BGB-HNSCC-201 Phase2 Patients With Recurrent or Metastatic Head & Neck Squamous Cell Carcinoma
Research type
Research Study
Full 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
IRAS ID
1007993
Contact name
Kajal Patel
Contact email
Sponsor organisation
BeiGene UK Ltd
Eudract number
2023-503418-63
Clinicaltrials.gov Identifier
Research summary
This is an open-label study, which means that the participants, study doctor, and the research team know that the participants are receiving study medication and know participants are receiving which doses of study medication. This is a multicenter and Phase 2 study of BGB-HNSCC-201.
This study will look at the safety and effectiveness of investigational anticancer medication tislelizumab (also known as BGB-A317) given either alone or in combination with other investigational anticancer medication(s), BGB-A425 and/or LBL-007 in recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC). The eligible primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx. This study aims to assess whether the addition of investigational agent(s) targeting different biologic pathways to tislelizumab has the potential to improve and/or extend the therapeutic benefit of tislelizumab in recurrent or metastatic HNSCC patients. A total of four cohorts are planned to be conducted as below:
Cohort 1: tislelizumab, Cohort 2: tislelizumab + BGB-A425, Cohort 3: tislelizumab + LBL-007 and Cohort 4: tislelizumab + BGB-A425 + LBL-007
Cohort 1 is reference arm, and all other cohorts are experimental arms. The treatment receive by each participant will be chosen by randomisation. In which participant will be randomly assigned by a computer program to receive treatment in any of the cohorts. Investigational medicine(s) will be an infusion into one of the veins in participant arm at the study site.
The research study is conducted and funded by BeiGene, Ltd. It is a global study including countries such as Australia, China, France, Italy, Spain, Turkey, Thailand and United Kingdom. Globally, 160 patients will participate in this study.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
23/NE/0159
Date of REC Opinion
11 Oct 2023
REC opinion
Further Information Favourable Opinion