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

Head and Neck Cancer Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05909904
• Other study ID #: BGB-HNSCC-201
• Status: Recruiting
• Phase: Phase 2
• Start date: July 21, 2023
• Est. completion date: January 2027

Study information

• Verified date: May 2024
• Source: BeiGene
• Contact: Study Director
• Phone: 1-877-828-5568
• Email: clinicaltrials[@]beigene.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: January 2027
• Est. primary completion date: January 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Cancer
• Head and Neck Squamous Cell Carcinoma
• Squamous Cell Carcinoma of Head and Neck

Intervention

Drug:
• Tislelizumab
Administered intravenously
• BGB-A425
Administered intravenously
• LBL-007
Administered intravenously

Locations

Country	Name	City	State
Australia	Cancer Research South Australia	Adelaide	South Australia
Australia	Greenslopes Private Hospital	Greenslopes	Queensland
Australia	Nepean Hospital	Kingswood	New South Wales
Australia	St John of God, Murdoch	Murdoch	Western Australia
Australia	North Shore Private Hospital	St Leonards	New South Wales
Australia	Northeast Health Wangaratta	Wangaratta	Victoria
Canada	The Ottawa Hospital Cancer Centre	Ottawa	Ontario
Canada	British Columbia Cancer Agency the Vancouver Centre	Vancouver	British Columbia
China	Beijing Cancer Hospital	Beijing	Beijing
China	Beijing Tongren Hospital, Cmu	Beijing	Beijing
China	The First Hospital of Jilin University	Changchun	Jilin
China	Hunan Cancer Hospital	Changsha	Hunan
China	The Second Xiangya Hospital of Central South University	Changsha	Hunan
China	Xiangya Hospital of Central South University	Changsha	Hunan
China	Sichuan Cancer Hospital and Institute	Chengdu	Sichuan
China	West China Hospital, Sichuan University	Chengdu	Sichuan
China	The First Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing
China	Fujian Cancer Hospital	Fuzhou	Fujian
China	Sun Yat Sen University Cancer Center	Guangzhou	Guangdong
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	Zhejiang University College of Medicine Second Affiliated Hospital	Hangzhou	Zhejiang
China	Anhui Provincial Cancer Hospital Aka West Branch of Anhui Province Hospital	Hefei	Anhui
China	Shandong Cancer Hospital	Jinan	Shandong
China	The First Affiliated Hospital of Nanchang University Branch Donghu	Nanchang	Jiangxi
China	The Tumor Hospital Affiliated to Guangxi Medical University	Nanning	Guangxi
China	Shanghai East Hospital	Shanghai	Shanghai
China	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin
China	Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology	Wuhan	Hubei
China	The First Affiliated Hospital of Xiamen University	Xiamen	Fujian
France	Centre Antoine Lacassagne	Nice
France	Institut Curie Paris	Paris
France	Ico Site Rene Gauducheau	Saint-Herblain
France	Institut Gustave Roussy	Villejuif
Georgia	Arensia Exploratory Medicine Llc	Tbilisi
Italy	Fondazione Irccs Istituto Nazionale Dei Tumori	Milano
Italy	Istituto Europeo Di Oncologia	Milano
Italy	Scientific Institute of Pavia Maugeri	Pavia
Italy	Istituto Clinico Humanitas	Rozzano
Korea, Republic of	Keimyung University Dongsan Hospital	Dalseo-gu	Daegu Gwang'yeogsi
Korea, Republic of	National Cancer Center	Goyang-si	Gyeonggido
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggido
Korea, Republic of	Asan Medical Center	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Samsung Medical Center	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Seoul National University Hospital	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Severance Hospital Yonsei University Health System	Seoul	Seoul Teugbyeolsi
Singapore	National Cancer Centre Singapore	Singapore
Spain	Ico Lhospitalet Hospital Duran I Reynals	Barcelona
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital Universitario Virgen Del Rocio	Sevilla
Spain	Hospital Universitario Miguel Servet	Zaragoza
Taiwan	Changhua Christian Hospital	Changhua
Taiwan	China Medical University Hospital	Taichung
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	Taipei Veterans General Hospital	Taipei
Thailand	Ramathibodi Hospital Mahidol University	Bangkok
Thailand	Siriraj Hospital	Bangkok
Thailand	Songklanagarind Hospital (Prince of Songkhla University)	Hat Yai
Thailand	Srinagarind Hospital (Khon Kaen University)	Nai Muang
Turkey	Tr Trakya University Health Research and Application Center (Hospital)	Edirne
Turkey	Medical Park Izmir Hospital	Izmir
United Kingdom	Royal Marsden Hospital	London
United Kingdom	Royal Marsden Hospital Sutton	Sutton
United States	Oncology and Hematology Associates of Southwest Virginia, Inc (Us Oncology Research)	Blacksburg	Virginia
United States	University of Kentucky Markey Cancer Center	Lexington	Kentucky
United States	Rocky Mountain Cancer Centers, Llp(Us Oncology Research)	Lone Tree	Colorado
United States	Florida Cancer Specialist Research Institute Lake Nona	Orlando	Florida
United States	Cancer Care Northwest	Spokane Valley	Washington
United States	Stanford Medicine	Stanford	California
United States	Florida Cancer Specialist Research Institute Panhandle	Tallahassee	Florida
United States	Northwest Cancer Specialist, Pc(Us Oncology Research)	Vancouver	Washington

Sponsors (1)

Lead Sponsor	Collaborator
BeiGene

Countries where clinical trial is conducted

United States,  Australia,  Canada,  China,  France,  Georgia,  Italy,  Korea, Republic of,  Singapore,  Spain,  Taiwan,  Thailand,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of Participants with Anti-Drug Antibodies (ADAs)	Number of participants with detectable ADAs	Up to approximately 3 years and 6 months