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

NCT05909904 | Active Not Recruiting Phase 2 Results DMC FDA Drug

• 3 other identifiers: BGB-HNSCC-201CTR202321232023-503418-63-00
• Study Type: interventional
• Target: 160
• Locations: 14 countries
• Sites: 73

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).

Conditions

Head and Neck Squamous Cell Carcinoma; Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 21.2 months

Secondary Outcomes (6)

• Progression-free Survival (PFS)

  Up to 21.2 months

• Duration of Response (DOR)

  Up to 21.2 months

• Clinical Benefit Rate (CBR)

  Up to 21.2 months

• Disease Control Rate (DCR)

  Up to 21.2 months

• Number of Participants With Treatment-Emergent Adverse Events

  From first dose to 30 days after last dose, maximum treatment duration was 19.3 months.

Study Arms (4)

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.

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.

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.

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.

Drug: Tislelizumab; Drug: BGB-A425; Drug: LBL-007

Interventions

Tislelizumab DRUG

Administered intravenously

Also known as: BGB-A317

Tislelizumab; Tislelizumab + Alcestobart; Tislelizumab + Surzebiclimab; Tislelizumab + Surzebiclimab + Alcestobart

BGB-A425 DRUG

Administered intravenously

Also known as: Surzebiclimab

Tislelizumab + Surzebiclimab; Tislelizumab + Surzebiclimab + Alcestobart

LBL-007 DRUG

Administered intravenously

Also known as: Alcestobart

Tislelizumab + Alcestobart; Tislelizumab + Surzebiclimab + Alcestobart

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• BeiGene: lead

Study Sites (73)

Valkyrie Clinical Trials

Los Angeles, California, 90067, United States

Location

Stanford Medicine

Stanford, California, 94305, United States

Location

Rocky Mountain Cancer Centers, Llp(Us Oncology Research)

Lone Tree, Colorado, 80124, United States

Location

Florida Cancer Specialist Research Institute Lake Nona

Orlando, Florida, 32827, United States

Location

Florida Cancer Specialist Research Institute Panhandle

Tallahassee, Florida, 32308, United States

Location

University of Kentucky Markey Cancer Center

Lexington, Kentucky, 40536, United States

Location

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

Blacksburg, Virginia, 24060, United States

Location

Cancer Care Northwest

Spokane Valley, Washington, 99216, United States

Location

Northwest Cancer Specialist, Pc(Us Oncology Research)

Vancouver, Washington, 98684, United States

Location

Nepean Hospital

Kingswood, New South Wales, 2747, Australia

Location

North Shore Private Hospital

St Leonards, New South Wales, 2065, Australia

Location

Gold Coast Private Hospital

Gold Coast, Queensland, 4215, Australia

Location

Greenslopes Private Hospital

Greenslopes, Queensland, 4120, Australia

Location

Cancer Research South Australia

Adelaide, South Australia, 5000, Australia

Location

Northeast Health Wangaratta

Wangaratta, Victoria, 3677, Australia

Location

St John of God, Murdoch

Murdoch, Western Australia, 6150, Australia

Location

British Columbia Cancer Agency the Vancouver Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, K1H 8L6, Canada

Location

Anhui Provincial Cancer Hospital Aka West Branch of Anhui Province Hospital

Hefei, Anhui, 230088, China

Location

Beijing Tongren Hospital, Cmu

Beijing, Beijing Municipality, 100010, China

Location

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 630014, China

Location

Fujian Cancer Hospital

Fuzhou, Fujian, 350014, China

Location

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361003, China

Location

Sun Yat Sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

The Tumor Hospital Affiliated to Guangxi Medical University

Nanning, Guangxi, 530021, China

Location

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

Wuhan, Hubei, 430030, China

Location

Xiangya Hospital of Central South University

Changsha, Hunan, 410008, China

Location

The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China

Location

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

Location

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

Location

The First Affiliated Hospital of Nanchang University Branch Donghu

Nanchang, Jiangxi, 330006, China

Location

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

Shandong Cancer Hospital

Jinan, Shandong, 250117, China

Location

Shanghai East Hospital

Shanghai, Shanghai Municipality, 200120, China

Location

Sichuan Cancer Hospital and Institute

Chengdu, Sichuan, 610041, China

Location

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

Centre Antoine Lacassagne

Nice, 06100, France

Location

Institut Curie Paris

Paris, 75005, France

Location

Ico Site Rene Gauducheau

SaintHerblain, 44805, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

Arensia Exploratory Medicine Llc

Tbilisi, 0112, Georgia

Location

Fondazione Irccs Istituto Nazionale Dei Tumori

Milan, 20133, Italy

Location

Istituto Europeo Di Oncologia

Milan, 20141, Italy

Location

Scientific Institute of Pavia Maugeri

Pavia, 27100, Italy

Location

Istituto Clinico Humanitas

Rozzano, 20089, Italy

Location

National Cancer Centre Singapore

Singapore, 168583, Singapore

Location

Keimyung University Dongsan Hospital

Dalseogu, Daegu Gwang'yeogsi, 42601, South Korea

Location

National Cancer Center

Goyang-si, Gyeonggi-do, 10408, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

Seoul National University Hospital

Seoul, Seoul Teugbyeolsi, 03080, South Korea

Location

Severance Hospital Yonsei University Health System

Seoul, Seoul Teugbyeolsi, 03722, South Korea

Location

Asan Medical Center

Seoul, Seoul Teugbyeolsi, 05505, South Korea

Location

Samsung Medical Center

Seoul, Seoul Teugbyeolsi, 06351, South Korea

Location

Ico Lhospitalet Hospital Duran I Reynals

Barcelona, 08908, Spain

Location

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

Hospital Universitario Virgen Del Rocio

Seville, 41013, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

Location

Changhua Christian Hospital

Changhua, 50006, Taiwan

Location

China Medical University Hospital

Taichung, 40447, Taiwan

Location

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

Ramathibodi Hospital Mahidol University

Bangkok, 10400, Thailand

Location

Siriraj Hospital

Bangkok, 10700, Thailand

Location

Songklanagarind Hospital (Prince of Songkhla University)

Hat Yai, 90110, Thailand

Location

Srinagarind Hospital (Khon Kaen University)

Muang, 40002, Thailand

Location

Tr Trakya University Health Research and Application Center (Hospital)

Edirne, 22030, Turkey (Türkiye)

Location

Medical Park Izmir Hospital

Izmir, 35575, Turkey (Türkiye)

Location

Royal Marsden Hospital

London, SW3 6JJ, United Kingdom

Location

Royal Marsden Hospital Sutton

Sutton, SM2 5PT, United Kingdom

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Head and Neck Neoplasms

Interventions

tislelizumab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site

Results Point of Contact

• Title: Study Director
• Organization: BeiGene

clinicaltrials@beigene.com

1 877-828-5568

Study Officials

• Study Director

  BeiGene

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2023
• First Posted: June 18, 2023
• Study Start: August 2, 2023
• Primary Completion: June 17, 2025
• Study Completion: July 9, 2026
• Last Updated: July 14, 2026
• Results First Posted: July 14, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See plan description
• Access Criteria: See plan description

Locations

TU (2); ES (4); KR (7); US (9); CA (2); CN (22); IT (4); TW (4); GE (1); FR (4); SG (1); AU (7); TH (4); GB (2)