BGB-HNSCC-201 - 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.

Studio Clinico

Patologia: Tumori della testa e del collo

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: Sì

Fase di studio: II

Linee di trattamento: Prima linea

Criteri di inclusione: 

- 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).

Criteri di esclusione: 

- 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.

Trattamento sperimentale: 

Tislelizumab + Surzebiclimab (BGB-A425).

Trattamento di controllo: 

NA

Obiettivi primari dello studio: 

- Objective Response Rate (ORR) [ Time Frame: Up to approximately 3 years and 6 months ]
    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

Centri partecipanti

Nord Italia

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2023-503418-63-00

Data di inserimento: 23.05.2024

Promotore

BeiGene

Principal Investigator ITALIA

Riferimento: Dr. Info non disponibile

Telefono: 00000

Email: nd@nd.it

Localita: nd