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

Running, not enrolling · Phase 2

Conditions studied: Head and Neck Squamous Cell Carcinoma, Head and Neck Cancer

In brief

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).

Key facts

Study ID

NCT05909904

Run by

BeiGene

People needed

160

Starts

2023-08-02

Expected to finish

2026-07-09

Last updated by the study team

2026-07-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• Note: Other inclusion and exclusion criteria may apply

Where it is running

• Stanford Medicine — Stanford, California, 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
• Florida Cancer Specialist Research Institute Panhandle — Tallahassee, Florida, United States
• University of Kentucky Markey Cancer Center — Lexington, Kentucky, United States
• Oncology and Hematology Associates of Southwest Virginia, Inc (Us Oncology Research) — Blacksburg, Virginia, United States
• Cancer Care Northwest — Spokane Valley, Washington, United States
• Northwest Cancer Specialist, Pc(Us Oncology Research) — Vancouver, Washington, United States
• Nepean Hospital — Kingswood, New South Wales, Australia
• North Shore Private Hospital — St Leonards, New South Wales, Australia
• Gold Coast Private Hospital — Gold Coast, Queensland, Australia
• Greenslopes Private Hospital — Greenslopes, Queensland, Australia
• Cancer Research South Australia — Adelaide, South Australia, Australia
• Northeast Health Wangaratta — Wangaratta, Victoria, Australia
• St John of God, Murdoch — Murdoch, Western Australia, Australia
• British Columbia Cancer Agency the Vancouver Centre — Vancouver, British Columbia, Canada
• The Ottawa Hospital Cancer Centre — Ottawa, Ontario, Canada
• Anhui Provincial Cancer Hospital Aka West Branch of Anhui Province Hospital — Hefei, Anhui, China
• Beijing Tongren Hospital, Cmu — Beijing, Beijing Municipality, China
• Beijing Cancer Hospital — Beijing, Beijing Municipality, China
• The First Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China
• Fujian Cancer Hospital — Fuzhou, Fujian, China
• The First Affiliated Hospital of Xiamen University — Xiamen, Fujian, China
• Sun Yat Sen University Cancer Center — Guangzhou, Guangdong, China
• Valkyrie Clinical Trials — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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