Studie přípravku V940/Placebo + Pembrolizumab a chemoterapie u metastatického dlaždicobuněčného nemalobuněčného karcinomu plic (V940-013) (INTerpath-13)
Fáze 2, randomizovaná, dvojitě zaslepená, placebem kontrolovaná studie přípravku V940 v kombinaci s pembrolizumabem a chemoterapií jako léčba první volby u pacientů s metastazujícím dlaždicobuněčným NSCLC (INTerpath-013)
Researchers want to know if intismeran autogene (the study treatment) given with pembrolizumab and chemotherapy can treat metastatic treatment-naive squamous non-small cell lung cancer (NSCLC). Intismeran autogene is designed to help a person's immune system attack their specific cancer.
The goal of this study is to learn if people who receive intismeran autogene with pembrolizumab and chemotherapy live longer overall and without the cancer growing or spreading compared to people who receive placebo with pembrolizumab and chemotherapy. A placebo looks like the study treatment but has no study treatment in it. Using a placebo helps researchers better understand the effects of the study treatment.
Přehled studie
Postavení
Typ studie
Zápis (Odhadovaný)
Fáze
- Fáze 2
Kontakty a umístění
Studijní kontakt
- Jméno: Toll Free Number
- Telefonní číslo: 1-888-577-8839
- E-mail: Trialsites@msd.com
Studijní místa
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Buenos Aires
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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1426ANZ
- Nábor
- Instituto Alexander Fleming ( Site 0201)
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Kontakt:
- Study Coordinator
- Telefonní číslo: +541132218956
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Ciudad Autonoma de Buenos Aires., Buenos Aires, Argentina, C1199ABB
- Nábor
- Hospital Italiano de Buenos Aires ( Site 0200)
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Kontakt:
- Study Coordinator
- Telefonní číslo: +541149590497
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Mar del Plata, Buenos Aires, Argentina, B7600FZO
- Nábor
- Instituto de Investigaciones Clínicas Mar del Plata ( Site 0205)
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Kontakt:
- Study Coordinator
- Telefonní číslo: +5492235937663
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Buenos Aires F.D.
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Caba., Buenos Aires F.D., Argentina, C1430EGF
- Nábor
- Clinica Adventista Belgrano ( Site 0206)
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Kontakt:
- Study Coordinator
- Telefonní číslo: +5491140141500
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Santa Fe Province
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Rosario, Santa Fe Province, Argentina, S2000DSV
- Nábor
- Fundacion Estudios Clinicos ( Site 0207)
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Kontakt:
- Study Coordinator
- Telefonní číslo: +5493413168137
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Rosario, Santa Fe Province, Argentina, S2000DSV
- Nábor
- Sanatorio Parque ( Site 0203)
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Kontakt:
- Study Coordinator
- Telefonní číslo: +543874044942
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New South Wales
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Westmead, New South Wales, Austrálie, 2145
- Nábor
- Westmead Hospital ( Site 0400)
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Kontakt:
- Study Coordinator
- Telefonní číslo: +61298455555
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Queensland
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Woolloongabba, Queensland, Austrálie, 4102
- Nábor
- Princess Alexandra Hospital ( Site 0403)
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Kontakt:
- Study Coordinator
- Telefonní číslo: +61731762111
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Western Australia
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Nedlands, Western Australia, Austrálie, 6009
- Nábor
- One Clinical Research ( Site 0402)
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Kontakt:
- Study Coordinator
- Telefonní číslo: +6186279 9466
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Antofagasta, Chile, 1263521
- Nábor
- Bradford Hill Norte ( Site 0308)
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Kontakt:
- Study Coordinator
- Telefonní číslo: 56442023631
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Region M. de Santiago
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Santiago, Region M. de Santiago, Chile, 7500653
- Nábor
- Centro de Estudios Clínicos SAGA ( Site 0307)
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Kontakt:
- Study Coordinator
- Telefonní číslo: +56991612199
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Santiago, Region M. de Santiago, Chile, 8420383
- Nábor
- Bradfordhill ( Site 0301)
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Kontakt:
- Study Coordinator
- Telefonní číslo: +56 2 29490970
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Santiago, Region M. de Santiago, Chile, 7500921
- Nábor
- Fundación Arturo López Pérez ( Site 0300)
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Kontakt:
- Study Coordinator
- Telefonní číslo: 56224205098
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Cote-d Or
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Dijon, Cote-d Or, Francie, 21000
- Nábor
- Centre Georges François Leclerc ( Site 0805)
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Kontakt:
- Study Coordinator
- Telefonní číslo: +33345348051
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Pays de la Loire Region
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Angers, Pays de la Loire Region, Francie, 49055
- Nábor
- Institut de Cancérologie de l'Ouest ( Site 0801)
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Kontakt:
- Study Coordinator
- Telefonní číslo: +33 (0)2.44 85 35 54
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Puy-de-Dome
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Clermont-Ferrand, Puy-de-Dome, Francie, 63001
- Nábor
- CHU GABRIEL MONTPIED ( Site 0802)
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Kontakt:
- Study Coordinator
- Telefonní číslo: +33473754440
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Milan, Itálie, 20132
- Nábor
- Ospedale San Raffaele-Oncologia Medica ( Site 1002)
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Kontakt:
- Study Coordinator
- Telefonní číslo: +390226436633
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Milan, Itálie, 20133
- Nábor
- Fondazione IRCCS Istituto Nazionale Dei Tumori ( Site 1000)
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Kontakt:
- Study Coordinator
- Telefonní číslo: +390223903829
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Perugia, Itálie, 06132
- Nábor
- AO Santa Maria della Misericordia-Oncology Department ( Site 1005)
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Kontakt:
- Study Coordinator
- Telefonní číslo: +390755782661
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Roma, Itálie, 00168
- Nábor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1001)
-
Kontakt:
- Study Coordinator
- Telefonní číslo: 00390630154277
-
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Emilia-Romagna
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Ravenna, Emilia-Romagna, Itálie, 48121
- Nábor
- Ospedale Santa Maria delle Croci-Dipartimento Oncoematologico ( Site 1004)
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Kontakt:
- Study Coordinator
- Telefonní číslo: +390544285247
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Seoul, Jižní Korea, 05505
- Nábor
- Asan Medical Center ( Site 0503)
-
Kontakt:
- Study Coordinator
- Telefonní číslo: +82230103215
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Seoul, Jižní Korea, 06351
- Nábor
- Samsung Medical Center ( Site 0502)
-
Kontakt:
- Study Coordinator
- Telefonní číslo: +82234101132
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Kyonggi-do
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Goyang-si, Kyonggi-do, Jižní Korea, 10408
- Nábor
- National Cancer Center ( Site 0504)
-
Kontakt:
- Study Coordinator
- Telefonní číslo: +82319200114
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Seongnam-si, Kyonggi-do, Jižní Korea, 13620
- Nábor
- Seoul National University Bundang Hospital ( Site 0500)
-
Kontakt:
- Study Coordinator
- Telefonní číslo: +82317877071
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North Chungcheong
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Cheongju-si, North Chungcheong, Jižní Korea, 28644
- Nábor
- Chungbuk National University Hospital-Internal medicine ( Site 0501)
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Kontakt:
- Study Coordinator
- Telefonní číslo: 043-269-6015
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Greater Poland Voivodeship
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Poznan, Greater Poland Voivodeship, Polsko, 60-569
- Nábor
- Wielkopolskie Centrum Pulmonologii i Torakochirurgii ( Site 1101)
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Kontakt:
- Study Coordinator
- Telefonní číslo: +48616654242
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Masovian Voivodeship
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Warsaw, Masovian Voivodeship, Polsko, 02-781
- Nábor
- Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Site 1100)
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Kontakt:
- Study Coordinator
- Telefonní číslo: +48225463066
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Podkarpackie Voivodeship
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Przemyśl, Podkarpackie Voivodeship, Polsko, 37-700
- Nábor
- Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1102)
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Kontakt:
- Study Coordinator
- Telefonní číslo: +48166775000
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Florida
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Tampa, Florida, Spojené státy, 33612
- Nábor
- Moffitt Cancer Center ( Site 0021)
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Kontakt:
- Study Coordinator
- Telefonní číslo: 813-745-7363
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Michigan
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Ann Arbor, Michigan, Spojené státy, 48105
- Nábor
- VA Ann Arbor Healthcare System ( Site 0019)
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Kontakt:
- Study Coordinator
- Telefonní číslo: 734-769-7100
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Missouri
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St Louis, Missouri, Spojené státy, 63110
- Nábor
- Washington University School of Medicine ( Site 0024)
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Kontakt:
- Study Coordinator
- Telefonní číslo: 314-362-5000
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New Jersey
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Paramus, New Jersey, Spojené státy, 07652
- Nábor
- Valley Health Systems - Ridgewood Campus ( Site 0010)
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Kontakt:
- Study Coordinator
- Telefonní číslo: 201-634-5578
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New York
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Albany, New York, Spojené státy, 12206
- Nábor
- New York Oncology Hematology (NYOH) - Albany Medical Center ( Site 9001)
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Kontakt:
- Study Coordinator
- Telefonní číslo: 518-489-0044
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Ohio
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Cleveland, Ohio, Spojené státy, 44195
- Nábor
- Cleveland Clinic - Ohio ( Site 0016)
-
Kontakt:
- Study Coordinator
- Telefonní číslo: 216-445-7855
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Oregon
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Corvallis, Oregon, Spojené státy, 97330
- Nábor
- Good Samaritan Regional Medical Center-Samaritan Pastega Regional Cancer Center ( Site 0025)
-
Kontakt:
- Study Coordinator
- Telefonní číslo: 541-768-4950
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Tennessee
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Nashville, Tennessee, Spojené státy, 37203
- Nábor
- Tennessee Oncology, PLLC - Elliston Place Plaza Medical Oncology & Hematology ( Site 9000)
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Kontakt:
- Study Coordinator
- Telefonní číslo: 615-961-9469
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Texas
-
Austin, Texas, Spojené státy, 78745
- Nábor
- Texas Oncology - Central/South Texas ( Site 8002)
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Kontakt:
- Study Coordinator
- Telefonní číslo: 512-427-9400
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Virginia
-
Fairfax, Virginia, Spojené státy, 22031
- Nábor
- Virginia Cancer Specialists ( Site 0003)
-
Kontakt:
- Study Coordinator
- Telefonní číslo: 730-280-5390
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Washington
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Seattle, Washington, Spojené státy, 98104
- Nábor
- Swedish Medical Center-Swedish Cancer Institute ( Site 0023)
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Kontakt:
- Study Coordinator
- Telefonní číslo: 855-922-6237
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Taichung, Tchaj-wan, 404
- Nábor
- China Medical University Hospital ( Site 0606)
-
Kontakt:
- Study Coordinator
- Telefonní číslo: +886422052121
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Tainan, Tchaj-wan, 70403
- Nábor
- National Cheng Kung University Hospital ( Site 0601)
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Kontakt:
- Study Coordinator
- Telefonní číslo: +88662353535
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Taipei, Tchaj-wan, 104
- Nábor
- Mackay Memorial Hospital ( Site 0604)
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Kontakt:
- Study Coordinator
- Telefonní číslo: +886225433535
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Taipei, Tchaj-wan, 11217
- Nábor
- Taipei Veterans General Hospital ( Site 0602)
-
Kontakt:
- Study Coordinator
- Telefonní číslo: +88628712121
-
Taipei, Tchaj-wan, 106
- Nábor
- National Taiwan University Cancer Center (NTUCC) ( Site 0600)
-
Kontakt:
- Study Coordinator
- Telefonní číslo: +886223220322
-
Taoyuan, Tchaj-wan, 33305
- Nábor
- Chang Gung Medical Foundation-Linkou Branch ( Site 0605)
-
Kontakt:
- Study Coordinator
- Telefonní číslo: +88633281200
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Ankara, Turecko (Türkiye), 06230
- Nábor
- Hacettepe Universitesi Tıp Fakultesi ( Site 1400)
-
Kontakt:
- Study Coordinator
- Telefonní číslo: +905436067759
-
Ankara, Turecko (Türkiye), 06800
- Nábor
- Ankara Bilkent Şehir Hastanesi ( Site 1402)
-
Kontakt:
- Study Coordinator
- Telefonní číslo: +905384724282
-
Ankara, Turecko (Türkiye), 06520
- Nábor
- Memorial Ankara Hastanesi ( Site 1401)
-
Kontakt:
- Study Coordinator
- Telefonní číslo: +9005321332009
-
Istanbul, Turecko (Türkiye), 34010
- Nábor
- Koç Üniversitesi Hastanesi ( Site 1403)
-
Kontakt:
- Study Coordinator
- Telefonní číslo: +905369410661
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Barcelona, Španělsko, 08035
- Nábor
- Hospital Universitari Vall d''Hebron ( Site 1310)
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Kontakt:
- Study Coordinator
- Telefonní číslo: +34 93 254 3450
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Madrid, Španělsko, 28034
- Nábor
- Hospital Ramon y Cajal ( Site 1314)
-
Kontakt:
- Study Coordinator
- Telefonní číslo: +34 91 336 82 63
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Madrid, Španělsko, 28040
- Nábor
- Hospital Clinico San Carlos... ( Site 1313)
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Kontakt:
- Study Coordinator
- Telefonní číslo: +34 913303000
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Seville, Španělsko, 41009
- Nábor
- Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 1312)
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Kontakt:
- Study Coordinator
- Telefonní číslo: +34 671560092
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Barcelona
-
Hospitalet, Barcelona, Španělsko, 08907
- Nábor
- ICO L Hospitalet ( Site 1311)
-
Kontakt:
- Study Coordinator
- Telefonní číslo: +34 93 260 77 44
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Cadiz
-
Jerez de la Frontera, Cadiz, Španělsko, 11407
- Nábor
- Hospital Jerez de la Frontera-UGC Oncología ( Site 1315)
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Kontakt:
- Study Coordinator
- Telefonní číslo: 956 03 22 44
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
Inclusion Criteria include, but are not limited to:
- Has a histologically or cytologically confirmed diagnosis of squamous non-small cell lung cancer (NSCLC) (Stage IV: M1a, M1b, M1c1, M1c2, AJCC Staging Manual, Version 9). NOTE: Mixed tumors will be characterized by the predominant cell type; however, small cell elements are not permitted.
- Has measurable disease per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by the local site investigator/radiology
- Has provided a tissue sample that is collected either at the time of or after the diagnosis of metastatic disease AND is from a site not previously irradiated
- Adverse events (AEs) due to previous anticancer therapies must have recovered to ≤Grade 1. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy are eligible
- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
- Hepatitis B surface antigen (HBsAg) positive participants are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization
- Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable. NOTE: Participants must have completed curative antiviral therapy at least 4 weeks prior to randomization
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization
- Has a life expectancy of at least 3 months
- Has adequate organ function
Exclusion Criteria:
Exclusion Criteria include, but are not limited to:
- Is HIV-infected with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
- Has received prior treatment with a cancer vaccine, including another personalized cancer vaccine (PCV)
- Has received prior systemic anticancer therapy for their metastatic NSCLC
- Has received prior therapy with an anti-programmed cell death 1 protein (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti-programmed cell death ligand 2 (anti-PD-L2) agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor. NOTE: Prior treatment with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent in the neoadjuvant or adjuvant setting for nonmetastatic NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC
- Has received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids
- Has received radiation therapy to the lung that is >30 gray within 6 months of start of study intervention
- Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed
- Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention
- Has known additional malignancy that is progressing or has required active treatment within the past 3 years
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Has severe hypersensitivity (≥Grade 3) to V940, pembrolizumab, or any of the protocol allowed chemotherapy agents and/or any of their excipients
- Has active autoimmune disease that has required systemic treatment in the past 2 years
- Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- Has active infection requiring systemic therapy
- Has a history of stem cell/solid organ transplant
- Has not adequately recovered from major surgery or has ongoing surgical complications
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Trojnásobný
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Intismeran Autogene + Pembrolizumab + Chemo
Induction phase: Participants receive pembrolizumab 400 mg intravenous (IV) infusion on Day 1 of a six week cycle plus a platinum doublet chemotherapy regimen (carboplatin area under the curve (AUC) 6 or 5 mg/mL/min IV infusion every 3 weeks (Q3W) × 2 doses combined either with paclitaxel 200 or 175 mg/m^2 IV infusion Q3W × 2 doses, OR with nab paclitaxel 100 mg/m^2 IV infusion weekly × 6 doses). Intismeran Autogene 1 mg intramuscular (IM) injection is administered on Days 1 and 22 of Cycle 2 Induction (Q3W) for up to 2 doses. Maintenance phase: Participants receive pembrolizumab 400 mg IV infusion on Day 1 every 6 weeks (Q6W) for up to 15 doses. Intismeran Autogene 1 mg IM injection is administered on Days 1 and 22 (Q3W) for up to 7 doses during maintenance. |
1 mg Intramuscular (IM) Injection
Ostatní jména:
200 mg IV Infusion
Ostatní jména:
Area Under the Curve (AUC) either 6 or 5 (mg/mL/min) IV Infusion 200 or 175 mg/m^2 IV Infusion 100 mg/m^2 IV Infusion |
|
Experimentální: Placebo + Pembrolizumab + Chemo
Induction phase: Participants receive pembrolizumab 400 mg intravenous (IV) infusion on Day 1 of a six week cycle plus a platinum doublet chemotherapy regimen (carboplatin area under the curve (AUC) 6 or 5 mg/mL/min IV infusion every 3 weeks (Q3W) × 2 doses combined either with paclitaxel 200 or 175 mg/m^2 IV infusion Q3W × 2 doses, OR with nab paclitaxel 100 mg/m^2 IV infusion weekly × 6 doses). Placebo intramuscular (IM) injection is administered on Days 1 and 22 of Cycle 2 Induction (Q3W) for up to 2 doses. Maintenance phase: Participants receive pembrolizumab 400 mg IV infusion on Day 1 every 6 weeks (Q6W) for up to 15 doses. Placebo IM injection is administered on Days 1 and 22 (Q3W) for up to 7 doses during maintenance. |
200 mg IV Infusion
Ostatní jména:
Area Under the Curve (AUC) either 6 or 5 (mg/mL/min) IV Infusion 200 or 175 mg/m^2 IV Infusion 100 mg/m^2 IV Infusion Placebo matched to Intismeran Autogene IM injection |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Progression Free Survival (PFS)
Časové okno: Up to ~32 months
|
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1). PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review (BICR) will be presented. |
Up to ~32 months
|
|
Overall Survival (OS)
Časové okno: Up to ~42 months
|
OS, defined as the time from randomization to death due to any cause. OS will be presented. |
Up to ~42 months
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Overall Response Rate (ORR)
Časové okno: Up to ~26 months
|
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experience CR or PR as assessed by BICR will be presented. |
Up to ~26 months
|
|
Duration of Response (DOR)
Časové okno: Up to ~42 months
|
For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by BICR will be presented. |
Up to ~42 months
|
|
Number of Participants who Experience an Adverse Event (AE)
Časové okno: Up to ~42 months
|
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who experience an AE will be presented. |
Up to ~42 months
|
|
Number of Participants who Discontinue Study Intervention Due to an AE
Časové okno: Up to ~24 months
|
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who discontinue study intervention due to an AE will be presented. |
Up to ~24 months
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Ředitel studie: Medical Director, Merck Sharp & Dohme LLC
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- V940-013
- V940-013 (Jiný identifikátor: MSD)
- U1111-1318-2495 (Identifikátor registru: UTN)
- 2025-520902-37-00 (Identifikátor registru: EU CT)
- 2025 (Grant/smlouva NIH USA)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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