Tislelizumab i kombination med undersøgelsesmidler hos deltagere med planocellulært karcinom i hoved og hals
Et randomiseret, fase 2, åbent, multi-arm studie af Tislelizumab i kombination med undersøgelsesmidler som førstelinjebehandling hos patienter med tilbagevendende eller metastatisk hoved- og halspladecellecarcinom
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
Denne undersøgelse vil teste, om tislelizumab alene og kombineret med andre undersøgelsesmidler kan bruges til at forbedre behandlingsresultater hos deltagere med planocellulært karcinom i hoved og hals. Hovedformålet med undersøgelsen er at bestemme, hvor mange deltagere der muligvis ikke længere har tegn på kræft eller en vis forbedring i tegn og symptomer på kræft efter behandling og at bestemme, hvilke uønskede hændelser eller bivirkninger, deltagerne kan opleve.
Tislelizumab bruges til at blokere den programmerede celledødsprotein-1-vej, så immunsystemets celler (T-celler) bedre kan beskytte kroppen mod infektion og finde tumorceller at angribe. Tislelizumab kan bruges i kombination med andre terapier som en lovende tilgang med potentielle terapeutiske fordele til behandling af deltagere med kræft. Undersøgelsen vil omfatte cirka 160 deltagere. Deltagerne vil blive tilfældigt tildelt (tilfældigt, svarende til at vende en mønt) til en af de forskellige behandlingsgrupper. Tislelizumab og forsøgsmidler vil blive administreret som en infusion gennem en vene med regelmæssige planlagte intervaller.
Undersøgelsen vil finde sted på flere centre verden over. Behandlinger vil fortsætte, indtil deltagerne ikke oplever nogen fordele, for mange bivirkninger eller trækker samtykket tilbage.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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New South Wales
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Kingswood, New South Wales, Australien, 2747
- Nepean Hospital
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St Leonards, New South Wales, Australien, 2065
- North Shore Private Hospital
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Queensland
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Gold Coast, Queensland, Australien, 4215
- Gold Coast Private Hospital
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Greenslopes, Queensland, Australien, 4120
- Greenslopes Private Hospital
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South Australia
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Adelaide, South Australia, Australien, 5000
- Cancer Research South Australia
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Victoria
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Wangaratta, Victoria, Australien, 3677
- Northeast Health Wangaratta
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Western Australia
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Murdoch, Western Australia, Australien, 6150
- St John of God, Murdoch
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 4E6
- British Columbia Cancer Agency the Vancouver Centre
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Ontario
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Ottawa, Ontario, Canada, K1H 8L6
- The Ottawa Hospital Cancer Centre
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London, Det Forenede Kongerige, SW3 6JJ
- Royal Marsden Hospital
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Sutton, Det Forenede Kongerige, SM2 5PT
- Royal Marsden Hospital Sutton
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California
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Los Angeles, California, Forenede Stater, 90067
- Valkyrie Clinical Trials
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Stanford, California, Forenede Stater, 94305
- Stanford Medicine
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Colorado
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Lone Tree, Colorado, Forenede Stater, 80124
- Rocky Mountain Cancer Centers, Llp(Us Oncology Research)
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Florida
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Orlando, Florida, Forenede Stater, 32827
- Florida Cancer Specialist Research Institute Lake Nona
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Tallahassee, Florida, Forenede Stater, 32308
- Florida Cancer Specialist Research Institute Panhandle
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Kentucky
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Lexington, Kentucky, Forenede Stater, 40536
- University of Kentucky Markey Cancer Center
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Virginia
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Blacksburg, Virginia, Forenede Stater, 24060
- Oncology and Hematology Associates of Southwest Virginia, Inc (Us Oncology Research)
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Washington
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Spokane Valley, Washington, Forenede Stater, 99216
- Cancer Care Northwest
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Vancouver, Washington, Forenede Stater, 98684
- Northwest Cancer Specialist, Pc(Us Oncology Research)
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Nice, Frankrig, 06100
- Centre Antoine Lacassagne
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Paris, Frankrig, 75005
- Institut Curie Paris
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SaintHerblain, Frankrig, 44805
- Ico Site Rene Gauducheau
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Villejuif, Frankrig, 94805
- Institut Gustave Roussy
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Tbilisi, Georgien, 0112
- ARENSIA Exploratory Medicine LLC
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Milan, Italien, 20133
- Fondazione IRCCS Istituto Nazionale dei Tumori
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Milan, Italien, 20141
- Istituto Europeo di Oncologia
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Pavia, Italien, 27100
- Scientific Institute of Pavia Maugeri
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Rozzano, Italien, 20089
- Istituto Clinico Humanitas
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Anhui
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Hefei, Anhui, Kina, 230088
- Anhui Provincial Cancer Hospital Aka West Branch of Anhui Province Hospital
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Beijing Municipality
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Beijing, Beijing Municipality, Kina, 100142
- Beijing Cancer Hospital
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Beijing, Beijing Municipality, Kina, 100010
- Beijing Tongren Hospital, CMU
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Chongqing Municipality
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Chongqing, Chongqing Municipality, Kina, 630014
- The First Affiliated Hospital of Chongqing Medical University
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Fujian
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Fuzhou, Fujian, Kina, 350014
- Fujian Cancer Hospital
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Xiamen, Fujian, Kina, 361003
- The First Affiliated Hospital of Xiamen University
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Guangdong
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Guangzhou, Guangdong, Kina, 510060
- Sun Yat Sen University Cancer Center
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Guangxi
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Nanning, Guangxi, Kina, 530021
- The Tumor Hospital Affiliated to Guangxi Medical University
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Hubei
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Wuhan, Hubei, Kina, 430030
- Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
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Hunan
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Changsha, Hunan, Kina, 410013
- Hunan Cancer Hospital
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Changsha, Hunan, Kina, 410008
- Xiangya Hospital of Central South University
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Changsha, Hunan, Kina, 410011
- The Second Xiangya Hospital of Central South University
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Jiangsu
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Suzhou, Jiangsu, Kina, 215006
- The First Affiliated Hospital of Soochow University
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Jiangxi
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Nanchang, Jiangxi, Kina, 330006
- The First Affiliated Hospital of Nanchang University Branch Donghu
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Jilin
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Changchun, Jilin, Kina, 130021
- The First Hospital of Jilin University
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Shandong
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Jinan, Shandong, Kina, 250117
- Shandong Cancer Hospital
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Kina, 200120
- Shanghai East Hospital
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Sichuan
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Chengdu, Sichuan, Kina, 610041
- West China Hospital, Sichuan University
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Chengdu, Sichuan, Kina, 610041
- Sichuan Cancer Hospital and Institute
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Tianjin Municipality
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Tianjin, Tianjin Municipality, Kina, 300060
- Tianjin Medical University Cancer Institute & Hospital
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Zhejiang
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Hangzhou, Zhejiang, Kina, 310022
- Zhejiang Cancer Hospital
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Hangzhou, Zhejiang, Kina, 310009
- The Second Affiliated Hospital of Zhejiang University School of Medicine
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Singapore, Singapore, 168583
- National Cancer Centre Singapore
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Barcelona, Spanien, 08908
- Ico Lhospitalet Hospital Duran I Reynals
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Madrid, Spanien, 28040
- Hospital Clinico San Carlos
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Seville, Spanien, 41013
- Hospital Universitario Virgen del Rocío
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Zaragoza, Spanien, 50009
- Hospital Universitario Miguel Servet
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Daegu Gwang'yeogsi
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Dalseogu, Daegu Gwang'yeogsi, Sydkorea, 42601
- Keimyung University Dongsan Hospital
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Gyeonggi-do
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Goyang-si, Gyeonggi-do, Sydkorea, 10408
- National Cancer Center
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Seongnam-si, Gyeonggi-do, Sydkorea, 13620
- Seoul National University Bundang Hospital
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Seoul Teugbyeolsi
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Seoul, Seoul Teugbyeolsi, Sydkorea, 03080
- Seoul National University Hospital
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Seoul, Seoul Teugbyeolsi, Sydkorea, 05505
- Asan Medical Center
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Seoul, Seoul Teugbyeolsi, Sydkorea, 06351
- Samsung Medical Center
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Seoul, Seoul Teugbyeolsi, Sydkorea, 03722
- Severance Hospital Yonsei University Health System
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Changhua, Taiwan, 50006
- Changhua Christian Hospital
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Taichung, Taiwan, 40447
- China Medical University Hospital
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Tainan, Taiwan, 704
- National Cheng Kung University Hospital
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Taipei, Taiwan, 11217
- Taipei Veterans General Hospital
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Bangkok, Thailand, 10700
- Siriraj Hospital
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Bangkok, Thailand, 10400
- Ramathibodi Hospital Mahidol University
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Hat Yai, Thailand, 90110
- Songklanagarind Hospital (Prince of Songkhla University)
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Muang, Thailand, 40002
- Srinagarind Hospital (Khon Kaen University)
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Edirne, Tyrkiet (Türkiye), 22030
- Tr Trakya University Health Research and Application Center (Hospital)
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Izmir, Tyrkiet (Türkiye), 35575
- Medical Park Izmir Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inklusionskriterier:
Deltagere med histologisk eller cytologisk bekræftet R/M HNSCC, der anses for uhelbredelig af lokale terapier
- De kvalificerede primære tumorplaceringer er oropharynx, mundhule, hypopharynx og larynx
- Deltagerne skulle ikke have haft forudgående systemisk terapi administreret i R/M-indstillingen; systemisk behandling, som blev afsluttet før randomisering/indskrivning, hvis den gives som en del af multimodal behandling for lokalt eller lokalt fremskreden sygdom, er tilladt
- Deltagerne skal have positiv PD-L1-ekspression (Kombineret positiv score [CPS] ≥ 1)
- Har mindst 1 målbar læsion som defineret i RECIST v1.1
- Eastern Cooperative Oncology Group Performance Status på 0 eller 1
- Tilstrækkelig hæmatologisk funktion og organfunktion som angivet af specifikke laboratorieværdier inden for 7 dage efter første dosis af undersøgelseslægemidlet
- Villig til at bruge en yderst effektiv præventionsmetode i hele undersøgelsens varighed og i ≥ 120 dage efter sidste dosis af undersøgelseslægemidler
Ekskluderingskriterier:
- Tilbagevendende eller metastatisk karcinom i nasopharynx (enhver histologi), planocellulært karcinom af ukendt primært, planocellulært karcinom, der stammer fra huden og spytkirtlens primære tumor eller ikke-pladeepitel-histologier (f.eks. slimhindemelanom)
- Tidligere behandling med et anti-PD-1, anti-PD-L1, PD-L2, T-celle immunoglobulin og mucin domæne indeholdende-3 (TIM-3), LAG-3 eller ethvert andet antistof eller lægemiddel, der er specifikt målrettet mod T- cellecostimulering eller immun checkpoint-veje
- Enhver aktiv malignitet ≤ 2 år før randomisering/indskrivning med undtagelse af den specifikke cancer, der undersøges i denne undersøgelse, dem med en ubetydelig risiko for metastaser eller død, og enhver lokalt tilbagevendende cancer, der er blevet behandlet kurativt (f.eks. resekeret basal- eller pladecellehud cancer, overfladisk blærekræft, lokaliseret prostatacancer og carcinom in situ i livmoderhalsen eller brystet)
- Anamnese med interstitiel lungesygdom, ikke-infektiøs pneumonitis eller ukontrollerede lungesygdomme, herunder lungefibrose og akutte lungesygdomme
- En historie med alvorlige overfølsomhedsreaktioner over for andre monoklonale antistoffer eller har oplevet en alvorlig immunmedieret bivirkning (imAE), en imAE, der førte til seponering af behandlingen, eller en hjerte- eller okulær imAE af enhver grad med tidligere immunterapi
Bemærk: Andre inklusions- og eksklusionskriterier kan være gældende
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Aktiv komparator: Tislelizumab
Participants received tislelizumab 200 milligrams (mg) by intravenous infusion (IV) on Day 1 of each 21-day cycle.
Treatment was administered for up to 2 years until disease progression, intolerable toxicity, withdrawal of informed consent, or another discontinuation criterion was met, whichever occurred first.
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Indgives intravenøst
Andre navne:
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Eksperimentel: Tislelizumab + Surzebiclimab
Participants received tislelizumab 200 mg by intravenous infusion and surzebiclimab 600 mg by intravenous infusion on Day 1 of each 21-day cycle.
Treatment was administered for up to 2 years until disease progression, intolerable toxicity, withdrawal of informed consent, or another discontinuation criterion was met, whichever occurred first.
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Indgives intravenøst
Andre navne:
Indgives intravenøst
Andre navne:
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Eksperimentel: Tislelizumab + Alcestobart
Participants received tislelizumab 200 mg by intravenous infusion and alcestobart 600 mg by intravenous infusion on Day 1 of each 21-day cycle.
Treatment was administered for up to 2 years until disease progression, intolerable toxicity, withdrawal of informed consent, or another discontinuation criterion was met, whichever occurred first.
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Indgives intravenøst
Andre navne:
Indgives intravenøst
Andre navne:
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Eksperimentel: Tislelizumab + Surzebiclimab + Alcestobart
Participants received tislelizumab 200 mg by intravenous infusion, surzebiclimab 600 mg by intravenous infusion, and alcestobart 600 mg by intravenous infusion on Day 1 of each 21-day cycle.
Treatment was administered for up to 2 years until disease progression, intolerable toxicity, withdrawal of informed consent, or another discontinuation criterion was met, whichever occurred first.
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Indgives intravenøst
Andre navne:
Indgives intravenøst
Andre navne:
Indgives intravenøst
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Objective Response Rate (ORR)
Tidsramme: Up to 21.2 months
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ORR is defined as percentage of participants who have a confirmed complete response (CR) or a confirmed partial response (PR) as assessed by the investigators using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Complete response is defined as disappearance of all target lesions, disappearance of all nontarget lesions and normalization of tumor marker level, and no new lesions. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, no unequivocal progression of non-target lesions, and no new lesions. |
Up to 21.2 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Progression-free Survival (PFS)
Tidsramme: Up to 21.2 months
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PFS is defined as the time from the date of randomization to the date of the first documentation of progressive disease (PD) assessed by the investigators per RECIST v1.1 or death, whichever occurred first. PD is defined as at least a 20% increase in the sum of diameters of target lesions, unequivocal progression of existing non-target lesions, or new lesions. |
Up to 21.2 months
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Duration of Response (DOR)
Tidsramme: Up to 21.2 months
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DOR is defined as the time from the first determination of a confirmed response per RECIST v1.1 until the first documentation of progression or death, whichever occurred first.
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Up to 21.2 months
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Clinical Benefit Rate (CBR)
Tidsramme: Up to 21.2 months
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CBR is defined as the percentage of participants with a best overall response of a confirmed CR, a confirmed PR, or durable stable disease (SD) (SD duration ≥ 24 weeks). SD is defined as neither sufficient decrease in size of target lesions to qualify for PR nor sufficient increase to qualify for PD, no progressive disease in nontarget lesions, and no new lesions. |
Up to 21.2 months
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Disease Control Rate (DCR)
Tidsramme: Up to 21.2 months
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DCR is defined as the percentage of participants with a best overall response of a confirmed CR, a confirmed PR, or SD.
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Up to 21.2 months
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Number of Participants With Treatment-Emergent Adverse Events
Tidsramme: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months.
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Number of participants with adverse events (AEs), including laboratory values, vital signs, physical examinations, and electrocardiogram findings. AEs were graded on a scale of Grade 1 to Grade 5, with Grade 1 being least severe and Grade 5 being most severe. An AE is defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a study drug, whether considered related to study drug or not. A serious adverse event (SAE) is any untoward medical occurrence that, at any dose resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect, or was considered a significant medical AE by the investigator based on medical judgement. |
From first dose to 30 days after last dose, maximum treatment duration was 19.3 months.
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Overall Survival (OS)
Tidsramme: Up to 21.2 months
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OS is defined as the time from the date of randomization to the date of death due to any cause.
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Up to 21.2 months
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Study Director, BeiGene
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- BGB-HNSCC-201
- 2023 (U.S. NIH-bevilling/kontrakt: GRAMMY Museum Foundation)
- CTR20232123 (Anden identifikator: ChinaDrugTrials)
- 2023-503418-63-00 (Ctis)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
BeiGene shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved.
BeiGene shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations.
Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeiGene review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.
IPD-delingstidsramme
IPD-delingsadgangskriterier
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- CSR
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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