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RecruitingLast updated: 6 December 2023

BGB-HNSCC-201: This study is evaluating how safe and effective immunotherapy is when given alone or in combination with new cancer drugs in people with first-line recurrent or metastatic squamous cell cancer of the head and neckA 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 summary


Eligible participants will be randomly allocated to one of four treatment arms that are evaluating immunotherapy (called tislelizumab) alone or in combination with other new, experimental drugs.

In Arm A (Active Comparator), participants will receive tislelizumab alone, which will be administered intravenously once every 3 weeks.

In Arm B (Experimental), participants will receive tislelizumab plus a new drug (called BGB-A425), both to be administered intavenously once every 3 weeks.

In Arm C (Experimental), participants will receive tislelizumab plus a new drug (called LBL-007), both to be administered intravenously once every 3 weeks.

In Arm D (Experimetnal), partcipants will receive tislelizumab plus two new drugs (BGB-A425 and LBL-007), all to be administered intravenously once every 3 weeks. 


This trial is treating patients with head and neck squamous cell carcinoma who have not received treatment for their recurrent or metastatic disease


Head and Neck Cancers Head and Neck





Trial Acronym


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Trial sponsor


Scientific 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



  • 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)


  • 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


  • You have had treatment, but your cancer has come back.
  • Your cancer has spread to other parts of the body.


  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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