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Brief Title: Tislelizumab in Combination With Investigational Agents in Participants With Head and Neck Squamous Cell Carcinoma
Official Title: A Randomized, Phase 2, Open-Label, Multi-Arm Study of Tislelizumab in Combination With Investigational Agents as First-Line Treatment in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Study ID: NCT05909904
Brief Summary: This study is designed to evaluate the efficacy and safety of tislelizumab and tislelizumab in combination with investigational agent(s) in first-line recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC).
Detailed Description: This study will test whether tislelizumab alone and combined with other investigational agents can be used to improve treatment outcomes in participants with head and neck squamous cell carcinoma. The main goals of the study are to determine how many participants may no longer have evidence of cancer or have some improvement in the signs and symptoms of cancer after treatment and to determine what adverse events, or side effects, participants might experience. 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
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, China
Beijing Cancer Hospital, Beijing, Beijing, China
The First Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing, 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, China
Sichuan Cancer Hospital and Institute, Chengdu, Sichuan, China
West China Hospital, Sichuan University, Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute and Hospital, Tianjin, Tianjin, China
Zhejiang University College of Medicine Second Affiliated Hospital, Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China
Centre Antoine Lacassagne, Nice, , France
Institut Curie Paris, Paris, , France
Ico Site Rene Gauducheau, Saint-Herblain, , France
Institut Gustave Roussy, Villejuif, , France
Arensia Exploratory Medicine Llc, Tbilisi, , Georgia
Fondazione Irccs Istituto Nazionale Dei Tumori, Milano, , Italy
Istituto Europeo Di Oncologia, Milano, , Italy
Scientific Institute of Pavia Maugeri, Pavia, , Italy
Istituto Clinico Humanitas, Rozzano, , Italy
Keimyung University Dongsan Hospital, Dalseo-gu, Daegu Gwang'yeogsi, Korea, Republic of
National Cancer Center, Goyang-si, Gyeonggido, Korea, Republic of
Seoul National University Bundang Hospital, Seongnam-si, Gyeonggido, Korea, Republic of
Seoul National University Hospital, Seoul, Seoul Teugbyeolsi, Korea, Republic of
Severance Hospital Yonsei University Health System, Seoul, Seoul Teugbyeolsi, Korea, Republic of
Asan Medical Center, Seoul, Seoul Teugbyeolsi, Korea, Republic of
Samsung Medical Center, Seoul, Seoul Teugbyeolsi, Korea, Republic of
National Cancer Centre Singapore, Singapore, , Singapore
Ico Lhospitalet Hospital Duran I Reynals, Barcelona, , Spain
Hospital Clinico San Carlos, Madrid, , Spain
Hospital Universitario Virgen Del Rocio, Sevilla, , Spain
Hospital Universitario Miguel Servet, Zaragoza, , Spain
Changhua Christian Hospital, Changhua, , Taiwan
China Medical University Hospital, Taichung, , Taiwan
National Cheng Kung University Hospital, Tainan, , 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), Nai Muang, , Thailand
Tr Trakya University Health Research and Application Center (Hospital), Edirne, , Turkey
Medical Park Izmir Hospital, Izmir, , Turkey
Royal Marsden Hospital, London, , United Kingdom
Royal Marsden Hospital Sutton, Sutton, , United Kingdom
Name: Study Director
Affiliation: BeiGene
Role: STUDY_DIRECTOR