrição (Real)
Estágio
- Fase 3
Contactos e Locais
Locais de estudo
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Berlin, Alemanha, 12203
- Site 121
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Dresden, Alemanha, 01307
- Site 210
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Essen, Alemanha, 45147
- Site 165
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Giessen, Alemanha, 35390
- Site 84
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Greifswald, Alemanha, 17475
- Site 62
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Hanover, Alemanha, 30625
- Site 112
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Leipzig, Alemanha, 04103
- Site 116
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München, Alemanha, 81675
- Site 168
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Würzburg, Alemanha, 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, Austrália, 2010
- Site 3
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Herston, Austrália, 4060
- Site 170
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Melbourne, Austrália, 3000
- Site 38
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Nedlands, Austrália, 6009
- Site 30
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Saint Leonards, Austrália, 2065
- Site 11
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Sydney, Austrália, 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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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, Coréia do Sul, 48108
- Site 161
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Goyang-si, Coréia do Sul, 10408
- Site 13
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Hwasun, Coréia do Sul, 58128
- Site 29
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Seoul, Coréia do Sul, 03080
- Site 137
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Seoul, Coréia do Sul, 05505
- Site 36
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Seoul, Coréia do Sul, 06351
- Site 47
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Soeul, Coréia do Sul, 03722
- Site 33
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Suwon, Coréia do Sul, 16499
- Site 164
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Barcelona, Espanha, 08035
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Madrid, Espanha, 28040
- Site 109
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Madrid, Espanha, 28040
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Madrid, Espanha, 28041
- Site 71
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Madrid, Espanha, 28050
- Site 166
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Pamplona, Espanha, 31008
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Pamplona, Espanha, 31008
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Valencia, Espanha, 46009
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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
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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
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La Jolla, California, Estados Unidos, 92037
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Orange, California, Estados Unidos, 92868
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Palo Alto, California, Estados Unidos, 94304
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Sacramento, California, Estados Unidos, 95817
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San Francisco, California, Estados Unidos, 94158
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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
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Florida
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Fort Myers, Florida, Estados Unidos, 33901
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Jacksonville, Florida, Estados Unidos, 32224
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Orlando, Florida, Estados Unidos, 32827
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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
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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
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Minnesota
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Maple Grove, Minnesota, Estados Unidos, 55369
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Rochester, Minnesota, Estados Unidos, 55905
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Missouri
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St Louis, Missouri, Estados Unidos, 63110
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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
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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
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45219
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Cleveland, Ohio, Estados Unidos, 44106
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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
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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
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Nashville, Tennessee, Estados Unidos, 37203
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Nashville, Tennessee, Estados Unidos, 37232
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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
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Winchester, Virginia, Estados Unidos, 22601
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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
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Wisconsin
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Madison, Wisconsin, Estados Unidos, 53705
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Bordeaux, França, 33075
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Brest, França, 29200
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Le Mans, França, 72000
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Lille, França, 59000
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Lyon, França, 69373
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Marseille, França, 13005
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Montpellier, França, 34298
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Nice, França, 06189
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Paris, França, 75005
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Paris, França, 75013
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Poitiers, França, 86000
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Rennes, França, 35042
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Rouen, França, 76038
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Toulouse, França, 31059
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Vandœuvre-lès-Nancy, França, 54519
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Villejuif, França, 94800
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Athens, Grécia, 124 62
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Heraklion, Grécia, 71500
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Thessaloniki, Grécia, 55236
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Amsterdam, Holanda, 1066 CX
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Nijmegen, Holanda, 6525 GA
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Utrecht, Holanda, 3584 CX
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Nyíregyháza, Hungria, 4400
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Pécs, Hungria, 7624
- Site 195
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Szeged, Hungria, 6725
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Haifa, Israel, 3109601
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Jerusalem, Israel, 9112001
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Ramat Gan, Israel, 5265601
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Tel Aviv, Israel, 6423906
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Brescia, Itália, 25123
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Cuneo, Itália, 12100
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Milan, Itália, 20133
- Site 128
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Milan, Itália, 20141
- Site 81
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Naples, Itália, 80131
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Naples, Itália, 80131
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Roma, Itália, 00161
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Rozzano, Itália, 20089
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Chūōku, Japão, 104-0045
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Fukuoka, Japão, 812-8582
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Kashiwa, Japão, 277-8577
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Miki, Japão, 761-0793
- Site 135
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Nagoya, Japão, 464-8681
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Natori, Japão, 981-1293
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Sendai, Japão, 980-8574
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Ōsaka-sayama, Japão, 589-8511
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Kaunas, Lituânia, 50161
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Vilnius, Lituânia, 08406
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Bydgoszcz, Polônia, 85-796
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Gdansk, Polônia, 80-214
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Gliwice, Polônia, 44-102
- Site 97
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Krakow, Polônia, 31-826
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Lodz, Polônia, 93-513
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Poznan, Polônia, 60-185
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Warsaw, Polônia, 02-781
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Coimbra, Portugal, 3004-561
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Lisbon, Portugal, 1998-018
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Porto, Portugal, 4200-072
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Cambridge, Reino Unido, CB2 0QQ
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Cardiff, Reino Unido, CF14 2TL
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Glasgow, Reino Unido, G12 0YN
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Liverpool, Reino Unido, L7 8YA
- Site 44
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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
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Bellinzona, Suíça, CH-6500
- Site 184
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Geneva, Suíça, 1211
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Lausanne, Suíça, 1011
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Sankt Gallen, Suíça, 9007
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Kaohsiung City, Taiwan, 807
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Kaohsiung City, Taiwan, 833
- Site 95
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Taichung, Taiwan, 40447
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Tainan, Taiwan, 70428
- Site 176
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Taipei, Taiwan, 112
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Taoyuan City, Taiwan, 333
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Olomouc, Tcheca, 779 00
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: Escolha do Investigador
|
Cetuximab Methotrexate Docetaxel |
|
Experimental: MCLA-158
|
MCLA-158 |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Overall Survival (OS)
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
- Diretor de estudo: Study Official, Genmab
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- MCLA-158-CL02
- 2023-510322-32-00 (Ctis)
- 2023 (Concessão/Contrato do NIH dos EUA)
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
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