A Study of Tislelizumab in Combination With Investigational Agents in Participants With Head and Neck Squamous Cell Carcinoma
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 Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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New South Wales
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Kingswood, New South Wales, Australia, 2747
- Nepean Hospital
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St Leonards, New South Wales, Australia, 2065
- North Shore Private Hospital
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Queensland
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Gold Coast, Queensland, Australia, 4215
- Gold Coast Private Hospital
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Greenslopes, Queensland, Australia, 4120
- Greenslopes Private Hospital
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South Australia
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Adelaide, South Australia, Australia, 5000
- Cancer Research South Australia
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Victoria
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Wangaratta, Victoria, Australia, 3677
- Northeast Health Wangaratta
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Western Australia
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Murdoch, Western Australia, Australia, 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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Anhui
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Hefei, Anhui, China, 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, China, 100142
- Beijing Cancer Hospital
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Beijing, Beijing Municipality, China, 100010
- Beijing Tongren Hospital, CMU
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Chongqing Municipality
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Chongqing, Chongqing Municipality, China, 630014
- The First Affiliated Hospital of Chongqing Medical University
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Fujian
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Fuzhou, Fujian, China, 350014
- Fujian Cancer Hospital
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Xiamen, Fujian, China, 361003
- The First Affiliated Hospital of Xiamen University
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Guangdong
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Guangzhou, Guangdong, China, 510060
- Sun Yat Sen University Cancer Center
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Guangxi
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Nanning, Guangxi, China, 530021
- The Tumor Hospital Affiliated to Guangxi Medical University
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Hubei
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Wuhan, Hubei, China, 430030
- Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
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Hunan
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Changsha, Hunan, China, 410013
- Hunan Cancer Hospital
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Changsha, Hunan, China, 410008
- Xiangya Hospital of Central South University
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Changsha, Hunan, China, 410011
- The second Xiangya hospital of central south university
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Jiangsu
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Suzhou, Jiangsu, China, 215006
- The First Affiliated Hospital of Soochow University
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Jiangxi
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Nanchang, Jiangxi, China, 330006
- The First Affiliated Hospital of Nanchang University Branch Donghu
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Jilin
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Changchun, Jilin, China, 130021
- The First hospital of Jilin University
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Shandong
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Jinan, Shandong, China, 250117
- Shandong Cancer Hospital
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Shanghai Municipality
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Shanghai, Shanghai Municipality, China, 200120
- Shanghai East Hospital
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Sichuan
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Chengdu, Sichuan, China, 610041
- West China Hospital, Sichuan University
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Chengdu, Sichuan, China, 610041
- Sichuan Cancer Hospital and Institute
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Tianjin Municipality
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Tianjin, Tianjin Municipality, China, 300060
- Tianjin Medical University Cancer Institute & Hospital
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Zhejiang
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Hangzhou, Zhejiang, China, 310022
- Zhejiang Cancer Hospital
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Hangzhou, Zhejiang, China, 310009
- The Second Affiliated hospital of Zhejiang University School of Medicine
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Nice, France, 06100
- Centre Antoine Lacassagne
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Paris, France, 75005
- Institut Curie Paris
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SaintHerblain, France, 44805
- Ico Site Rene Gauducheau
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Villejuif, France, 94805
- Institut Gustave Roussy
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Tbilisi, Georgia, 0112
- ARENSIA Exploratory Medicine LLC
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Milan, Italy, 20133
- Fondazione IRCCS Istituto Nazionale dei Tumori
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Milan, Italy, 20141
- Istituto Europeo di Oncologia
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Pavia, Italy, 27100
- Scientific Institute of Pavia Maugeri
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Rozzano, Italy, 20089
- Istituto Clinico Humanitas
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Singapore, Singapore, 168583
- National Cancer Centre Singapore
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Daegu Gwang'yeogsi
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Dalseogu, Daegu Gwang'yeogsi, South Korea, 42601
- Keimyung University Dongsan Hospital
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Gyeonggi-do
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Goyang-si, Gyeonggi-do, South Korea, 10408
- National Cancer Center
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Seongnam-si, Gyeonggi-do, South Korea, 13620
- Seoul National University Bundang Hospital
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Seoul Teugbyeolsi
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Seoul, Seoul Teugbyeolsi, South Korea, 03080
- Seoul National University Hospital
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Seoul, Seoul Teugbyeolsi, South Korea, 05505
- Asan Medical Center
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Seoul, Seoul Teugbyeolsi, South Korea, 06351
- Samsung Medical Center
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Seoul, Seoul Teugbyeolsi, South Korea, 03722
- Severance Hospital Yonsei University Health System
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Barcelona, Spain, 08908
- Ico Lhospitalet Hospital Duran I Reynals
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Madrid, Spain, 28040
- Hospital Clinico San Carlos
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Seville, Spain, 41013
- Hospital Universitario Virgen del Rocio
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Zaragoza, Spain, 50009
- Hospital Universitario Miguel Servet
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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, Turkey (Türkiye), 22030
- Tr Trakya University Health Research and Application Center (Hospital)
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Izmir, Turkey (Türkiye), 35575
- Medical Park Izmir Hospital
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London, United Kingdom, SW3 6JJ
- Royal Marsden Hospital
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Sutton, United Kingdom, SM2 5PT
- Royal Marsden Hospital Sutton
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California
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Los Angeles, California, United States, 90067
- Valkyrie Clinical Trials
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Stanford, California, United States, 94305
- Stanford Medicine
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Colorado
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Lone Tree, Colorado, United States, 80124
- Rocky Mountain Cancer Centers, Llp(Us Oncology Research)
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Florida
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Orlando, Florida, United States, 32827
- Florida Cancer Specialist Research Institute Lake Nona
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Tallahassee, Florida, United States, 32308
- Florida Cancer Specialist Research Institute Panhandle
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Kentucky
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Lexington, Kentucky, United States, 40536
- University of Kentucky Markey Cancer Center
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Virginia
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Blacksburg, Virginia, United States, 24060
- Oncology and Hematology Associates of Southwest Virginia, Inc (Us Oncology Research)
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Washington
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Spokane Valley, Washington, United States, 99216
- Cancer Care Northwest
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Vancouver, Washington, United States, 98684
- Northwest Cancer Specialist, Pc(Us Oncology Research)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Participants with histologically or cytologically confirmed R/M HNSCC that is considered 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/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 programmed cell death protein ligand-1 (PD-L1) expression (Combined Positive Score [CPS] ≥ 1)
- Have at least 1 measurable lesion as defined per Response Evaluation Criteria in Solid Tumors (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:
- Recurrent or metastatic carcinoma of the nasopharynx (any histology), squamous cell carcinoma of unknown primary, squamous cell carcinoma that originated from the skin and salivary gland primary tumor or non-squamous histologies (eg, mucosal melanoma)
- Prior therapy with an anti-programmed cell death protein-1 (anti-PD-1), anti-PD-L1, anti-programmed cell death ligand-2 (PD-L2), T-cell immunoglobulin and mucin-domain containing-3 (TIM-3), lymphocyte activation gene-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
Note: Other inclusion and exclusion criteria may apply
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: 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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Administered intravenously
Other Names:
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Experimental: 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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Administered intravenously
Other Names:
Administered intravenously
Other Names:
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Experimental: 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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Administered intravenously
Other Names:
Administered intravenously
Other Names:
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Experimental: 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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Administered intravenously
Other Names:
Administered intravenously
Other Names:
Administered intravenously
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Objective Response Rate (ORR)
Time Frame: 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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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Progression-free Survival (PFS)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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)
Time Frame: 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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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Study Director, BeiGene
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BGB-HNSCC-201
- 2023 (U.S. NIH Grant/Contract: GRAMMY Museum Foundation)
- CTR20232123 (Other Identifier: ChinaDrugTrials)
- 2023-503418-63-00 (Ctis)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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 Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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