A Study of Tislelizumab in Combination With Investigational Agents in Participants With Head and Neck Squamous Cell Carcinoma
NCT ID: NCT05909904
Last Updated: 2025-10-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
160 participants
INTERVENTIONAL
2023-07-21
2026-05-28
Brief Summary
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Detailed Description
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Tislelizumab is used to block the programmed cell death protein-1 pathway so that immune system cells (T-cells) can better protect the body from infection and find tumor cells to attack. Tislelizumab may be used in combination with other therapies as a promising approach with potential therapeutic benefits to treat participants with cancer. The study will enroll approximately 160 participants. Participants will be randomly assigned (by chance, similar to flipping a coin) to one of the various treatment groups. Tislelizumab and investigational agents will be administered as an infusion through a vein at regularly scheduled intervals.
The study will take place at multiple centers worldwide. Treatments will continue until participants experience no benefits, too many side effects, or withdraw consent.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Tislelizumab
Tislelizumab 200 milligrams (mg) administered once every 3 weeks
Tislelizumab
Administered intravenously
Tislelizumab + BGB-A425
Tislelizumab 200 mg administered once every 3 weeks with BGB-A425
Tislelizumab
Administered intravenously
BGB-A425
Administered intravenously
Tislelizumab + LBL-007
Tislelizumab 200 mg administered once every 3 weeks with LBL-007
Tislelizumab
Administered intravenously
LBL-007
Administered intravenously
Tislelizumab + BGB-A425 + LBL-007
Tislelizumab 200 mg administered once every 3 weeks with BGB-A425 and LBL-007
Tislelizumab
Administered intravenously
BGB-A425
Administered intravenously
LBL-007
Administered intravenously
Interventions
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Tislelizumab
Administered intravenously
BGB-A425
Administered intravenously
LBL-007
Administered intravenously
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. The eligible primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx
2. Participants should not have had prior systemic therapy administered in the R/M setting; systemic therapy which was completed prior to randomization/enrollment if given as part of multimodal treatment for locally or locoregionally advanced disease 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 values within 7 days of first dose of study drug
* Willing to use a highly effective method of birth control for the duration of the study and for ≥ 120 days after the last dose of study drug(s)
Exclusion Criteria
* Prior therapy with an anti-PD-1, anti-PD-L1, PD-L2, T-cell immunoglobulin and TIM-3, LAG-3, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways
* Any active malignancy ≤ 2 years before randomization/enrollment except for the specific cancer under investigation in this study, those with a negligible risk of metastasis or death, and any locally recurring cancer that has been treated curatively (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, localized prostate cancer, and carcinoma in situ of the cervix or breast)
* History of interstitial lung disease, noninfectious pneumonitis, or uncontrolled lung diseases including pulmonary fibrosis, and acute lung diseases
* A history of severe hypersensitivity reactions to other monoclonal antibodies or has experienced a severe immune-mediated adverse event (imAE), an imAE that led to treatment discontinuation, or a cardiac or ocular imAE of any grade with prior immunotherapy
18 Years
ALL
No
Sponsors
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BeiGene
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
BeiGene
Locations
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Valkyrie Clinical Trials
Los Angeles, California, United States
Stanford Medicine
Stanford, California, United States
Rocky Mountain Cancer Centers, Llp(Us Oncology Research)
Lone Tree, Colorado, United States
Florida Cancer Specialist Research Institute Lake Nona
Orlando, Florida, United States
Florida Cancer Specialist Research Institute Panhandle
Tallahassee, Florida, United States
University of Kentucky Markey Cancer Center
Lexington, Kentucky, United States
Oncology and Hematology Associates of Southwest Virginia, Inc (Us Oncology Research)
Blacksburg, Virginia, United States
Cancer Care Northwest
Spokane Valley, Washington, United States
Northwest Cancer Specialist, Pc(Us Oncology Research)
Vancouver, Washington, United States
Nepean Hospital
Kingswood, New South Wales, Australia
North Shore Private Hospital
St Leonards, New South Wales, Australia
Gold Coast Private Hospital
Gold Coast, Queensland, Australia
Greenslopes Private Hospital
Greenslopes, Queensland, Australia
Cancer Research South Australia
Adelaide, South Australia, Australia
Northeast Health Wangaratta
Wangaratta, Victoria, Australia
St John of God, Murdoch
Murdoch, Western Australia, Australia
British Columbia Cancer Agency the Vancouver Centre
Vancouver, British Columbia, Canada
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada
Anhui Provincial Cancer Hospital Aka West Branch of Anhui Province Hospital
Hefei, Anhui, China
Beijing Tongren Hospital, Cmu
Beijing, Beijing Municipality, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Sun Yat Sen University Cancer Center
Guangzhou, Guangdong, China
The Tumor Hospital Affiliated to Guangxi Medical University
Nanning, Guangxi, China
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Hunan Cancer Hospital
Changsha, Hunan, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University Branch Donghu
Nanchang, Jiangxi, China
The First Hospital of Jilin University
Changchun, Jilin, China
Shandong Cancer Hospital
Jinan, Shandong, China
Shanghai East Hospital
Shanghai, Shanghai Municipality, China
Sichuan Cancer Hospital and Institute
Chengdu, Sichuan, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Centre Antoine Lacassagne
Nice, , France
Institut Curie Paris
Paris, , France
Ico Site Rene Gauducheau
SaintHerblain, , France
Institut Gustave Roussy
Villejuif, , France
Arensia Exploratory Medicine Llc
Tbilisi, , Georgia
Fondazione Irccs Istituto Nazionale Dei Tumori
Milan, , Italy
Istituto Europeo Di Oncologia
Milan, , Italy
Scientific Institute of Pavia Maugeri
Pavia, , Italy
Istituto Clinico Humanitas
Rozzano, , Italy
National Cancer Centre Singapore
Singapore, , Singapore
Keimyung University Dongsan Hospital
Dalseogu, Daegu Gwang'yeogsi, South Korea
National Cancer Center
Goyang-si, Gyeonggi-do, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, South Korea
Severance Hospital Yonsei University Health System
Seoul, Seoul Teugbyeolsi, South Korea
Asan Medical Center
Seoul, Seoul Teugbyeolsi, South Korea
Samsung Medical Center
Seoul, Seoul Teugbyeolsi, South Korea
Ico Lhospitalet Hospital Duran I Reynals
Barcelona, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Hospital Universitario Virgen Del Rocio
Seville, , Spain
Hospital Universitario Miguel Servet
Zaragoza, , Spain
Changhua Christian Hospital
Changhua, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan City, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Ramathibodi Hospital Mahidol University
Bangkok, , Thailand
Siriraj Hospital
Bangkok, , Thailand
Songklanagarind Hospital (Prince of Songkhla University)
Hat Yai, , Thailand
Srinagarind Hospital (Khon Kaen University)
Muang, , Thailand
Tr Trakya University Health Research and Application Center (Hospital)
Edirne, , Turkey (Türkiye)
Medical Park Izmir Hospital
Izmir, , Turkey (Türkiye)
Royal Marsden Hospital
London, , United Kingdom
Royal Marsden Hospital Sutton
Sutton, , United Kingdom
Countries
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Other Identifiers
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CTR20232123
Identifier Type: OTHER
Identifier Source: secondary_id
2023-503418-63-00
Identifier Type: CTIS
Identifier Source: secondary_id
BGB-HNSCC-201
Identifier Type: -
Identifier Source: org_study_id
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