Estudio de Volrustomig en mujeres con cáncer de cuello uterino localmente avanzado de alto riesgo (eVOLVE-Cervical) (eVOLVECervical)
9 de noviembre de 2026 actualizado por: AstraZeneca
Un estudio global de fase III, aleatorizado, doble ciego, controlado con placebo, multicéntrico, de Volrustomig en mujeres con cáncer de cuello uterino localmente avanzado de alto riesgo que no han progresado después de una quimiorradioterapia concurrente basada en platino (eVOLVE-Cervical)
This is a phase III, randomized, double-blind, placebo-controlled, multi-center, global study to explore the efficacy and safety of volrustomig in women with high-risk LACC (FIGO 2018 stage IIIA to IVA cervical cancer) who have not progressed following platinum-based CCRT.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Descripción detallada
Women with locally advanced cervical cancer will be randomized in a 1:1 ratio to receive treatment with Volrustomig or Placebo.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
800
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: AstraZeneca Clinical Study Information Center
- Número de teléfono: 1-877-240-9479
- Correo electrónico: information.center@astrazeneca.com
Ubicaciones de estudio
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Berlin, Alemania, 13353
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Bonn, Alemania, 53127
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Hamburg, Alemania, 20246
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Leipzig, Alemania, 04103
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Barretos, Brasil, 14784-400
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Belo Horizonte, Brasil, 30130-100
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Curitiba, Brasil, 80730-150
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Fortaleza, Brasil, 60430-230
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Fortaleza, Brasil, 60336-045
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Goiânia, Brasil, 74110-060
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Ijuí, Brasil, 98700-000
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Natal, Brasil, 59075-740
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Porto Alegre, Brasil, 90619-900
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Porto Alegre, Brasil, 98850-170
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Porto Alegre, Brasil, 90570-060
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Porto Velho, Brasil, 76834-899
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Recife, Brasil, 52010-075
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Rio de Janeiro, Brasil, 20220-410
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Salvador, Brasil, 40050 410
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São Paulo, Brasil, 01246-000
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São Paulo, Brasil, 1323001
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São Paulo, Brasil, 01323-000
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Teresina, Brasil, 64049-200
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Ontario
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Hamilton, Ontario, Canadá, L8V 1C3
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London, Ontario, Canadá, N6A 5W9
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Toronto, Ontario, Canadá, M4N 3M5
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Toronto, Ontario, Canadá, M5G 2M9
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Quebec
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Montreal, Quebec, Canadá, H3G 1A4
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Montreal, Quebec, Canadá, H2X 0C1
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Ste-Foy, Quebec, Canadá, G1V 4G2
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Daegu, Corea del Sur, 42601
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Goyang-si, Corea del Sur, 10408
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Gyeonggi-do, Corea del Sur, 13605
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Seoul, Corea del Sur, 03080
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Seoul, Corea del Sur, 06351
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Seoul, Corea del Sur, 5505
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Seoul, Corea del Sur, 03722
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Aarhus N, Dinamarca, 8200
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København Ø, Dinamarca, 2100
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Odense, Dinamarca, 5000
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A Coruña, España, 15009
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Barcelona, España, 08036
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Barcelona, España, 8035
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Córdoba, España, 14004
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Girona, España, 17007
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Hospitalet deLlobregat, España, 08907
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Madrid, España, 28034
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Madrid, España, 28040
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Madrid, España, 28041
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Madrid, España, 28046
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Palma de Mallorca, España, 07010
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Valencia, España, 46010
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Valencia, España, 46009
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Alabama
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Birmingham, Alabama, Estados Unidos, 35233
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Arizona
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Phoenix, Arizona, Estados Unidos, 85016
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Tucson, Arizona, Estados Unidos, 85711
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Arkansas
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Little Rock, Arkansas, Estados Unidos, 72205
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California
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La Jolla, California, Estados Unidos, 92093
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West Hollywood, California, Estados Unidos, 90048
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Georgia
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Atlanta, Georgia, Estados Unidos, 30322
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Augusta, Georgia, Estados Unidos, 30912
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Savannah, Georgia, Estados Unidos, 31405
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Illinois
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Melrose Park, Illinois, Estados Unidos, 60160
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46202
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Louisiana
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New Orleans, Louisiana, Estados Unidos, 70112
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New Orleans, Louisiana, Estados Unidos, 70121
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Shreveport, Louisiana, Estados Unidos, 71103
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New York
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New York, New York, Estados Unidos, 10016
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Syracuse, New York, Estados Unidos, 13210
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Ohio
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Cleveland, Ohio, Estados Unidos, 44195
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Columbus, Ohio, Estados Unidos, 43210
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Oregon
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Eugene, Oregon, Estados Unidos, 97401
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19107
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Rhode Island
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Providence, Rhode Island, Estados Unidos, 02905
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Texas
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Dallas, Texas, Estados Unidos, 75390
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Fort Worth, Texas, Estados Unidos, 76104
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Houston, Texas, Estados Unidos, 77030
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Tyler, Texas, Estados Unidos, 75702
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Virginia
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Charlottesville, Virginia, Estados Unidos, 22908
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Fairfax, Virginia, Estados Unidos, 22031
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Richmond, Virginia, Estados Unidos, 23298
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Calicut, India, 673601
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Jaipur, India, 302017
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Lucknow, India, 226003
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Madurai, India, 625107
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Mohali, India, 160055
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Nagpur, India, 440001
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Nashik, India, 422009
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Nashik, India, 422011
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New Delhi, India, 110029
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Vadodara, India, 391760
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Bari, Italia, 70124
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Bologna, Italia, 40138
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Catania, Italia, 95126
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Florence, Italia, 50141
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Lecco, Italia, 23900
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Milan, Italia, 20141
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Milan, Italia, 20159
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Milan, Italia, 20133
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Monza, Italia, 20900
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Naples, Italia, 80131
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Roma, Italia, 161
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Rome, Italia, 00168
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Turin, Italia, 10128
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Fukuoka, Japón, 812-8582
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Ginowan-shi, Japón, 901-2725
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Hidaka-shi, Japón, 350-1298
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Kagoshima, Japón, 890-8520
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Kurume-shi, Japón, 830-0011
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Kōtoku, Japón, 135-8550
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Maebashi, Japón, 371-8511
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Matsuyama, Japón, 791-0280
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Morioka, Japón, 028-3695
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Nagoya, Japón, 464-8681
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Osaka, Japón, 541-8567
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Sapporo, Japón, 003-0804
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Sapporo, Japón, 060-8638
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Shinjuku-ku, Japón, 160-8582
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Suita-shi, Japón, 565-0871
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Sunto-gun, Japón, 411-8777
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Toon-Shi, Japón, 791-0295
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Coyoacán, México, 04380
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Culiacán, México, 80040
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Guadalajara, México, 44650
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Guadalajra, México, 44260
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Mexico City, México, 03240
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Monterrey, México, 64460
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México, México, 04700
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México, México, 14080
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Oslo, Noruega, 424
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Trondheim, Noruega, 7030
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Concepción, Perú, 12125
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Lima, Perú, LIMA 29
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Lima, Perú, Lima 34
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Lima, Perú, 15036
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Lima, Perú, 15038
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Lima, Perú, 15102
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Lima, Perú, Lima39
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Bialystok, Polonia, 15-027
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Gdansk, Polonia, 80-214
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Gliwice, Polonia, 44-101
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Krakow, Polonia, 30-348
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Lodz, Polonia, 90-513
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Poznan, Polonia, 61-866
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Warsaw, Polonia, 02-781
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Wroclaw, Polonia, 53-413
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Beijing, Porcelana, 100730
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Beijing, Porcelana, 100142
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Beijing, Porcelana, 100026
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Changde, Porcelana, 415000
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Changsha, Porcelana, 410008
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Changsha, Porcelana, 410013
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Chengdu, Porcelana, 610041
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Chengdu, Porcelana, 610044
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Chongqing, Porcelana, 400030
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Fuzhou, Porcelana, 350014
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Ganzhou, Porcelana, 341000
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Guangzhou, Porcelana, 510060
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Guangzhou, Porcelana, 510120
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Hangzhou, Porcelana, 310022
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Harbin, Porcelana, 150081
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Kunming, Porcelana, 650118
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Lanzhou, Porcelana, 730050
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Lanzhou, Porcelana, 730000
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Linyi, Porcelana, 276001
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Luzhou, Porcelana, 646000
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Nanchang, Porcelana, 330006
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Nanchang, Porcelana, 330029
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Shandong, Porcelana
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Shanghai, Porcelana, 200032
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Shanghai, Porcelana, 200080
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Shenyang, Porcelana, 110004
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Shenzhen, Porcelana, 518036
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Shenzhen, Porcelana, 518116
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Tianjin, Porcelana, 300060
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Wuhan, Porcelana, 430022
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Wuhan, Porcelana, 430030
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Xi'an, Porcelana, 710061
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Yibin, Porcelana, 610500
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Yinchuan, Porcelana, 750004
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Zhengzhou, Porcelana, 450008
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Zhengzhou, Porcelana, 450052
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Zhuzhou, Porcelana, 412007
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San Juan, Puerto Rico, 00927
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Bangkok, Tailandia, 10400
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Bangkok, Tailandia, 10330
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Bangkok, Tailandia, 10700
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Muang, Tailandia, 50200
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Udon Thani, Tailandia, 41330
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Changhua, Taiwán, 50006
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Kaohsiung City, Taiwán, 833
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Kaohsiung City, Taiwán, 81362
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New Taipei City, Taiwán, 220
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Taichung, Taiwán, 40447
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Taichung, Taiwán, 40705
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Tainan, Taiwán, 704
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Taipei, Taiwán, 11217
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Taipei, Taiwán, 10449
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Taoyuan, Taiwán, 333
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Adana, Turquía (Türkiye), 01250
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Ankara, Turquía (Türkiye), 06490
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Ankara, Turquía (Türkiye), 06100
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Cordaleo, Turquía (Türkiye), 35575
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Istanbul, Turquía (Türkiye), 32098
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Istanbul, Turquía (Türkiye), 34214
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
15 años y mayores (Niño, Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Femenino
Descripción
Inclusion Criteria:
For inclusion in the study, patients should fulfill the following criteria:
- Female.
- Aged at least 15 years at the time of screening. Note: Participants < 18 years of age: physical changes should be aligned with Tanner Stage III.
- Body weight > 35 kg.
- Histologically documented FIGO 2018 Stage IIIA to IVA cervical adenocarcinoma, cervical squamous carcinoma, or cervical adenosquamous carcinoma, with no evidence of metastatic disease.
- Initial staging procedures performed no more than 56 days prior to the first dose of CCRT.
- Provision of FFPE tumor sample to assess the PD-L1 expression.
- Must not have progressed following CCRT, participants with persistent disease after definitive CCRT must not be amenable to other available therapies with curative intent.
- WHO/ECOG performance status of 0 or 1; duration of life expectancy of ≥ 12 weeks.
- Adequate organ and bone marrow function.
- Capable of providing signed informed consent.
Exclusion Criteria:
Patients should not enter the study if any of the following exclusion criteria are fulfilled:
- Diagnosis of small cell (neuroendocrine) or mucinous adenocarcinoma of cervical cancer.
- Evidence of metastatic disease.
- Intent to administer a fertility-sparing treatment regimen.
- History of organ transplant or allogenic stem cell transplant.
- History of active primary immunodeficiency or active or prior documented autoimmune or inflammatory disorders.
- Uncontrolled intercurrent illness.
- History of another primary malignancy except for a) Malignancy treated with curative intent with no known active disease ≥2 years before the first dose of study intervention; b) Adequately treated nonmelanoma skin cancer or lentigo maligna, or carcinoma in situ without evidence of disease.
- Unresolved toxicities from previous CCRT except for irreversible toxicity that is not reasonably expected to be exacerbated.
- Prior history or presence of vesicovaginal, colovaginal, or rectovaginal fistula.
- History of anaphylaxis to any biologic therapy or vaccine.
- Current or prior use of immunosuppressive medication within 14 days before the first dose of the study intervention is excluded. The following are exceptions to this criterion: a) Intranasal, inhaled, topical steroids, or local steroid injections (eg, intraarticular injection); b) Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication or chemotherapy premedication) or a single dose for palliative purpose (eg, pain control); c) Physiologic doses of oral corticosteroids, ie, not exceeding 10 mg/day of prednisone (or equivalent) in the preceding 14 days.
- Patients who have undergone a previous hysterectomy, including a supracervical hysterectomy, or will have a hysterectomy as part of their initial cervical cancer therapy.
- Any prior (besides prior CCRT) or concurrent treatment for cervical cancer.
- Major surgical procedures within 4 weeks prior to the first dose of the study intervention or still recovering from prior surgery.
- Exposure to immune mediated therapy prior to the study for any indication.
- Receipt of live attenuated vaccine within 30 days prior to the first dose of the study intervention.
- Participants with a known allergy or hypersensitivity to the study intervention, or any excipients of the study intervention.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador de placebos: Placebo
Placebo |
IV Infusion
Otros nombres:
|
|
Experimental: Volrustomig
Volrustomig |
IV Infusion |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Progression-free Survival (PFS) based on the investigator assessment in all randomized participants (FAS)
Periodo de tiempo: Up to approximately 7 years
|
PFS is defined as the time from date of randomization until RECIST 1.1- defined radiological progression or histopathologically confirmed progression as assessed by the Investigator or death due to any cause, whichever occurs earlier. |
Up to approximately 7 years
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Overall Survival (OS) in all randomized participants
Periodo de tiempo: Up to approximately 7 years
|
OS defined as time from randomization until the date of death due to any cause. |
Up to approximately 7 years
|
|
Objective Response Rate (ORR) in all randomized participants
Periodo de tiempo: Up to approximately 7 years
|
ORR is defined as the proportion of participants who have a CR or PR, as determined by Investigator per RECIST 1.1 |
Up to approximately 7 years
|
|
Duration of Response (DoR) in all randomized participants
Periodo de tiempo: Up to approximately 7 years
|
DoR in participants with a CR or PR: Time from date of first detection of CR or PR until the date of RECIST 1.1-defined radiological progression or histopathologically confirmed progression. |
Up to approximately 7 years
|
|
Time to First Subsequent Therapy or death (TFST) in all randomized participants
Periodo de tiempo: Up to approximately 7 years
|
TFST: The time from randomization until the start date of the first subsequent anti-cancer therapy after discontinuation of randomized treatment, or death due to any cause. |
Up to approximately 7 years
|
|
Time to second progression or death (PFS2) in all randomized participants
Periodo de tiempo: Up to approximately 7 years
|
PFS2: The time from randomization to the earliest of the progression event (following the initial Investigator-assessed progression), after first subsequent therapy, or death. The date of second progression will be recorded by the Investigator in the eCRF and defined according to local standard clinical practice. |
Up to approximately 7 years
|
|
PFS by BICR in all randomized participants
Periodo de tiempo: Up to approximately 7 years
|
Endpoints based on the PFS by BICR assessment according to RECIST 1.1. |
Up to approximately 7 years
|
|
The incidence of local progression, and distant disease progression as the first documented progression event in all randomized participants
Periodo de tiempo: Up to approximately 7 years
|
Incidence of Local Progression, and Distant Disease Progression: Number and percentage of participants who develop local progression, distant disease recurrence. |
Up to approximately 7 years
|
|
PK of volrustomig
Periodo de tiempo: Up to approximately 7 years
|
Concentration of volrustomig in serum and PK parameters as data allow. |
Up to approximately 7 years
|
|
The immunogenicity of volrustomig
Periodo de tiempo: Up to approximately 7 years
|
Incidence of ADAs against volrustomig in serum. |
Up to approximately 7 years
|
|
Incidence of adverse events of volrustomig compared to placebo
Periodo de tiempo: Up to approximately 7 years
|
An AE is defined as the development of any untoward medical occurrence (other than progression of the malignancy under evaluation) in a patient or clinical study participant administered a medicinal product, and which does not necessarily have a causal relationship with this treatment. |
Up to approximately 7 years
|
|
Participant-reported disease-related symptoms
Periodo de tiempo: Up to approximately 7 years
|
Change from baseline as measured by the European Organization for Research and Treatment of Cancer IL318 (EORTC IL318, Symptom Experience subscale of the EORTC Quality of Life Questionnaire Symptom Specific Scale for Cervical Cancer (EORTC QLQ-CX24)). The score of scale for EORTC IL318 is from 1-4. |
Up to approximately 7 years
|
|
Participant-reported physical functioning
Periodo de tiempo: Up to approximately 7 years
|
Change from baseline of physical functioning as measured by the Patient Reported Outcomes Measurement Information System - Short Form - Physical Functioning 8c (PROMIS SF-PF 8c). The score of scale for PROMIS SF-PF 8c is from 1-5. |
Up to approximately 7 years
|
|
Participant-reported global health status/Quality of Life
Periodo de tiempo: Up to approximately 7 years
|
Change from baseline of Global Health Status/ Quality of Life (GHS/QoL) as measured by the European Organization for Research and Treatment of Cancer IL172 (EORTC IL172). The score of scale for EORTC IL172 is from 1-7. |
Up to approximately 7 years
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
22 de septiembre de 2023
Finalización primaria (Estimado)
26 de noviembre de 2027
Finalización del estudio (Estimado)
30 de septiembre de 2030
Fechas de registro del estudio
Enviado por primera vez
4 de septiembre de 2023
Primero enviado que cumplió con los criterios de control de calidad
6 de octubre de 2023
Publicado por primera vez (Actual)
12 de octubre de 2023
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
10 de noviembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
9 de noviembre de 2026
Última verificación
1 de noviembre de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- D7984C00002
- GOG-3092 (Otro identificador: Gynecologic Oncology Group Foundation)
- ENGOT-cx19/GEICO (Otro identificador: European Network for Gynaecological Oncological Trial groups)
- 165663 (Identificador de registro: FDA-IND)
- 2023-504374-38-00 (Otro identificador: EU CT)
- 2023 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Marco de tiempo para compartir IPD
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Criterios de acceso compartido de IPD
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Sí
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. .