Phase
Condition
Carcinoma
Head And Neck Cancer
Lung Cancer
Treatment
LBL-007
BGB-A425
Tislelizumab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Participants with histologically or cytologically confirmed R/M HNSCC that isconsidered incurable by local therapies
The eligible primary tumor locations are oropharynx, oral cavity, hypopharynx,and larynx
Participants should not have had prior systemic therapy administered in the R/Msetting; systemic therapy which was completed prior to randomization/enrollmentif given as part of multimodal treatment for locally or locoregionally advanceddisease is allowed
Participants must have positive PD-L1 expression (Combined Positive Score [CPS] ≥ 1)
Have at least 1 measurable lesion as defined per RECIST v1.1
Eastern Cooperative Oncology Group Performance Status of 0 or 1
Adequate hematologic and organ function as indicated by specific laboratory valueswithin 7 days of first dose of study drug
Willing to use a highly effective method of birth control for the duration of thestudy and for ≥ 120 days after the last dose of study drug(s)
Exclusion
Exclusion Criteria:
Recurrent or metastatic carcinoma of the nasopharynx (any histology), squamous cellcarcinoma of unknown primary, squamous cell carcinoma that originated from the skinand salivary gland primary tumor or non-squamous histologies (eg, mucosal melanoma)
Prior therapy with an anti-PD-1, anti-PD-L1, PD-L2, T-cell immunoglobulin and mucindomain containing-3 (TIM-3), LAG-3, or any other antibody or drug specificallytargeting T-cell costimulation or immune checkpoint pathways
Any active malignancy ≤ 2 years before randomization/enrollment except for thespecific cancer under investigation in this study, those with a negligible risk ofmetastasis or death, and any locally recurring cancer that has been treatedcuratively (eg, resected basal or squamous cell skin cancer, superficial bladdercancer, localized prostate cancer, and carcinoma in situ of the cervix or breast)
History of interstitial lung disease, noninfectious pneumonitis, or uncontrolledlung diseases including pulmonary fibrosis, and acute lung diseases
A history of severe hypersensitivity reactions to other monoclonal antibodies or hasexperienced a severe immune-mediated adverse event (imAE), an imAE that led totreatment discontinuation, or a cardiac or ocular imAE of any grade with priorimmunotherapy
Note: Other inclusion and exclusion criteria may apply
Study Design
Study Description
Connect with a study center
Nepean Hospital
Kingswood, New South Wales 2747
AustraliaSite Not Available
North Shore Private Hospital
St Leonards, New South Wales 2065
AustraliaSite Not Available
Gold Coast Private Hospital
Gold Coast, Queensland 4215
AustraliaSite Not Available
Greenslopes Private Hospital
Greenslopes, Queensland 4120
AustraliaSite Not Available
Cancer Research South Australia
Adelaide, South Australia 5000
AustraliaSite Not Available
Northeast Health Wangaratta
Wangaratta, Victoria 3677
AustraliaSite Not Available
St John of God, Murdoch
Murdoch, Western Australia 6150
AustraliaSite Not Available
British Columbia Cancer Agency the Vancouver Centre
Vancouver, British Columbia V5Z 4E6
CanadaSite Not Available
The Ottawa Hospital Cancer Centre
Ottawa, Ontario K1H 8L6
CanadaSite Not Available
Anhui Provincial Cancer Hospital Aka West Branch of Anhui Province Hospital
Hefei, Anhui 230088
ChinaSite Not Available
Beijing Cancer Hospital
Beijing, Beijing 100142
ChinaSite Not Available
Beijing Tongren Hospital, Cmu
Beijing, Beijing 100010
ChinaSite Not Available
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing 630014
ChinaSite Not Available
Fujian Cancer Hospital
Fuzhou, Fujian 350014
ChinaSite Not Available
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian 361003
ChinaSite Not Available
Sun Yat Sen University Cancer Center
Guangzhou, Guangdong 510060
ChinaSite Not Available
The Tumor Hospital Affiliated to Guangxi Medical University
Nanning, Guangxi 530021
ChinaSite Not Available
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei 430030
ChinaSite Not Available
Hunan Cancer Hospital
Changsha, Hunan 410013
ChinaSite Not Available
The Second Xiangya Hospital of Central South University
Changsha, Hunan 410011
ChinaSite Not Available
Xiangya Hospital of Central South University
Changsha, Hunan 410008
ChinaSite Not Available
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu 215006
ChinaSite Not Available
The First Affiliated Hospital of Nanchang University Branch Donghu
Nanchang, Jiangxi 330006
ChinaSite Not Available
The First Hospital of Jilin University
Changchun, Jilin 130021
ChinaSite Not Available
Shandong Cancer Hospital
Jinan, Shandong 250117
ChinaSite Not Available
Shanghai East Hospital
Shanghai, Shanghai 200120
ChinaSite Not Available
Sichuan Cancer Hospital and Institute
Chengdu, Sichuan 610041
ChinaSite Not Available
West China Hospital, Sichuan University
Chengdu, Sichuan 610041
ChinaSite Not Available
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin 300060
ChinaSite Not Available
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin 300060
ChinaSite Not Available
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang 310009
ChinaSite Not Available
Zhejiang Cancer Hospital
Hangzhou, Zhejiang 310022
ChinaSite Not Available
Zhejiang University College of Medicine Second Affiliated Hospital
Hangzhou, Zhejiang 310009
ChinaActive - Recruiting
Centre Antoine Lacassagne
Nice, 06100
FranceSite Not Available
Institut Curie Paris
Paris, 75005
FranceSite Not Available
Ico Site Rene Gauducheau
Saint-Herblain, 44805
FranceSite Not Available
Ico Site Rene Gauducheau
SaintHerblain, 44805
FranceSite Not Available
Institut Gustave Roussy
Villejuif, 94805
FranceSite Not Available
Arensia Exploratory Medicine Llc
Tbilisi, 0112
GeorgiaSite Not Available
Fondazione Irccs Istituto Nazionale Dei Tumori
Milano, 20133
ItalySite Not Available
Istituto Europeo Di Oncologia
Milano, 20141
ItalySite Not Available
Scientific Institute of Pavia Maugeri
Pavia, 27100
ItalySite Not Available
Istituto Clinico Humanitas
Rozzano, 20089
ItalySite Not Available
Keimyung University Dongsan Hospital
Dalseo-gu, Daegu Gwang'yeogsi 42601
Korea, Republic ofSite Not Available
Keimyung University Dongsan Hospital
Dalseogu, Daegu Gwang'yeogsi 42601
Korea, Republic ofSite Not Available
National Cancer Center
Goyangsi, Gyeonggi-do 10408
Korea, Republic ofSite Not Available
Seoul National University Bundang Hospital
Seongnamsi, Gyeonggi-do 13620
Korea, Republic ofSite Not Available
National Cancer Center
Goyang-si, Gyeonggido 10408
Korea, Republic ofSite Not Available
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggido 13620
Korea, Republic ofSite Not Available
Asan Medical Center
Seoul, Seoul Teugbyeolsi 05505
Korea, Republic ofSite Not Available
Samsung Medical Center
Seoul, Seoul Teugbyeolsi 06351
Korea, Republic ofSite Not Available
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi 03080
Korea, Republic ofSite Not Available
Severance Hospital Yonsei University Health System
Seoul, Seoul Teugbyeolsi 03722
Korea, Republic ofSite Not Available
National Cancer Centre Singapore
Singapore, 168583
SingaporeSite Not Available
Ico Lhospitalet Hospital Duran I Reynals
Barcelona, 08908
SpainSite Not Available
Hospital Clinico San Carlos
Madrid, 28040
SpainSite Not Available
Hospital Universitario Virgen Del Rocio
Sevilla, 41013
SpainSite Not Available
Hospital Universitario Miguel Servet
Zaragoza, 50009
SpainSite Not Available
Changhua Christian Hospital
Changhua, 50006
TaiwanSite Not Available
China Medical University Hospital
Taichung, 40447
TaiwanSite Not Available
National Cheng Kung University Hospital
Tainan, 704
TaiwanSite Not Available
Taipei Veterans General Hospital
Taipei, 11217
TaiwanSite Not Available
Ramathibodi Hospital Mahidol University
Bangkok, 10400
ThailandSite Not Available
Siriraj Hospital
Bangkok, 10700
ThailandSite Not Available
Songklanagarind Hospital (Prince of Songkhla University)
Hat Yai, 90110
ThailandSite Not Available
Srinagarind Hospital (Khon Kaen University)
Muang, 40002
ThailandSite Not Available
Srinagarind Hospital (Khon Kaen University)
Nai Muang, 40002
ThailandSite Not Available
Tr Trakya University Health Research and Application Center (Hospital)
Edirne, 22030
TurkeySite Not Available
Medical Park Izmir Hospital
Izmir, 35575
TurkeySite Not Available
Royal Marsden Hospital
London, SW3 6JJ
United KingdomSite Not Available
Royal Marsden Hospital Sutton
Sutton, SM2 5PT
United KingdomSite Not Available
Valkyrie Clinical Trials
Los Angeles, California 90067
United StatesSite Not Available
Stanford Medicine
Stanford, California 94305
United StatesSite Not Available
Rocky Mountain Cancer Centers, Llp(Us Oncology Research)
Lone Tree, Colorado 80124
United StatesSite Not Available
Florida Cancer Specialist Research Institute Lake Nona
Orlando, Florida 32827
United StatesSite Not Available
Florida Cancer Specialist Research Institute Panhandle
Tallahassee, Florida 32308
United StatesSite Not Available
University of Kentucky Markey Cancer Center
Lexington, Kentucky 40536
United StatesSite Not Available
Oncology and Hematology Associates of Southwest Virginia, Inc (Us Oncology Research)
Blacksburg, Virginia 24060
United StatesSite Not Available
Cancer Care Northwest
Spokane Valley, Washington 99216
United StatesSite Not Available
Northwest Cancer Specialist, Pc(Us Oncology Research)
Vancouver, Washington 98684
United StatesSite Not Available
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