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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05909904




Registration number
NCT05909904
Ethics application status
Date submitted
9/06/2023
Date registered
18/06/2023
Date last updated
3/05/2024

Titles & IDs
Public title
Tislelizumab in Combination With Investigational Agents in Participants With Head and Neck Squamous Cell Carcinoma
Scientific 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
Secondary ID [1] 0 0
BGB-HNSCC-201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Head and Neck Squamous Cell Carcinoma 0 0
Head and Neck Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tislelizumab
Treatment: Drugs - BGB-A425
Treatment: Drugs - LBL-007

Active Comparator: Tislelizumab - Tislelizumab 200 milligrams (mg) administered once every 3 weeks

Experimental: Tislelizumab + BGB-A425 - Tislelizumab 200 mg administered once every 3 weeks with BGB-A425

Experimental: Tislelizumab + LBL-007 - Tislelizumab 200 mg administered once every 3 weeks with LBL-007

Experimental: Tislelizumab + BGB-A425 + LBL-007 - Tislelizumab 200 mg administered once every 3 weeks with BGB-A425 and LBL-007


Treatment: Drugs: Tislelizumab
Administered intravenously

Treatment: Drugs: BGB-A425
Administered intravenously

Treatment: Drugs: LBL-007
Administered intravenously
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective Response Rate (ORR)
Timepoint [1] 0 0
Up to approximately 3 years and 6 months
Secondary outcome [1] 0 0
Progression-free Survival (PFS)
Timepoint [1] 0 0
Up to approximately 3 years and 6 months
Secondary outcome [2] 0 0
Duration of Response (DOR)
Timepoint [2] 0 0
Up to approximately 3 years and 6 months
Secondary outcome [3] 0 0
Clinical Benefit Rate (CBR)
Timepoint [3] 0 0
Up to approximately 3 years and 6 months
Secondary outcome [4] 0 0
Disease Control Rate (DCR)
Timepoint [4] 0 0
Up to approximately 3 years and 6 months
Secondary outcome [5] 0 0
Number of Participants with Adverse Events
Timepoint [5] 0 0
Up to approximately 3 years and 6 months
Secondary outcome [6] 0 0
Overall Survival (OS)
Timepoint [6] 0 0
Up to approximately 3 years and 6 months
Secondary outcome [7] 0 0
Number of Participants with Anti-Drug Antibodies (ADAs)
Timepoint [7] 0 0
Up to approximately 3 years and 6 months

Eligibility
Key inclusion criteria
- Participants with histologically or cytologically confirmed R/M HNSCC that is
considered incurable by local therapies

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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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-PD-1, anti-PD-L1, PD-L2, T-cell immunoglobulin and mucin
domain containing-3 (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

Note: Other inclusion and exclusion criteria may apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/07/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2027
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Nepean Hospital - Kingswood
Recruitment hospital [2] 0 0
North Shore Private Hospital - St Leonards
Recruitment hospital [3] 0 0
Greenslopes Private Hospital - Greenslopes
Recruitment hospital [4] 0 0
Cancer Research South Australia - Adelaide
Recruitment hospital [5] 0 0
Northeast Health Wangaratta - Wangaratta
Recruitment hospital [6] 0 0
St John of God, Murdoch - Murdoch
Recruitment postcode(s) [1] 0 0
2747 - Kingswood
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
4120 - Greenslopes
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment postcode(s) [5] 0 0
3677 - Wangaratta
Recruitment postcode(s) [6] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Kentucky
Country [5] 0 0
United States of America
State/province [5] 0 0
Virginia
Country [6] 0 0
United States of America
State/province [6] 0 0
Washington
Country [7] 0 0
Canada
State/province [7] 0 0
British Columbia
Country [8] 0 0
Canada
State/province [8] 0 0
Ontario
Country [9] 0 0
China
State/province [9] 0 0
Anhui
Country [10] 0 0
China
State/province [10] 0 0
Beijing
Country [11] 0 0
China
State/province [11] 0 0
Chongqing
Country [12] 0 0
China
State/province [12] 0 0
Fujian
Country [13] 0 0
China
State/province [13] 0 0
Guangdong
Country [14] 0 0
China
State/province [14] 0 0
Guangxi
Country [15] 0 0
China
State/province [15] 0 0
Hubei
Country [16] 0 0
China
State/province [16] 0 0
Hunan
Country [17] 0 0
China
State/province [17] 0 0
Jiangsu
Country [18] 0 0
China
State/province [18] 0 0
Jiangxi
Country [19] 0 0
China
State/province [19] 0 0
Jilin
Country [20] 0 0
China
State/province [20] 0 0
Shandong
Country [21] 0 0
China
State/province [21] 0 0
Shanghai
Country [22] 0 0
China
State/province [22] 0 0
Sichuan
Country [23] 0 0
China
State/province [23] 0 0
Tianjin
Country [24] 0 0
China
State/province [24] 0 0
Zhejiang
Country [25] 0 0
France
State/province [25] 0 0
Nice
Country [26] 0 0
France
State/province [26] 0 0
Paris
Country [27] 0 0
France
State/province [27] 0 0
Saint-Herblain
Country [28] 0 0
France
State/province [28] 0 0
Villejuif
Country [29] 0 0
Georgia
State/province [29] 0 0
Tbilisi
Country [30] 0 0
Italy
State/province [30] 0 0
Milano
Country [31] 0 0
Italy
State/province [31] 0 0
Pavia
Country [32] 0 0
Italy
State/province [32] 0 0
Rozzano
Country [33] 0 0
Korea, Republic of
State/province [33] 0 0
Daegu Gwang'yeogsi
Country [34] 0 0
Korea, Republic of
State/province [34] 0 0
Gyeonggido
Country [35] 0 0
Korea, Republic of
State/province [35] 0 0
Seoul Teugbyeolsi
Country [36] 0 0
Singapore
State/province [36] 0 0
Singapore
Country [37] 0 0
Spain
State/province [37] 0 0
Barcelona
Country [38] 0 0
Spain
State/province [38] 0 0
Madrid
Country [39] 0 0
Spain
State/province [39] 0 0
Sevilla
Country [40] 0 0
Spain
State/province [40] 0 0
Zaragoza
Country [41] 0 0
Taiwan
State/province [41] 0 0
Changhua
Country [42] 0 0
Taiwan
State/province [42] 0 0
Taichung
Country [43] 0 0
Taiwan
State/province [43] 0 0
Tainan
Country [44] 0 0
Taiwan
State/province [44] 0 0
Taipei
Country [45] 0 0
Thailand
State/province [45] 0 0
Bangkok
Country [46] 0 0
Thailand
State/province [46] 0 0
Hat Yai
Country [47] 0 0
Thailand
State/province [47] 0 0
Nai Muang
Country [48] 0 0
Turkey
State/province [48] 0 0
Edirne
Country [49] 0 0
Turkey
State/province [49] 0 0
Izmir
Country [50] 0 0
United Kingdom
State/province [50] 0 0
London
Country [51] 0 0
United Kingdom
State/province [51] 0 0
Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
BeiGene
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT05909904
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Study Director
Address 0 0
BeiGene
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Study Director
Address 0 0
Country 0 0
Phone 0 0
1-877-828-5568
Fax 0 0
Email 0 0
clinicaltrials@beigene.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05909904