Head and Neck Squamous Cell CarcinomaPhase 2NCT05909904
A Study of Tislelizumab in Combination With Investigational Agents in Participants With Head and Neck Squamous Cell Carcinoma
A Phase 2 study testing Tislelizumab, BGB-A425 and LBL-007 in people with Head and Neck Squamous Cell Carcinoma and Head and Neck Cancer, run by BeiGene at 73 sites in 14 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma, Head and Neck Cancer
- What is being tested?
- Tislelizumab, BGB-A425 and LBL-007
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 73 sitesin 14 countries
- Study dates
- 2 Aug 2023to 23 Jul 2026
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
73 sites in 14 countries.
73 sites in 14 countries
China22 sites
Beijing Tongren Hospital, Cmu
Beijing, Beijing Municipality, 100010
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
The First Hospital of Jilin University
Changchun, Jilin, 130021
Xiangya Hospital of Central South University
Changsha, Hunan, 410008
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
Hunan Cancer Hospital
Changsha, Hunan, 410013
Sichuan Cancer Hospital and Institute
Chengdu, Sichuan, 610041
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 630014
Fujian Cancer Hospital
Fuzhou, Fujian, 350014
Sun Yat Sen University Cancer Center
Guangzhou, Guangdong, 510060
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Anhui Provincial Cancer Hospital Aka West Branch of Anhui Province Hospital
Hefei, Anhui, 230088
Shandong Cancer Hospital
Jinan, Shandong, 250117
The First Affiliated Hospital of Nanchang University Branch Donghu
Nanchang, Jiangxi, 330006
The Tumor Hospital Affiliated to Guangxi Medical University
Nanning, Guangxi, 530021
Shanghai East Hospital
Shanghai, Shanghai Municipality, 200120
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430030
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003
United States9 sites
Oncology and Hematology Associates of Southwest Virginia, Inc (Us Oncology Research)
Blacksburg, Virginia, 24060
University of Kentucky Markey Cancer Center
Lexington, Kentucky, 40536
Rocky Mountain Cancer Centers, Llp(Us Oncology Research)
Lone Tree, Colorado, 80124
Valkyrie Clinical Trials
Los Angeles, California, 90067
Florida Cancer Specialist Research Institute Lake Nona
Orlando, Florida, 32827
Cancer Care Northwest
Spokane Valley, Washington, 99216
Stanford Medicine
Stanford, California, 94305
Florida Cancer Specialist Research Institute Panhandle
Tallahassee, Florida, 32308
Northwest Cancer Specialist, Pc(Us Oncology Research)
Vancouver, Washington, 98684
Australia7 sites
Cancer Research South Australia
Adelaide, South Australia, 5000
Gold Coast Private Hospital
Gold Coast, Queensland, 4215
Greenslopes Private Hospital
Greenslopes, Queensland, 4120
Nepean Hospital
Kingswood, New South Wales, 2747
St John of God, Murdoch
Murdoch, Western Australia, 6150
North Shore Private Hospital
St Leonards, New South Wales, 2065
Northeast Health Wangaratta
Wangaratta, Victoria, 3677
South Korea7 sites
Keimyung University Dongsan Hospital
Dalseogu, Daegu Gwang'yeogsi, 42601
National Cancer Center
Goyang-si, Gyeonggi-do, 10408
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, 03080
Severance Hospital Yonsei University Health System
Seoul, Seoul Teugbyeolsi, 03722
Asan Medical Center
Seoul, Seoul Teugbyeolsi, 05505
Samsung Medical Center
Seoul, Seoul Teugbyeolsi, 06351
France4 sites
Centre Antoine Lacassagne
Nice, 06100
Institut Curie Paris
Paris, 75005
Ico Site Rene Gauducheau
SaintHerblain, 44805
Institut Gustave Roussy
Villejuif, 94805
Italy4 sites
Fondazione Irccs Istituto Nazionale Dei Tumori
Milan, 20133
Istituto Europeo Di Oncologia
Milan, 20141
Scientific Institute of Pavia Maugeri
Pavia, 27100
Istituto Clinico Humanitas
Rozzano, 20089
Spain4 sites
Ico Lhospitalet Hospital Duran I Reynals
Barcelona, 08908
Hospital Clinico San Carlos
Madrid, 28040
Hospital Universitario Virgen Del Rocio
Seville, 41013
Hospital Universitario Miguel Servet
Zaragoza, 50009
Taiwan4 sites
Changhua Christian Hospital
Changhua, 50006
China Medical University Hospital
Taichung, 40447
National Cheng Kung University Hospital
Tainan, 704
Taipei Veterans General Hospital
Taipei, 11217
Thailand4 sites
Ramathibodi Hospital Mahidol University
Bangkok, 10400
Siriraj Hospital
Bangkok, 10700
Songklanagarind Hospital (Prince of Songkhla University)
Hat Yai, 90110
Srinagarind Hospital (Khon Kaen University)
Muang, 40002
Canada2 sites
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, K1H 8L6
British Columbia Cancer Agency the Vancouver Centre
Vancouver, British Columbia, V5Z 4E6
Turkey (Türkiye)2 sites
Tr Trakya University Health Research and Application Center (Hospital)
Edirne, 22030
Medical Park Izmir Hospital
Izmir, 35575
United Kingdom2 sites
Royal Marsden Hospital
London, SW3 6JJ
Royal Marsden Hospital Sutton
Sutton, SM2 5PT
About this study
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
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).
Read the 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.
- Being tested
- Tislelizumab, BGB-A425, LBL-007
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TislelizumabDrug
Also called BGB-A317
Administered intravenously
BGB-A425Drug
Also called Surzebiclimab
Administered intravenously
LBL-007Drug
Also called Alcestobart
Administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| Tislelizumab | Active comparator | 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. Receives: Drug: Tislelizumab |
| Tislelizumab + Surzebiclimab | Experimental | 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. Receives: Drug: Tislelizumab; Drug: BGB-A425 |
| Tislelizumab + Alcestobart | Experimental | 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. Receives: Drug: Tislelizumab; Drug: LBL-007 |
| Tislelizumab + Surzebiclimab + Alcestobart | Experimental | 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. Receives: Drug: Tislelizumab; Drug: BGB-A425; Drug: LBL-007 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
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.
Measured: Up to 21.2 months
Secondary outcomes (6)
Progression-free Survival (PFS)
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.
Measured: Up to 21.2 months
Duration of Response (DOR)
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.
Measured: Up to 21.2 months
Clinical Benefit Rate (CBR)
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.
Measured: Up to 21.2 months
Disease Control Rate (DCR)
DCR is defined as the percentage of participants with a best overall response of a confirmed CR, a confirmed PR, or SD.
Measured: Up to 21.2 months
Number of Participants With Treatment-Emergent Adverse Events
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.
Measured: From first dose to 30 days after last dose, maximum treatment duration was 19.3 months.
Overall Survival (OS)
OS is defined as the time from the date of randomization to the date of death due to any cause.
Measured: Up to 21.2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start2 Aug 2023
- Primary completion17 Jun 2025
- Study completion23 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by BeiGeneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- BeiGene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, BeiGene
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05909904
- Sponsor's protocol ID
- BGB-HNSCC-201
- Other IDs
- CTR20232123, 2023-503418-63-00, 2023
- Status last verified
- Aug 2026
- First submitted
- 9 Jun 2023
- Last updated
- 1 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.