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

Head and Neck Cancer Clinical Trial

Official 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

Clinical Trial Summary

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).

Clinical Trial Description

This study will test whether tislelizumab alone and combined with other investigational agents can be used to improve treatment outcomes in participants with head and neck squamous cell carcinoma. The main goals of the study are to determine how many participants may no longer have evidence of cancer or have some improvement in the signs and symptoms of cancer after treatment and to determine what adverse events, or side effects, participants might experience. Tislelizumab is used to block the programmed cell death protein-1 pathway so that immune system cells (T-cells) can better protect the body from infection and find tumor cells to attack. Tislelizumab may be used in combination with other therapies as a promising approach with potential therapeutic benefits to treat participants with cancer. The study will enroll approximately 160 participants. Participants will be randomly assigned (by chance, similar to flipping a coin) to one of the various treatment groups. Tislelizumab and investigational agents will be administered as an infusion through a vein at regularly scheduled intervals. The study will take place at multiple centers worldwide. Treatments will continue until participants experience no benefits, too many side effects, or withdraw consent. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05909904
Study type Interventional
Source BeiGene
Contact Study Director
Phone 1-877-828-5568
Email clinicaltrials@beigene.com
Status Recruiting
Phase Phase 2
Start date July 21, 2023
Completion date January 2027
View Details
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