En global studie av Volrustomig (MEDI5752) för deltagare med icke-resekterade lokalt avancerade skivepitelcancer i huvud och nacke efter definitiv samtidig kemoradioterapi (eVOLVE-HNSCC)
29 september 2026 uppdaterad av: AstraZeneca
En fas III, randomiserad, öppen, multicenter, global studie av Volrustomig (MEDI5752) som sekventiell terapi kontra observation hos deltagare med icke-resekterad lokalt avancerad skivepitelcancer i huvud och hals, som inte har utvecklats efter definitiv samtidig kemoradioterapi (eVOLVE- HNSCC)
The main purpose of this study is to assess the efficacy and safety of volrustomig compared to observation in participants with unresected locally advanced head and neck squamous cell carcinoma (LA-HNSCC) who have not progressed after receiving definitive concurrent chemoradiotherapy (cCRT).
Studieöversikt
Status
Rekrytering
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
1145
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: AstraZeneca Clinical Study Information Center
- Telefonnummer: 1-877-240-9479
- E-post: information.center@astrazeneca.com
Studieorter
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Charleroi, Belgien, 6060
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Edegem, Belgien, 2650
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Jette, Belgien, 1090
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La Louvière, Belgien, 7100
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Namur, Belgien, 5000
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Barretos, Brasilien, 14784-400
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Florianópolis, Brasilien, 88034-000
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Fortaleza, Brasilien, 60336-045
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Ijuí, Brasilien, 98700-000
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Ipatinga, Brasilien, 35162-189
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Londrina, Brasilien, 86015-520
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Natal, Brasilien, 59075-740
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Porto Alegre, Brasilien, 91350200
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Ribeirão Preto, Brasilien, 14051-140
- Upphängd
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Rio de Janeiro, Brasilien, 20231-050
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São Paulo, Brasilien, 04538-132
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São Paulo, Brasilien, 01509-900
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Teresina, Brasilien, 64049-200
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Cebu City, Filippinerna, 6000
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General Santos, Filippinerna, 9500
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Iloilo City, Filippinerna, 5000
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Manila, Filippinerna, 1008
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Pasig, Filippinerna, 1605
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Quezon City, Filippinerna, 1112
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West San Juan City, Filippinerna, 1502
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Avignon, Frankrike, 84918
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Bordeaux, Frankrike, 33075
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Le Mans, Frankrike, 72000
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Lyon, Frankrike, 69373
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Nice, Frankrike, 06100
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Saint-Herblain, Frankrike, 44805
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Toulouse, Frankrike, 31059
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Villejuif, Frankrike, 94805
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Alabama
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Birmingham, Alabama, Förenta staterna, 35233
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Arizona
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Phoenix, Arizona, Förenta staterna, 85028
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Prescott Valley, Arizona, Förenta staterna, 86314
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Arkansas
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Springdale, Arkansas, Förenta staterna, 72762
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California
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Fountain Valley, California, Förenta staterna, 92708
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Fullerton, California, Förenta staterna, 92835
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Los Angeles, California, Förenta staterna, 90024
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Orange, California, Förenta staterna, 92868
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Santa Rosa, California, Förenta staterna, 95403
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Whittier, California, Förenta staterna, 90602
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Colorado
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Aurora, Colorado, Förenta staterna, 80045
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Colorado Springs, Colorado, Förenta staterna, 80909
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Lone Tree, Colorado, Förenta staterna, 80124
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District of Columbia
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Washington D.C., District of Columbia, Förenta staterna, 20037
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Florida
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Fort Myers, Florida, Förenta staterna, 33901
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Gainesville, Florida, Förenta staterna, 32610
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Miami, Florida, Förenta staterna, 33125
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Palm Bay, Florida, Förenta staterna, 32909
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West Palm Beach, Florida, Förenta staterna, 33401
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Illinois
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Niles, Illinois, Förenta staterna, 60714
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Iowa
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Des Moines, Iowa, Förenta staterna, 50309
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Kansas
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Kansas City, Kansas, Förenta staterna, 66160
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Kentucky
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Louisville, Kentucky, Förenta staterna, 40202
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Louisiana
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Baton Rouge, Louisiana, Förenta staterna, 70817
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Shreveport, Louisiana, Förenta staterna, 71101
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Maryland
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Baltimore, Maryland, Förenta staterna, 21231
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Bethesda, Maryland, Förenta staterna, 20817
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Hyattsville, Maryland, Förenta staterna, 20782
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Towson, Maryland, Förenta staterna, 21204
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Upper Marlboro, Maryland, Förenta staterna, 20774
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Massachusetts
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Boston, Massachusetts, Förenta staterna, 02215
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Fairhaven, Massachusetts, Förenta staterna, 02719
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Michigan
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Ann Arbor, Michigan, Förenta staterna, 48105
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Ann Arbor, Michigan, Förenta staterna, 48109
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Minnesota
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Minneapolis, Minnesota, Förenta staterna, 55417
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Missouri
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Columbia, Missouri, Förenta staterna, 65211
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St Louis, Missouri, Förenta staterna, 63110
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St Louis, Missouri, Förenta staterna, 63110
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New Jersey
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East Brunswick, New Jersey, Förenta staterna, 08816
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Hackensack, New Jersey, Förenta staterna, 07601
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New Brunswick, New Jersey, Förenta staterna, 08901
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New Mexico
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Albuquerque, New Mexico, Förenta staterna, 87108
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New York
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New York, New York, Förenta staterna, 10065
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New York, New York, Förenta staterna, 10075
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Stony Brook, New York, Förenta staterna, 11794
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North Carolina
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Charlotte, North Carolina, Förenta staterna, 28204
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Winston-Salem, North Carolina, Förenta staterna, 27157
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Ohio
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Cleveland, Ohio, Förenta staterna, 44106
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Oregon
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Portland, Oregon, Förenta staterna, 97213
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Portland, Oregon, Förenta staterna, 97239
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Pennsylvania
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Philadelphia, Pennsylvania, Förenta staterna, 19107
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Pittsburgh, Pennsylvania, Förenta staterna, 15261
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York, Pennsylvania, Förenta staterna, 17403
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South Dakota
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Sioux Falls, South Dakota, Förenta staterna, 57105
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Sioux Falls, South Dakota, Förenta staterna, 57104
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Tennessee
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Nashville, Tennessee, Förenta staterna, 37212
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Texas
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Austin, Texas, Förenta staterna, 78745
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Dallas, Texas, Förenta staterna, 75251
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Flower Mound, Texas, Förenta staterna, 75028
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Houston, Texas, Förenta staterna, 77030
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Odessa, Texas, Förenta staterna, 79761
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Tyler, Texas, Förenta staterna, 75702
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Utah
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Salt Lake City, Utah, Förenta staterna, 84112
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West Jordan, Utah, Förenta staterna, 84088
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Virginia
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Fairfax, Virginia, Förenta staterna, 22031
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Norfolk, Virginia, Förenta staterna, 23502
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Richmond, Virginia, Förenta staterna, 23230
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Washington
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Spokane, Washington, Förenta staterna, 99204
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Tacoma, Washington, Förenta staterna, 98405
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Tacoma, Washington, Förenta staterna, 98415
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Bengaluru, Indien, 560027
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Hyderabad, Indien, 500032
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Jaipur, Indien, 302022
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Kanpur, Indien, 208005
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Kochi, Indien, 682027
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Kolkata, Indien, 700099
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Lucknow, Indien, 226003
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Madurai, Indien, 625107
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Mohali, Indien, 160055
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Nashik, Indien, 422002
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New Delhi, Indien, 110076
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Thiruvananthapuram, Indien, 695011
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Vadodara, Indien, 391760
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Varanasi, Indien, 221005
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Aviano, Italien, 33081
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Florence, Italien, 50139
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Milan, Italien, 20133
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Modena, Italien, 41124
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Naples, Italien, 80131
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Padova, Italien, 35128
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Pavia, Italien, 27100
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Rozzano, Italien, 20089
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Bunkyō City, Japan, 113-8431
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Bunkyō City, Japan, 113-8519
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Chiba, Japan, 260-8717
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Chiba, Japan, 260-8677
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Chūōku, Japan, 104-0045
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Fukuoka, Japan, 811-1395
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Hidaka-shi, Japan, 350-1298
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Hiroshima, Japan, 734-8551
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Kashiwa, Japan, 277-8577
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Kobe, Japan, 650-0017
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Kyoto, Japan, 606-8507
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Kōtoku, Japan, 135-8550
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Nagoya, Japan, 464-8681
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Nagoya, Japan, 466-8560
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Niigata, Japan, 951-8520
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Okayama, Japan, 700-8558
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Osaka, Japan, 541-8567
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Osakasayama-shi, Japan, 589-8511
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Sagamihara-shi, Japan, 252-0375
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Sapporo, Japan, 060-8638
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Sendai, Japan, 980-8574
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Shinjuku-ku, Japan, 160-0023
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Shiwa-gun, Japan, 028-3695
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Sunto-gun, Japan, 411-8777
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Yokohama, Japan, 241-8515
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Yokohama, Japan, 236-0004
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Regina, Kanada, S4T 7T1
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Alberta
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Calgary, Alberta, Kanada, T2N 5G2
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Edmonton, Alberta, Kanada, T6G 1Z2
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British Columbia
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Kelowna, British Columbia, Kanada, V1Y 5L3
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Ontario
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Kingston, Ontario, Kanada, K7L 2V7
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London, Ontario, Kanada, N6A 5W9
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Toronto, Ontario, Kanada, M4N 3M5
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Quebec
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Chicoutimi, Quebec, Kanada, G7H 5H6
- Har inte rekryterat ännu
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Montreal, Quebec, Kanada, H4A 3J1
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Montreal, Quebec, Kanada, H3T 1E2
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Montreal, Quebec, Kanada, H2X 0C1
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Beijing, Kina, 100210
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Beijing, Kina, 100142
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Bengbu, Kina, 233004
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Changchun, Kina, 130000
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Changsha, Kina, 410008
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Changsha, Kina, 410013
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Chengdu, Kina, 610000
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Chengdu, Kina, 610072
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Chengdu, Kina, 610042
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Chongqing, Kina, 400016
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Chongqing, Kina, 400030
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Dongwan, Kina, 523058
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Fuzhou, Kina, 350014
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Guangzhou, Kina, 510080
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Guangzhou, Kina, 510060
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Guangzhou, Kina, 510095
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Guangzhou, Kina, 510700
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Guiyang, Kina, 550002
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Hangzhou, Kina, 310022
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Harbin, Kina, 150049
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Hefei, Kina, 230001
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Huizhou, Kina, 516001
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Jinan, Kina, 250117
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Kunming, Kina, 650118
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Lanzhou, Kina, 730000
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Nanchang, Kina, 330029
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Nanning, Kina, 530021
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Shanghai, Kina, 20032
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Shenyang, Kina, 110004
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Shijiazhuang, Kina, 050000
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Tianjin, Kina, 300060
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Tianjin, Kina, 300060
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Wuhan, Kina, 430030
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Wuhan, Kina, 430060
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Wuxi, Kina, 214122
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Xi'an, Kina, 710061
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Xiamen, Kina, 361003
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Zhengzhou, Kina, 450008
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Zhuhai, Kina, 519000
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Ürümqi, Kina, 830000
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George Town, Malaysia, 10450
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Johor Bahru, Malaysia, 81100
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Kuala Lumpur, Malaysia, 59100
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Kuala Lumpur, Malaysia, 50586
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Kuala Selangor, Malaysia, 62250
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Kuching, Malaysia, 93586
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Bialystok, Polen, 15-027
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Bielsko-Biala, Polen, 43-300
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Bydgoszcz, Polen, 85-796
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Gliwice, Polen, 44-102
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Olsztyn, Polen, 10-228
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Piotrkow Trybunalski, Polen, 97-300
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Siedlce, Polen, 08-110
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Tomaszów Mazowiecki, Polen, 97-200
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Warsaw, Polen, 02-781
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San Juan, Puerto Rico, 00927
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Badalona, Spanien, 08916
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Barcelona, Spanien, 08035
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Barcelona, Spanien, 08036
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Jaén, Spanien, 23007
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Madrid, Spanien, 28007
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Madrid, Spanien, 28034
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Madrid, Spanien, 28040
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Valencia, Spanien, 46026
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Valencia, Spanien, 46014
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Aberdeen, Storbritannien, AB25 2ZN
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Cambridge, Storbritannien, CB2 0XY
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Hampshire, Storbritannien, SO16 6YD
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Leeds, Storbritannien, LS9 7TF
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London, Storbritannien, EC1A 7BE
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London, Storbritannien, SW3 6JJ
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London, Storbritannien, SE1 9RT
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Manchester, Storbritannien, M20 4BX
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Metropolitan Borough of Wirral, Storbritannien, CH63 4JY
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Northwood, Storbritannien, HA6 2RN
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Sutton, Storbritannien, SM2 5PT
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Taunton, Storbritannien, TA1 5DA
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Goyang-si, Sydkorea, 410-769
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Gyeonggi-do, Sydkorea, 13620
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Incheon, Sydkorea, 21565
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Seoul, Sydkorea, 06351
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Seoul, Sydkorea, 5505
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Seoul, Sydkorea, 3722
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Suwon, Sydkorea, 16247
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Changhua, Taiwan, 500
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Kaohsiung City, Taiwan, 80756
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Kaohsiung City, Taiwan, 833401
- Rekrytering
- Research Site
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Taichung, Taiwan, 40705
- Rekrytering
- Research Site
-
Taichung, Taiwan, 404
- Rekrytering
- Research Site
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Taipei, Taiwan, 10002
- Rekrytering
- Research Site
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Taipei, Taiwan, 11217
- Rekrytering
- Research Site
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Taoyuan, Taiwan, 333
- Rekrytering
- Research Site
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-
-
-
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Bangkok, Thailand, 10300
- Rekrytering
- Research Site
-
Bangkok, Thailand, 10400
- Rekrytering
- Research Site
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Bangkok, Thailand, 10700
- Rekrytering
- Research Site
-
Chaing Mai, Thailand, 50200
- Rekrytering
- Research Site
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Hat Yai, Thailand, 90110
- Rekrytering
- Research Site
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Khon Kaen, Thailand, 40002
- Indragen
- Research Site
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Lampang, Thailand, 52000
- Rekrytering
- Research Site
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Muang, Thailand, 22000
- Rekrytering
- Research Site
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Mueang, Thailand, 20000
- Rekrytering
- Research Site
-
-
-
-
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Ankara, Turkiet (Türkiye), 06230
- Rekrytering
- Research Site
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Ankara, Turkiet (Türkiye), 6200
- Rekrytering
- Research Site
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Antalya, Turkiet (Türkiye), 07059
- Rekrytering
- Research Site
-
Cordaleo, Turkiet (Türkiye), 35575
- Rekrytering
- Research Site
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Eskişehir, Turkiet (Türkiye), 26040
- Rekrytering
- Research Site
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Istanbul, Turkiet (Türkiye), 34722
- Indragen
- Research Site
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Yenimahalle, Turkiet (Türkiye), 06170
- Rekrytering
- Research Site
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Berlin, Tyskland, 12200
- Rekrytering
- Research Site
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Erlangen, Tyskland, 91054
- Rekrytering
- Research Site
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Essen, Tyskland, 45122
- Rekrytering
- Research Site
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Freiburg im Breisgau, Tyskland, 79106
- Rekrytering
- Research Site
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Greifswald, Tyskland, 17475
- Rekrytering
- Research Site
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Hamburg, Tyskland, 20246
- Rekrytering
- Research Site
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Hanover, Tyskland, 30625
- Rekrytering
- Research Site
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Leipzig, Tyskland, 04103
- Rekrytering
- Research Site
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Lübeck, Tyskland, 23538
- Rekrytering
- Research Site
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München, Tyskland, 81675
- Rekrytering
- Research Site
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Rostock, Tyskland, 18059
- Rekrytering
- Research Site
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Tübingen, Tyskland, 72076
- Rekrytering
- Research Site
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Ulm, Tyskland, 89075
- Rekrytering
- Research Site
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Würzburg, Tyskland, 97070
- Rekrytering
- Research Site
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Budapest, Ungern, 1083
- Rekrytering
- Research Site
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Budapest, Ungern, 1122
- Rekrytering
- Research Site
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Budapest, Ungern, 1062
- Rekrytering
- Research Site
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Budapest, Ungern, 1145
- Rekrytering
- Research Site
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Gyula, Ungern, 5700
- Rekrytering
- Research Site
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Győr, Ungern, 9024
- Rekrytering
- Research Site
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Kecskemét, Ungern, 6000
- Rekrytering
- Research Site
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Miskolc, Ungern, 3526
- Rekrytering
- Research Site
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Nyíregyháza, Ungern, 4400
- Rekrytering
- Research Site
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Pécs, Ungern, 7624
- Rekrytering
- Research Site
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Szekszárd, Ungern, 7100
- Rekrytering
- Research Site
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Da Nang, Vietnam, 550000
- Rekrytering
- Research Site
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Hanoi, Vietnam, 100000
- Rekrytering
- Research Site
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Ho Chi Minh City, Vietnam, 700000
- Rekrytering
- Research Site
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Huế, Vietnam, 530000
- Rekrytering
- Research Site
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Hà Nội, Vietnam, 100000
- Rekrytering
- Research Site
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Vinh, Vietnam, 460000
- Rekrytering
- Research Site
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-
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Graz, Österrike, 8036
- Rekrytering
- Research Site
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Innsbruck, Österrike, 6020
- Rekrytering
- Research Site
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Linz, Österrike, 4010
- Rekrytering
- Research Site
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Salzburg, Österrike, 5020
- Rekrytering
- Research Site
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Vienna, Österrike, 1080
- Rekrytering
- Research Site
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 130 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Histologically or cytologically documented locally advanced squamous cell carcinoma of the oropharynx, hypopharynx, oral cavity, or larynx with no evidence of metastatic disease (i.e. M0).
- Confirmed unresected Stage III, Stage IVA or IVB according to the eighth edition of the American Joint Committee on Cancer (AJCC) staging manual (tumor, node, metastasis (TNM) staging system).
- Participants will have completed definitive concurrent chemoradiotherapy (cCRT) with curative intent prior to randomization.
Exclusion Criteria:
-
Histologically/cytologically confirmed head and neck cancer of any other primary anatomic location in the head and neck not specified in the inclusion criteria including participants with squamous cell carcinoma of unknown primary or non-squamous histologies (eg, nasopharynx or salivary gland). Participants with >1 primary tumors are not eligible for the study.
-
Participants with any of the following:
- LA-HNSCC that was resected before definitive cCRT
- LA-HNSCC that was treated and is recurrent at the time of screening
-
Participants who have received radiotherapy (RT) alone as definitive local therapy for LA-HNSCC.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Study Arm
Participants in this arm will receive volrustomig. |
volrustomig
Andra namn:
|
|
Inget ingripande: Observation Arm
Patients in this arm will undergo observation. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Progression-Free Survival (PFS) in participants with unresected LA-HNSCC with PD-L1 expressing tumors
Tidsram: Up to approximately 8 years
|
PFS is defined as time from randomization until first objective radiological progression per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR), or death due to any cause (in the absence of progression). The analysis will include all randomized participants with PD-L1 expressing tumors. |
Up to approximately 8 years
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Progression-Free Survival (PFS) in the unresected LA-HNSCC intent-to-treat (ITT) population
Tidsram: Up to approximately 8 years
|
PFS is defined as time from randomization until first objective radiological progression per RECIST 1.1 as assessed by BICR, or death due to any cause (in the absence of progression). The analysis will include all randomized participants. |
Up to approximately 8 years
|
|
Landmark Progression-Free Survival (PFS) Rates
Tidsram: Up to approximately 8 years
|
PFS is defined as time from randomization until first objective radiological progression per RECIST 1.1 as assessed by BICR, or death due to any cause (in the absence of progression). These analyses will include participants with PD-L1 expressing tumors and all randomized participants. |
Up to approximately 8 years
|
|
Overall Survival (OS) in participants with unresected LA-HNSCC with PD-L1 expressing tumors
Tidsram: Up to approximately 8 years
|
Overall survival (OS) is defined as the time from randomization until the date of death due to any cause. The analysis will include all randomized participants with PD-L1 expressing tumors. |
Up to approximately 8 years
|
|
Landmark Overall Survival (OS) Rates
Tidsram: Up to approximately 8 years
|
OS is defined as the time from randomization until the date of death due to any cause. These analyses will include participants with PD-L1 expressing tumors as randomized and all randomized participants. |
Up to approximately 8 years
|
|
Overall Survival (OS) in the unresected LA-HNSCC ITT population
Tidsram: Up to approximately 8 years
|
OS is defined as the time from randomization until the date of death due to any cause. The analysis will include all randomized participants. |
Up to approximately 8 years
|
|
Progression Free Survival 2 (PFS2)
Tidsram: Up to approximately 8 years
|
PFS2 is defined as the time from randomization until the earliest of the progression event (following the initial investigator-assessed progression), after the start of the first subsequent therapy, or death from any cause, whichever occurs first. The date of the second progression will be recorded by the investigator in the eCRF and defined according to local standard clinical practice. These analyses will include participants with PD-L1 expressing tumors as randomized and all randomized participants. |
Up to approximately 8 years
|
|
Presence of Anti-Drug-Antibodies (ADAs) against volrustomig in serum
Tidsram: Up to approximately 8 years
|
To investigate the immunogenicity of volrustomig. |
Up to approximately 8 years
|
|
Participant-reported physical functioning
Tidsram: Up to approximately 8 years
|
Change from baseline of physical functioning as measured by scores on the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v.20 - Physical Function 8c are reported on a T score metric (mean = 50 and SD = 10), with higher scores reflecting better physical functioning. The analysis will include all randomized participants. |
Up to approximately 8 years
|
|
Participant-reported global health status (GHS)/quality of life (QoL)
Tidsram: Up to approximately 8 years
|
Change from baseline of Global Health Status/Quality of Life subscale scores as measured by the European Organization for Research and Treatment of Cancer (EORTC) Item Library 172 are transformed to a 0-100 range; a higher score represents higher quality of life. The analysis will include all randomized participants. |
Up to approximately 8 years
|
|
Percentage of participants with Adverse Events
Tidsram: Up to approximately 8 years
|
Adverse Events as assessed by Common Terminology Criteria for Adverse Events (CTCAE). |
Up to approximately 8 years
|
|
Area under the curve (AUC)
Tidsram: Up to approximately 8 years
|
The concentration of Volrustomig in serum will be determined. Area under the curve is the integral of the concentration-time curve. The AUC reflects the actual body exposure to drug after administration. The AUC is dependent on the rate of elimination of the drug from the body and the dose administered. |
Up to approximately 8 years
|
|
Maximum plasma concentration of the drug (Cmax)
Tidsram: Up to approximately 8 years
|
The concentration of Volrustomig in serum will be determined (Cmax will be derived). |
Up to approximately 8 years
|
|
The time taken to reach the maximum concentration (Tmax)
Tidsram: Up to approximately 8 years
|
The concentration of Volrustomig in serum will be determined (Tmax will be derived). |
Up to approximately 8 years
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studiestol: Robert Haddad, MD, Dana Farber Cancer Institute Massachusetts, USA
- Studiestol: Lisa Licitra, MD, Fondazione IRCCS Istituto Nazionale dei Tumori and University of Milan Milan, Italy
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
14 december 2023
Primärt slutförande (Beräknad)
17 april 2030
Avslutad studie (Beräknad)
28 februari 2031
Studieregistreringsdatum
Först inskickad
3 november 2023
Först inskickad som uppfyllde QC-kriterierna
10 november 2023
Första postat (Faktisk)
13 november 2023
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
30 september 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
29 september 2026
Senast verifierad
1 september 2026
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- D798EC00001
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.
All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Tidsram för IPD-delning
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles.
For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Kriterier för IPD Sharing Access
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool .
Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .