Tislelizumab in Combination With Investigational Agents in Participants With Head and Neck Squamous Cell Carcinoma

Last updated: January 7, 2025
Sponsor: BeiGene
Overall Status: Active - Not Recruiting

Phase

2

Condition

Carcinoma

Head And Neck Cancer

Lung Cancer

Treatment

LBL-007

BGB-A425

Tislelizumab

Clinical Study ID

NCT05909904
BGB-HNSCC-201
CTR20232123
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants with histologically or cytologically confirmed R/M HNSCC that isconsidered 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/Msetting; systemic therapy which was completed prior to randomization/enrollmentif given as part of multimodal treatment for locally or locoregionally advanceddisease 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 valueswithin 7 days of first dose of study drug

  • Willing to use a highly effective method of birth control for the duration of thestudy and for ≥ 120 days after the last dose of study drug(s)

Exclusion

Exclusion Criteria:

  • Recurrent or metastatic carcinoma of the nasopharynx (any histology), squamous cellcarcinoma of unknown primary, squamous cell carcinoma that originated from the skinand 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 mucindomain containing-3 (TIM-3), LAG-3, or any other antibody or drug specificallytargeting T-cell costimulation or immune checkpoint pathways

  • Any active malignancy ≤ 2 years before randomization/enrollment except for thespecific cancer under investigation in this study, those with a negligible risk ofmetastasis or death, and any locally recurring cancer that has been treatedcuratively (eg, resected basal or squamous cell skin cancer, superficial bladdercancer, localized prostate cancer, and carcinoma in situ of the cervix or breast)

  • History of interstitial lung disease, noninfectious pneumonitis, or uncontrolledlung diseases including pulmonary fibrosis, and acute lung diseases

  • A history of severe hypersensitivity reactions to other monoclonal antibodies or hasexperienced a severe immune-mediated adverse event (imAE), an imAE that led totreatment discontinuation, or a cardiac or ocular imAE of any grade with priorimmunotherapy

Note: Other inclusion and exclusion criteria may apply

Study Design

Total Participants: 160
Treatment Group(s): 3
Primary Treatment: LBL-007
Phase: 2
Study Start date:
July 21, 2023
Estimated Completion Date:
January 31, 2027

Study 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.

Connect with a study center

  • Nepean Hospital

    Kingswood, New South Wales 2747
    Australia

    Site Not Available

  • North Shore Private Hospital

    St Leonards, New South Wales 2065
    Australia

    Site Not Available

  • Gold Coast Private Hospital

    Gold Coast, Queensland 4215
    Australia

    Site Not Available

  • Greenslopes Private Hospital

    Greenslopes, Queensland 4120
    Australia

    Site Not Available

  • Cancer Research South Australia

    Adelaide, South Australia 5000
    Australia

    Site Not Available

  • Northeast Health Wangaratta

    Wangaratta, Victoria 3677
    Australia

    Site Not Available

  • St John of God, Murdoch

    Murdoch, Western Australia 6150
    Australia

    Site Not Available

  • British Columbia Cancer Agency the Vancouver Centre

    Vancouver, British Columbia V5Z 4E6
    Canada

    Site Not Available

  • The Ottawa Hospital Cancer Centre

    Ottawa, Ontario K1H 8L6
    Canada

    Site Not Available

  • Anhui Provincial Cancer Hospital Aka West Branch of Anhui Province Hospital

    Hefei, Anhui 230088
    China

    Site Not Available

  • Beijing Cancer Hospital

    Beijing, Beijing 100142
    China

    Site Not Available

  • Beijing Tongren Hospital, Cmu

    Beijing, Beijing 100010
    China

    Site Not Available

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing 630014
    China

    Site Not Available

  • Fujian Cancer Hospital

    Fuzhou, Fujian 350014
    China

    Site Not Available

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian 361003
    China

    Site Not Available

  • Sun Yat Sen University Cancer Center

    Guangzhou, Guangdong 510060
    China

    Site Not Available

  • The Tumor Hospital Affiliated to Guangxi Medical University

    Nanning, Guangxi 530021
    China

    Site Not Available

  • Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei 430030
    China

    Site Not Available

  • Hunan Cancer Hospital

    Changsha, Hunan 410013
    China

    Site Not Available

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan 410011
    China

    Site Not Available

  • Xiangya Hospital of Central South University

    Changsha, Hunan 410008
    China

    Site Not Available

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu 215006
    China

    Site Not Available

  • The First Affiliated Hospital of Nanchang University Branch Donghu

    Nanchang, Jiangxi 330006
    China

    Site Not Available

  • The First Hospital of Jilin University

    Changchun, Jilin 130021
    China

    Site Not Available

  • Shandong Cancer Hospital

    Jinan, Shandong 250117
    China

    Site Not Available

  • Shanghai East Hospital

    Shanghai, Shanghai 200120
    China

    Site Not Available

  • Sichuan Cancer Hospital and Institute

    Chengdu, Sichuan 610041
    China

    Site Not Available

  • West China Hospital, Sichuan University

    Chengdu, Sichuan 610041
    China

    Site Not Available

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin 300060
    China

    Site Not Available

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin 300060
    China

    Site Not Available

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang 310009
    China

    Site Not Available

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang 310022
    China

    Site Not Available

  • Zhejiang University College of Medicine Second Affiliated Hospital

    Hangzhou, Zhejiang 310009
    China

    Active - Recruiting

  • Centre Antoine Lacassagne

    Nice, 06100
    France

    Site Not Available

  • Institut Curie Paris

    Paris, 75005
    France

    Site Not Available

  • Ico Site Rene Gauducheau

    Saint-Herblain, 44805
    France

    Site Not Available

  • Ico Site Rene Gauducheau

    SaintHerblain, 44805
    France

    Site Not Available

  • Institut Gustave Roussy

    Villejuif, 94805
    France

    Site Not Available

  • Arensia Exploratory Medicine Llc

    Tbilisi, 0112
    Georgia

    Site Not Available

  • Fondazione Irccs Istituto Nazionale Dei Tumori

    Milano, 20133
    Italy

    Site Not Available

  • Istituto Europeo Di Oncologia

    Milano, 20141
    Italy

    Site Not Available

  • Scientific Institute of Pavia Maugeri

    Pavia, 27100
    Italy

    Site Not Available

  • Istituto Clinico Humanitas

    Rozzano, 20089
    Italy

    Site Not Available

  • Keimyung University Dongsan Hospital

    Dalseo-gu, Daegu Gwang'yeogsi 42601
    Korea, Republic of

    Site Not Available

  • Keimyung University Dongsan Hospital

    Dalseogu, Daegu Gwang'yeogsi 42601
    Korea, Republic of

    Site Not Available

  • National Cancer Center

    Goyangsi, Gyeonggi-do 10408
    Korea, Republic of

    Site Not Available

  • Seoul National University Bundang Hospital

    Seongnamsi, Gyeonggi-do 13620
    Korea, Republic of

    Site Not Available

  • National Cancer Center

    Goyang-si, Gyeonggido 10408
    Korea, Republic of

    Site Not Available

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggido 13620
    Korea, Republic of

    Site Not Available

  • Asan Medical Center

    Seoul, Seoul Teugbyeolsi 05505
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    Seoul, Seoul Teugbyeolsi 06351
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul, Seoul Teugbyeolsi 03080
    Korea, Republic of

    Site Not Available

  • Severance Hospital Yonsei University Health System

    Seoul, Seoul Teugbyeolsi 03722
    Korea, Republic of

    Site Not Available

  • National Cancer Centre Singapore

    Singapore, 168583
    Singapore

    Site Not Available

  • Ico Lhospitalet Hospital Duran I Reynals

    Barcelona, 08908
    Spain

    Site Not Available

  • Hospital Clinico San Carlos

    Madrid, 28040
    Spain

    Site Not Available

  • Hospital Universitario Virgen Del Rocio

    Sevilla, 41013
    Spain

    Site Not Available

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009
    Spain

    Site Not Available

  • Changhua Christian Hospital

    Changhua, 50006
    Taiwan

    Site Not Available

  • China Medical University Hospital

    Taichung, 40447
    Taiwan

    Site Not Available

  • National Cheng Kung University Hospital

    Tainan, 704
    Taiwan

    Site Not Available

  • Taipei Veterans General Hospital

    Taipei, 11217
    Taiwan

    Site Not Available

  • Ramathibodi Hospital Mahidol University

    Bangkok, 10400
    Thailand

    Site Not Available

  • Siriraj Hospital

    Bangkok, 10700
    Thailand

    Site Not Available

  • Songklanagarind Hospital (Prince of Songkhla University)

    Hat Yai, 90110
    Thailand

    Site Not Available

  • Srinagarind Hospital (Khon Kaen University)

    Muang, 40002
    Thailand

    Site Not Available

  • Srinagarind Hospital (Khon Kaen University)

    Nai Muang, 40002
    Thailand

    Site Not Available

  • Tr Trakya University Health Research and Application Center (Hospital)

    Edirne, 22030
    Turkey

    Site Not Available

  • Medical Park Izmir Hospital

    Izmir, 35575
    Turkey

    Site Not Available

  • Royal Marsden Hospital

    London, SW3 6JJ
    United Kingdom

    Site Not Available

  • Royal Marsden Hospital Sutton

    Sutton, SM2 5PT
    United Kingdom

    Site Not Available

  • Valkyrie Clinical Trials

    Los Angeles, California 90067
    United States

    Site Not Available

  • Stanford Medicine

    Stanford, California 94305
    United States

    Site Not Available

  • Rocky Mountain Cancer Centers, Llp(Us Oncology Research)

    Lone Tree, Colorado 80124
    United States

    Site Not Available

  • Florida Cancer Specialist Research Institute Lake Nona

    Orlando, Florida 32827
    United States

    Site Not Available

  • Florida Cancer Specialist Research Institute Panhandle

    Tallahassee, Florida 32308
    United States

    Site Not Available

  • University of Kentucky Markey Cancer Center

    Lexington, Kentucky 40536
    United States

    Site Not Available

  • Oncology and Hematology Associates of Southwest Virginia, Inc (Us Oncology Research)

    Blacksburg, Virginia 24060
    United States

    Site Not Available

  • Cancer Care Northwest

    Spokane Valley, Washington 99216
    United States

    Site Not Available

  • Northwest Cancer Specialist, Pc(Us Oncology Research)

    Vancouver, Washington 98684
    United States

    Site Not Available

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