Clinical trial NCT05909904: Tislelizumab in Combination With Investigational Agents in Participants With Head and Neck Squamous Cell Carcinoma
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Head and Neck Squamous Cell Carcinoma
Head and Neck Cancer
Lead sponsor: BeiGene
Sponsor class: INDUSTRY
First posted: 2023-06-18
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

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

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Up to approximately 3 years and 6 months
Secondary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: Up to approximately 3 years and 6 months
measure: Duration of Response (DOR)
timeFrame: Up to approximately 3 years and 6 months
measure: Clinical Benefit Rate (CBR)
timeFrame: Up to approximately 3 years and 6 months
measure: Disease Control Rate (DCR)
timeFrame: Up to approximately 3 years and 6 months
measure: Number of Participants with Adverse Events
timeFrame: Up to approximately 3 years and 6 months
measure: Overall Survival (OS)
timeFrame: Up to approximately 3 years and 6 months
measure: Number of Participants with Anti-Drug Antibodies (ADAs)
timeFrame: Up to approximately 3 years and 6 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Valkyrie Clinical Trials
state: California
city: Stanford
country: United States
facility: Stanford Medicine
state: California
city: Lone Tree
country: United States
facility: Rocky Mountain Cancer Centers, Llp(Us Oncology Research)
state: Colorado
city: Orlando
country: United States
facility: Florida Cancer Specialist Research Institute Lake Nona
state: Florida
city: Tallahassee
country: United States
facility: Florida Cancer Specialist Research Institute Panhandle
state: Florida
city: Lexington
country: United States
facility: University of Kentucky Markey Cancer Center
state: Kentucky
city: Blacksburg
country: United States
facility: Oncology and Hematology Associates of Southwest Virginia, Inc (Us Oncology Research)
state: Virginia
city: Spokane Valley
country: United States
facility: Cancer Care Northwest
state: Washington
city: Vancouver
country: United States
facility: Northwest Cancer Specialist, Pc(Us Oncology Research)
state: Washington
city: Kingswood
country: Australia
facility: Nepean Hospital
state: New South Wales
city: St Leonards
country: Australia
facility: North Shore Private Hospital
state: New South Wales
city: Gold Coast
country: Australia
facility: Gold Coast Private Hospital
state: Queensland
city: Greenslopes
country: Australia
facility: Greenslopes Private Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Cancer Research South Australia
state: South Australia
city: Wangaratta
country: Australia
facility: Northeast Health Wangaratta
state: Victoria
city: Murdoch
country: Australia
facility: St John of God, Murdoch
state: Western Australia
city: Vancouver
country: Canada
facility: British Columbia Cancer Agency the Vancouver Centre
state: British Columbia
city: Ottawa
country: Canada
facility: The Ottawa Hospital Cancer Centre
state: Ontario
city: Hefei
country: China
facility: Anhui Provincial Cancer Hospital Aka West Branch of Anhui Province Hospital
state: Anhui
city: Beijing
country: China
facility: Beijing Tongren Hospital, Cmu
state: Beijing
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Fuzhou
country: China
facility: Fujian Cancer Hospital
state: Fujian
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
state: Fujian
city: Guangzhou
country: China
facility: Sun Yat Sen University Cancer Center
state: Guangdong
city: Nanning
country: China
facility: The Tumor Hospital Affiliated to Guangxi Medical University
state: Guangxi
city: Wuhan
country: China
facility: Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
state: Hubei
city: Changsha
country: China
facility: Xiangya Hospital of Central South University
state: Hunan
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University Branch Donghu
state: Jiangxi
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Jinan
country: China
facility: Shandong Cancer Hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai East Hospital
state: Shanghai
city: Chengdu
country: China
facility: Sichuan Cancer Hospital and Institute
state: Sichuan
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute & Hospital
state: Tianjin
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Paris
country: France
facility: Institut Curie Paris
city: SaintHerblain
country: France
facility: Ico Site Rene Gauducheau
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Tbilisi
country: Georgia
facility: Arensia Exploratory Medicine Llc
city: Milano
country: Italy
facility: Fondazione Irccs Istituto Nazionale Dei Tumori
city: Milano
country: Italy
facility: Istituto Europeo Di Oncologia
city: Pavia
country: Italy
facility: Scientific Institute of Pavia Maugeri
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
city: Dalseogu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital
state: Daegu Gwang'yeogsi
city: Goyangsi
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi-do
city: Seongnamsi
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Seoul Teugbyeolsi
city: Singapore
country: Singapore
facility: National Cancer Centre Singapore
city: Barcelona
country: Spain
facility: Ico Lhospitalet Hospital Duran I Reynals
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Del Rocio
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital Mahidol University
city: Bangkok
country: Thailand
facility: Siriraj Hospital
city: Hat Yai
country: Thailand
facility: Songklanagarind Hospital (Prince of Songkhla University)
city: Muang
country: Thailand
facility: Srinagarind Hospital (Khon Kaen University)
city: Edirne
country: Turkey
facility: Tr Trakya University Health Research and Application Center (Hospital)
city: Izmir
country: Turkey
facility: Medical Park Izmir Hospital
city: London
country: United Kingdom
facility: Royal Marsden Hospital
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital Sutton
Study officials:
affiliation: BeiGene
name: Study Director
role: STUDY_DIRECTOR
References: