Vaiheen 3 tutkimus petosemtamabin arvioimiseksi verrattuna tutkijan valitsemaan monoterapiaan aiemmin hoidetuilla pään ja kaulan okasolusyöpäpotilailla
Vaiheen 3 avoin, satunnaistettu kontrolloitu tutkimus petosemtamabin tehon ja turvallisuuden arvioimiseksi verrattuna tutkijan valitsemaan monoterapiaan aiemmin hoidetuilla potilailla, joilla on parantumaton, metastasoitunut/toistuva pään ja kaulan okasolusyöpä
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.
Tutkimuksen yleiskatsaus
Tila
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Vaihe 3
Yhteystiedot ja paikat
Opiskelupaikat
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Amsterdam, Alankomaat, 1066 CX
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Nijmegen, Alankomaat, 6525 GA
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Utrecht, Alankomaat, 3584 CX
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Caba, Argentiina, C1280AEB
- Site 58
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Córdoba, Argentiina, X5008HHW
- Site 45
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Rosario, Argentiina, S2000KZE
- Site 110
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Viedma, Argentiina, 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, Brasilia, 70390-140
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Porto Alegre, Brasilia, 90110-270
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Porto Alegre, Brasilia, 90610-000
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Recife, Brasilia, 50040-000
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Rio de Janeiro, Brasilia, 22281-100
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São Paulo, Brasilia, 01509-900
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São Paulo, Brasilia, 04538-132
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Providencia, Chile, 7500859
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Recoleta, Chile, 8420000
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Santiago, Chile, 7500921
- Site 27
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Santiago, Chile, 7560908
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Barcelona, Espanja, 08035
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Madrid, Espanja, 28040
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Madrid, Espanja, 28040
- Site 75
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Madrid, Espanja, 28041
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Madrid, Espanja, 28050
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Pamplona, Espanja, 31008
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Pamplona, Espanja, 31008
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Valencia, Espanja, 46009
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Busan, Etelä -Korea, 48108
- Site 161
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Goyang-si, Etelä -Korea, 10408
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Hwasun, Etelä -Korea, 58128
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Seoul, Etelä -Korea, 03080
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Seoul, Etelä -Korea, 05505
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Seoul, Etelä -Korea, 06351
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Soeul, Etelä -Korea, 03722
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Suwon, Etelä -Korea, 16499
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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, Italia, 25123
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Cuneo, Italia, 12100
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Milan, Italia, 20133
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Milan, Italia, 20141
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Naples, Italia, 80131
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Naples, Italia, 80131
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Roma, Italia, 00161
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Rozzano, Italia, 20089
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Chūōku, Japani, 104-0045
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Fukuoka, Japani, 812-8582
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Kashiwa, Japani, 277-8577
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Miki, Japani, 761-0793
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Nagoya, Japani, 464-8681
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Natori, Japani, 981-1293
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Sendai, Japani, 980-8574
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Ōsaka-sayama, Japani, 589-8511
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Montreal, Kanada, H2X 0A9
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Toronto, Kanada, M4N 3M5
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Athens, Kreikka, 124 62
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Heraklion, Kreikka, 71500
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Thessaloniki, Kreikka, 55236
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Kaunas, Liettua, 50161
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Vilnius, Liettua, 08406
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Coimbra, Portugali, 3004-561
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Lisbon, Portugali, 1998-018
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Porto, Portugali, 4200-072
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Bydgoszcz, Puola, 85-796
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Gdansk, Puola, 80-214
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Gliwice, Puola, 44-102
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Krakow, Puola, 31-826
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Lodz, Puola, 93-513
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Poznan, Puola, 60-185
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Warsaw, Puola, 02-781
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Bordeaux, Ranska, 33075
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Brest, Ranska, 29200
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Le Mans, Ranska, 72000
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Lille, Ranska, 59000
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Lyon, Ranska, 69373
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Marseille, Ranska, 13005
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Montpellier, Ranska, 34298
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Nice, Ranska, 06189
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Paris, Ranska, 75005
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Paris, Ranska, 75013
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Poitiers, Ranska, 86000
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Rennes, Ranska, 35042
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Rouen, Ranska, 76038
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Toulouse, Ranska, 31059
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Vandœuvre-lès-Nancy, Ranska, 54519
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Villejuif, Ranska, 94800
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Berlin, Saksa, 12203
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Dresden, Saksa, 01307
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Essen, Saksa, 45147
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Giessen, Saksa, 35390
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Greifswald, Saksa, 17475
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Hanover, Saksa, 30625
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Leipzig, Saksa, 04103
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München, Saksa, 81675
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Würzburg, Saksa, 97080
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Bellinzona, Sveitsi, CH-6500
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Geneva, Sveitsi, 1211
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Lausanne, Sveitsi, 1011
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Sankt Gallen, Sveitsi, 9007
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Kaohsiung City, Taiwan, 807
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Kaohsiung City, Taiwan, 833
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Taichung, Taiwan, 40447
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Tainan, Taiwan, 70428
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Taipei, Taiwan, 112
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Taoyuan City, Taiwan, 333
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Olomouc, Tšekki, 779 00
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Nyíregyháza, Unkari, 4400
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Pécs, Unkari, 7624
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Szeged, Unkari, 6725
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Cambridge, Yhdistynyt kuningaskunta, CB2 0QQ
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Cardiff, Yhdistynyt kuningaskunta, CF14 2TL
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Glasgow, Yhdistynyt kuningaskunta, G12 0YN
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Liverpool, Yhdistynyt kuningaskunta, L7 8YA
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London, Yhdistynyt kuningaskunta, E20 1JQ
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London, Yhdistynyt kuningaskunta, EC1A 7BE
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London, Yhdistynyt kuningaskunta, SE1 9RT
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London, Yhdistynyt kuningaskunta, SW3 6JJ
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Manchester, Yhdistynyt kuningaskunta, M20 4BX
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Middlesex, Yhdistynyt kuningaskunta, HA6 2RN
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Newcastle upon Tyne, Yhdistynyt kuningaskunta, NE7 7DN
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Sutton, Yhdistynyt kuningaskunta, SM2 5PT
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Alabama
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Mobile, Alabama, Yhdysvallat, 36608
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Arizona
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Prescott, Arizona, Yhdysvallat, 86301
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Scottsdale, Arizona, Yhdysvallat, 85054
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California
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Duarte, California, Yhdysvallat, 91010
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La Jolla, California, Yhdysvallat, 92037
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Orange, California, Yhdysvallat, 92868
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Palo Alto, California, Yhdysvallat, 94304
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Sacramento, California, Yhdysvallat, 95817
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San Francisco, California, Yhdysvallat, 94158
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Colorado
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Lone Tree, Colorado, Yhdysvallat, 80124
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District of Columbia
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Washington D.C., District of Columbia, Yhdysvallat, 20010
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Florida
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Fort Myers, Florida, Yhdysvallat, 33901
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Jacksonville, Florida, Yhdysvallat, 32224
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Orlando, Florida, Yhdysvallat, 32827
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Tampa, Florida, Yhdysvallat, 33612
- Site 138
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Georgia
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Atlanta, Georgia, Yhdysvallat, 30322
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Illinois
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Chicago, Illinois, Yhdysvallat, 60607
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Chicago, Illinois, Yhdysvallat, 60611
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Chicago, Illinois, Yhdysvallat, 60637
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Indiana
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Indianapolis, Indiana, Yhdysvallat, 46202
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Kentucky
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Louisville, Kentucky, Yhdysvallat, 40202
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Louisiana
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Baton Rouge, Louisiana, Yhdysvallat, 70809
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New Orleans, Louisiana, Yhdysvallat, 70121
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Maryland
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Columbia, Maryland, Yhdysvallat, 21044
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Massachusetts
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Boston, Massachusetts, Yhdysvallat, 02215
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Michigan
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Ann Arbor, Michigan, Yhdysvallat, 48109
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Detroit, Michigan, Yhdysvallat, 48201
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Minnesota
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Maple Grove, Minnesota, Yhdysvallat, 55369
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Rochester, Minnesota, Yhdysvallat, 55905
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Missouri
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St Louis, Missouri, Yhdysvallat, 63110
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New Jersey
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Hackensack, New Jersey, Yhdysvallat, 07601
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New Mexico
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Albuquerque, New Mexico, Yhdysvallat, 87131
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New York
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New York, New York, Yhdysvallat, 10029
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The Bronx, New York, Yhdysvallat, 10461
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North Carolina
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Chapel Hill, North Carolina, Yhdysvallat, 27514
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Durham, North Carolina, Yhdysvallat, 27710
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Ohio
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Cincinnati, Ohio, Yhdysvallat, 45219
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Cleveland, Ohio, Yhdysvallat, 44106
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Cleveland, Ohio, Yhdysvallat, 44195
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Columbus, Ohio, Yhdysvallat, 43210
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Oregon
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Portland, Oregon, Yhdysvallat, 97213
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Pennsylvania
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Bensalem, Pennsylvania, Yhdysvallat, 19020
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Philadelphia, Pennsylvania, Yhdysvallat, 19107
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South Carolina
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Charleston, South Carolina, Yhdysvallat, 29425
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Tennessee
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Chattanooga, Tennessee, Yhdysvallat, 37404
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Memphis, Tennessee, Yhdysvallat, 38103
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Nashville, Tennessee, Yhdysvallat, 37203
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Nashville, Tennessee, Yhdysvallat, 37232
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Texas
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Denison, Texas, Yhdysvallat, 75020
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El Paso, Texas, Yhdysvallat, 79915
- Site 34
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Houston, Texas, Yhdysvallat, 77030
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Houston, Texas, Yhdysvallat, 77030
- Site 7
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Pearland, Texas, Yhdysvallat, 77584
- Site 94
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Utah
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Salt Lake City, Utah, Yhdysvallat, 84112
- Site 4
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Virginia
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Blacksburg, Virginia, Yhdysvallat, 24060
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Charlottesville, Virginia, Yhdysvallat, 22908
- Site 22
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Winchester, Virginia, Yhdysvallat, 22601
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Washington
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Seattle, Washington, Yhdysvallat, 98109
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Spokane, Washington, Yhdysvallat, 99202
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Wisconsin
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Madison, Wisconsin, Yhdysvallat, 53705
- Site 216
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Active Comparator: Tutkijan valinta
|
Cetuximab Methotrexate Docetaxel |
|
Kokeellinen: MCLA-158
|
MCLA-158 |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Overall Survival (OS)
Aikaikkuna: Up to approximately 3 years
|
OS was defined as the time from randomization to death due to any cause. |
Up to approximately 3 years
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: Up to first 6 cycles
|
Clearance of plasma and central volume of distribution based on population PK model |
Up to first 6 cycles
|
Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Opintojohtaja: Study Official, Genmab
Julkaisuja ja hyödyllisiä linkkejä
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- MCLA-158-CL02
- 2023-510322-32-00 (Ctis)
- 2023 (Yhdysvaltain NIH-apuraha/sopimus)
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
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