Trial Title:
Tislelizumab in Combination With Investigational Agents in Participants With Head and Neck Squamous Cell Carcinoma
NCT ID:
NCT05909904
Condition:
Head and Neck Squamous Cell Carcinoma
Head and Neck Cancer
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Tislelizumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Tislelizumab
Description:
Administered intravenously
Arm group label:
Tislelizumab
Arm group label:
Tislelizumab + BGB-A425
Arm group label:
Tislelizumab + BGB-A425 + LBL-007
Arm group label:
Tislelizumab + LBL-007
Other name:
BGB-A317
Intervention type:
Drug
Intervention name:
BGB-A425
Description:
Administered intravenously
Arm group label:
Tislelizumab + BGB-A425
Arm group label:
Tislelizumab + BGB-A425 + LBL-007
Intervention type:
Drug
Intervention name:
LBL-007
Description:
Administered intravenously
Arm group label:
Tislelizumab + BGB-A425 + LBL-007
Arm group label:
Tislelizumab + LBL-007
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.
Criteria for eligibility:
Criteria:
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)
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Stanford Medicine
Address:
City:
Stanford
Zip:
94305
Country:
United States
Status:
Recruiting
Facility:
Name:
Rocky Mountain Cancer Centers, Llp(Us Oncology Research)
Address:
City:
Lone Tree
Zip:
80124
Country:
United States
Status:
Recruiting
Facility:
Name:
Florida Cancer Specialist Research Institute Lake Nona
Address:
City:
Orlando
Zip:
32827
Country:
United States
Status:
Recruiting
Facility:
Name:
Florida Cancer Specialist Research Institute Panhandle
Address:
City:
Tallahassee
Zip:
32308
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Kentucky Markey Cancer Center
Address:
City:
Lexington
Zip:
40536
Country:
United States
Status:
Recruiting
Facility:
Name:
Oncology and Hematology Associates of Southwest Virginia, Inc (Us Oncology Research)
Address:
City:
Blacksburg
Zip:
24060
Country:
United States
Status:
Recruiting
Facility:
Name:
Cancer Care Northwest
Address:
City:
Spokane Valley
Zip:
99216
Country:
United States
Status:
Recruiting
Facility:
Name:
Northwest Cancer Specialist, Pc(Us Oncology Research)
Address:
City:
Vancouver
Zip:
98684
Country:
United States
Status:
Recruiting
Facility:
Name:
Nepean Hospital
Address:
City:
Kingswood
Zip:
2747
Country:
Australia
Status:
Recruiting
Facility:
Name:
North Shore Private Hospital
Address:
City:
St Leonards
Zip:
2065
Country:
Australia
Status:
Recruiting
Facility:
Name:
Greenslopes Private Hospital
Address:
City:
Greenslopes
Zip:
4120
Country:
Australia
Status:
Recruiting
Facility:
Name:
Cancer Research South Australia
Address:
City:
Adelaide
Zip:
5000
Country:
Australia
Status:
Recruiting
Facility:
Name:
Northeast Health Wangaratta
Address:
City:
Wangaratta
Zip:
3677
Country:
Australia
Status:
Recruiting
Facility:
Name:
St John of God, Murdoch
Address:
City:
Murdoch
Zip:
6150
Country:
Australia
Status:
Recruiting
Facility:
Name:
British Columbia Cancer Agency the Vancouver Centre
Address:
City:
Vancouver
Zip:
V5Z 4E6
Country:
Canada
Status:
Recruiting
Facility:
Name:
The Ottawa Hospital Cancer Centre
Address:
City:
Ottawa
Zip:
K1H 8L6
Country:
Canada
Status:
Recruiting
Facility:
Name:
Anhui Provincial Cancer Hospital Aka West Branch of Anhui Province Hospital
Address:
City:
Hefei
Zip:
230088
Country:
China
Status:
Recruiting
Facility:
Name:
Beijing Tongren Hospital, Cmu
Address:
City:
Beijing
Zip:
100010
Country:
China
Status:
Recruiting
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Zip:
100142
Country:
China
Status:
Recruiting
Facility:
Name:
The First Affiliated Hospital of Chongqing Medical University
Address:
City:
Chongqing
Zip:
630014
Country:
China
Status:
Recruiting
Facility:
Name:
Fujian Cancer Hospital
Address:
City:
Fuzhou
Zip:
350014
Country:
China
Status:
Recruiting
Facility:
Name:
The First Affiliated Hospital of Xiamen University
Address:
City:
Xiamen
Zip:
361003
Country:
China
Status:
Recruiting
Facility:
Name:
Sun Yat Sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Facility:
Name:
The Tumor Hospital Affiliated to Guangxi Medical University
Address:
City:
Nanning
Zip:
530021
Country:
China
Status:
Recruiting
Facility:
Name:
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
Address:
City:
Wuhan
Zip:
430030
Country:
China
Status:
Recruiting
Facility:
Name:
Xiangya Hospital of Central South University
Address:
City:
Changsha
Zip:
410008
Country:
China
Status:
Recruiting
Facility:
Name:
The Second Xiangya Hospital of Central South University
Address:
City:
Changsha
Zip:
410011
Country:
China
Status:
Recruiting
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Zip:
410013
Country:
China
Status:
Recruiting
Facility:
Name:
The First Affiliated Hospital of Nanchang University Branch Donghu
Address:
City:
Nanchang
Zip:
330006
Country:
China
Status:
Recruiting
Facility:
Name:
The First Hospital of Jilin University
Address:
City:
Changchun
Zip:
130021
Country:
China
Status:
Recruiting
Facility:
Name:
Shandong Cancer Hospital
Address:
City:
Jinan
Zip:
250117
Country:
China
Status:
Recruiting
Facility:
Name:
Shanghai East Hospital
Address:
City:
Shanghai
Zip:
200120
Country:
China
Status:
Recruiting
Facility:
Name:
Sichuan Cancer Hospital and Institute
Address:
City:
Chengdu
Zip:
610041
Country:
China
Status:
Recruiting
Facility:
Name:
West China Hospital, Sichuan University
Address:
City:
Chengdu
Zip:
610041
Country:
China
Status:
Recruiting
Facility:
Name:
Tianjin Medical University Cancer Institute and Hospital
Address:
City:
Tianjin
Zip:
300060
Country:
China
Status:
Recruiting
Facility:
Name:
Zhejiang University College of Medicine Second Affiliated Hospital
Address:
City:
Hangzhou
Zip:
310009
Country:
China
Status:
Recruiting
Facility:
Name:
Zhejiang Cancer Hospital
Address:
City:
Hangzhou
Zip:
310022
Country:
China
Status:
Recruiting
Facility:
Name:
Keimyung University Dongsan Hospital
Address:
City:
Dalseogu
Zip:
42601
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
National Cancer Center
Address:
City:
Goyangsi
Zip:
10408
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Seoul National University Bundang Hospital
Address:
City:
Seongnamsi
Zip:
13620
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Seoul National University Hospital
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Severance Hospital Yonsei University Health System
Address:
City:
Seoul
Zip:
03722
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Asan Medical Center
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Samsung Medical Center
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
National Cancer Centre Singapore
Address:
City:
Singapore
Zip:
168583
Country:
Singapore
Status:
Recruiting
Facility:
Name:
Changhua Christian Hospital
Address:
City:
Changhua
Zip:
50006
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
China Medical University Hospital
Address:
City:
Taichung
Zip:
40447
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
National Cheng Kung University Hospital
Address:
City:
Tainan
Zip:
704
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Taipei Veterans General Hospital
Address:
City:
Taipei
Zip:
11217
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Ramathibodi Hospital Mahidol University
Address:
City:
Bangkok
Zip:
10400
Country:
Thailand
Status:
Recruiting
Facility:
Name:
Siriraj Hospital
Address:
City:
Bangkok
Zip:
10700
Country:
Thailand
Status:
Recruiting
Facility:
Name:
Songklanagarind Hospital (Prince of Songkhla University)
Address:
City:
Hat Yai
Zip:
90110
Country:
Thailand
Status:
Recruiting
Facility:
Name:
Srinagarind Hospital (Khon Kaen University)
Address:
City:
Muang
Zip:
40002
Country:
Thailand
Status:
Recruiting
Start date:
July 21, 2023
Completion date:
January 2027
Lead sponsor:
Agency:
BeiGene
Agency class:
Industry
Source:
BeiGene
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05909904
