En fase 3-studie for å evaluere petosemtamab sammenlignet med investigator's Choice monoterapi hos tidligere behandlede hode- og nakkeplateepitelkarsinompasienter
En fase 3 åpen, randomisert kontrollert studie for å evaluere effekten og sikkerheten til petosemtamab sammenlignet med investigator's Choice monoterapibehandling hos tidligere behandlede pasienter med uhelbredelig, metastatisk/residiverende plateepitelkarsinom i hode og nakke
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.
Studieoversikt
Status
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Fase 3
Kontakter og plasseringer
Studiesteder
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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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Brussels, Belgia, 1200
- Site 56
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Ghent, Belgia, 9000
- Site 92
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Leuven, Belgia, 3000
- Site 72
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Liège, Belgia, 4000
- Site 108
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Namur, Belgia, 5000
- Site 69
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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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Montreal, Canada, H2X 0A9
- Site 172
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Toronto, Canada, 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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Alabama
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Mobile, Alabama, Forente stater, 36608
- Site 160
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Arizona
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Prescott, Arizona, Forente stater, 86301
- Site 102
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Scottsdale, Arizona, Forente stater, 85054
- Site 125
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California
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Duarte, California, Forente stater, 91010
- Site 82
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La Jolla, California, Forente stater, 92037
- Site 25
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Orange, California, Forente stater, 92868
- Site 173
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Palo Alto, California, Forente stater, 94304
- Site 28
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Sacramento, California, Forente stater, 95817
- Site 127
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San Francisco, California, Forente stater, 94158
- Site 46
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Colorado
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Lone Tree, Colorado, Forente stater, 80124
- Site 130
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District of Columbia
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Washington D.C., District of Columbia, Forente stater, 20010
- Site 104
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Florida
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Fort Myers, Florida, Forente stater, 33901
- Site 12
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Jacksonville, Florida, Forente stater, 32224
- Site 123
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Orlando, Florida, Forente stater, 32827
- Site 9
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Tampa, Florida, Forente stater, 33612
- Site 138
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Georgia
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Atlanta, Georgia, Forente stater, 30322
- Site 187
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Illinois
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Chicago, Illinois, Forente stater, 60607
- Site 152
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Chicago, Illinois, Forente stater, 60611
- Site 213
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Chicago, Illinois, Forente stater, 60637
- Site 68
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Indiana
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Indianapolis, Indiana, Forente stater, 46202
- Site 31
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Kentucky
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Louisville, Kentucky, Forente stater, 40202
- Site 8
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Louisiana
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Baton Rouge, Louisiana, Forente stater, 70809
- Site 40
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New Orleans, Louisiana, Forente stater, 70121
- Site 100
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Maryland
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Columbia, Maryland, Forente stater, 21044
- Site 153
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Massachusetts
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Boston, Massachusetts, Forente stater, 02215
- Site 77
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Michigan
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Ann Arbor, Michigan, Forente stater, 48109
- Site 103
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Detroit, Michigan, Forente stater, 48201
- Site 5
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Minnesota
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Maple Grove, Minnesota, Forente stater, 55369
- Site 49
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Rochester, Minnesota, Forente stater, 55905
- Site 124
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Missouri
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St Louis, Missouri, Forente stater, 63110
- Site 18
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New Jersey
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Hackensack, New Jersey, Forente stater, 07601
- Site 86
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New Mexico
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Albuquerque, New Mexico, Forente stater, 87131
- Site 15
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New York
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New York, New York, Forente stater, 10029
- Site 24
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The Bronx, New York, Forente stater, 10461
- Site 214
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North Carolina
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Chapel Hill, North Carolina, Forente stater, 27514
- Site 98
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Durham, North Carolina, Forente stater, 27710
- Site 122
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Ohio
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Cincinnati, Ohio, Forente stater, 45219
- Site 23
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Cleveland, Ohio, Forente stater, 44106
- Site 218
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Cleveland, Ohio, Forente stater, 44195
- Site 87
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Columbus, Ohio, Forente stater, 43210
- Site 32
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Oregon
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Portland, Oregon, Forente stater, 97213
- Site 26
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Pennsylvania
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Bensalem, Pennsylvania, Forente stater, 19020
- Site 151
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Philadelphia, Pennsylvania, Forente stater, 19107
- Site 158
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South Carolina
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Charleston, South Carolina, Forente stater, 29425
- Site 50
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Tennessee
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Chattanooga, Tennessee, Forente stater, 37404
- Site 60
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Memphis, Tennessee, Forente stater, 38103
- Site 54
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Nashville, Tennessee, Forente stater, 37203
- Site 59
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Nashville, Tennessee, Forente stater, 37232
- Site 67
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Texas
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Denison, Texas, Forente stater, 75020
- Site 55
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El Paso, Texas, Forente stater, 79915
- Site 34
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Houston, Texas, Forente stater, 77030
- Site 51
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Houston, Texas, Forente stater, 77030
- Site 7
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Pearland, Texas, Forente stater, 77584
- Site 94
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Utah
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Salt Lake City, Utah, Forente stater, 84112
- Site 4
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Virginia
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Blacksburg, Virginia, Forente stater, 24060
- Site 10
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Charlottesville, Virginia, Forente stater, 22908
- Site 22
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Winchester, Virginia, Forente stater, 22601
- Site 156
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Washington
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Seattle, Washington, Forente stater, 98109
- Site 163
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Spokane, Washington, Forente stater, 99202
- Site 6
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Wisconsin
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Madison, Wisconsin, Forente stater, 53705
- Site 216
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Bordeaux, Frankrike, 33075
- Site 105
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Brest, Frankrike, 29200
- Site 211
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Le Mans, Frankrike, 72000
- Site 162
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Lille, Frankrike, 59000
- Site 149
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Lyon, Frankrike, 69373
- Site 118
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Marseille, Frankrike, 13005
- Site 115
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Montpellier, Frankrike, 34298
- Site 106
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Nice, Frankrike, 06189
- Site 169
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Paris, Frankrike, 75005
- Site 114
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Paris, Frankrike, 75013
- Site 167
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Poitiers, Frankrike, 86000
- Site 136
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Rennes, Frankrike, 35042
- Site 141
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Rouen, Frankrike, 76038
- Site 107
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Toulouse, Frankrike, 31059
- Site 119
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Vandœuvre-lès-Nancy, Frankrike, 54519
- Site 142
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Villejuif, Frankrike, 94800
- Site 113
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Athens, Hellas, 124 62
- Site 91
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Heraklion, Hellas, 71500
- Site 120
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Thessaloniki, Hellas, 55236
- Site 83
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Haifa, Israel, 3109601
- Site 19
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Jerusalem, Israel, 9112001
- Site 1
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Ramat Gan, Israel, 5265601
- Site 14
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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, Japan, 104-0045
- Site 132
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Fukuoka, Japan, 812-8582
- Site 192
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Kashiwa, Japan, 277-8577
- Site 131
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Miki, Japan, 761-0793
- Site 135
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Nagoya, Japan, 464-8681
- Site 139
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Natori, Japan, 981-1293
- Site 186
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Sendai, Japan, 980-8574
- Site 134
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Ōsaka-sayama, Japan, 589-8511
- Site 133
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Kaunas, Litauen, 50161
- Site 180
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Vilnius, Litauen, 08406
- Site 181
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Amsterdam, Nederland, 1066 CX
- Site 76
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Nijmegen, Nederland, 6525 GA
- Site 61
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Utrecht, Nederland, 3584 CX
- Site 66
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Bydgoszcz, Polen, 85-796
- Site 190
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Gdansk, Polen, 80-214
- Site 143
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Gliwice, Polen, 44-102
- Site 97
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Krakow, Polen, 31-826
- Site 177
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Lodz, Polen, 93-513
- Site 200
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Poznan, Polen, 60-185
- Site 117
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Warsaw, Polen, 02-781
- Site 179
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Coimbra, Portugal, 3004-561
- Site 182
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Lisbon, Portugal, 1998-018
- Site 183
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Porto, Portugal, 4200-072
- Site 185
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Barcelona, Spania, 08035
- Site 78
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Madrid, Spania, 28040
- Site 109
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Madrid, Spania, 28040
- Site 75
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Madrid, Spania, 28041
- Site 71
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Madrid, Spania, 28050
- Site 166
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Pamplona, Spania, 31008
- Site 63
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Pamplona, Spania, 31008
- Site 64
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Valencia, Spania, 46009
- Site 74
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Cambridge, Storbritannia, CB2 0QQ
- Site 65
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Cardiff, Storbritannia, CF14 2TL
- Site 174
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Glasgow, Storbritannia, G12 0YN
- Site 171
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Liverpool, Storbritannia, L7 8YA
- Site 44
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London, Storbritannia, E20 1JQ
- Site 157
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London, Storbritannia, EC1A 7BE
- Site 140
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London, Storbritannia, SE1 9RT
- Site 90
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London, Storbritannia, SW3 6JJ
- Site 42
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Manchester, Storbritannia, M20 4BX
- Site 48
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Middlesex, Storbritannia, HA6 2RN
- Site 70
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Newcastle upon Tyne, Storbritannia, NE7 7DN
- Site 191
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Sutton, Storbritannia, SM2 5PT
- Site 43
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Bellinzona, Sveits, CH-6500
- Site 184
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Geneva, Sveits, 1211
- Site 189
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Lausanne, Sveits, 1011
- Site 194
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Sankt Gallen, Sveits, 9007
- Site 178
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Busan, Sør -Korea, 48108
- Site 161
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Goyang-si, Sør -Korea, 10408
- Site 13
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Hwasun, Sør -Korea, 58128
- Site 29
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Seoul, Sør -Korea, 03080
- Site 137
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Seoul, Sør -Korea, 05505
- Site 36
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Seoul, Sør -Korea, 06351
- Site 47
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Soeul, Sør -Korea, 03722
- Site 33
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Suwon, Sør -Korea, 16499
- Site 164
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Kaohsiung City, Taiwan, 807
- Site 17
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Kaohsiung City, Taiwan, 833
- Site 95
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Taichung, Taiwan, 40447
- Site 53
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Tainan, Taiwan, 70428
- Site 176
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Taipei, Taiwan, 112
- Site 35
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Taoyuan City, Taiwan, 333
- Site 52
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Olomouc, Tsjekkia, 779 00
- Site 201
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Berlin, Tyskland, 12203
- Site 121
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Dresden, Tyskland, 01307
- Site 210
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Essen, Tyskland, 45147
- Site 165
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Giessen, Tyskland, 35390
- Site 84
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Greifswald, Tyskland, 17475
- Site 62
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Hanover, Tyskland, 30625
- Site 112
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Leipzig, Tyskland, 04103
- Site 116
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München, Tyskland, 81675
- Site 168
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Würzburg, Tyskland, 97080
- Site 99
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Nyíregyháza, Ungarn, 4400
- Site 204
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Pécs, Ungarn, 7624
- Site 195
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Szeged, Ungarn, 6725
- Site 198
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Etterforskerens valg
|
Cetuximab Methotrexate Docetaxel |
|
Eksperimentell: MCLA-158
|
MCLA-158 |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall Survival (OS)
Tidsramme: Up to approximately 3 years
|
OS was defined as the time from randomization to death due to any cause. |
Up to approximately 3 years
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Up to first 6 cycles
|
Clearance of plasma and central volume of distribution based on population PK model |
Up to first 6 cycles
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Study Official, Genmab
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- MCLA-158-CL02
- 2023-510322-32-00 (Ctis)
- 2023 (U.S. NIH-stipend/kontrakt)
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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