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

Korábbi kezelés

• 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

Más betegség

• History of interstitial lung disease, noninfectious pneumonitis, or uncontrolled lung diseases including pulmonary fibrosis, and acute lung diseases

Laborértékek

• 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

Életkor

• 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)

Egyéb

• 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)

• 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)