Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 2
BeiGene (Voir sur ClinicalTrials)
juillet 2023
mai 2026
02 juillet 2025
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).
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 04/09/2024 13:49:38 | Contact (sur clinicalTrials) | |||
| CLCC INSTITUT GUSTAVE ROUSSY | Caroline EVEN | 11/06/2024 12:52:55 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Antoine Lacassagne - 06100 - Nice - France | Contact (sur clinicalTrials) | ||||
| Ico Site Rene Gauducheau - 44805 - SaintHerblain - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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)
- 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 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