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

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).

Study Overview

• Status: Recruiting
• Conditions: Head and Neck Cancer; Head and Neck Squamous Cell Carcinoma
• Intervention / Treatment: Drug: Tislelizumab; Drug: BGB-A425; Drug: LBL-007

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.

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Study Director; Phone Number: 1-877-828-5568; Email: clinicaltrials@beigene.com

Study Locations

• Australia
  • New South Wales
    • Kingswood, New South Wales, Australia, 2747
      • Recruiting
      • Nepean Hospital
    • St Leonards, New South Wales, Australia, 2065
      • Recruiting
      • North Shore Private Hospital
  • Queensland
    • Gold Coast, Queensland, Australia, 4215
      • Recruiting
      • Gold Coast Private Hospital
    • Greenslopes, Queensland, Australia, 4120
      • Recruiting
      • Greenslopes Private Hospital
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Recruiting
      • Cancer Research South Australia
  • Victoria
    • Wangaratta, Victoria, Australia, 3677
      • Recruiting
      • Northeast Health Wangaratta
  • Western Australia
    • Murdoch, Western Australia, Australia, 6150
      • Recruiting
      • St John of God, Murdoch
• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4E6
      • Recruiting
      • British Columbia Cancer Agency the Vancouver Centre
• China
  • Anhui
    • Hefei, Anhui, China, 230088
      • Recruiting
      • Anhui Provincial Cancer Hospital Aka West Branch of Anhui Province Hospital
  • Beijing
    • Beijing, Beijing, China, 100142
      • Recruiting
      • Beijing Cancer Hospital
    • Beijing, Beijing, China, 100010
      • Recruiting
      • Beijing Tongren Hospital, CMU
  • Chongqing
    • Chongqing, Chongqing, China, 630014
      • Recruiting
      • The First Affiliated Hospital of Chongqing Medical University
  • Fujian
    • Fuzhou, Fujian, China, 350014
      • Recruiting
      • Fujian Cancer Hospital
    • Xiamen, Fujian, China, 361003
      • Recruiting
      • The First Affiliated Hospital of Xiamen University
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Sun Yat Sen University Cancer Center
  • Guangxi
    • Nanning, Guangxi, China, 530021
      • Recruiting
      • The Tumor Hospital Affiliated to Guangxi Medical University
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Recruiting
      • Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
  • Hunan
    • Changsha, Hunan, China, 410008
      • Recruiting
      • Xiangya Hospital of Central South University
    • Changsha, Hunan, China, 410013
      • Recruiting
      • Hunan Cancer Hospital
    • Changsha, Hunan, China, 410011
      • Recruiting
      • The Second Xiangya Hospital of Central South University
  • Jiangsu
    • Suzhou, Jiangsu, China, 215006
      • Recruiting
      • The First Affiliated Hospital of Soochow University
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • Recruiting
      • The First Affiliated Hospital of Nanchang University Branch Donghu
  • Jilin
    • Changchun, Jilin, China, 130021
      • Recruiting
      • The First Hospital of Jilin University
  • Shandong
    • Jinan, Shandong, China, 250117
      • Recruiting
      • Shandong Cancer Hospital
  • Shanghai
    • Shanghai, Shanghai, China, 200120
      • Recruiting
      • Shanghai East Hospital
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Recruiting
      • West China Hospital, Sichuan University
    • Chengdu, Sichuan, China, 610041
      • Recruiting
      • Sichuan Cancer Hospital and Institute
  • Tianjin
    • Tianjin, Tianjin, China, 300060
      • Recruiting
      • Tianjin Medical University Cancer Institute and Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Recruiting
      • Zhejiang Cancer Hospital
    • Hangzhou, Zhejiang, China, 310009
      • Recruiting
      • Zhejiang University College of Medicine Second Affiliated Hospital
• France
  • Nice, France, 06100
    • Recruiting
    • Centre Antoine Lacassagne
  • Villejuif, France, 94805
    • Recruiting
    • Institut Gustave Roussy
• Georgia
  • Tbilisi, Georgia, 0112
    • Recruiting
    • Arensia Exploratory Medicine Llc
• Italy
  • Milano, Italy, 20141
    • Recruiting
    • Istituto Europeo Di Oncologia
  • Milano, Italy, 20133
    • Recruiting
    • Fondazione IRCCS Istituto Nazionale dei Tumori
  • Pavia, Italy, 27100
    • Recruiting
    • Scientific Institute of Pavia Maugeri
• Korea, Republic of
  • Daegu Gwang'yeogsi
    • Dalseogu, Daegu Gwang'yeogsi, Korea, Republic of, 42601
      • Recruiting
      • Keimyung University Dongsan Hospital
  • Gyeonggido
    • Goyangsi, Gyeonggido, Korea, Republic of, 10408
      • Recruiting
      • National Cancer Center
    • Seongnamsi, Gyeonggido, Korea, Republic of, 13620
      • Recruiting
      • Seoul National University Bundang Hospital
  • Seoul Teugbyeolsi
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03080
      • Recruiting
      • Seoul National University Hospital
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06351
      • Recruiting
      • Samsung Medical Center
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03722
      • Recruiting
      • Severance Hospital Yonsei University Health System
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 05505
      • Recruiting
      • Asan Medical Center
• Singapore
  • Singapore, Singapore, 168583
    • Recruiting
    • National Cancer Centre Singapore
• Spain
  • Barcelona, Spain, 08908
    • Recruiting
    • ICO lHospitalet Hospital Duran i Reynals
  • Madrid, Spain, 28040
    • Recruiting
    • Hospital Clinico San Carlos
  • Sevilla, Spain, 41013
    • Recruiting
    • Hospital Universitario Virgen del Rocio
  • Zaragoza, Spain, 50009
    • Recruiting
    • Hospital Universitario Miguel Servet
• Taiwan
  • Changhua, Taiwan, 50006
    • Recruiting
    • Changhua Christian Hospital
  • Taichung, Taiwan, 40447
    • Recruiting
    • China Medical University Hospital
  • Tainan, Taiwan, 704
    • Recruiting
    • National Cheng Kung University Hospital
  • Taipei, Taiwan, 11217
    • Recruiting
    • Taipei Veterans General Hospital
• Thailand
  • Bangkok, Thailand, 10700
    • Recruiting
    • Siriraj Hospital
  • Bangkok, Thailand, 10400
    • Recruiting
    • Ramathibodi Hospital Mahidol University
  • Hat Yai, Thailand, 90110
    • Recruiting
    • Songklanagarind Hospital (Prince of Songkhla University)
  • Muang, Thailand, 40002
    • Recruiting
    • Srinagarind Hospital (Khon Kaen University)
• United States
  • California
    • Stanford, California, United States, 94305
      • Recruiting
      • Stanford Medicine
  • Colorado
    • Lone Tree, Colorado, United States, 80124
      • Recruiting
      • Rocky Mountain Cancer Centers, Llp(Us Oncology Research)
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • Recruiting
      • University of Kentucky Markey Cancer Center
  • Virginia
    • Blacksburg, Virginia, United States, 24060
      • Recruiting
      • Oncology and Hematology Associates of Southwest Virginia, Inc (Us Oncology Research)
  • Washington
    • Spokane Valley, Washington, United States, 99216
      • Recruiting
      • Cancer Care Northwest
    • Vancouver, Washington, United States, 98684
      • Recruiting
      • Northwest Cancer Specialist, Pc(Us Oncology Research)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Tislelizumab; Tislelizumab 200 milligrams (mg) administered once every 3 weeks	Drug: Tislelizumab; Administered intravenously; Other Names: BGB-A317
Experimental: Tislelizumab + BGB-A425; Tislelizumab 200 mg administered once every 3 weeks with BGB-A425	Drug: Tislelizumab; Administered intravenously; Other Names: BGB-A317; Drug: BGB-A425; Administered intravenously
Experimental: Tislelizumab + LBL-007; Tislelizumab 200 mg administered once every 3 weeks with LBL-007	Drug: Tislelizumab; Administered intravenously; Other Names: BGB-A317; Drug: LBL-007; Administered intravenously
Experimental: Tislelizumab + BGB-A425 + LBL-007; Tislelizumab 200 mg administered once every 3 weeks with BGB-A425 and LBL-007	Drug: Tislelizumab; Administered intravenously; Other Names: BGB-A317; Drug: BGB-A425; Administered intravenously; Drug: LBL-007; Administered intravenously

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Up to approximately 3 years and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 assessed by the investigators per RECIST v1.1 or death, whichever occurs first	Up to approximately 3 years and 6 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 occurs first	Up to approximately 3 years and 6 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 a durable stable disease (SD) (SD duration ≥ 24 weeks)	Up to approximately 3 years and 6 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	Up to approximately 3 years and 6 months
Number of Participants with Adverse Events	Number of participants with adverse events, including laboratory values, vital signs, physical examinations, and electrocardiogram findings	Up to approximately 3 years and 6 months
Overall Survival (OS)	OS is defined as the time from the date of randomization to the date of death due to any cause	Up to approximately 3 years and 6 months
Number of Participants with Anti-Drug Antibodies (ADAs)	Number of participants with detectable ADAs	Up to approximately 3 years and 6 months

Collaborators and Investigators

• Sponsor: BeiGene
• Investigators: Study Director: Study Director, BeiGene

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2023
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: June 9, 2023
• First Submitted That Met QC Criteria: June 9, 2023
• First Posted (Actual): June 18, 2023

Study Record Updates

• Last Update Posted (Estimated): March 4, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Head and Neck Neoplasms; Neoplasms, Squamous Cell; Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Antineoplastic Agents; Antineoplastic Agents, Immunological; Tislelizumab
• Other Study ID Numbers: BGB-HNSCC-201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No